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FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/97ISR Number: 100000158Report Type:Expedited (15-DaCompany Report #001-0945-970644 Age:47 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Apnoea Clonic Convulsion Health Professional Neurontin (Gabapentin) PS Tylenol (Paracetamol) SS Elavil (Amitriptyline Hydrochloride) SS Manufacturer Route Duration ORAL 2700 MG PER Overdose DAY(900 MG TID), ORAL 100 MG, PRN 10 MG, QHS, UNKNOWN Date:11/10/97ISR Number: 3000018-XReport Type:Expedited (15-DaCompany Report #001-0945-970659 Age:28 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Cardiac Arrest Respiratory Distress Health Professional Neurontin 400 Mg (Gabapentin) PS Wellbutrin (Amfebutamone Hydrochloride) C Manufacturer Route Duration 400MG BID,PER ORAL Date:11/10/97ISR Number: 3000198-6Report Type:Expedited (15-DaCompany Report #001-0945-970563 Age:53 YR Gender:Female I/FU:F ORAL Outcome Dose Duration Hospitalization 300 MG, Initial or Prolonged BID,PER ORAL 2 WK PT Report Source Product Role Blood Creatine Health Neurontin PS Phosphokinase Increased Professional Estradiol Levothyroxine Mvi Vitamins Calcium C C C C C Cardiomegaly Chest Pain Haemoglobin Decreased Lung Infiltration Pericarditis Pleural Effusion Red Blood Cell Count Decreased White Blood Cell Count Decreased Manufacturer Route ORAL Date:11/12/97ISR Number: 3000388-2Report Type:Expedited (15-DaCompany Report #001-0945-970660 Age:77 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG, TID, Other PER ORAL PT Report Source Product Role Bradycardia Cardiac Arrest Health Professional Neurontin 300 Mg (Gabapentin) PS Convulsion Extrasystoles Syncope 22-Aug-2005 Page: 1 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/97ISR Number: 3000531-5Report Type:Expedited (15-DaCompany Report #001-0945-970469 Age:39 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 1200 MG/900 Initial or Prolonged MG/1200MG PT Report Source Product Role Complex Partial Seizures Health Neurontin PS Feeling Drunk Professional Daypro Dilantin Kapseals Dilantin Kapseals Folic Acid Premarin Sudafed Synthroid Vitamins SS C C C C C C C Manufacturer Route ORAL Liver Function Test DAILY, ORAL Abnormal Vomiting Date:11/12/97ISR Number: 3097789-3Report Type:Expedited (15-DaCompany Report #001-0945-970414 Age: Gender: I/FU:F Outcome Dose Duration Congenital Anomaly 400 MG,TID, / PT Report Source Product Role Blood Creatinine Health Neurontin PS Increased Professional Tegretol SS Depo-Provera SS Prenatal Vitamins SS Manufacturer Route EXPOSURE Complications Of Maternal INUTERO Exposure To Therapeutic 400 MG,TID, Drugs EXPOSURE IN Hydronephrosis UTERO Multiple Congenital STOPPED 1 Abnormalities MONTH BEFORE Vesicoureteric Reflux CONCEPTION ORAL Date:11/13/97ISR Number: 3005992-3Report Type:Direct Age:75 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Asthenia 400MG PO 6 MON Initial or Prolonged Brain Neoplasm Cerebellar Infarction Condition Aggravated Depressed Level Of Consciousness Dizziness Hypotension Mental Impairment Myocardial Infarction Company Report # Report Source Product Role Neurontin PS Date:11/20/97ISR Number: 3002019-4Report Type:Expedited (15-DaCompany Report #001-0945-970373 Age: Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 2 10:40 AM PT Breath Sounds Decreased Haemoptysis Hypoxia Left Ventricular Failure Lung Infiltration Lymphocyte Count Decreased Muscle Spasms Neutrophil Count Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Pneumonia Pulmonary Haemorrhage Pyrexia Dose Report Source Product Health Professional Neurontin (Gabapentin) Trazodon Ultram (Tramadol Hydrochloride) Role Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration Rales Sinus Tachycardia White Blood Cell Count Increased PS C C Date:11/20/97ISR Number: 3002190-4Report Type:Expedited (15-DaCompany Report #001-0945-970481 Age:45 YR Gender:Female I/FU:F Outcome Dose Other UNK PT Report Source Product Role Retinitis Pigmentosa Health Neurotin PS Duration Professional Date:11/20/97ISR Number: 3005890-5Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Other 600 TID PT Company Report # Report Source Product Role Gabapentin PS Duration Nightmare Date:11/21/97ISR Number: 3002209-0Report Type:Expedited (15-DaCompany Report #001-0945-970680 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization 300 MG TID, Initial or Prolonged PER ORAL PT Report Source Product Role Arthralgia Health Neurontin PS Gastroenteritis Professional Helicobacter Joint Stiffness Sedation Risperidone (Risperidone) Prevacid (Lansoprazole) Propulsid SS C ORAL (Cisapride) Xanax (Alprazolam) C C Date:12/01/97ISR Number: 3003154-7Report Type:Expedited (15-DaCompany Report #001-0945-970696 Age:83 YR Gender:Female I/FU:I Outcome Dose Disability 600MG TID, PT Report Source Product Role Balance Disorder Consumer Neurontin PS Vasotec Levothyroxine Multiple Vitamins Potassium Indomethacin C C C C C Fall PER ORAL Fatigue Date:12/01/97ISR Number: 3003565-XReport Type:Expedited (15-DaCompany Report #001-0945-970562 Age:31 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 3 Manufacturer Route Duration 10:40 AM PT Coordination Abnormal Dysarthria Palpitations Sedation ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Tongue Oedema Dose Report Source Product Role Health Professional Neurontin 300mg /Gabapentin PS Klonopin Prozac Ritalin Tylenol C C C C Manufacturer Route Duration ORAL 300MG, TID, PER ORAL Date:12/01/97ISR Number: 3006217-5Report Type:Direct Age:55 YR Gender:Female I/FU:I Outcome PT Dose Duration Other Amnesia 300 MG PO QID 2 MON Date:12/03/97ISR Number: 3007268-7Report Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100MG P.O. Initial or Prolonged Q8HOUR Other PT Company Report # Report Source Product Role Gabapentin PS Atenolol Chlorthalidone C C Manufacturer Route ORAL Company Report # Report Source Pruritus Product Role Gabapentin PS Manufacturer Route ORAL Urticaria Date:12/05/97ISR Number: 3004252-4Report Type:Expedited (15-DaCompany Report #97USA12050 Age: Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Congenital Anomaly TRANSPLACENTAL Complications Of Maternal Health Tegretol PS Exposure To Therapeutic Professional Neurontin SS TRANSPLACENTAL Drugs Congenital Genitourinary Abnormality Hydronephrosis Urethral Valves Date:12/09/97ISR Number: 3004776-XReport Type:Expedited (15-DaCompany Report #001-0945-970644 Age:47 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 2700 MG (900, Initial or Prolonged MG TID), PER PT Report Source Product Role Apnoea Health Neurontin PS Clonic Convulsion Professional Encephalopathy Company Overdose Representative Tylenol SS Elavil SS ORAL 100 MG PRN Speech Disorder 10 MG QHS Date:12/10/97ISR Number: 3006332-6Report Type:Expedited (15-DaCompany Report #044-0945-970079 Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 4 10:40 AM PT Chest Pain Coordination Abnormal Epilepsy Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pleuritic Pain Vision Blurred Dose Report Source Product Role Foreign Health Professional Neurontin Tegretol Warfarin Digoxin Frumil Sotalol Clindamycin Cephradine PS C C C C C C C Date:12/11/97ISR Number: 3007729-0Report Type:Direct Age:25 YR Gender:Female I/FU:I Outcome Dose Disability 250 QID Other 300 MG QID Manufacturer Route Manufacturer Route Duration PT Company Report # Report Source Product Role Attention Depakote PS Deficit/Hyperactivity Neurontin SS Duration ORAL Disorder Thrombocytopenia Date:12/29/97ISR Number: 3015056-0Report Type:Expedited (15-DaCompany Report #001-0945-970680 Age:43 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 900 MG (300 Initial or Prolonged MG, TID) PER PT Report Source Product Role Manufacturer Route Arthralgia Health Neurontin PS ORAL Blood Thyroid Stimulating Professional Risperidone SS ORAL Xanax Prevacid Propulsid C C C Hormone Increased ORAL 1 MON Joint Stiffness 0.5 MG (,HS), Reiter'S Syndrome PER ORAL Sedation Thyroxine Decreased Date:12/31/97ISR Number: 3012904-5Report Type:Direct Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG III PO Initial or Prolonged TID PT Company Report # Report Source Dermatitis Exfoliative Product Role Gabapentin PS Manufacturer Route ORAL Face Oedema Oedema Peripheral Date:12/31/97ISR Number: 3012906-9Report Type:Direct Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG PO QD Initial or Prolonged 22-Aug-2005 Page: 5 10:40 AM PT Company Report # Report Source Product Role Manufacturer Route Confusional State Gabapentin PS Parke Davis ORAL Coordination Abnormal Fall Hallucination Trental Diltiazem Atenolol Elavil C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/97ISR Number: 3013663-2Report Type:Expedited (15-DaCompany Report #001-0945-973040 Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG (300 Initial or Prolonged MG, QID), PER PT Report Source Product Role Convulsion Consumer Neurontin PS Lasix Klonopin Coumadin Aldactone Lactulose Neomycin C C C C C C Manufacturer Route ORAL Infection Vision Blurred ORAL Date:12/31/97ISR Number: 3078536-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other 2.00 GRAM Company Report #9720452 PT Report Source Product Role Manufacturer Convulsion Health Zithromax PS ORAL Gastric Disorder Professional Tegretol SS ORAL Neurontin SS ORAL Paxil Birth Control C C Route Duration TOTAL: DAILY: Nausea ORAL Vomiting 1200.00 MG TOTAL: DAILY: ORAL ORAL Date:01/02/98ISR Number: 3014010-2Report Type:Expedited (15-DaCompany Report #001-0945-973023 Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600-1500 MG Initial or Prolonged PER DAY PER PT Report Source Product Role Medication Error Literature Neutotin PS Manufacturer Route ORAL Health Professional ORAL 3 MON Date:01/05/98ISR Number: 3013768-6Report Type:Expedited (15-DaCompany Report #001-0945-973040 Age:67 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 1200 MG (300 Initial or Prolonged MG, QID), PER PT Report Source Product Role Convulsion Consumer Neurontin PS Lasix Klonopin Coumadin Aldactone Lactulose Neomycin C C C C C C Manufacturer Route ORAL Infection Vision Blurred ORAL Visual Disturbance Date:01/07/98ISR Number: 3017460-3Report Type:Direct Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Other 300MG 1T QID PT Balance Disorder Headache 22-Aug-2005 Page: 6 10:40 AM Company Report # Report Source Product Role Neurontin PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/98ISR Number: 3016621-7Report Type:Expedited (15-DaCompany Report #001-0945-970680 Age:43 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 900 MG (300 Initial or Prolonged MG, TID), PER PT Report Source Product Role Manufacturer Route Arthralgia Health Neurontin PS ORAL Blood Thyroid Stimulating Professional Risperidone SS ORAL Depakote Xanax Prevacid Propulsid Mellaril C C C C C Hormone Increased ORAL Joint Stiffness 0.5 MG (,HS), Sedation PER ORAL Thyroxine Decreased Date:01/15/98ISR Number: 3016250-5Report Type:Expedited (15-DaCompany Report #001-0945-970579 Age:32 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 2700 MG (900 PT Report Source Product Role Coma Condition Aggravated Health Professional Neurontin 300mg (Gabapentin) PS Tegretol (Carbamazepine) (Risperidone) (Lorazepam) (Levothyroxine) (Fluoxetine) C C C C C Haemorrhagic Stroke MG, TID) PER Hyponatraemia ORAL Date:01/29/98ISR Number: 3020666-0Report Type:Expedited (15-DaCompany Report #001-0945-980045 Age: Gender:Female I/FU:I Manufacturer Route ORAL Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Deep Vein Thrombosis Health Professional Neurontin Estrogens PS C Date:01/29/98ISR Number: 3086385-XReport Type:Periodic Age:61 YR Gender:Male I/FU:I Outcome Dose Other 15 MG TWICE Route Manufacturer Route Company Report #8-97303-006K PT Report Source Product Role Condition Aggravated Consumer Redux PS Nadolol SS Neurontin SS Zoloft SS Aspirin Chroimium P Darvocet Daypro K Dur Lasix Multivitamin C C C C C C C Duration Oedema DAILY, ORAL Palpitations 20 MG ONCE Pruritus DAILY 300 MG THREE TIMES DAILY 100 MG FOUR TIMES DAILY 22-Aug-2005 Page: 7 Manufacturer 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3021463-2Report Type:Expedited (15-DaCompany Report #001-0945-980037 Age: Gender: I/FU:I Outcome Dose Death UNK PT Report Source Product Role Cardiac Disorder Health Neurontin PS Professional Doxepin Zoloft C C Manufacturer Route Manufacturer Route Duration Date:02/02/98ISR Number: 3116164-6Report Type:Periodic Age:22 YR Gender:Female I/FU:I Outcome Dose Duration Other 100 MG /TWICE Company Report #A0057361 PT Report Source Product Role Dermatitis Health Lamictal PS ORAL Gabapentin SS ORAL Professional PER DAY/ ORAL Company 100 MG /TWICE Representative PER DAY/ORAL Date:02/03/98ISR Number: 3022196-9Report Type:Expedited (15-DaCompany Report #044-0073-980004 Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 400 MG DAILY Initial or Prolonged PER ORAL PT Report Source Product Role Abortion Spontaneous Foreign Phenytoin Sodium PS Neurontin SS Manufacturer Route ORAL Health Professional 400 MG DAILY Date:02/04/98ISR Number: 3024241-3Report Type:Direct Age:31 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Manufacturer Route Other 900 MG/DAY Headache Date:02/04/98ISR Number: 3024243-7Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Other 300 MG TID PT PS Company Report # Report Source Product Role Gabapentin PS Apap Ecasa Colestipol Felodipine Hctz Lisinopril Metroprolol Simvastatin C C C C C C C C Manufacturer Route Manufacturer Route Duration Nausea Date:02/04/98ISR Number: 3024245-0Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Other 300 MG PO TID 22-Aug-2005 Page: 8 Gabapentin 10:40 AM PT Dry Mouth Company Report # Report Source Product Role Gabapentin PS Baclofen Propoxyphene Lorazepam Maalox Docusate Sodium ... Ofloxacin C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Apap ........ Date:02/04/98ISR Number: 3024246-2Report Type:Direct Age:74 YR Gender:Male I/FU:I Outcome Dose Other 300 MG /DAY PT Company Report # Report Source Product Role Fatigue Gabapentin PS Fluid Retention Oedema Allopurinol Bethanechol Biscodyl Bumetanide Captopril Fentanyl Finasteride Guaifenisin Ipratropium Isosorbide Metolazone C C C C C C C C C C C Manufacturer Route Manufacturer Route Duration Date:02/04/98ISR Number: 3024250-4Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Dose Other 300 MG C C PT Company Report # Report Source Product Role Gabapentin PS Amitriptyline Aspirin Atenolol Baclofen Docusate Pepcid Motrin Prazosin Zoloft Trazodone C C C C C C C C C C Duration Dysarthria Date:02/04/98ISR Number: 3024251-6Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Other 300 MG PO TID PT PT 22-Aug-2005 Page: 9 PT Product Role Gabapentin PS Report Source Product Role Gabapentin PS 10:40 AM Route ORAL Manufacturer Route ORAL Company Report # Report Source Product Role Gabapentin PS Apap Allopurinol Atenolol C C C Duration Oedema Manufacturer Company Report # Amnesia Date:02/04/98ISR Number: 3024257-7Report Type:Direct Age:71 YR Gender:Male I/FU:I Outcome Dose Other 900 MG/DAY Report Source Lethargy Date:02/04/98ISR Number: 3024252-8Report Type:Direct Age:69 YR Gender:Male I/FU:I Outcome Dose Duration Disability 300 MG PO BID Company Report # Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diltiazem Fluvastatin Gemfibrosil Isosorbide Naftifine Potassium Chloride Prazosin C C C C C C C Date:02/05/98ISR Number: 3023942-0Report Type:Expedited (15-DaCompany Report #001-0945-980053 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 3600 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Arthralgia Consumer Neurontin PS Levaquin Diflucan Herbs C C C Manufacturer Route ORAL Difficulty In Walking Myalgia ORAL Date:02/05/98ISR Number: 3024370-4Report Type:Direct Age:76 YR Gender:Male I/FU:I Outcome Dose Other 300 MG ONE PT Company Report # Report Source Product Role Gabapentin PS Insulin Nph Vit E Doxepin Famotidine C C C C Duration Fatigue TID Date:02/05/98ISR Number: 3024454-0Report Type:Direct Age: Gender:Male I/FU:I Company Report # Manufacturer Route Outcome Dose Other 300 MG Q HS PT Report Source Product Role Dermatitis Health Gabapentin PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Professional Date:02/05/98ISR Number: 3024466-7Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Dose Other 300 MG BID PT Report Source Product Role Bone Pain Health Gabapentin PS Headache Neck Pain Professional Asa Prazosin Capsaicin Simvastatin Methocarbamol C C C C C Duration Date:02/06/98ISR Number: 3029535-3Report Type:Direct Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 500MG TO Initial or Prolonged 2100MG/DAY 22-Aug-2005 Page: 10 Company Report # 10:40 AM PT Psychotic Disorder Company Report # Report Source Product Role Gabapentin PS Allegra Lasix C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid Lithium Xyprexa Premarin Temazepam Stelazine C C C C C C Date:02/17/98ISR Number: 3030420-1Report Type:Expedited (15-DaCompany Report #044-0945-973003 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 500 MG DAILY, Initial or Prolonged PER ORAL PT Report Source Product Role Hepatic Function Abnormal Foreign Neurontin PS Ferrous Sulfate Sodium Docusate Phosphate Enema Diazepam C C C C Manufacturer Route ORAL Health Professional Date:02/17/98ISR Number: 3031315-XReport Type:Expedited (15-DaCompany Report #9802119 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Required 100.00 MG Intervention to TOTAL DAILY Prevent Permanent ORAL Impairment/Damage ORAL PT Report Source Product Role Manufacturer Route Alopecia Consumer Zoloft PS ORAL Intervertebral Disc Prilosec SS ORAL Protrusion Neurontin SS ORAL Back Pain Condition Aggravated ORAL Migraine Pain In Extremity Stress Thyroid Disorder Date:02/23/98ISR Number: 3036498-3Report Type:Expedited (15-DaCompany Report #001-0945-980106 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 800 MG Initial or Prolonged (DAILY) PER PT Report Source Product Role Antinuclear Antibody Consumer Neurontin PS Positive Health Dna Antibody Positive Professional Manufacturer Route ORAL ORAL Supraventricular Tachycardia Systemic Lupus Erythematosus Date:02/24/98ISR Number: 3038016-2Report Type:Direct Age:77 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Anaemia INTRAVENOUS 135MG/M2 IV Initial or Prolonged Asthenia Q21 DAYS Ecchymosis 300MG/PO Haematochezia INTRAVENOUS 75 MG/M2 IV Neuropathy Peripheral Q21 DAYS Purpura Thrombocytopenia 22-Aug-2005 Page: 11 10:40 AM Company Report # Report Source Product Role Taxol PS Neurontin SS Cisplatin SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/98ISR Number: 3036490-9Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Gabapentin PS Manufacturer Route Duration Coordination Abnormal ORAL 300 MG PO BID Dizziness AND 600 MG HS Muscle Twitching Sedation Vision Blurred Date:02/25/98ISR Number: 3036674-XReport Type:Expedited (15-DaCompany Report #971217-107013517 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 50 MG, PRN, Initial or Prolonged ORAL PT Report Source Product Role Cerebrovascular Accident Study Ultram PS Neurontin Prozac SS C Route ORAL Health Professional Date:02/27/98ISR Number: 3041985-8Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Other 900MG QD Manufacturer Company Report # PT Report Source Product Role Platelet Count Decreased Health Neurontin PS Manufacturer Route Manufacturer Route Duration Professional Date:02/27/98ISR Number: 3044063-7Report Type:Direct Age:57 YR Gender:Female I/FU:I Outcome Dose Other 500 MG TO Company Report # PT Report Source Product Role Decreased Activity Health Gabapentin PS Duration Psychotic Disorder Professional 2100 MG/DAY Allegra Lasix Synthroid Lithium Zyprexa Stelazine Premarin Temazepam Date:03/02/98ISR Number: 3129834-0Report Type:Periodic Age:49 YR Gender:Male I/FU:I Outcome Dose Other 100.00 MG C C C C C C C C Company Report #9712638 PT Report Source Product Role Manufacturer Route Choreoathetosis Health Zoloft PS ORAL Coordination Abnormal Professional Neurontin SS ORAL Buspar C Duration TOTAL: DAILY: Drug Interaction ORAL Headache 900.00 TOTAL: Nervous System Disorder TID: ORAL Speech Disorder Thinking Abnormal 22-Aug-2005 Page: 12 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3141207-3Report Type:Periodic Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG (100 Initial or Prolonged MG, TID), PER Company Report #001-0945-973038 PT Report Source Product Role Skin Disorder Health Neurontin PS Haldol (Haloperidol) Cogentin Debrox Prilosec Phazyme Depakote Asa C C C C C C C Manufacturer Route ORAL Professional ORAL Date:03/02/98ISR Number: 3148217-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG (400 Company Report #001-0945-970029 PT Report Source Product Role Chest Pain Headache Health Professional Neurontin (Gabapentin) PS Leukopenia Company Myalgia Representative Manufacturer Route ORAL MG, BID), PER ORAL Nausea Date:03/02/98ISR Number: 3148218-2Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Diplopia Medication Error Health Professional Neurontin 300 Mg (Gabapentin) PS Manufacturer Route Duration 300 MG (QHS), Vith Nerve Paralysis PER ORAL Company Report #001-0945-970047 ORAL Insulin Glucophage Heemalog Senokot Date:03/02/98ISR Number: 3148221-2Report Type:Periodic Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 Disability MG, TID) PER C C C C Company Report #001-0945-970051 PT Report Source Product Role Cardiac Failure Deafness Health Professional Neurontin 300 Mg (Gabapentin) PS Pinolol Amitriptyline Mestinon Prozac Klonopin Phentermine Fenfluramine Percocet C C C C C C C C Delirium Hallucination, Auditory ORAL Lethargy Medication Error Renal Failure 22-Aug-2005 Page: 13 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3148223-6Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (600 Company Report #001-0945-970059 PT Report Source Product Role Blood Creatinine Increased Health Professional Neurontin 300 Mg (Gabapentin) PS Acyclovir Mycophenolate Tacrolimus Lactulose Insulin Ursodid Lasix Prednisone Procardia Prilosec C C C C C C C C C C Manufacturer Route ORAL Blood Urea Increased MG, BID) PER Encephalopathy ORAL Date:03/02/98ISR Number: 3148226-1Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Deep Vein Thrombosis Health Professional Neurontin (Gabapentin) PS Elavil Motrin Ultram Axid C C C C Date:03/02/98ISR Number: 3148229-7Report Type:Periodic Age:10 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - Company Report #001-0945-970109 Manufacturer Route ORAL Company Report #001-0945-970141 PT Report Source Product Convulsion Consumer Neurontin 300 Mg Role Manufacturer Route Initial or Prolonged SEE TEXT, PER Dermatitis (Gabapentin) PS ORAL Topimax SS ORAL Sabril C ORAL PER ORAL Date:03/02/98ISR Number: 3148231-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Company Report #001-0945-970175 PT Report Source Product Role Phlebitis Health Professional Neurontin 300 Mg (Gabapentin) PS Dilantin Decadron C C Manufacturer Route ORAL MG, TID), PER ORAL Date:03/02/98ISR Number: 3148234-0Report Type:Periodic Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1500 MG (500 MG, TID), PER 22-Aug-2005 Page: 14 10:40 AM Company Report #001-0945-970195 PT Report Source Product Role Mania Health Professional Neurontin (Gabapentin) PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL (Folic Acid) Ativan (Valproic Acid) Multivitamins (Lithium) Tylenol Date:03/02/98ISR Number: 3148237-6Report Type:Periodic Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Other MG, TID), PER C C C C C C Company Report #001-0945-970203 PT Report Source Product Role Medication Error Renal Failure Acute Health Professional Neurontin 300 Mg (Gabapentin) PS Coumadin Lasix (Enalapril) C C C Manufacturer Route ORAL ORAL Date:03/02/98ISR Number: 3148240-6Report Type:Periodic Age:82 YR Gender: I/FU:I Outcome Dose Disability Company Report #001-0945-970214 PT Report Source Product Role Difficulty In Walking Disorientation Medication Error Mental Disorder Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:03/02/98ISR Number: 3148242-XReport Type:Periodic Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - Company Report #001-0945-970300 PT Report Source Product Cardiac Failure Consumer Neurontin 300 Mg Role Initial or Prolonged 600 MG (300 Congestive (Gabapentin) PS (Quinapril) Synthroid Meclizine (Famoridine) (Cimetidine) (Calcium) C C C C C C ORAL MG, TID), PER ORAL Date:03/02/98ISR Number: 3148244-3Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Deafness Ear Discomfort Health Professional Neurontin 300 Mg (Gabapentin) PS Manufacturer Route Duration 300 MG (ONE DOSE) PER ORAL 22-Aug-2005 Page: 15 Company Report #001-0945-970302 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3148246-7Report Type:Periodic Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 Company Report #001-0945-970367 PT Report Source Product Role Manufacturer Route Thermal Burn Vomiting Consumer Neurontin 300 Mg (Gabapentin) PS ORAL Tegretol 200mg (Carbamazepine) SS ORAL Synthroid (Quinapril) (Melozine) (Famotidine) C C C C MG, TID), PER ORAL 1 TAB BID/1 1/2 TABS AT BEDTIME (200 MG), PER ORAL Date:03/02/98ISR Number: 3148248-0Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Disability Company Report #001-0945-970383 PT Report Source Product Role Medication Error Psychotic Disorder Health Professional Neurontin (Gabapentin) PS (Clonazepam) Metamucil Tylenol (Olanzapine) Multivitamins Electroconvulsive C C C C C C Manufacturer Route Duration 1200 MG (600 MG, BID), PER ORAL ORAL Date:03/02/98ISR Number: 3148251-0Report Type:Periodic Age:7 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2 GM, PER Other ORAL PT Report Source Product Role Anaemia Lymphocytosis Health Professional Neurontin (Gabapentin) PS (Zinc) Tranxene C C Date:03/02/98ISR Number: 3148253-4Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 Company Report #001-0945-970388 Report Source Product Role Abnormal Behaviour Coordination Abnormal Health Professional Neurontin 300 Mg (Gabapentin) PS Tegretol (Lithium) C C Drug Level Above MG, TID) PER Therapeutic ORAL 22-Aug-2005 Page: 16 10:40 AM Route ORAL Company Report #001-0945-970433 PT Mania Medication Error Tremor Manufacturer Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3148254-6Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Disability Company Report #001-0945-970449 PT Report Source Product Role Asthenia Bradyphrenia Health Professional Neurontin (Gabapentin) PS Ultram Trazodone C C Manufacturer Route Duration ORAL 800 MG Diarrhoea (DAILY) PER Disturbance In Attention ORAL Dysphagia Memory Impairment Nausea Sedation Tongue Discolouration Tongue Disorder Vomiting Date:03/02/98ISR Number: 3148255-8Report Type:Periodic Age:7 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-970454 PT Report Source Product Role Gingivitis Rectal Haemorrhage Consumer Neurontin 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG Weight Increased (DAILY), PER ORAL Date:03/02/98ISR Number: 3148258-3Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL Company Report #001-0945-970486 PT Report Source Product Role Deep Vein Thrombosis Health Professional Neurontin (Gabapentin) PS Depakote Dilantin C C Manufacturer Route ORAL Date:03/02/98ISR Number: 3148260-1Report Type:Periodic Age:8 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3 DOSES, PER Company Report #001-0945-970500 PT Report Source Product Role Abnormal Behaviour Health Professional Neurontin (Gabapentin) PS Manufacturer Route ORAL ORAL Date:03/02/98ISR Number: 3148518-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged "MAXIMUM Company Report #001-0945-970514 PT Report Source Product Role Medication Error Pneumonia Health Professional Neurontin (Gabapentin) PS DOSAGE" PER ORAL Date:03/02/98ISR Number: 3148519-8Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 17 10:40 AM Company Report #001-0945-970538 Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Dose PT Report Source Product Role Blood Potassium Increased Medication Error Health Professional Neurontin (Gabapentin) PS Klonopin Zyprexa Percocet Trilafon C C C C Manufacturer Route Duration ORAL 600MG (DAILY) Oedema PER ORAL White Blood Cell Count Increased Date:03/02/98ISR Number: 3148520-4Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-970549 PT Report Source Product Role Atrioventricular Block First Degree Health Professional Neurontin 300mg (Gabapentin) PS Aspirin C Manufacturer Route Duration ORAL 1200MG (600MG Bradycardia , BID) PER Cerebrovascular Accident ORAL Supraventricular Extrasystoles Date:03/02/98ISR Number: 3148523-XReport Type:Periodic Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2700MG Company Report #001-0945-970574 PT Report Source Product Role Bradycardia Condition Aggravated Consumer Neurontin 300mg (Gabapentin) PS Convulsion (900MG, TID) Dizziness PER ORAL Mental Impairment Visual Disturbance Dilantin Kapseals 100mg (Phenytoin Manufacturer Route ORAL Sodium) SS Aspirin Sertraline Oxybutynin Fellodipine Docusate C C C C C ORAL SEE TEXT, PER ORAL Date:03/02/98ISR Number: 3148525-3Report Type:Periodic Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900MG (300MG Company Report #001-0945-970608 PT Report Source Product Role Apnoea Lethargy Health Professional Neurontin 300mg (Gabapentin) PS Procardia Paxil Cipro Fosamax Lactulose` Insulin C C C C C C TID) PER ORAL 22-Aug-2005 Page: 18 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3148527-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-970613 PT Report Source Product Role Deep Vein Thrombosis Health Professional Neurontin 300mg (Gabapentin) PS Elavil C Manufacturer Route Duration ORAL 900MG (300MG TID) PER ORAL Date:03/02/98ISR Number: 3148528-9Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Disability Company Report #001-09145-970636 PT Report Source Product Role Hypoaesthesia Consumer Neurontin 300mg (Gabapentin) PS Manufacturer Route Duration ORAL 600MG (DAILY) PER ORAL Date:03/02/98ISR Number: 3148529-0Report Type:Periodic Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900MG (300MG Company Report #001-0945-970673 PT Report Source Product Role Abdominal Pain Upper Dizziness Consumer Neurontin 300mg (Gabapentin) PS Methadone C Manufacturer Route ORAL Headache TID) PER ORAL Date:03/02/98ISR Number: 3148530-7Report Type:Periodic Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - Company Report #001-0945-970692 PT Report Source Product Pyrexia Health Neurontin 300mg Role Manufacturer Route Initial or Prolonged 1800MG (600MG Spinal Fracture Professional (Gabapentin) PS Cefizox Zithromax Coumadin Digoxin Ativan Norvasc Inderal La Zantac C C C C C C C C ORAL TID) PER ORAL Date:03/02/98ISR Number: 3148531-9Report Type:Periodic Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900MG (300MG Company Report #001-0945-973011 PT Report Source Product Role Aphonia Decreased Appetite Consumer Neurontin Capsules 300mg (Gabapentin) PS Morphine Percocet Dilaudid C C C Dysphagia TID) PER ORAL Medication Error Pneumonia Aspiration Sedation Weight Decreased 22-Aug-2005 Page: 19 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3148532-0Report Type:Periodic Age:79 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900MG (300MG Company Report #001-0945-973033 PT Report Source Product Role Activated Partial Thromboplastin Time Health Professional Neurontin (Gabapentin) PS Coumadin Synthroid Bumex Allopurinol Maxzide C C C C C Manufacturer Route ORAL Prolonged TID) PER ORAL International Normalised Ratio Increased Phlebitis Prothrombin Time Prolonged Date:03/02/98ISR Number: 3148535-6Report Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose UNKNOWN PT Company Report #001-0945-973034 Report Source Product Role Neurontin (Gabapentin) PS Digoxin Verapamil Calcitonin Soma Meprobamate C C C C C Manufacturer Route Manufacturer Route Duration Medication Error Oedema Peripheral 1200MG (400MG TID) UNK Date:03/02/98ISR Number: 3148536-8Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1600MG (DAILY) PER Company Report #001-0945-973042 PT Report Source Product Role Haematemesis Medication Error Consumer Neurontin (Gabapentin) PS ORAL ORAL Dilantin Percocet Propulsid Elavil C C C C Date:03/04/98ISR Number: 3040401-XReport Type:Expedited (15-DaCompany Report #001-0945-980134 Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Required 300 MG DAILY Intervention to PER ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Retinal Tear Health Neurontin PS Manufacturer Route ORAL Professional Date:03/04/98ISR Number: 3040402-1Report Type:Expedited (15-DaCompany Report #001-0945-980139 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 20 10:40 AM PT Report Source Product Role Blood Creatine Phosphokinase Increased Rhabdomyolysis Health Professional Neurontin Insulin Digoxin Ms Contin Zantac Ecotrin PS C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/98ISR Number: 3040403-3Report Type:Expedited (15-DaCompany Report #001-0945-980150 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization 180 MG DAILY Initial or Prolonged PT Report Source Product Role Blood Potassium Decreased Health Neurontin PS Heart Rate Decreased Professional Atenolol Verapamil C C Date:03/04/98ISR Number: 3050449-7Report Type:Direct Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Required 1200 MG PO Intervention to TID Prevent Permanent Impairment/Damage Route Manufacturer Route Company Report # PT Report Source Product Role Cutaneous Lupus Health Neurontin PS Erythematosus Professional ORAL Rash Erythematous Date:03/10/98ISR Number: 3049193-1Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome Dose Manufacturer Company Report # PT Report Source Product Role Diplopia Health Gabapentin PS Vision Blurred Professional Enalapril Fentanyl Nortriptyline Hydromorphone Naproxen C C C C C Manufacturer Route Duration ORAL 300 MG TID Date:03/10/98ISR Number: 3088051-3Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Manufacturer Route Nausea Gabapentin PS Vomiting Xanax C 300 MG BID Date:03/11/98ISR Number: 3054874-XReport Type:Expedited (15-DaCompany Report #001-0945-980140 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 900 MG (300 Initial or Prolonged MG , TID), PT Report Source Product Role Coma Health Neurontin PS Convulsion Professional Mysoline Multiple Other Medications C Pneumonia Aspiration PER ORAL; SEVERAL YEARS THERAPY Date:03/11/98ISR Number: 3054887-8Report Type:Expedited (15-DaCompany Report #001-0945-973038 Age:56 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 21 10:40 AM PT Electroencephalogram Abnormal Haemorrhagic Stroke Obsessive-Compulsive Disorder C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Skin Disorder Transient Ischaemic Attack Dose Report Source Product Role Health Neurontin PS Haldol Debrox Prilosec Phazyme Depakote Cogentin Atarax Asa C C C C C C C C Manufacturer Route Duration ORAL 300 MG (100 Professional MG, TID), PER ORAL Date:03/12/98ISR Number: 3053249-7Report Type:Expedited (15-DaCompany Report #001-0945-970227 Age:30 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 300 MG BID, Initial or Prolonged PER ORAL PT Report Source Product Role Fatigue Health Neurontin PS Entacyl Elavil Flonase Hydrocodone Naproxen Rocephin Prednisone Morphine C C C C C C C C Manufacturer Route ORAL Professional Date:03/13/98ISR Number: 3055506-7Report Type:Expedited (15-DaCompany Report #001-0945-980174 Age:1 DY Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization SEE TEXT, Initial or Prolonged OTHER Benign Congenital Health Hypotonia Professional Blood Glucose Increased Neurontin PS Klonopin SS Synthroid Zoloft Prenatal Vitamins C C C SEE TEXT, Complications Of Maternal OTHER Exposure To Therapeutic Drugs Date:03/13/98ISR Number: 3055508-0Report Type:Expedited (15-DaCompany Report #001-0945-980163 Age:72 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Hodgkin'S Disease Mass Consumer Neurontin Dilantin Fosamax PS C C Manufacturer Route Manufacturer Route Duration Date:03/16/98ISR Number: 3056553-1Report Type:Expedited (15-DaCompany Report #044-0945-980005 Age:25 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG (400 Initial or Prolonged MG, TID), PER ORAL 22-Aug-2005 Page: 22 10:40 AM PT Report Source Product Role Arthralgia Foreign Neurontin PS Arthritis Health Synovitis Professional ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamotrigine C Date:03/17/98ISR Number: 3056019-9Report Type:Expedited (15-DaCompany Report #001-0945-980165 Age:83 YR Gender:Male I/FU:I Outcome Dose Duration Death 400 MG (,100 Hospitalization MG QAM, 100 Initial or Prolonged MG PT Report Source Product Role Hypoxia Health Neurontin PS Pneumonia Professional Miacalcin Testosterone C C Route Pneumonitis Pulmonary Fibrosis Rib Fracture White Blood Cell Count Increased Date:03/18/98ISR Number: 3056375-1Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Other I PO Q HS, I Manufacturer PT Company Report # Report Source Dermatitis Product Role Manufacturer Route Neurontin PS Parke-Davis ORAL Product Role Manufacturer Route Neurontin PS Baclofen Oxycontin Flexeril C C C Haemorrhage PO BID Skin Fissures Date:03/19/98ISR Number: 3057780-XReport Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Duration Oedema Peripheral 300 MG PO TID 4 WK ORAL Date:03/23/98ISR Number: 3058470-XReport Type:Expedited (15-DaCompany Report #001-0945-980172 Age:26 YR Gender:Female I/FU:I Outcome Dose Other 3600 MG PT Report Source Product Role Astrocytoma Consumer Neurontin PS Dilantin With Phenobarbital Tylenol C C Manufacturer Route Duration ORAL Condition Aggravated (DAILY) PER ORAL Date:03/23/98ISR Number: 3058472-3Report Type:Expedited (15-DaCompany Report #001-0945-970427 Age:41 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged 22-Aug-2005 Page: 23 10:40 AM PT Report Source Product Role Asthenia Health Neurontin PS Chromaturia Fatigue Feeling Jittery Haematocrit Decreased Haemolysis Haemolytic Anaemia Palpitations Restlessness Professional Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/98ISR Number: 3058475-9Report Type:Expedited (15-DaCompany Report #001-0945-980106 Age:45 YR Gender:Male I/FU:F Outcome Dose PT Report Source Product Role Antinuclear Antibody Health Neurontin PS Positive Professional Manufacturer Route Duration ORAL 800 MG (DAILY) PER Dna Antibody Positive ORAL Leukopenia Rheumatoid Factor Positive Supraventricular Tachycardia Systemic Lupus Erythematosus Date:03/24/98ISR Number: 3058769-7Report Type:Expedited (15-DaCompany Report #001-0945-980178 Age:35 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900 MG Initial or Prolonged (300MG, TID) PT Report Source Product Role Benign Intracranial Health Neurontin PS Hypertension Professional Manufacturer Route ORAL Headache PER ORAL Vision Blurred Date:03/25/98ISR Number: 3148868-3Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Other 15 MG DAILY ORAL PT Report Source Product Role Manufacturer Route Chest Pain Health Redux PS ORAL Drug Withdrawal Syndrome Professional Desyrel SS ORAL Duration 1 YR Dyspnoea 50 MG AT Company Report #8-97305-041H Palpitations BEDTIME ORAL Vasodilatation Neurontin SS ORAL Ultram SS ORAL Wellbutrin SS ORAL Baclofen Desyrel Neurontin Ultram Vicodin Wellbutrin C C C C C C 2 DAILY ORAL 2 DAILY ORAL 400 DAILY ORAL Date:03/31/98ISR Number: 3059424-XReport Type:Expedited (15-DaCompany Report #001-0945-980037 Age: Gender: I/FU:F Outcome Dose Death PT Report Source Product Role Chemotherapy Cardiotoxicity Attenuation Health Professional Neurontin (Doxepin) Zoloft (Sertraline Hydrochloride) PS C Duration Date:03/31/98ISR Number: 3067072-0Report Type:Direct Age:28 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 24 10:40 AM Company Report # C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent Dose Duration Impairment/Damage PO 300MG TID PT Report Source Pancreatitis Product Role Gabapentin PS Saquinavir Fluconazole Dapsone Meqace Zovirax Ms Contin Zantac Epivir Bactrim Trazadone C C C C C C C C C C Manufacturer Route ORAL Date:04/01/98ISR Number: 3058750-8Report Type:Expedited (15-DaCompany Report #001-0945-980203 Age:60 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Ammonia Increased Autoimmune Hepatitis Confusional State Hepatic Function Abnormal Health Professional Company Representative Neurontin PS Manufacturer Route Manufacturer Route Duration Date:04/01/98ISR Number: 3064583-9Report Type:Direct Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Required 2 PO TID Intervention to Prevent Permanent Impairment/Damage Company Report # PT Report Source Product Role Alanine Aminotransferase Health Neurontin PS Increased Blood Creatine Phosphokinase Increased Myositis Professional Date:04/02/98ISR Number: 3058131-7Report Type:Expedited (15-DaCompany Report #001-0945-980204 Age: Gender:Unknown I/FU:I ORAL Outcome Dose Other PT Report Source Product Role Blood Creatinine Increased Renal Tubular Necrosis Health Professional Neurontin Ticlid Hydralazine Axid PS C C C Date:04/05/98ISR Number: 3153527-7Report Type:Periodic Age:14 YR Gender:Female I/FU:I Outcome Dose Other DAILY, ORAL Route Manufacturer Route Company Report #97USA10341 PT Report Source Product Role Stevens-Johnson Syndrome Health Tegretol PS ORAL Professional Neurontin SS ORAL Duration 900 MG DAILY, ORAL 22-Aug-2005 Page: 25 Manufacturer Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3071810-0Report Type:Direct Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization NS Initial or Prolonged PT Product Role Gabapentin PS Manufacturer Route Manufacturer Route Mental Impairment PT Company Report # Report Source Choreoathetosis Product Role Neurontin PS Dysarthria Dyskinesia Gait Disturbance Mental Impairment Urinary Incontinence Date:04/13/98ISR Number: 3073159-9Report Type:Direct Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600MG 9AM; Initial or Prolonged 600MG PO Q Report Source Acute Prerenal Failure Date:04/13/98ISR Number: 3072359-1Report Type:Direct Age:97 YR Gender:Female I/FU:I Outcome Dose Duration Death 200MG Q HS Hospitalization Initial or Prolonged Company Report # PT Amnesia Company Report # Report Source Product Role Manufacturer Route Gabapentin PS Parke Davis ORAL Carbamazepine Combivir Diazepam Zoloft Oramorph C C C C C Diplopia Dysarthria AFTERNOON;900 Gait Disturbance MG PO Q PM, Sedation Date:04/14/98ISR Number: 3064329-4Report Type:Expedited (15-DaCompany Report #001-0945-980174 Age:1 DY Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Drugs Hypotonia Health Professional Neurontin Klonopin Synthroid Zoloft Prenatal Vitamins PS SS C C C Manufacturer Route Manufacturer Route Date:04/14/98ISR Number: 3064330-0Report Type:Expedited (15-DaCompany Report #001-0945-980140 Age:53 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 300 MG TID Initial or Prolonged ORAL PT Report Source Product Role Coma Health Neurontin PS Convulsion Professional Mysoline C Drug Ineffective Pneumonia Aspiration Date:04/20/98ISR Number: 3072440-7Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG Q DAY Initial or Prolonged 22-Aug-2005 Page: 26 10:40 AM ORAL Company Report # PT Report Source Product Role Asthenia Health Gabapentin PS Neuropathy Peripheral Professional Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/98ISR Number: 3070077-7Report Type:Periodic Age:79 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 900 MG (300 Initial or Prolonged MG TID), PER Company Report #001-0945-973033 PT Report Source Product Role Activated Partial Health Neurontin PS Thromboplastin Time Professional Coumadin Synthroid Bumex Allopurinol Digxin Maxzide C C C C C C Manufacturer Route ORAL Prolonged ORAL International Normalised Ratio Increased Phlebitis Prothrombin Time Prolonged Date:04/24/98ISR Number: 3072536-XReport Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly QAM QNOON QPM PT Company Report # Report Source Abortion Spontaneous Product Role Manufacturer Neurontin PS Parke-Davis Manufacturer Route Complications Of Maternal QHS Exposure To Therapeutic Drugs Heart Disease Congenital Premature Baby Premature Labour Date:04/28/98ISR Number: 3072215-9Report Type:Expedited (15-DaCompany Report #001-0945-980172 Age:26 YR Gender:Female I/FU:F Outcome Dose Other 3600 MG PT Report Source Product Role Astrocytoma Consumer Neurontin PS Condition Aggravated (DAILY) PER Route Duration ORAL Glioma ORAL Tylenol Felbatol Phenobarbital Dilantin Date:05/01/98ISR Number: 3073037-5Report Type:Direct Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG BID Initial or Prolonged ORAL 22-Aug-2005 Page: 27 10:40 AM PT Coordination Abnormal C C C C Company Report # Report Source Product Role Manufacturer Route Gabapentin PS Parke-Davis ORAL Ibuprofen Multivitamins Famotidine Benztropine Lorazepam Lithium Levothyroxine Thioridazine C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/98ISR Number: 3080313-9Report Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Gabapentin PS Manufacturer Route Manufacturer Route Duration Confusional State 300 MG TID Dizziness Irritability Date:05/01/98ISR Number: 3080639-9Report Type:Expedited (15-DaCompany Report # Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Required 300 MG QAM PO Intervention to AND 400 MG Prevent Permanent TID PO Impairment/Damage 4 MG PO QD PT Report Source Chromatopsia Product Role Gabapentin PS ORAL Prednisone C ORAL Amlodipine C ORAL Clonidine C ORAL Bicitra C ORAL Digoxin C ORAL Penuk C ORAL Vision Blurred 10 MG PO QD 0.1 MG PO BID 2 TABS PO TID 0.125 MG PO 250 MG PO BID Date:05/04/98ISR Number: 3074314-4Report Type:Expedited (15-DaCompany Report #001-0945-980165 Age:83 YR Gender:Male I/FU:F Outcome Dose Duration Death 400 MG (,100 Hospitalization MG QAM, 100 PT Report Source Product Role Cryptogenic Organizing Health Neurontin PS Pneumonia Professional Manufacturer Route ORAL Initial or Prolonged MG Q NOON, Hypoxia Pneumonitis 200 MG QHS)PO Pulmonary Fibrosis Rib Fracture Miacalcin Testosterone C C Date:05/05/98ISR Number: 3073884-XReport Type:Expedited (15-DaCompany Report #001-0945-980283 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG Initial or Prolonged (,DAILY), PER PT Report Source Product Role Sepsis Health Neurontin PS Insulin Warfarin Darvocet Phoslo C C C C Manufacturer Route ORAL Professional ORAL Date:05/05/98ISR Number: 3073885-1Report Type:Expedited (15-DaCompany Report #001-0945-980111 Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Death 3600 MG (1200 Other MG, TID) PT Report Source Product Role Fatigue Health Neurontin PS Hepatic Function Abnormal Professional Accupril C Hepatitis C Insomnia Liver Function Test Abnormal 22-Aug-2005 Page: 28 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/98ISR Number: 3072734-5Report Type:Direct Age:43 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Manufacturer Route Gabapentin PS Parke-Davis ORAL Clozapine SS Novartic ORAL Divalproex Fluphenazine Levothyroxine Lithium Carbonate Benztropine Lorazepam C C C C C C Manufacturer Route Manufacturer Route Duration Sedation 600MG TID ORAL 12.5 MG BID ORAL Date:05/08/98ISR Number: 3074736-1Report Type:Expedited (15-DaCompany Report #001-0945-980286 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Osteonecrosis Health Professional Company Representative Neurontin PS Duration Date:05/08/98ISR Number: 3074737-3Report Type:Expedited (15-DaCompany Report #001-0945-980292 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG (300 Initial or Prolonged MG,QID) Other Required Intervention to Prevent Permanent PT Report Source Product Role Bronchioloalveolar Consumer Neurontin PS Soma (Carisoprodol) (Hydrocodone) Amitriptyline Prozac (Fluoxetine C C C Carcinoma Drug Withdrawal Syndrome Dysgeusia Dyspnoea Headache ORAL Impairment/Damage Malaise Pancreatitis Pneumonia Mycoplasmal Pyrexia Tongue Oedema Hydrochloride) Date:05/11/98ISR Number: 3076680-2Report Type:Expedited (15-DaCompany Report #001-0945-980285 Age:58 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 29 10:40 AM PT Bladder Disorder Burning Sensation Feeling Of Body Temperature Change Hypoaesthesia Nerve Conduction Studies Abnormal Paraesthesia Polyneuropathy Rash Erythematous Rash Macular Rash Pruritic Red Blood Cell Sedimentation Rate Increased C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Dose Report Source Product Role Literature Neurontin PS Amitriptyline Bupivacaine Clonidine Clonidine Dilantin Carbamazepine Mexilatine Desimpramine C C C C C C C C Manufacturer Route Duration ORAL 600 - 2400 MG Health PER DAY PER Professional ORAL Date:05/12/98ISR Number: 3076586-9Report Type:Expedited (15-DaCompany Report #001-0073-980205 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blood Sodium Decreased Convulsion Inappropriate Antidiuretic Hormone Secretion Mental Disorder Health Professional Dilantin Neurontin PS SS Manufacturer Route Manufacturer Route Date:05/13/98ISR Number: 3079264-5Report Type:Expedited (15-DaCompany Report #001-0945-970219 Age:67 YR Gender:Female I/FU:F Outcome Dose Disability 900-1200 MG Other (DAILY) PER PT Report Source Product Role Blindness Consumer Neurontin PS Tegretol C Duration Condition Aggravated Eye Haemorrhage ORAL Macular Degeneration ORAL Trandate Hydrochlorothiaz Date:05/13/98ISR Number: 3079266-9Report Type:Expedited (15-DaCompany Report #001-0945-980311 Age:37 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 30 10:40 AM PT Abdominal Discomfort Dermatitis Diarrhoea Dizziness Ecchymosis Facial Palsy Fatigue Hypoaesthesia Loss Of Consciousness Mental Disorder Migraine Movement Disorder Nausea Palpitations Pyrexia Speech Disorder Syncope C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Weight Decreased Dose Report Source Product Role Consumer Neurontin PS Manufacturer Route Duration ORAL SEE TEXT, PER ORAL Date:05/19/98ISR Number: 3079442-5Report Type:Direct Age:35 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Gabapentin Phenytoin Vancomycin Ranitidine Docusate Fes04 Ibuprofen Codeinie Ofloxacin PS SS C C C C C C C Manufacturer Route Manufacturer Route Duration Dystonia Date:05/19/98ISR Number: 3081180-XReport Type:Expedited (15-DaCompany Report #001-0073-980221 Age:52 YR Gender:Female I/FU:I Outcome Dose Other 300 MG (100 PT Report Source Product Role Amnesia Consumer Dilantin PS ORAL Neurontin SS ORAL Glucotrol K-Dur C C Duration Blood Potassium Decreased MG, TID), PER Diarrhoea ORAL Dysarthria 900 MG (300 Face Oedema MG,TID), PER Fluid Retention ORAL Oedema Peripheral Tongue Oedema Weight Increased Date:05/21/98ISR Number: 3082334-9Report Type:Expedited (15-DaCompany Report #001-0945-980326 Age:43 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 2400 MG Initial or Prolonged PT Report Source Product Role Chest Pain Health Neurontin PS Medication Error Professional Glucotrol Lodine Klonopin Imitrex Ultram C C C C C Manufacturer Route Manufacturer Route Date:05/26/98ISR Number: 3082534-8Report Type:Expedited (15-DaCompany Report #001-0945-980320 Age:38 YR Gender:Male I/FU:I Outcome Dose Death UNKNOWN PT Report Source Product Role Health Neurontin PS Sedation Doxepin SS Syncope Methadone C Duration Drowning 1800 MG (600 Overdose Professional MG,TID) UNKNOWN 22-Aug-2005 Page: 31 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/98ISR Number: 3167664-4Report Type:Periodic Age:7 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 700 MG (100 Initial or Prolonged MG, 7 TIMES Company Report #001-0916-970004 PT Report Source Product Role Manufacturer Route Condition Aggravated Health Carbamazepine PS Convulsion Professional Neurontin (Gabapentin) SS ORAL Ritalin (Methylphenidate Hydrochloride) SS ORAL Otitis Media DAILY) 400 MG (100 MG, QID) 5 DAY Date:05/26/98ISR Number: 3167667-XReport Type:Periodic Age:7 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 700 MG (100 Initial or Prolonged MG, 7 TIMES Company Report #001-0916-970004 PT Report Source Product Role Manufacturer Route Convulsion Health Carbamazepine PS Otitis Media Professional Neurontin (Gabapentin) SS ORAL Ritalin (Methylphenidate Hydrochloride) SS ORAL DAILY) 400 MG (100 MG QID) 5 DAY Date:05/28/98ISR Number: 3084794-6Report Type:Expedited (15-DaCompany Report #001-0945-980346 Age: Gender:Female I/FU:I Outcome Dose Duration Death 300 MG DAILY, Other PER ORAL PT Report Source Product Role Neoplasm Malignant Health Neurontin PS Manufacturer Route ORAL Professional Date:05/28/98ISR Number: 3084796-XReport Type:Expedited (15-DaCompany Report #001-0945-940034 Age:63 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 300 MG DAILY, Initial or Prolonged PER ORAL Disability PT Report Source Product Role Blister Health Neurontin PS Infection Professional Mysoline C Joint Stiffness Oedema Peripheral Skin Exfoliation Toxic Epidermal Necrolysis Date:06/02/98ISR Number: 3087573-9Report Type:Expedited (15-DaCompany Report #001-0945-980357 Age:42 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 32 PT Arthralgia Dermatitis Drug Hypersensitivity Dyspnoea Face Oedema Increased Appetite Myalgia 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Dose Report Source Product Role Health Neurontin PS Stelazine Xanax C C Manufacturer Route Duration ORAL 3600 MG (900 Professional MG, QID), PER ORAL Date:06/02/98ISR Number: 3087579-XReport Type:Expedited (15-DaCompany Report #001-0073-980253 Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 400 MG (,150 Initial or Prolonged MG IN AM AND PT Report Source Product Role Manufacturer Route Arthralgia Health Dilantin PS ORAL Dermatitis Professional Neurontin SS ORAL Dermatomyositis HS,100 MG AT Drug Interaction NOON), PER Hypotension ORAL MONTHS Muscle Atrophy 900 MG (300 MG.TID), PER ORAL. WEEKS Date:06/03/98ISR Number: 3089637-2Report Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 100MG PO TID Initial or Prolonged PT Anorexia Dehydration Company Report # Report Source Product Role Gabapentin PS Manufacturer Route ORAL Pyrexia Date:06/04/98ISR Number: 3090234-3Report Type:Direct Age:35 YR Gender:Female I/FU:I Outcome Dose PT Company Report # Report Source Product Role Manufacturer Neurontin PS Parke Davis Hydrocortisone Multivitamin With Minerals Sertraline Ramitidine Synthroid Divalprox Na Folic Acid Thiamine C Duration Face Oedema 900MG TID( Rash Maculo-Papular WITH DOSAGE GRADUALLY INCREASED FROM 300MG Date:06/08/98ISR Number: 3092316-9Report Type:Expedited (15-DaCompany Report #001-0945-980159 Age: Gender:Female I/FU:I Outcome Disability 22-Aug-2005 Page: 33 PT Asthenia Blood Sodium Decreased Body Temperature Decreased 10:40 AM C C C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysphagia Dyspnoea Fatigue Dose Report Source Product Role Consumer Neurontin Neurontin PS SS Tegretol C Manufacturer Route Manufacturer Route Manufacturer Route Duration Hypotension Pain 500 MG Paraesthesia Parosmia Pneumonia Tinnitus Vertigo Vision Blurred Weight Decreased Date:06/11/98ISR Number: 3092515-6Report Type:Expedited (15-DaCompany Report #001-0073-980205 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blood Sodium Decreased Condition Aggravated Convulsion Inappropriate Antidiuretic Hormone Secretion Mental Disorder Health Professional Dilantin Neurontin PS SS Date:06/11/98ISR Number: 3092519-3Report Type:Expedited (15-DaCompany Report #001-0945-980203 Age:60 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Ammonia Increased Confusional State Liver Function Test Abnormal Health Professional Company Representative Neurontin PS Duration Date:06/18/98ISR Number: 3096884-2Report Type:Expedited (15-DaCompany Report #001-0945-980286 Age: Gender:Female I/FU:F Outcome Dose Other UNKNOWN PT Report Source Product Role Health Neurontin PS Professional Steroid SS Manufacturer Route Manufacturer Route Duration Osteonecrosis UNKNOWN UNKNOWN UNKNOWN Company SEVERAL YEARS Representative AGO Date:06/19/98ISR Number: 3096905-7Report Type:Expedited (15-DaCompany Report #034-0945-980003 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization UNK, PER ORAL Initial or Prolonged 22-Aug-2005 Page: 34 10:40 AM PT Report Source Product Role Blister Foreign Neurontin PS Dermatitis Health Professional Company Representative ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/98ISR Number: 3096906-9Report Type:Expedited (15-DaCompany Report #034-0945-980004 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization UNK, PER ORAL Initial or Prolonged PT Report Source Product Role Blister Foreign Neurontin PS Dermatitis Health Professional Company Representative Manufacturer Route ORAL Date:06/23/98ISR Number: 3097741-8Report Type:Expedited (15-DaCompany Report #001-0945-980392 Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1500 MG Initial or Prolonged (EVERY PT Report Source Product Role Coma Consumer Neurontin PS Lasix Tylenol W/Codeine Corag Lanoxin Humalog Humalin Colchicine C C C C C C C Manufacturer Route ORAL Confusional State Convulsion NIGHT), PER Overdose ORAL Pneumonia Tremor Ulcer Haemorrhage Date:06/24/98ISR Number: 3097902-8Report Type:Expedited (15-DaCompany Report #001-0945-980346 Age: Gender:Female I/FU:F Outcome Dose Duration Death 300 MG Other (,DAILY), PER PT Report Source Product Role Gallbladder Cancer Health Neurontin PS Professional Manufacturer Route ORAL ORAL Date:06/30/98ISR Number: 3100267-6Report Type:Expedited (15-DaCompany Report #001-0945-980417 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNK, UNKNOWN PT Report Source Product Role Convulsion Cough Health Professional Neurontin (Gabapentin) PS Tegretol (Carbamazepine) SS Lung Disorder Rash Maculo-Papular Manufacturer Route Manufacturer Route UNK, UNKNOWN Sdz Gli 328 (Ganciclovir) Phenobarb (Phenobarbital Sodium) (Glipizide) C C C C Date:06/30/98ISR Number: 3100291-3Report Type:Expedited (15-DaCompany Report #044-0945-980036 Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG (800 PT Report Source Product Role Abdominal Pain Upper Back Pain Foreign Health Neurontin (Gabapentin) PS Dysuria Professional (Carbamazepine) C MG, TID) , Muscle Spasms UNKNOWN Urinary Incontinence 22-Aug-2005 Page: 35 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Labetalol) C Date:07/01/98ISR Number: 3100340-2Report Type:Expedited (15-DaCompany Report #001-0945-980348 Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 2400 MG Initial or Prolonged (,DAILY), PER PT Report Source Product Role Diarrhoea Consumer Neurontin PS Manufacturer Route ORAL Gastrointestinal Disorder Liver Function Test ORAL Abnormal Tinnitus Date:07/01/98ISR Number: 3100344-XReport Type:Expedited (15-DaCompany Report #002-0945-980011 Age:46 YR Gender:Female I/FU:I Outcome Dose Death 900 MG PT Report Source Product Role Death Foreign Neurontin PS Lorazepam Risperidone C C Manufacturer Route Duration ORAL Health (,DAILY), PER Professional ORAL Date:07/01/98ISR Number: 3104400-1Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Other 300MG PO TID PT Company Report # Report Source Product Role Headache Gabapentin PS Sedation Cisapride Salsalate Lansoprazol Prazosin C C C C Manufacturer Route Simethicone Date:07/01/98ISR Number: 3104422-0Report Type:Direct Age:43 YR Gender:Male I/FU:I Outcome Dose Death PT C Company Report # Report Source Product Role Ativan Buspar Cardura Depakote Desyrel Haldol Mellaril Neurontin Propilsid Risperdal PS SS SS SS SS SS SS SS SS SS Manufacturer Route Manufacturer Route Duration Condition Aggravated Medication Error Psychotic Disorder Date:07/06/98ISR Number: 3102982-7Report Type:Expedited (15-DaCompany Report #001-0945-980423 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 36 10:40 AM PT Report Source Product Role Drug Interaction Oesophageal Ulcer Health Professional Neurontin Unspecified Antacid PS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/98ISR Number: 3102984-0Report Type:Expedited (15-DaCompany Report #001-0945-980412 Age:7 YR Gender:Female I/FU:I Outcome Dose Other 300 MG PT Report Source Product Role Haematocrit Decreased Health Neurontin PS Haemoglobin Decreased Professional Tetrabenazine Lorazepam Chloral Hydrate Acetaminophen Ibuprofen Vancomycin Ceftazidime Cefazolin C C C C C C C C Manufacturer Route Duration ORAL (,EVERY 8 HOURS), PER ORAL Date:07/06/98ISR Number: 3184947-2Report Type:Periodic Age:17 YR Gender:Female I/FU:I Outcome Dose Other Company Report #91692 PT Report Source Product Role Depression Headache Other Klonopin Tablets (Clonazepam) PS Neurontin (Gabapentin) SS Manufacturer Route Duration OCCLUSIVE DRESSING Mood Altered 2.0000 MG 1.0 Sedation X PER DAY ORAL Date:07/07/98ISR Number: 3102593-3Report Type:Expedited (15-DaCompany Report #001-0945-980283 Age:60 YR Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization 300 MG Initial or Prolonged (DAILY), PER Condition Aggravated Health Neuropathy Peripheral Professional Neurontin PS Insulin Warfarin Darvocet Phoslo C C C C ORAL Pain In Extremity ORAL Sepsis Date:07/07/98ISR Number: 3102594-5Report Type:Expedited (15-DaCompany Report #001-0945-980422 Age:16 YR Gender:Female I/FU:I Outcome Dose Duration Other 1500 MG (300 PT Report Source Product Role Drug Interaction Health Neurontin PS Petit Mal Epilepsy Professional Diflucan SS Diphenhydramine Bactrim Amitriptyline Acetaminophen C C C C MG, 5X DAILY) PER ORAL ONCE WEEKLY 22-Aug-2005 Page: 37 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/98ISR Number: 3102596-9Report Type:Expedited (15-DaCompany Report #001-0945-980421 Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Disorientation Consumer Neurontin PS Manufacturer Route ORAL Monoparesis ORAL Date:07/07/98ISR Number: 3103871-4Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Lethargy 300 MG TID PO 4 DAY Initial or Prolonged Mental Impairment Tremor Company Report # Report Source Product Role Neurontin PS Manufacturer Route ORAL Date:07/10/98ISR Number: 3104309-3Report Type:Expedited (15-DaCompany Report #033-0945-980019 Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 1200 MG DAILY Hospitalization Initial or Prolonged PT Report Source Product Role Cardiac Arrest Foreign Neurontin PS Convulsion Pulmonary Embolism Health Professional Tegritol SS Date:07/13/98ISR Number: 3108784-XReport Type:Direct Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100 MG PO QD 1 WK Initial or Prolonged PT Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Choreoathetosis Neurontin PS Tardive Dyskinesia Vomiting Premarin Levothyroxine C C ORAL Digoxin Duragesic Oxycodan Compazine Ultram Zoloft Dss Senna Scopolamine Patch C C C C C C C C C Date:07/14/98ISR Number: 3104962-4Report Type:Expedited (15-DaCompany Report #001-0945-980449 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Other 1600 MG (800 PT Report Source Product Role Gastrinoma Consumer Neurontin PS Darvon (Dextropropoxyphene Hydrochloride) Asa (Acetylsalicylic Acid) C Migraine MG, BID), PER Retinal Vein Thrombosis ORAL Vision Blurred Visual Acuity Reduced 22-Aug-2005 Page: 38 10:40 AM C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3104964-8Report Type:Expedited (15-DaCompany Report #034-0945-980003 Age:78 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 300 MG Initial or Prolonged (DAILY) PER PT Report Source Product Role Dermatitis Foreign Gabapentin PS Eosinophilia Health Phantom Pain Professional Pruritus Rash Maculo-Papular Rash Vesicular Thrombocythaemia Company Representative (Ipratropium Bromide) (Lorazepam) (Salbutamol) (Triflusal) "Budenoside" "Oxpentilfylline: C C C C C C Manufacturer Route ORAL ORAL Date:07/14/98ISR Number: 3104967-3Report Type:Expedited (15-DaCompany Report #034-0945-980004 Age:73 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 300 MG Initial or Prolonged (DAILY) PER PT Report Source Product Role Blister Foreign Neurontin PS Dermatitis Health Pruritus Professional Pyrexia Rash Maculo-Papular Company Representative Carbamazepine Amitriptyline C C Manufacturer Route ORAL ORAL Date:07/16/98ISR Number: 3105982-6Report Type:Expedited (15-DaCompany Report #001-0945-980447 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 3200 MG (800 Initial or Prolonged MG,QID), PER PT Report Source Product Role Inappropriate Health Neurontin PS Antidiuretic Hormone Professional Manufacturer Route ORAL Secretion ORAL Multiple Other Medications C Date:07/16/98ISR Number: 3105983-8Report Type:Expedited (15-DaCompany Report #001-0945-980392 Age:47 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 1500 MG Initial or Prolonged (,EVERY PT Report Source Product Role Coma Consumer Neurontin PS Lasix Tylenol W/Codeine Corag Lanoxin Humalog Humulin (Colchine) C C C C C C C Confusional State Convulsion NIGHT), PER Medication Error ORAL Pneumonia Tremor Ulcer Haemorrhage Date:07/16/98ISR Number: 3105987-5Report Type:Expedited (15-DaCompany Report #001-0945-980357 Age:42 YR Gender:Female I/FU:F Outcome Other 22-Aug-2005 Page: 39 PT Arthralgia Dermatitis Drug Hypersensitivity 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dyspnoea Face Oedema Increased Appetite Report Source Product Role Myalgia Health Neurontin PS Weight Increased Professional Stelazine Xanax C C Manufacturer Route Duration ORAL 3600 MG (900 MG, QID), PER ORAL Date:07/17/98ISR Number: 3108232-XReport Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Required 300 MG ONE Intervention to CAP, BY MOUTH Prevent Permanent Impairment/Damage PT Company Report # Report Source Bradycardia Product Role Gabapentin PS Lovastatin Docusate Hydrocortisone C C C Manufacturer Route Manufacturer Route Hypotension Date:07/20/98ISR Number: 3107255-4Report Type:Expedited (15-DaCompany Report #001-0945-980451 Age:8 DY Gender:Female I/FU:I Outcome Dose Duration Hospitalization 4400 MG Initial or Prolonged (,DAILY) SEE Other TEXT FOR PT Report Source Product Role Complications Of Maternal Health Neurontin PS Exposure To Therapeutic Professional Tegretol SS Drugs Dehydration THERAPY DATES Haemorrhage Intracranial 600 MG (,DAILY) SEE TEXT FOR THERAPY DATES (Folic Acid) C Date:07/21/98ISR Number: 3107303-1Report Type:Expedited (15-DaCompany Report #001-0073-980221 Age:52 YR Gender:Female I/FU:F Outcome Dose Other 300 MG (100 PT Report Source Product Role Manufacturer Route Blood Potassium Decreased Consumer Dilantin PS ORAL Neurontin Capsules 100 Mg (Gabapentin) SS ORAL Duration Diarrhoea MG, TID), PER Dysarthria ORAL Eyelid Oedema Face Oedema 900MG (100 Fluid Retention MG, TID) PER Memory Impairment ORAL Oedema Peripheral Tongue Oedema Weight Increased Glucotrol (Glipizide) K-Dur (Potassium Chloride) Date:07/28/98ISR Number: 3110720-7Report Type:Expedited (15-DaCompany Report #001-0945-980292 Age:51 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged Other Required 22-Aug-2005 Page: 40 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage Dose PT Report Source Product Role Adenoma Benign Health Neurontin PS Chills Professional Soma Hydrocodone Amitriptyline Prozac C C C C Manufacturer Route Duration ORAL 1200 MG (300 MG QID) PER Dysgeusia ORAL Dyspnoea Headache Lung Infiltration Pancreatitis Pneumonia Mycoplasmal Pyrexia Tongue Oedema Date:07/28/98ISR Number: 3110729-3Report Type:Expedited (15-DaCompany Report #001-0073-980221 Age:52 YR Gender:Female I/FU:F Outcome Dose Other 300 MG (100 PT Report Source Product Role Manufacturer Route Blood Potassium Decreased Health Dilantin PS ORAL Diarrhoea Professional Neurontin SS ORAL Glucotrol K-Dur C C Duration MG TID) PER Dysarthria ORAL Eyelid Oedema 900 MG (300 Face Oedema MG TID) PER Fluid Retention ORAL Memory Oedema Tongue Weight Impairment Peripheral Oedema Increased Date:07/31/98ISR Number: 3111333-3Report Type:Expedited (15-DaCompany Report #044-0945-980059 Age:35 YR Gender:Female I/FU:I Outcome Dose Death 3200MG PT Report Source Product Role Manufacturer Route Pulmonary Embolism Foreign Neurontin PS ORAL Zyprexa SS ORAL Camcolit Epilim Dolmatil Tertroxin Zimovane C C C C C Duration Health (1600MG,BID), Professional PER ORAL 100MG (, DAILY), PER ORAL Date:07/31/98ISR Number: 3252994-8Report Type:Periodic Age:71 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0991-980850 PT Report Source Product Role Manufacturer Route Oedema Peripheral Weight Increased Consumer Rezulin Tablets 400 Mg (Troglitazone) PS ORAL Neurontin Capsules 300 Mg (Gabapentin) SS ORAL Prilosec Mevacor C C Duration 400 MG (DAILY) PER ORAL 300 MG, PER ORAL 22-Aug-2005 Page: 41 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid Humulin Lasix Quinine Percocet C C C C C Date:08/04/98ISR Number: 3116637-6Report Type:Expedited (15-DaCompany Report #001-0945-980543 Age:26 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization (,TID), PER Initial or Prolonged ORAL PT Report Source Product Role Abdominal Pain Consumer Neurontin PS Lamictal Paxil Zyprexa Ancef C C C C Manufacturer Route ORAL Anxiety Condition Aggravated Lower Limb Fracture Pancreatitis Staphylococcal Infection Date:08/05/98ISR Number: 3113424-XReport Type:Expedited (15-DaCompany Report #033-0945-980020 Age:20 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Pyrexia Foreign Neurontin PS Rash Maculo-Papular Health Toxic Skin Eruption Professional Alepsal Gardenal Lansoyl Di-Antalvic C C C C Manufacturer Route ORAL ORAL Date:08/05/98ISR Number: 3113742-5Report Type:Direct Age:79 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged Creatinine Renal Clearance Decreased Oedema Peripheral Gabapentin Losartan Troglitrazone PS SS SS Date:08/07/98ISR Number: 3114479-9Report Type:Expedited (15-DaCompany Report #001-0945-980480 Age:41 YR Gender:Female I/FU:I Outcome Dose Disability 900MG PT Report Source Product Role Amnesia Consumer Neurontin PS Aphasia (300MG,TID), Arthritis PER ORAL Catatonia Confusional State 22-Aug-2005 Page: 42 Manufacturer Route Duration 10:40 AM Dilantin (Phenytoin Sodium) Unspecified Antihypertensive Meds Depakote Clonidine Prednisone C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/98ISR Number: 3114481-7Report Type:Expedited (15-DaCompany Report #001-0945-980533 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1500MG, Initial or Prolonged DAILY, PER PT Report Source Product Role Pulmonary Thrombosis Health Neurontin PS Phenytoin Coumadin (Warfarin Sodium) C Manufacturer Route ORAL Professional ORAL C Date:08/19/98ISR Number: 3118959-1Report Type:Expedited (15-DaCompany Report #002-0945-980014 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Other 300 MG DAILY PT Report Source Product Role Gait Disturbance Foreign Neurontin PS Lethargy Health Liver Function Test Abnormal Neuroleptic Malignant Syndrome Parkinson'S Disease Pyrexia Professional Sinemet (Levodopa, Carbidopa) C Manufacturer Route ORAL PER ORAL Date:08/19/98ISR Number: 3118964-5Report Type:Expedited (15-DaCompany Report #001-0945-980451 Age:8 DY Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Cerebral Haemorrhage UNKNOWN 4400 MG DAILY Initial or Prolonged Neonatal UNKNOWN Other Complications Of Maternal UNKNOWN 600 MG DAILY Report Source Product Role Health Neurontin PS Tegretol SS Professional Manufacturer Route Exposure To Therapeutic UNKNOWN Drugs Dehydration Date:08/19/98ISR Number: 3119094-9Report Type:Direct Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Required 300 MG TID PO Intervention to Prevent Permanent Impairment/Damage PT 22-Aug-2005 Page: 43 10:40 AM C Company Report # Product Role Abnormal Dreams Gabapentin PS Increased Appetite Platelet Count Decreased Red Blood Cell Count Decreased Thirst White Blood Cell Count Decreased Lorazepam Psyllium Premarin Paroxetine Furosemide Hydroxyzine Thiamine Hcl Multi-Vitamins C C C C C C C C Date:08/19/98ISR Number: 3119095-0Report Type:Direct Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Required 100 MG TID PO Intervention to Prevent Permanent Impairment/Damage (Folic Acid) PT Report Source Manufacturer Route ORAL Company Report # Report Source Product Role Aggression Gabapentin PS Agitation Hallucination Multi-Vitamins C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/98ISR Number: 3119097-4Report Type:Direct Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Required 300 MG/QD/PO Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Fall Gabapentin PS Gait Disturbance Thiothixene Multi-Vitamins Benztropine Mesylate Lactulose C C C C Manufacturer Route ORAL Date:08/20/98ISR Number: 3119479-0Report Type:Expedited (15-DaCompany Report #033-0945-980026 Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 900 MG (300 Initial or Prolonged MG, TID) PT Report Source Product Role Fall Foreign Neurontin PS Femoral Neck Fracture Health Muscular Weakness Professional Lioresal (Baclofen) C Manufacturer Route ORAL Date:08/26/98ISR Number: 3121928-9Report Type:Expedited (15-DaCompany Report #001-0945-980578 Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 200 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Asthenia Consumer Neurontin PS Sinemet Empirin Tylenol Klonopin Prozac Amantadine Mirapex C C C C C C C Confusional State Coordination Abnormal ORAL Dehydration Fatigue Haemoglobin Decreased Nightmare Platelet Count Decreased Manufacturer Route ORAL Date:08/27/98ISR Number: 3122068-5Report Type:Direct Age:86 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 100 MG TID Initial or Prolonged PT Company Report # Report Source Confusional State Product Role Neurontin PS Manufacturer Route Manufacturer Route Coordination Abnormal Dizziness Dysarthria Date:09/01/98ISR Number: 3124222-5Report Type:Expedited (15-DaCompany Report #049-0945-980016 Age:1 DY Gender:Male I/FU:I Outcome Dose Other IN UTERO PT Report Source Product Role Anaemia Foreign Neurontin PS Apgar Score Low Health Complications Of Maternal Professional Valproate SS Duration EXPOSURE 3 MG DAILYExposure To Therapeutic IN UTERO Drugs EXPOSURE Neonatal Apnoeic Attack 22-Aug-2005 Page: 44 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/98ISR Number: 3124225-0Report Type:Expedited (15-DaCompany Report #049-0945-980017 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged 3 GM DAILY PT Report Source Product Role Convulsion Foreign Neurontin PS ORAL Health Valproate SS ORAL Manufacturer Route Professional PER ORAL Date:09/01/98ISR Number: 3124785-XReport Type:Expedited (15-DaCompany Report #001-0945-980608 Age:22 YR Gender:Female I/FU:I Outcome Dose Duration Other 2400 MG (900 PT Report Source Product Role Arthralgia Consumer Neurontin PS Felbatol SS Manufacturer Route Manufacturer Route Breast Hyperplasia MG QAM, 600 Complications Of Maternal MG QNOON AND Exposure To Therapeutic QPM, 300 MG Drugs QHS) IN UTERO Hirsutism 400 MG DAILY, Migraine IN UTERO Precocious Puberty EXPOSURE Date:09/03/98ISR Number: 3125675-9Report Type:Direct Age:34 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG TID PO Initial or Prolonged PT Dyspnoea Tongue Coated Tongue Disorder Company Report # Report Source Product Role Neurantin PS ORAL Urticaria Date:09/04/98ISR Number: 3126807-9Report Type:Expedited (15-DaCompany Report #001-0945-980618 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1500 MG (500 Initial or Prolonged MG, TID), PER Other ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Coronary Artery Occlusion Health Neurontin PS Inappropriate Professional Coumadin Trazodone Lasix Serzone Rezulin C C C C C Manufacturer Route ORAL Antidiuretic Hormone Secretion Date:09/08/98ISR Number: 3127826-9Report Type:Expedited (15-DaCompany Report #033-0945-980020 Age:20 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 1200 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Acne Foreign Neurontin PS Pyrexia Health Rash Maculo-Papular Professional Alepsal Gardenal Lansoyl Di-Antalvic C C C C ORAL Toxic Skin Eruption 22-Aug-2005 Page: 45 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/98ISR Number: 3127350-3Report Type:Expedited (15-DaCompany Report #001-0945-980578 Age:72 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 200 MG DAILY Initial or Prolonged PER ORAL PT Report Source Product Role Asthenia Consumer Neurontin PS Sinemet Tylenol Klonopin Prozac Amantadine Mirapex C C C C C C Route ORAL Confusional State Coordination Abnormal Dehydration Dyskinesia Fatigue Feeding Disorder Haemoglobin Decreased Nightmare Platelet Count Decreased Vitamin B12 Decreased Date:09/11/98ISR Number: 3128706-5Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 200 MG TID Initial or Prolonged ORAL Manufacturer PT Company Report # Report Source Bleeding Time Prolonged Product Role Gabapentin PS Ciprofloxacin Ranitidine Sulfameth/Trimeth C C C Manufacturer Route ORAL Blood Fibrinogen Increased Haematocrit Decreased Haemoptysis Thrombocytopenia Date:09/13/98ISR Number: 3134279-3Report Type:Expedited (15-DaCompany Report #001-0945-980447 Age:65 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 3200 MG (800 PT Report Source Product Role Inappropriate Antidiuretic Hormone Health Professional Neurontin (Gabapentin) PS Secretion MG QID) PER Manufacturer Route ORAL ORAL Multiple Other Medications (Unspecified) Date:09/15/98ISR Number: 3237561-4Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #8-98175-071A PT Report Source Product Role Anaemia Consumer Duract PS Neurontin Ergomar Imipiramine Talacen Vicodin Zoloft SS C C C C C Manufacturer Route Duration Cough Date:09/16/98ISR Number: 3131206-XReport Type:Direct Age:38 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Aug-2005 Page: 46 C 10:40 AM Company Report # ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Dose Report Source Vaginal Haemorrhage 300 MG Product Role Neurontin PS Prozac Ultram C C Manufacturer Route Manufacturer Route Duration 3 QHS Date:09/17/98ISR Number: 3131069-2Report Type:Direct Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Required 300 MG BID Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Dyspnoea Neurontin PS Fluid Retention Pharyngeal Oedema Elavil Premarin Lasix Ms Contin Ultram Tranxene Entex La Vancenase Nasal Spray C C C C C C C ORAL C Date:09/22/98ISR Number: 3134274-4Report Type:Expedited (15-DaCompany Report #044-0945-980059 Age:35 YR Gender:Female I/FU:F Outcome Dose Duration Death 3200 MG (1600 PT Report Source Product Role Manufacturer Route Pulmonary Embolism Foreign Neurontin PS ORAL Zyprexa SS ORAL Health MG, BID) PER Professional ORAL 10 MG DAILY PER ORAL Camcolit (Lithium Carbonate) Epilim (Valproate Sodium) Dolmatil (Sulpiride) Tertroxin (Liothyronine Sodium) Zimovane (Zopiclone) C C C C C Date:09/23/98ISR Number: 3134277-XReport Type:Expedited (15-DaCompany Report #001-0945-980543 Age:26 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization UNKNOWN TID Initial or Prolonged PER ORAL PT Report Source Product Role Abdominal Pain Consumer Neurontin PS Lamictal Paxil Zyprexa (Olanzapine) Ancef (Cefazolin Sodium) C C C Lower Limb Fracture Pancreatitis Staphylococcal Infection 22-Aug-2005 Page: 47 10:40 AM C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/98ISR Number: 3136219-XReport Type:Expedited (15-DaCompany Report #001-0945-98-649 Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Death 2400 MG (800 Hospitalization MG TID), PER Initial or Prolonged ORAL PT Report Source Product Role Pneumonia Health Neurontin PS Respiratory Failure Professional Manufacturer Route ORAL Date:10/01/98ISR Number: 3137324-4Report Type:Expedited (15-DaCompany Report #033-0945-980037 Age:1 DY Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly 3 TABLET Other (DAILY) PT Report Source Product Role Complications Of Maternal Foreign Neurontin PS Exposure To Therapeutic Health Drugs Professional Manufacturer Route Manufacturer Route PLACETAL Foetal Distress Syndrome Foetal Growth Retardation Neonatal Respiratory Distress Syndrome Depamide (Valpromide) Tranxene (Clorazepate Dipotassium) C C Date:10/01/98ISR Number: 3137327-XReport Type:Expedited (15-DaCompany Report #049-0945-980016 Age:1 DY Gender:Male I/FU:F Outcome Dose Duration Hospitalization IN UTERO Initial or Prolonged EXPOSURE Congenital Anomaly 3 GM DAILYOther IN UTERO PT Report Source Product Role Apgar Score Low Foreign Neurontin PS Blood Incompatibility Health Haemolytic Anaemia Of Professional Valproate SS Newborn Complications Of Maternal EXPOSURE Exposure To Therapeutic Drugs Congenital Central Nervous System Anomaly Convulsion Premature Labour Date:10/01/98ISR Number: 3137329-3Report Type:Expedited (15-DaCompany Report #049-0945-980017 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged 3 GM DAILY PT Report Source Product Role Manufacturer Route Complications Of Maternal Foreign Neurontin PS ORAL Exposure To Therapeutic Health Valproate SS ORAL Drugs Professional Diazepam SS Felbamate SS PER ORAL Epilepsy INTRAVENOUS Premature Labour INTRAVENOUS INTRAVENOUS INTRAVENOUS Date:10/01/98ISR Number: 3260849-8Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #001-0073-970439 PT Report Source Product Role Manufacturer Route Convulsion Drug Level Below Therapeutic Health Professional Dilantin Kalseals 100 Mg (Phenytoin Sodium) PS ORAL Neurontin 400 Mg (Gabapentin) SS ORAL 300/400 MG Pneumonia (QHS), PER ORAL 3600 MG DAILY 22-Aug-2005 Page: 48 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (400 MG) PER ORAL Cardizem Isordil C C Date:10/02/98ISR Number: 3137732-1Report Type:Expedited (15-DaCompany Report #001-0073-980398 Age:63 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 500 MG DAILY Initial or Prolonged PER ORAL UNKNOWN PT Report Source Product Role Convulsion Consumer Dilantin Kapseals PS Neurontin SS Folic Acid Norvasc (Amlodipine Besilate) Lipitor (Atorvastatin) C Manufacturer Route ORAL Drug Interaction Erectile Dysfunction 2400 MG (400 Medication Error MG DAILY Myocardial Infarction UNKNOWN Pulmonary Oedema C C Date:10/05/98ISR Number: 3138779-1Report Type:Expedited (15-DaCompany Report #001-0945-980412 Age:7 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 300 MG (EVERY Initial or Prolonged 8 HOURS), PER Other ORAL 8 HR PT Report Source Product Role Anaemia Health Neurontin PS Condition Aggravated Professional Tetrabenazine Lorazepam Chloral Hydrate Acetaminophen Ibuprofen SS C C C C Haematocrit Decreased Haemoglobin Decreased Haemorrhage Manufacturer Route ORAL Vancomycin Ceftazidime Cefazolin C C C Date:10/06/98ISR Number: 3138768-7Report Type:Expedited (15-DaCompany Report #001-0945-980665 Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Other 3600 MG DAILY PT Report Source Product Role Abortion Spontaneous Health Neurontin PS Manufacturer Route Manufacturer Route Professional Date:10/06/98ISR Number: 3138771-7Report Type:Expedited (15-DaCompany Report #001-0945-980691 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Other 1200 MG (400 PT Report Source Product Role Cardiac Arrest Consumer Neurontin PS Dysphonia MG, TID) PER ORAL Prilosec (Omeprazole) Klonopin (Clonazepam) Welbutrin (Amfebutamone Hydrochloride) Prolupsid 22-Aug-2005 Page: 49 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Cisapride) Buspar (Buspirone Hydrochloride) C C Date:10/06/98ISR Number: 3138774-2Report Type:Expedited (15-DaCompany Report #049-0945-980019 Age: Gender:Female I/FU:I Outcome Dose Other PER ORAL PT Report Source Product Role Agranulocytosis Foreign Neutrontin PS Manufacturer Route Duration ORAL Health Professional Date:10/07/98ISR Number: 3139352-1Report Type:Expedited (15-DaCompany Report #9905902 Age:36 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 25.000 MG PO Initial or Prolonged QD Other PT Report Source Product Role Aphasia Foreign Gabitril PS Gabapentin Carbamazepine SS C Manufacturer Route ORAL Convulsion Neurosis Obsessive Thoughts Status Epilepticus Date:10/13/98ISR Number: 3141708-8Report Type:Expedited (15-DaCompany Report #001-0945-980692 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1500 MG Initial or Prolonged (DAILY) PER Disability ORAL PT Report Source Product Role Benign Hepatic Neoplasm Health Neurontin PS Deafness Professional Lithium Buspirone Carbamazepine C C C Haemangioma Ototoxicity Manufacturer Route ORAL Date:10/13/98ISR Number: 3142422-5Report Type:Expedited (15-DaCompany Report #001-0945-980693 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG DAILY Initial or Prolonged PER ORAL PT Report Source Product Role Anxiety Consumer Neurontin PS Darvocet-N Humulin-R Humulin-N C C C Manufacturer Route ORAL Myocardial Infarction Paraesthesia Rash Erythematous Date:10/13/98ISR Number: 3142473-0Report Type:Expedited (15-DaCompany Report #033-0945-980038 Age: Gender:Not SpecifiI/FU:I Outcome Dose Death PLACENTAL 22-Aug-2005 Page: 50 PT Report Source Product Role Complications Of Maternal Foreign Neurontin PS Exposure To Therapeutic Drugs Intra-Uterine Death Neoplasm Health Professional Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/98ISR Number: 3142512-7Report Type:Expedited (15-DaCompany Report #033-0945-980034 Age: Gender:Female I/FU:I Outcome Dose Other ORAL PT Report Source Product Role Abortion Spontaneous Foreign Neurontin PS Complications Of Maternal Exposure To Therapeutic Drugs Mass Health Professional Manufacturer Route Duration ORAL Date:10/15/98ISR Number: 3143029-6Report Type:Expedited (15-DaCompany Report #001-0945-980578 Age:72 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 200 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Confusional State Consumer Neurontin PS Sinemet Empirin Tylenol Klonopin Prozac Amantadine Mirapex C C C C C C C Manufacturer Route ORAL Coordination Abnormal Dehydration ORAL Fatigue Haemoglobin Decreased Muscular Weakness Nightmare Platelet Count Decreased Vitamin B12 Decreased Date:10/16/98ISR Number: 3143128-9Report Type:Expedited (15-DaCompany Report #033-0945-980034 Age:31 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Foreign Health Neurontin (Gabapentin) PS 2400MG Professional (DAILY) PER ORAL Manufacturer Route Duration ORAL Tegretol C Date:10/16/98ISR Number: 3143129-0Report Type:Expedited (15-DaCompany Report #033-0945-980038 Age: Gender:Unknown I/FU:F Outcome Dose Death PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Foreign Health Neurontin (Gabapentin) PS Drugs Professional Tegretol C Manufacturer Route Duration OTHER 2400MG (DAILY) Foetal Disorder PLACENTTAL Neoplasm Date:10/19/98ISR Number: 3144271-0Report Type:Direct Age:71 YR Gender:Male I/FU:I Outcome Dose Other ALPHA PT Company Report # Report Source Product Role Manufacturer Route Tegretol PS ORAL Gabapentin SS ORAL Duration Cognitive Disorder Condition Aggravated CAPSULES PO, Depressed Level Of BETA TABLETS Consciousness PO, DOUBLE BLINDED ALPHA CAPSULES PO, BETA TABLETS PO, DOUBLE 22-Aug-2005 Page: 51 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report BLINDED Lamotrigine SS ORAL ALPHA CAPSULES PO, BETA TABLETS PO, DOUBLE BLINDED Date:10/28/98ISR Number: 3149020-8Report Type:Expedited (15-DaCompany Report #001-0945-980759 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Drug Interaction Drug Toxicity Gastrointestinal Motility Disorder Intentional Misuse Health Professional Neurontin Tylenol PS SS Manufacturer Route Manufacturer Route Date:10/29/98ISR Number: 3149662-XReport Type:Expedited (15-DaCompany Report #001-0945-980748 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Death 1200 MG (600 PT Report Source Product Role Depression Health Neurontin PS Euphoric Mood Professional Prozac Ultram Lodine C C C MG BID) PER ORAL Date:10/29/98ISR Number: 3149665-5Report Type:Expedited (15-DaCompany Report #001-0945-980760 Age:40 YR Gender:Female I/FU:I ORAL Outcome Dose Other 900 MG (300 PT Report Source Product Role Convulsion Consumer Neurontin PS Dilantin SS Estrace Prilosec Ms Contin C C C Manufacturer Route Duration ORAL Drug Interaction MG TID) PER Meningitis ORAL Oedema Peripheral 200 MG IN AM; 300 MG IN PM Date:10/30/98ISR Number: 3150210-9Report Type:Expedited (15-DaCompany Report #9834536 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Required 50.00 MG Intervention to TOTAL:PRN:ORA Prevent Permanent L Impairment/Damage 50.00 MG PT Report Source Product Role Manufacturer Route Arthralgia Consumer Vistaril PS ORAL Zoloft SS ORAL Neurontin SS ORAL Synthroid C Hypersensitivity Paralysis TOTAL:DAILY:O RAL 600.00 MG TOTAL:TID:ORA L 22-Aug-2005 Page: 52 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3150242-0Report Type:Expedited (15-DaCompany Report #001-0945-980749 Age:5 YR Gender:Male I/FU:I Outcome Dose Other 300 MG PT Report Source Product Role Neurontin PS Diamox C Manufacturer Route Duration Benign Intracranial ORAL Hypertension (DAILY), PER ORAL Date:11/02/98ISR Number: 3150275-4Report Type:Expedited (15-DaCompany Report #1998-002643 Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 200 MG/PO Initial or Prolonged 2000 MG/PO PT Report Source Product Role Manufacturer Route Anaemia Foreign Viramune PS ORAL Ascites Study Nelfinavir SS ORAL Asthenia Health Indinavir SS ORAL Balance Disorder Professional Nevrontin SS ORAL Acyclovir Septra Ds Megace Losec Stemetil Ms Contin Clarithromycin Ethambutol Fluconazole C C C C C C C C C 2400 MG/PO 1200 MG/PO Blood Alkaline Phosphatase Increased Blood Creatinine Increased Blood Lactate Dehydrogenase Increased Blood Sodium Decreased Depressed Level Of Consciousness Diarrhoea Dyspnoea Fall Haemoglobin Decreased Heart Rate Increased Hypotension Malaise Metabolic Acidosis Nausea Oedema Peripheral Oral Intake Reduced Ph Urine Decreased Proteinuria Renal Failure Acute Renal Tubular Disorder Sedation Vomiting Date:11/02/98ISR Number: 3151612-7Report Type:Expedited (15-DaCompany Report #001-0945-980716 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Convulsion Health Professional Neurontin PS Duration Date:11/02/98ISR Number: 3152104-1Report Type:Expedited (15-DaCompany Report #9834323 Age:72 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 53 10:40 AM PT Balance Disorder Drug Interaction Nervous System Disorder Report Source Foreign Health Professional Company Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Dose Product Role Manufacturer Diflucan PS ORAL Gabapentin SS ORAL Prednisolone SS ORAL Route Duration 50.00 MG TOTAL; DAILY; ORAL 400.00 MG TOTAL; ORAL ORAL Date:11/02/98ISR Number: 3268071-6Report Type:Periodic Age:71 YR Gender:Female I/FU:F Outcome Dose Other Company Report #001-0991-980850 PT Report Source Product Role Manufacturer Route Oedema Peripheral Weight Increased Consumer Rezulin Tablets 400 Mg (Troglitazone) PS ORAL Neurontin Capsules 300 Mg (Gabapentin) SS ORAL Duration 400 MG (,DAILY), PER ORAL 300 MG, PER ORAL Prilosec (Omeprazole) Mevacor (Lovastatin) Synthroid (Levothyroxine Sodium) Humulin (Insulin Human Injection, Isophane) Lasix (Furosemide) C C C C C (Quinine) Percocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone Date:11/02/98ISR Number: 3271014-2Report Type:Periodic Age:69 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #001-0991-981543 PT Report Source Product Role Manufacturer Route Oedema Peripheral Weight Increased Consumer Rezulin Tablets 200 Mg (Troglitazone) PS ORAL Neurontin (Gabapentin) SS ORAL Humulin Dyazide Hyzaar Catapres Indocin Lipitor Zoloft C C C C C C C Duration 200 MG (, DAILY), PER ORAL 600 MG (,TID), PER ORAL 22-Aug-2005 Page: 54 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/98ISR Number: 3152772-4Report Type:Expedited (15-DaCompany Report #001-0945-980783 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 400 MG (100 Initial or Prolonged MG, QID), PER PT Report Source Product Role Diarrhoea Consumer Neurontin PS Cozaar Insulin Nph Insulin Proamatine Lasix C C C C C Manufacturer Route ORAL Dizziness Orthostatic Hypotension ORAL Date:11/06/98ISR Number: 3153238-8Report Type:Direct Age:46 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Dermatitis UNKNOWN UNKNOWN 3 Initial or Prolonged Face Oedema Pruritus Company Report # Report Source Product Role Health Neurontin PS Professional Dilantin C Manufacturer Route Manufacturer Route DAY Date:11/09/98ISR Number: 3154270-0Report Type:Expedited (15-DaCompany Report #001-0073-980398 Age:63 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 500 MG (, Initial or Prolonged DAILY), PER PT Report Source Product Role Convulsion Consumer Dilantin PS Neurontin SS (Folic Acid) C Drug Interaction Erectile Dysfunction ORAL Myocardial Infarction 2400 MG (2400 Pulmonary Oedema MG, DAILY) ORAL Norvasc Lipitor Neurontin .. C C C C Date:11/09/98ISR Number: 3154759-4Report Type:Expedited (15-DaCompany Report #001-0945-980665 Age:29 YR Gender:Female I/FU:F Outcome Dose Other UNKNOWN PT Report Source Product Role Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration Abortion Spontaneous Complications Of Maternal 3600 MG DAILY Exposure To Therapeutic UNKNOWN Drugs Date:11/11/98ISR Number: 3155171-4Report Type:Direct Age:40 YR Gender:Male I/FU:I Outcome Dose Other 300MG QID PT Company Report # Report Source Product Role Manufacturer Route Neurontin PS Parke-Davis ORAL Duration Thrombocytopenia Date:11/13/98ISR Number: 3157205-XReport Type:Expedited (15-DaCompany Report #001-0945-980692 Age:44 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 55 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Dose PT Report Source Product Role Benign Hepatic Neoplasm Condition Aggravated Health Professional Neurontin (Gabapentin) PS Lithium Buspirone Carbamazepine C C C Manufacturer Route Duration ORAL 1500 MG DAILY Deafness Neurosensory PER ORAL Haemangioma Ototoxicity Date:11/16/98ISR Number: 3158141-5Report Type:Expedited (15-DaCompany Report #049-0945-980019 Age:71 YR Gender:Female I/FU:F Outcome Dose Duration Death 1200 MG Hospitalization (DAILY), PER Initial or Prolonged ORAL Other 40 MG PT Report Source Product Role Agranulocytosis Foreign Neurontin PS ORAL Cardiac Arrest Health Cardiac Failure Professional Antra SS ORAL Arelix SS ORAL Lopirin Phenhydan Xanef Lopedium Lasix C C C C C Clonic Convulsion Manufacturer Route Condition Aggravated (DAILY), PER Convulsion ORAL Csf Protein Increased 6 MG (DAILY0, Delirium PER ORAL Depressed Level Of Consciousness Depression Diarrhoea Encephalopathy Gastrointestinal Haemorrhage Infection Multi-Organ Failure Pneumonia Proteinuria Psychotic Disorder Renal Failure Respiratory Failure Sepsis Staphylococcal Sepsis Whipple'S Disease Date:11/19/98ISR Number: 3160681-XReport Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1 TID Initial or Prolonged PT Company Report # Report Source Product Role Manufacturer Route Cystitis Neurontin PS Parke-Davis ORAL Fibroadenoma Of Breast Head Injury Lung Disorder Pneumonia Tricuspid Valve Incompetence Darvocet Percocet Mebaral Tenormin C C C C Manufacturer Route Date:11/20/98ISR Number: 3160861-3Report Type:Expedited (15-DaCompany Report #001-0945-980830 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1800 MG (600 Initial or Prolonged MG, TID), PER 22-Aug-2005 Page: 56 10:40 AM PT Report Source Product Role Delirium Health Neurontin PS Intentional Misuse Professional ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Neurontin SS Date:11/23/98ISR Number: 3161609-9Report Type:Expedited (15-DaCompany Report #001-0945-980829 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Other 900 MG (300 Required MG TID) PER Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Anaphylactic Reaction Consumer Neurontin PS Bactrim Atarax Prozac Reglan Xanax Prevacid SS C C C C C Manufacturer Route ORAL Anuria Pruritus Date:11/27/98ISR Number: 3163650-9Report Type:Expedited (15-DaCompany Report #9839160 Age:31 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 50.00 MG Initial or Prolonged TOTAL:DAILY Required Intervention to ORAL Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Alcohol Problem Consumer Zoloft PS ORAL Navane Alcohol SS SS ORAL ORAL Neurontin SS ORAL Buspar Cozaar C C Intentional Misuse Date:11/30/98ISR Number: 3163941-1Report Type:Expedited (15-DaCompany Report #9838796 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 5.00 MG Initial or Prolonged TOTAL: DAILY: Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Arterial Occlusive Consumer Glucotrol PS ORAL Congestive Neurontin SS ORAL Diabetic Neuropathy Emotional Disorder Fluid Retention Glycosylated Haemoglobin Increased Haematoma Oedema Peripheral Peripheral Coldness Pseudomonas Infection Skin Discolouration Skin Ulcer Staphylococcal Infection Wound Infection Glucophage Propulsid Prilosec Zocor Vitamins C C C C C Disease Cardiac Failure Date:11/30/98ISR Number: 3164189-7Report Type:Expedited (15-DaCompany Report #001-0945-980839 Age: Gender:Male I/FU:I Outcome Dose Other X 1 DOSE 22-Aug-2005 Page: 57 PT Report Source Product Role Feeling Abnormal Consumer Neurontin PS Suicidal Ideation Other Duration 1 DAY 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/98ISR Number: 3165284-9Report Type:Expedited (15-DaCompany Report #033-0945-980038 Age: Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Abortion Missed Complications Of Maternal Foreign Health Neurontin (Gabapentin) PS Exposure To Therapeutic Professional Tegretol C Manufacturer Route Manufacturer Route Manufacturer Route Duration 2400 MG (,DAILY), Drugs PLACENTAL Congenital Anomaly Hydrops Foetalis Mediastinum Neoplasm Neuroblastoma Oedema Teratoma Date:12/01/98ISR Number: 3165338-7Report Type:Expedited (15-DaCompany Report #001-0945-980840 Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Psychiatric Symptom Consumer Neurontin PS Duration Date:12/02/98ISR Number: 3165631-8Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Other 150 MG PO QD; PT Complications Of Maternal Company Report # Report Source Product Role Phenobarbital PS Klonapin SS Exposure To Therapeutic SEE IMAGE FOR Drugs THERAPY Sedation 1 MG; SEE Small For Dates Baby IMAGE FOR THERAPY ORAL Neurontin SS 1300 MG; SEE IMAGE FOR THERAPY Date:12/04/98ISR Number: 3166592-8Report Type:Expedited (15-DaCompany Report #001-0945-980859 Age: Gender:Female I/FU:I Outcome Dose Disability 900 MG (, PT Report Source Product Role Deafness Health Neurontin PS Manufacturer Route Manufacturer Route Duration Professional DAILY) Date:12/04/98ISR Number: 3167133-1Report Type:Expedited (15-DaCompany Report #001-0945-980749 Age:5 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Benign Intracranial Hypertension Health Professional Neurontin (Gabapentin) PS Diamox C Duration 300 MG (DAILY), PER ORAL 22-Aug-2005 Page: 58 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/98ISR Number: 3168027-8Report Type:Expedited (15-DaCompany Report #001-0945-980649 Age:74 YR Gender:Male I/FU:F Outcome Dose Duration Death 2400 MG (800 Hospitalization MG, TID) PER Initial or Prolonged ORAL 1 YR PT Report Source Product Role Acute Respiratory Health Neurontin PS Distress Syndrome Professional Manufacturer Route ORAL Lung Disorder Necrosis Pneumonia Respiratory Failure Date:12/07/98ISR Number: 3168258-7Report Type:Direct Age:67 YR Gender:Female I/FU:I Outcome Dose PT Company Report # Report Source Product Role Gabapentin PS Amlodipine Besylate Multi-Vitamins Lactulose Glipizide Metformin Carbamazepine Lorazepam C C C C C C C Manufacturer Route Duration Abnormal Behaviour ORAL 300 MG / QHS Coordination Abnormal / PO Hypomania Date:12/07/98ISR Number: 3168267-8Report Type:Direct Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Other 300 MG AM PO PT Ecchymosis Company Report # Report Source Product Role Neurontin PS Paxil Coumadin C C Manufacturer Route ORAL Date:12/09/98ISR Number: 3168761-XReport Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 400 MG PO BID Initial or Prolonged Other PT Company Report # Report Source Diplopia Product Role Neurontin PS Manufacturer Route ORAL Date:12/09/98ISR Number: 3169039-0Report Type:Expedited (15-DaCompany Report #001-0945-980860 Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Required 1200 MG (600 Intervention to MG, BID) PER Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Anaphylactic Shock Health Neurontin PS Bronchospasm Professional Paxil C Cough Dyspnoea Face Oedema Date:12/09/98ISR Number: 3169210-8Report Type:Expedited (15-DaCompany Report #001-0073-980589 Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 59 10:40 AM PT Drug Effect Decreased Liver Function Test Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Platelet Count Decreased Dose Report Source Product Health Professional Dilantin (Phenytoin Sodium) Neurontin (Gabapentin) Role Manufacturer Route Duration PS SS ORAL 4800 MG (DAILY), PER ORAL Unspecified Chemotherapy Phenobarb Neurontin Date:12/10/98ISR Number: 3169886-5Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT SS C C Company Report # Report Source Flushing Swelling Product Role Neutontin Aspirin Some Inhalers PS C C Manufacturer Route Manufacturer Route Date:12/14/98ISR Number: 3170533-7Report Type:Expedited (15-DaCompany Report #981207-016014873 Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 75 MG, BID, Required ORAL Intervention to 500 MG, QD, Prevent Permanent ORAL PT Report Source Product Role Alanine Aminotransferase Increased Foreign Health Topamax (Topiramate) Tablets PS ORAL Aspartate Professional Paracetamol SS ORAL Aminotransferase Increased Impairment/Damage 600 MG, QD, Blood Bilirubin Increased Gabapentin SS ORAL Vigabatrin SS ORAL Blood Creatinine ORAL Increased 2 UNKNOWN, Drug Toxicity BID, ORAL Encephalopathy Gamma-Glutamyltransferase Increased Hepatitis Renal Failure Acute Sepsis Date:12/14/98ISR Number: 3170599-4Report Type:Expedited (15-DaCompany Report #046-0945-980003 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization SEE TEXT, PER Initial or Prolonged ORAL PT Report Source Product Role Epilepsy Foreign Neurontin PS Grand Mal Convulsion Health Renitec Seloken Trombyl Cipramil Lamictal C C C C C Professional 22-Aug-2005 Page: 60 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/98ISR Number: 3171087-1Report Type:Expedited (15-DaCompany Report #001-0945-980874 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG (200 Initial or Prolonged MG TID) PER PT Report Source Product Role Condition Aggravated Consumer Neurontin PS Vitamin Nos Zantac Multivitamins(Ergoca lciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, Vitamin B-12 C C Manufacturer Route ORAL Schizophrenia Stress ORAL C C Date:12/16/98ISR Number: 3170868-8Report Type:Expedited (15-DaCompany Report #001-0945-980870 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Idiopathic Thrombocytopenic Purpura Health Professional Neurontin (Gabapentin) PS Date:12/16/98ISR Number: 3231547-1Report Type:Periodic Age:49 YR Gender:Female I/FU:F Outcome Dose Duration Other 25MG DAILY AS Manufacturer Route Manufacturer Route Company Report #8-98175-071A PT Report Source Product Role Anaemia Health Duract PS ORAL Cough Professional Neurontin (Gabapentin) SS ORAL Ergomar C NEEDED ORAL 300MG DAILY ORAL Imipramine Klonopin Lipitor Neurontin Premarin Reglan Vicodin Vitamin E Zoloft C C C C C C C C C Date:12/17/98ISR Number: 3171707-1Report Type:Expedited (15-DaCompany Report #001-0945-980608 Age:22 MON Gender:Female I/FU:I Outcome Dose Duration Other 2400 MG (,900 PT Report Source Product Role Arthralgia Consumer Neurontin PS Felbatol SS Complications Of Maternal MG QAM, 60 MG Exposure To Therapeutic QNOON AND Drugs QPM, 300 MG Hair Growth Abnormal QHS), OTHER) Hypertrophy Breast 400 MG Migraine (,DAILY), Precocious Puberty OTHER 22-Aug-2005 Page: 61 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/98ISR Number: 3171710-1Report Type:Expedited (15-DaCompany Report #001-0945-980869 Age:64 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Medication Error Sepsis Health Professional Neurontin PS Manufacturer Route Manufacturer Route Date:12/17/98ISR Number: 3171727-7Report Type:Expedited (15-DaCompany Report #001-0073-980597 Age:14 YR Gender:Male I/FU:I Outcome Dose Other 100MG PT Report Source Product Role Idiopathic Health Dilantin PS ORAL Thrombocytopenic Purpura Professional Neurontin SS ORAL Duration AM/200MG PM, PER ORAL 1200MG (600MG BID) PER ORAL Date:12/18/98ISR Number: 3171758-7Report Type:Expedited (15-DaCompany Report #049-0945-980025 Age: Gender:Male I/FU:I Outcome Dose Death 2400 MG PT Report Source Product Role Renal Impairment Foreign Neurontin PS Manufacturer Route Duration Health (,DAILY), PER Professional ORAL Company Representative Date:12/22/98ISR Number: 3173529-4Report Type:Direct Age:54 YR Gender:Female I/FU:I Company Report # ORAL Outcome Dose Duration Hospitalization Initial or Prolonged PT Acute Tonsillitis Angioneurotic Oedema Dermatitis Face Oedema Liver Function Test Abnormal Rash Generalised Rash Maculo-Papular Stomatitis Throat Irritation Urinary Tract Infection Date:12/29/98ISR Number: 3174159-0Report Type:Direct Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG PO TID Initial or Prolonged +100 MG HS 2 Disability DAYS 22-Aug-2005 Page: 62 10:40 AM Report Source PT Tardive Dyskinesia Product Role Phenytoin Gabapentin PS SS Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Gabapentin PS Clozapine Baclofen I-Thyroxine Ipratropium C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/98ISR Number: 3176418-4Report Type:Expedited (15-DaCompany Report #001-0945-980839 Age:46 YR Gender:Male I/FU:F Outcome Dose Other X 1 DOSE PT Report Source Product Role Feeling Abnormal Health Neurontin PS Mania Suicidal Ideation Professional Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:12/30/98ISR Number: 3176821-2Report Type:Expedited (15-DaCompany Report #001-0945-980859 Age: Gender:Female I/FU:F Outcome Dose Disability 900 MG PT Report Source Product Role Deafness Health Neurontin PS Duration Professional (DAILY) Date:12/30/98ISR Number: 3176825-XReport Type:Expedited (15-DaCompany Report #049-0945-980025 Age:73 YR Gender:Male I/FU:F Outcome Dose Duration Death 3200 MG (800 Hospitalization MG, QID), PER Initial or Prolonged ORAL PT Report Source Product Role Arrhythmia Foreign Neurontin PS Blood Urea Decreased Health Cardio-Respiratory Arrest Professional Creatinine Renal Clearance Decreased Dehydration Drug Toxicity Electrolyte Imbalance Pulmonary Embolism Renal Impairment Vomiting ORAL Date:12/31/98ISR Number: 3177135-7Report Type:Expedited (15-DaCompany Report #001-0945-980829 Age:50 YR Gender:Female I/FU:F Outcome Dose Duration Other Required 900 MG (300 Intervention to MG, TID) PER Prevent Permanent ORAL Impairment/Damage UNKNOWN PT Report Source Product Role Anaphylactoid Reaction Pruritus Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Bactrim (Sulfamethoxazole, Trimethoprim) SS Manufacturer Route ORAL UNKNOWN Atarax (Hydroxyzine Hydrochloride) Prozac (Fluoxetine Hydrochloride) Reglan (Metoclopramide) Xanax (Alprazolam) Prevacid (Lansoprazole) C C C C C Date:01/06/99ISR Number: 3177774-3Report Type:Expedited (15-DaCompany Report #001-0945-980830 Age:51 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 1800 MG (600 Initial or Prolonged MG TID) PER 22-Aug-2005 Page: 63 10:40 AM PT Report Source Product Role Delirium Health Neurontin PS Intentional Misuse Professional Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:01/06/99ISR Number: 3177775-5Report Type:Expedited (15-DaCompany Report #001-0945-980919 Age:34 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100 MG (QHS), Initial or Prolonged PER ORAL; PT Report Source Product Role Blindness Consumer Neurontin PS Prozac C Manufacturer Route ORAL Dizziness Headache Histoplasmosis Paraesthesia Sedation Vision Blurred Date:01/11/99ISR Number: 3179461-4Report Type:Expedited (15-DaCompany Report #111386 Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly .5 MG 2 X PER PT Report Source Product Role Manufacturer Route Benign Congenital Foreign Rivotril PS ORAL Hypotonia Other Depakine (Valproate Sodium) 500 Mg SS ORAL Neurontin (Gabapentin) 100 Mg SS ORAL DAY ORAL Breech Presentation Complications Of Maternal 500 MG 3 X Exposure To Therapeutic PER DAY ORAL Drugs Drug Withdrawal Syndrome 200 MG 2 X Neonatal PER DAY ORAL Ear Malformation Facial Dysmorphism Hypospadias Premature Baby Prepuce Redundant Small For Dates Baby Tremor Neonatal Date:01/11/99ISR Number: 3179532-2Report Type:Expedited (15-DaCompany Report #LBID002990002 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG, PER Initial or Prolonged DAY, PER ORAL PT Report Source Product Role Manufacturer Route Agitation Consumer Lithobid PS ORAL Therapeutic Zyprexa SS ORAL Feeling Drunk Benzotropine SS ORAL Nausea Tremor Wellbutrin Neurontin SS SS ORAL Klonopin SS ORAL Ambien SS ORAL Zoloft SS ORAL Lithobid SS ORAL Drug Level Above PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL 600 MG, PER DAY, PER ORAL Date:01/11/99ISR Number: 3294263-6Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Company Report #2972/20771 PT Report Source Product Role Drug Effect Decreased Keratoconjunctivitis Consumer Company Detrol Tablets (2 Mg) PS Sicca Representative Tegretol SS 2 MG-2Q1DY;ORAL 22-Aug-2005 Page: 64 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin SS Date:01/12/99ISR Number: 3179781-3Report Type:Expedited (15-DaCompany Report #001-0945-980860 Age:45 YR Gender:Female I/FU:F Outcome Dose Duration Required Intervention to 1200 MG (600 Prevent Permanent MG, BID), PER Impairment/Damage ORAL PT Report Source Product Role Anaphylactic Shock Bronchospasm Health Professional Neurontin (Gabapentin) PS Paxil (Paroxetine Hydrochloride) C Manufacturer Route ORAL Cough Dermatitis Dyspnoea Face Oedema Date:01/12/99ISR Number: 3179783-7Report Type:Expedited (15-DaCompany Report #001-0945-980923 Age:36 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Health Professional Neurontin (Gabapentin) PS Lamictal (Lamotrigine) SS Mysoline (Primidone) SS Folic Acid C Manufacturer Route Manufacturer Route Duration 3000 MG, DAILY 200 MG, DAILY 500 MG, DAILY Date:01/14/99ISR Number: 3180681-3Report Type:Expedited (15-DaCompany Report #033-0945-980049 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Other 6 CAPSULES (, PT Report Source Product Role Rash Papular Foreign Neurontin PS ORAL Study DAILY), PER Health ORAL Professional Triatec (Ramipril) Lexomil (Bromazepam) Rivotril (Clonazepam) Coversyl (Perindopril) Esberiven Forte (Rutoside, Melilot) Stagib (Metformin Embonate) Glucophagea (Metformin Hydrochloride) C C C C C C C Date:01/14/99ISR Number: 3180699-0Report Type:Expedited (15-DaCompany Report #001-0073-980624 Age:31 YR Gender:Female I/FU:I Outcome Dose Death 600 MG (, PT Report Source Product Role Death Health Dilantin PS Neurontin SS Zarontin SS Prenatal Vitamins C Duration Professional DAILY) 900 MG (, DAILY) 1500 MG (, DAILY) 22-Aug-2005 Page: 65 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/99ISR Number: 3180838-1Report Type:Expedited (15-DaCompany Report #033-0945-990001 Age:1 DY Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly SEE TEXT, Other PLACENTAL; IN PT Report Source Product Role Complications Of Maternal Foreign Neurontin PS Exposure To Therapeutic Health Drugs Professional Rivotril SS Depakine SS Manufacturer Route Manufacturer Route UTERO Facial Dysmorphism EXPOSURE; Feeling Jittery PLACENTAL Hypospadias SEE TEXT, Hypotonia PLACENTAL; IN Premature Baby UTERO Skin Hypertrophy EXPOSURE; PLACENTAL SEE TEXT, PLACENTAL; IN UTERO EXPOSURE; PLACENTAL Date:01/19/99ISR Number: 3295967-1Report Type:Periodic Age:30 YR Gender:Male I/FU:F Outcome Dose Company Report #WAES 97050892 PT Report Source Product Role Crystalluria Health Cap Crixivan Unk PS Hyperbilirubinaemia Renal Failure Acute Professional Neurontin Unk Epivir SS C Duration PO ORAL Zerit C Date:01/20/99ISR Number: 3182805-0Report Type:Expedited (15-DaCompany Report #001-0945-980923 Age:36 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Health Professional Neurontin (Gabapentin) PS Lamictal (Lamotrigine) SS Mysoline (Primidone) SS Folic Acid C Manufacturer Route Manufacturer Route Duration 3000 MG DAILY 200 MG DAILY 500 MG DAILY Date:01/25/99ISR Number: 3187823-4Report Type:Expedited (15-DaCompany Report #SP-9900050 Age:20 YR Gender:Female I/FU:I Outcome PT Dose Duration Required Cellulitis INTRAVENOUS INTRAVENOUS 5 Intervention to Convulsion MG/KG Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 66 10:40 AM Report Source Product Role Health Remicade PS Gabapentin Doxepin Oxycodone Azathioprine Omeprazole Prednisone SS SS SS C C C Professional FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/99ISR Number: 3185295-7Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Liver Function Test Abnormal Product Role Lisinopril Diflucan Gabapentin Macrodantin PS SS SS SS Manufacturer Route Manufacturer Route Manufacturer Route Date:01/26/99ISR Number: 3186035-8Report Type:Expedited (15-DaCompany Report #001-0945-990025 Age:1 DY Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Health Professional Neurontin (Gabapentin) PS Prenatal Vitamins Folic Acid C C Duration TRANSPLACENTAL Complications Of Maternal Exposure To Therapeutic SEE TEXT, Drugs PLACENTAL IN Convulsion UTERO EXPOSURE Date:01/26/99ISR Number: 3197622-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other 50.00 MG Company Report #9837475 PT Report Source Product Role Drug Ineffective Health Viagra Tablets PS ORAL Drug Interaction Professional Neurontin SS ORAL Duration TOTAL:PRN:ORA L ORAL Date:01/29/99ISR Number: 3188590-0Report Type:Expedited (15-DaCompany Report #033-0945-980049 Age:72 YR Gender:Female I/FU:F Outcome Dose Other 6 CAPSULE PT Report Source Product Role Condition Aggravated Foreign Neurontin PS Eczema Study Toxic Skin Eruption Health Triatec Lexomil Rivotril Coversyl Esberiven Stagid Glucophage C C C C C C C Manufacturer Route Duration ORAL (DAILY) PER ORAL Professional Date:01/29/99ISR Number: 3188593-6Report Type:Expedited (15-DaCompany Report #001-0945-990035 Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 2100 MG Initial or Prolonged (DAILY) PER PT Report Source Product Role Asthma Health Neurontin PS Bronchitis Professional Unspecified Antihypertensive C Dermatitis ORAL; 2400 MG Herpes Zoster SEE IMAGE Pain Pyrexia 22-Aug-2005 Page: 67 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/99ISR Number: 3188595-XReport Type:Expedited (15-DaCompany Report #001-0945-980783 Age:51 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 400 MG (100 Initial or Prolonged MG, QID) PER PT Report Source Product Role Diarrhoea Consumer Neurontin PS Cozaar Insulin Nph Insulin Proamatine Lasix C C C C C Manufacturer Route ORAL Dizziness Orthostatic Hypotension ORAL Renal Disorder Date:02/01/99ISR Number: 3189846-8Report Type:Expedited (15-DaCompany Report #001-0945-990043 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 2400 MG, Required (DAILY), Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Anaphylactic Shock Health Neurontin PS Hemiplegia Professional Lipitor Naprosyn SS C Date:02/01/99ISR Number: 3301104-7Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Manufacturer Route Manufacturer Route Company Report #A0067798 PT Report Source Product Role Asthenia Consumer Lamictal Tablet PS Duration 25 MG TWICE Dizziness PER DAY ORAL Fatigue Hyperhidrosis Sedation Gabapentin (Formulation Unknown) Sertraline SS ORAL Hydrochloride Doxazosin Mesylate Moexipril Hydrochloride Lisinopril Potassium Chloride Frusemide Date:02/04/99ISR Number: 3192107-4Report Type:Expedited (15-DaCompany Report #002-0945-990003 Age:69 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 68 10:40 AM PT Blood Creatine Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Body Temperature Increased Chest Pain Confusional State Cough Diarrhoea Musculoskeletal Stiffness Neutrophil Count Increased C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Paralysis Pleural Effusion Sedation Report Source Product Role White Blood Cell Count Foreign Gabapentin PS ORAL Increased Health Lovastatin SS ORAL Atenolol Nitroglycerin Norvasc Rocaltrol Calcium Carbonate Losec Nitroglycerin Restoril Dulcolax Extra Strength Tylenol Lactulose Colace Atasol Eprex Penta C C C C C C C C C Manufacturer Route Duration 900 MG (300 MG, TID), PER Professional ORAL 20 MG (DAILY) PER ORAL Date:02/05/99ISR Number: 3199732-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other 50 MG, PER C C C C C C Company Report #FLUV002980264 PT Report Source Product Role Manufacturer Route Dermatitis Health Luvox PS ORAL Drug Interaction Professional Neurontin (Gabapentin) SS ORAL Duration ORAL PER ORAL Date:02/09/99ISR Number: 3194448-3Report Type:Expedited (15-DaCompany Report #034-0945-990002 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG DAILY Initial or Prolonged PER ORAL PT Report Source Product Role Coordination Abnormal Foreign Gabapentin PS ORAL Muscle Twitching Health Tremor Professional (Amitriptyline Hydrochloride) SS ORAL Doxazosin Mesilate Lacidipine Calcium Carbonate Insulin Human Acetylsalicylic Acid C C C C C 50 MG DAILY PER ORAL Date:02/09/99ISR Number: 3194450-1Report Type:Expedited (15-DaCompany Report #001-0945-980919 Age:34 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 69 10:40 AM PT Blindness Unilateral Dizziness Headache Histoplasmosis Paraesthesia Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Vision Blurred Dose Report Source Product Role Consumer Neurontin PS Prozac C Manufacturer Route Duration ORAL 100 MG(QHS) PER ORAL Date:02/09/99ISR Number: 3194989-9Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Company Report # PT Report Source Product Role Manufacturer Route Palpitations Health Arthrotec PS ORAL Ventricular Extrasystoles Professional Neurontin SS ORAL Prozac C Duration 75 MG BID PO 600 MG TID PO 3 MON Date:02/11/99ISR Number: 3195858-0Report Type:Expedited (15-DaCompany Report #049-0945-980025 Age:73 YR Gender:Male I/FU:F Outcome Dose Duration Death 3200 MG (800 Hospitalization MG, QID), PER Initial or Prolonged ORAL PT Report Source Product Role Arrhythmia Foreign Neurontin PS Blood Creatinine Health Increased Professional Blood Urea Increased Cardio-Respiratory Arrest Dehydration Drug Toxicity Electrolyte Imbalance Pulmonary Embolism Renal Impairment Vomiting Company Representative Tegretol C Manufacturer Route ORAL Date:02/17/99ISR Number: 3200356-1Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose PT Company Report # Report Source Product Role Palpitations Arthrotec PS ORAL Ventricular Extrasystoles Neurontin SS ORAL Prozac C Manufacturer Route Duration 75MG BID PO 600MG TID PO Date:02/19/99ISR Number: 3204464-0Report Type:Expedited (15-DaCompany Report #199910754DDC Age:84 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged RESPIRATORY (INHALATION) 30 DAY 1 DAY 22-Aug-2005 Page: 70 INH 10:40 AM PT Report Source Product Role Atrioventricular Block Status Epilepticus Thrombocytopenia Foreign Terbutaline Sulfate (Bricanyl) Aerosol (Solution) PS 1 WK Methylprednisolone Gabapentin Heparin-Fraction, Sodium Salt SS SS Phenytoin SS Amoxicillin Trihydrate SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/99ISR Number: 3203557-1Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome Dose Other 300 MG TID Company Report # PT Report Source Product Role Manufacturer Route Oedema Health Gabapentin PS ORAL Weight Increased Professional Neurontin Humalog Humulin Ultralente Asa Atenolol Captopril Propulsid Prilosec Premarin Paxil Klonopin Valium Duragesic Oxycodone Alupent Allegra Ntg SS C C C C C C C C C C C C C C C C ORAL Duration Date:02/22/99ISR Number: 3204891-1Report Type:Expedited (15-DaCompany Report #001-0945-990101 Age: Gender: I/FU:I Outcome Dose Duration Death 1200 MG (X1) PT Report Source Product Role Medication Error Health Neurontin PS Manufacturer Route ORAL Professional PER ORAL Date:02/22/99ISR Number: 3205029-7Report Type:Expedited (15-DaCompany Report #1274/11153 Age:84 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 16 MG-3Q1DY; PT Report Source Product Role Thrombocytopenia Foreign Medrol PS Manufacturer Route ORAL Other ORAL Consumer Company Representative Amoxicillin & Clavulanic Acid SS Phenytoin SS Terbutaline SS NASAL Gabapentine SS ORAL Tinzaparine Sodium SS ORAL 2 GM/DAY;ORAL INTRAVENOUS IV NASAL 400 MG-3D1DY;ORAL SUBCUTANEOUS 2500 IU-1Q1DY;SC Date:02/23/99ISR Number: 3311544-8Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Company Report #1998-002917 PT Report Source Product Role Manufacturer Route Dizziness Dysarthria Consumer Flomax (Tamsulosin) Capsules / 0.4 Mg PS ORAL Gait Disturbance Ativan SS ORAL Paraesthesia Elavil SS ORAL Sedation Neurontin SS ORAL Duration 0.4 MG/PO 1 MG/PO 100 MG/PO PO 22-Aug-2005 Page: 71 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3208681-5Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Other 100.00 MG Company Report #9838101 PT Report Source Product Role Ecchymosis Health Zoloft Tablets PS Gabapentin SS Manufacturer Route Duration ORAL Professional TOTAL: DAILY: ORAL 600.00 MG TOTAL: BID Date:02/25/99ISR Number: 3209965-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #9828199 PT Report Source Product Role Diarrhoea Health Zoloft Tablets PS Drug Interaction Professional Neurontin Ambien Hydrocodone / Acetaminophen Unknown Rstrogen SS C Manufacturer Route Duration ORAL C C Date:02/26/99ISR Number: 3208421-XReport Type:Expedited (15-DaCompany Report #001-0945-990043 Age:56 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Required 2400 MG Intervention to (,DAILY), Prevent Permanent UNKNOWN Impairment/Damage PT Report Source Product Role Anaphylactic Reaction Condition Aggravated Health Professional Neurontin (Gabapentin) PS Lipitor (Atorvastatin) SS Manufacturer Route Naprosyn C Date:02/26/99ISR Number: 3208598-6Report Type:Expedited (15-DaCompany Report #044-0945-990016 Age:1 DY Gender:Unknown I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Cleft Lip Cleft Palate Foreign Health Neurontin (Gabapentin) PS Complications Of Maternal Professional Phenytoin SS Manufacturer Route Manufacturer Route SEE TEXT, PLACENTAL Exposure To Therapeutic SEE TEXT, Drugs PLACENTAL Congenital Megacolon Intestinal Obstruction Date:02/26/99ISR Number: 3211129-8Report Type:Periodic Age:71 YR Gender:Male I/FU:I Outcome Dose Other Company Report #001-0945-980362 PT Report Source Product Role Atrial Fibrillation Consumer Neurontin (Gabapentin) PS Lasix Norvasc Iron Hytrin Pravachol C C C C C Duration 300 MG (100 MG, TID) PER ORAL 22-Aug-2005 Page: 72 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3211133-XReport Type:Periodic Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Encephalopathy Health Professional Company Representative Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3211135-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #001-0945-980381 Company Report #001-0945-980413 PT Report Source Product Role Decreased Activity Fatigue Health Professional Neurontin (Gabapentin) PS Sertraline Klonopin Lamictal C C C Duration 2700 MG (900 Hypotension MG, TID), Paraesthesia Date:02/26/99ISR Number: 3211139-0Report Type:Periodic Age:27 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3600 MG (1200 Company Report #001-0945-980441 PT Report Source Product Role Depression Hostility Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Zantac C Injury MG, TID) PER Suicide Attempt ORAL Date:02/26/99ISR Number: 3211142-0Report Type:Periodic Age:41 YR Gender:Male I/FU:I Company Report #001-0945-980460 ORAL Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Deep Vein Thrombosis Health Professional Neurontin (Gabapentin) PS Naproxen C Manufacturer Route ORAL MG, TID) PER ORAL Date:02/26/99ISR Number: 3211145-6Report Type:Periodic Age:78 YR Gender:Male I/FU:I Outcome Dose Other Company Report #001-0945-980477 PT Report Source Product Role Eye Haemorrhage Vitreous Floaters Consumer Neurontin (Gabapentin) PS Toprol Casodex Zocor C C C 300 MG (DAILY) PER ORAL 22-Aug-2005 Page: 73 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3211149-3Report Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 Company Report #001-0945-980511 PT Report Source Product Role Pneumonia Health Professional Neurontin (Gabapentin) PS Manufacturer Route ORAL MG, TID) PER ORAL Premarin Provera Lasix Monopril Prilosec Zoloft Immunosuppressive Therapy Cyclosporin A Prednisone Estrace Date:02/26/99ISR Number: 3211153-5Report Type:Periodic Age:34 YR Gender:Male I/FU:I Outcome Dose Other C C C C C C C C C C Company Report #001-0945-980523 PT Report Source Product Role Coma Dysphagia Health Professional Neurontin (Gabapentin) PS Unspecified Opiates Methadone SS C Manufacturer Route Manufacturer Route Duration 2400 MG (800 Hypoaesthesia MG, TID) Reflexes Abnormal Vision Blurred Date:02/26/99ISR Number: 3211157-2Report Type:Periodic Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - Company Report #001-0945-980536 PT Report Source Product Medication Error Health Neurontin Capsules Role Initial or Prolonged 900 MG (300 Thrombocytopenia Professional 300 Mg (Gabapentin) PS Daypro C ORAL MG, TID) PER ORAL Date:02/26/99ISR Number: 3211161-4Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG DAILY) Company Report #001-0945-980556 PT Report Source Product Role Confusional State Medication Error Health Professional Neurontin (Gabapentin) PS Digoxin Accupril Tylenol Coreg Thyroid C C C C C Pyrexia PER ORAL 22-Aug-2005 Page: 74 2 DAY 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3211164-XReport Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG Company Report #001-0945-980579 PT Report Source Product Role Facial Palsy Medication Error Health Professional Neurontin (Gabapentin) PS Tegretol Sinequan C C Manufacturer Route ORAL (DAILY) PER ORAL Date:02/26/99ISR Number: 3211167-5Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Company Report #001-0945-980582 PT Report Source Product Role Atrioventricular Block Confusional State Health Professional Neurontin (Gabapentin) PS Many Unspecified Medications C Manufacturer Route Manufacturer Route Depressed Level Of MG, TID) Consciousness Date:02/26/99ISR Number: 3211171-7Report Type:Periodic Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2700 MG DAILY Company Report #001-0945-980591 PT Report Source Product Role Oedema Peripheral Health Professional Neurontin (Gabapentin) PS Mexiletine Ms Contin Synthroid Insulin C C C C PER ORAL ORAL Date:02/26/99ISR Number: 3211177-8Report Type:Periodic Age:24 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Cognitive Disorder Overdose Health Professional Neurontin Capsules 400 Mg (Gabapentin) Tylenol (Paracetamol) Date:02/26/99ISR Number: 3211181-XReport Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-980600 Role Manufacturer Route SS Company Report #001-0945-980607 PT Report Source Product Role Cerebrovascular Accident Consumer Neurontin (Gabapentin) PS Soma Morphine Sulfate Xanax C C C Duration (DAILY) PER 22-Aug-2005 Page: 75 Route PS 100 MG ORAL Manufacturer 2 DAY 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3211184-5Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Company Report #001-0945-980611 PT Report Source Product Role Henoch-Schonlein Purpura Renal Failure Acute Health Professional Neurontin (Gabapentin) PS Manufacturer Route ORAL MG, TID) PER ORAL Date:02/26/99ISR Number: 3211188-2Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-980615 PT Report Source Product Role Medication Error Platelet Count Decreased Health Professional Neurontin (Gabapentin) PS Prednisone Serzone Wellbutrin Folic Acid Desyrel Vicodin Syn-Throin C C C C C C C Manufacturer Route Manufacturer Route Duration 900 MG (300 MG, TID), Date:02/26/99ISR Number: 3211193-6Report Type:Periodic Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3600 MG (1200 MG, TID) PER ORAL Company Report #001-0945-980663 PT Report Source Product Role Mental Disorder Health Professional Neurontin (Gabapentin) PS ORAL Multiple Unspecified Medications Date:02/26/99ISR Number: 3211197-3Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Report Source Product Role Accidental Overdose Mania Health Professional Neurontin (Gabapentin) Zyprexa PS C Manufacturer Route Manufacturer Route Company Report #001-0945-980685 PT Report Source Product Role Stevens-Johnson Syndrome Consumer Neurontin (Gabapentin) PS Duration 1200 MG (300 MG, QID) PER ORAL 22-Aug-2005 Page: 76 Company Report #001-0945-980673 PT Date:02/26/99ISR Number: 3211201-2Report Type:Periodic Age:16 YR Gender:Male I/FU:I Outcome Dose Other C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3211288-7Report Type:Periodic Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Thrombocytopenia Health Professional Neurontin (Gabapentin) Phenobarb PS C Date:02/26/99ISR Number: 3211292-9Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2700, DAILY, Company Report #001-0945-980699 Manufacturer Route Manufacturer Route Manufacturer Route Company Report #001-0945-980702 PT Report Source Product Role Aggression Confusional State Health Professional Neurontin (Gabapentin) PS UNKNOWN Date:02/26/99ISR Number: 3211295-4Report Type:Periodic Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Company Report #001-0945-980710 PT Report Source Product Role Convulsion Consumer Neurontin (Gabapentin) PS ORAL Depakote (Valproate Semisodium) SS ORAL Buspar Zoloft C C MG, TID), PER ORAL 250 MG (TOOK ONE DOSE), PER ORAL Date:02/26/99ISR Number: 3211298-XReport Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-980718 PT Report Source Product Role Anger Anxiety Consumer Neurontin (Gabapentin) PS Cardizem Atenolol Estrogen Nos Flexeril C C C C Manufacturer Route Duration ORAL 900 MG (300 Arthropathy MG, TID), PER Asthma ORAL Balance Disorder Chest Discomfort Headache Heart Rate Increased Muscle Spasms Pain In Extremity Pyrexia Suicidal Ideation Thinking Abnormal Date:02/26/99ISR Number: 3211302-9Report Type:Periodic Age:16 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 77 10:40 AM Company Report #001-0945-980732 PT Report Source Product Role Blood Thyroid Stimulating Hormone Decreased Convulsion Depression Lethargy Health Professional Neurontin (Gabapentin) Clonazepam Zoloft PS C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3211308-XReport Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (300 Company Report #001-0945-989772 PT Report Source Product Role Medication Error Oedema Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Lorazepam Remeron Vicodin Synthroid Soma C C C C C Manufacturer Route ORAL MG, QID) PER ORAL Date:02/26/99ISR Number: 3211311-XReport Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 Company Report #001-0945-980831 PT Report Source Product Role Pancreatitis Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Vicodin Prilosec C C Manufacturer Route ORAL MG, TID), PER ORAL Date:02/26/99ISR Number: 3211315-7Report Type:Periodic Age:17 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE TEXT, UNKNOWN Company Report #001-0945-980861 PT Report Source Product Role Bipolar Disorder Medication Error Consumer Neurontin (Gabapentin) PS Manufacturer Route Wellbutrin Trazodone Depakote Date:02/26/99ISR Number: 3211320-0Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG, C C C Company Report #001-0945-980888 PT Report Source Product Role Pancreatitis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Divalproex C Manufacturer Route ORAL DAILY, PER ORAL Date:02/26/99ISR Number: 3211323-6Report Type:Periodic Age:24 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL 300 MG (150 MG, BID), PER ORAL 22-Aug-2005 Page: 78 10:40 AM Company Report #001-0945-980906 PT Report Source Product Role Manufacturer Route Medication Error Stevens-Johnson Syndrome Health Professional Neurontin (Gabapentin) PS ORAL Zyban (Amfebutamone) SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3211328-5Report Type:Periodic Age:27 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-980921 PT Report Source Product Role Breast Engorgement Chills Consumer Neurontin (Gabapentin) PS Prozac Valium Xanax C C C Manufacturer Route Manufacturer Route Duration 1600 MG (600 Dizziness MG BID, 400 Galactorrhoea MG Headache Insomnia Medication Error Suicidal Ideation Vomiting Date:02/26/99ISR Number: 3211332-7Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 Company Report #001-0945-990003 PT Report Source Product Role Epistaxis Haemoglobin Decreased Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Headache Company Photophobia Representative Aciclovir Prilosec Tylenol Imitrex C C C C ORAL MG, BID), PER ORAL Thrombocytopenia Date:02/26/99ISR Number: 3211336-4Report Type:Periodic Age:23 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 Company Report #001-0945-973006 PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route ORAL Drugs MG TID) PER Porphyria ORAL Premature Labour Desyrel Nepragan Toprol Compazine Date:02/26/99ISR Number: 3211357-1Report Type:Periodic Age:79 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 C C C C Company Report #001-0945-973033 PT Report Source Product Role Activated Partial Thromboplastin Time Health Professional Neurontin (Gabapentin) PS Coumadin Synthroid Bumex Allopurinol Digoxin Maxzide C C C C C C Prolonged MG, TID) PER International Normalised ORAL Ratio Increased Phlebitis Prothrombin Time Prolonged 22-Aug-2005 Page: 79 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3212580-2Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900 MG (300 Initial or Prolonged MG, TID), PER Company Report #001-0945-980046 PT Report Source Product Role Coordination Abnormal Consumer Neurontin PS Cough Medicine Desyrel Klonopin (Clonazepam) Cipro Premarin Luvox Depakote Imitrex Paxil C C Manufacturer Route ORAL Depression Diplopia ORAL; 1800 Disorientation MG, 2400 MG Drug Level Above (600 MG, Therapeutic Drug Toxicity Dysarthria Fatigue Gait Disturbance Medication Error Stress Date:02/26/99ISR Number: 3212589-9Report Type:Periodic Age:26 YR Gender:Female I/FU:I Outcome Dose Disability C C C C C C C Company Report #001-0945-980052 PT Report Source Product Role Deafness Health Professional Neurontin (Gabapentin) PS Depakote (Valproate Semisodium) C Manufacturer Route Duration 1200 MG (600 MG, BID), PER ORAL Date:02/26/99ISR Number: 3212597-8Report Type:Periodic Age:23 YR Gender:Female I/FU:I Company Report #001-0945-980087 ORAL Outcome Dose Duration Hospitalization 1800 MG 900 Initial or Prolonged MG, BID), PER PT Report Source Product Role Thrombocytopenia Health Neurontin PS Sabril (Vigabatrin) Diamox (Acetazolamide) Contraceptive Pill (Oral Contraceptive Nos) C Manufacturer Route ORAL Professional ORAL Date:02/26/99ISR Number: 3212604-2Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2000 MG, Initial or Prolonged DAILY, PER C C Company Report #001-0945-980115 PT Report Source Product Role Anxiety Health Neurontin PS Coordination Abnormal Professional Dysarthria ORAL Liver Function Test Abnormal Medication Error Orthostatic Hypotension 22-Aug-2005 Page: 80 10:40 AM Accupril (Quinapril Hydrochloride) Pravachol (Pravastatin Sodium) Fioricet (Caffeine, Butalbital, Paracetamol) C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Centrum (Vitamins Nos, Minerals Nos) Date:02/26/99ISR Number: 3212613-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other C Company Report #001-0945-980121 PT Report Source Product Role Renal Failure Health Professional Company Representative Neurontin PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3212619-4Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Other 2400 MG (800 Company Report #001-0945-980136 PT Report Source Product Role Photophobia Health Neurontin PS Vision Blurred Professional MG, TID), PER Visual Acuity Reduced ORAL Tegretol (Carbamazepine) Insulin Paxil (Paroxetine Hydrochloride) Glucophage (Metformin Hydrochloride) Toprol Xl (Metoprolol Succinate) Lasix (Furosemide) Zocor (Simvastatin) Beconase (Beclometasone Dipropionate) Asa (Acetylsalicylic Acid) C C C C C C C C C ORAL Date:02/26/99ISR Number: 3212624-8Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged 22-Aug-2005 Page: 81 10:40 AM Company Report #001-0945-980138 PT Report Source Product Role Amnesia Consumer Neurontin PS Malaise Status Epilepticus Health Professional Vanceril (Beclometasone) Proventil (Salbutamol) Beconase (Beclometasone Dipropionate) Tegretol (Carbamazepine) C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3212630-3Report Type:Periodic Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2700 MG (900 Initial or Prolonged MG, TID), PER Company Report #001-0945-980151 PT Report Source Product Role Convulsion Health Neurontin PS Diabetes Mellitus Professional Depakote C Manufacturer Route ORAL ORAL Date:02/26/99ISR Number: 3212658-3Report Type:Periodic Age:16 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 4800 MG (1100 Company Report #001-0945-980161 PT Report Source Product Role Clonic Convulsion Drug Level Below Health Professional Neurontin (Gabapentin) PS Tegretol (Carbamazepine) Mysoline Tranxene Synthroid C C C C Manufacturer Route Manufacturer Route Therapeutic MG TID, 1500 Overdose MG AT Date:02/26/99ISR Number: 3212676-5Report Type:Periodic Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG (300 Initial or Prolonged MG, BID), PER Company Report #001-0945-980164 PT Report Source Product Role Abdominal Pain Consumer Neurontin PS Dyspnoea ORAL Lipitor ORAL (Atorvastatin) Lopressor (Metoprolol Tartrate) Vitamins Date:02/26/99ISR Number: 3212678-9Report Type:Periodic Age:77 YR Gender:Female I/FU:I Outcome Dose Disability 300 MG, C C C Company Report #001-0945-980184 PT Report Source Product Role Amblyopia Health Neurontin PS Visual Acuity Reduced Professional DAILY, PER ORAL Glucotrol (Glipizide) Glucophage (Metformin Hydrochloride) Rezulin (Troglitazone) Spironolactone Precose (Acarbose) Mevacor (Lovastatin) Norvasc (Amlodipine Besilate) Daypro (Oxaprozin) Humulin L (Insulin Human Zinc 22-Aug-2005 Page: 82 Manufacturer Route Duration 10:40 AM C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suspension) Date:02/26/99ISR Number: 3212684-4Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #001-0945-980189 PT Report Source Product Role Deafness Medication Error Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration 1200 MG, AT BEDTIME Lithobid (Lithium Carbonate) Tegretol (Carbamazepine) Benadryl (Diphenydramine Hydrochloride) Date:02/26/99ISR Number: 3212688-1Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Other 1800 MG, C C C Company Report #001-0945-980206 PT Report Source Product Role Cataract Health Neurontin PS Scotoma Professional Synthroid C Duration DAILY Date:02/26/99ISR Number: 3212694-7Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Other 1800 MG (600 PT Report Source Product Role Depression Consumer Neurontin PS Headache MG, TID) PER Oedema Peripheral ORAL Company Report #001-0945-980219 ORAL Pulmonary Oedema Lithium Premarin (Estrogens Conjugated) Prempro (Medroxyprogesterone ) Synthroid (Levothyroxine Sodium) Hytrin (Terazosin Hydrochloride) Klonopin (Clonazepam) Cardizem (Diltiazem Hydrochloride) Trazodone Date:02/26/99ISR Number: 3212699-6Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Abdominal Pain 900 MG (300 Initial or Prolonged Hyperhidrosis MG, TID) 3 MON Medication Error 22-Aug-2005 Page: 83 10:40 AM C C C C C C C C Company Report #001-0945-980277 Report Source Product Role Health Neurontin PS Oxycontin Prozac (Fluoxetine Hydrochloride) C Professional C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3212704-7Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 800 MG (400 Initial or Prolonged MG, BID), PER Company Report #001-0945-980299 PT Report Source Product Role Atrial Fibrillation Health Neurontin PS Medication Error Professional Risperdal (Risperidone) C Manufacturer Route ORAL ORAL Date:02/26/99ISR Number: 3212709-6Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose Other 2400 MG, Company Report #001-0945-980307 PT Report Source Product Role Pancreatitis Health Neurontin PS Unspecified Medications C Manufacturer Route Duration ORAL Professional DAILY, PER ORAL Date:02/26/99ISR Number: 3212713-8Report Type:Periodic Age:24 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 2700 MG, Initial or Prolonged DAILY Company Report #001-0945-980327 PT Report Source Product Role Medication Error Health Neurontin PS Pneumonia Professional Amitriptyline Ultram Oral Contraceptive Nos C C C Manufacturer Route Date:02/26/99ISR Number: 3212717-5Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Other 1500 MG, Company Report #001-0945-980328 PT Report Source Product Role Burning Sensation Consumer Neurontin PS Tegretol C Manufacturer Route Manufacturer Route Duration Convulsion DAILY Feeling Abnormal Headache Insomnia Sedation Thinking Abnormal Visual Disturbance Visual Field Defect Date:02/26/99ISR Number: 3212722-9Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Other 50 MG, DAILY, Company Report #001-0945-980360 PT Report Source Product Role Medication Error Consumer Neurontin PS Vitamins C Pancreatitis PER ORAL 22-Aug-2005 Page: 84 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3408310-1Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0073-980355 PT Report Source Product Drug Interaction Drug Level Changed Health Professional Dilantin Suspension 125 Mg/5 Ml (Phenytoin Sodium) Lamotrigine Neurontin(Gabapentin ) Carbamazepine Declomycin(Demeclocy cline Hydrochloride) Risperdal(Risperidon e) Ativan (Lorazepam) Jevity (Potassium Bicarbonate, Potassium Bitartrate, Soya Oil, Corn Oil, Role Manufacturer Route Manufacturer Route Duration PS SS SS SS SS SS SS SS PER TUBE Vagal Nerve Stimulator Date:02/26/99ISR Number: 3410096-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose SS Company Report #001-0945-980670 PT Report Source Product Role Anxiety Decreased Appetite Consumer Neurontin Capsules 300 Mg (Gabapenitn) PS Duration 1500 MG (300 Disorientation MG, FIVE Insomnia TIMES DAILY) Weight Decreased PER ORAL Date:02/26/99ISR Number: 3410097-3Report Type:Periodic Age: Gender:Unknown I/FU:I Company Report #001-0945-980674 ORAL Outcome Dose PT Report Source Product Role Weight Increased Health Professional Neurontin (Gabapentin) PS Date:02/26/99ISR Number: 3410098-5Report Type:Periodic Age:45 YR Gender:Male I/FU:I Outcome Dose Manufacturer Route Manufacturer Route Duration Company Report #001-0945-980675 PT Report Source Product Role Skin Lesion Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Lamictal (Lamotrigine) C Duration ORAL 1200 MG (300 MG, QID), PER ORAL Date:02/26/99ISR Number: 3410099-7Report Type:Periodic Age:38 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Galactorrhoea Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 300 MG (, AT 22-Aug-2005 Page: 85 Company Report #001-0945-980678 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report BEDTIME), PER ORAL Depakote (Valproate Semisodium) Date:02/26/99ISR Number: 3410100-0Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose PT C Company Report #001-0945-980679 Report Source Product Role Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration Chest Pain Depressed Level Of ORAL 50 MG (, Consciousness DAILY), PER Heart Rate Decreased ORAL Date:02/26/99ISR Number: 3410101-2Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980681 PT Report Source Product Role Anxiety Dizziness Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 600 MG (300 MG, BID), PER ORAL Nardil (Phenelzine Sulfate) Premarin (Estrogens Conjugated) Daypro (Oxaprozin) Axid (Nizatidine Lorazepam (Quinidine Sulfate) Levo-T (Levothyroxine) Klonopin (Clonazepam) C C C C C C C C ORAL Date:02/26/99ISR Number: 3410102-4Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980682 PT Report Source Product Role Dermatitis Pruritus Consumer Neurontin (Gabapentin) PS Prozac (Fluoxetine Hydrochloride) Ativan (Lorazepam) Zyprexa (Olanzapine) C C C Manufacturer Route Duration ORAL 1500 MG (, DAILY), PER ORAL Date:02/26/99ISR Number: 3410103-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose 22-Aug-2005 Page: 86 Company Report #001-0945-980686 PT Report Source Product Role Blood Glucose Increased Consumer Health Professional Neurontin (Gabapentin) PS Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410104-8Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980687 PT Report Source Product Role Alopecia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL (Baclofen) Daypro (Oxaprozin) Bellergal -S (Phenobarbital, Ergotamine Tartrate, Belladonna Alkaloids Ambien (Zolpidem Tartrate) Estrogen Date:02/26/99ISR Number: 3410105-XReport Type:Periodic Age:40 YR Gender:Male I/FU:I Outcome Dose C C C C C Company Report #001-0945-980688 PT Report Source Product Role Ill-Defined Disorder Overdose Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 6000 MG (, Suicidal Ideation DAILY), PER ORAL Date:02/26/99ISR Number: 3410106-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980695 PT Report Source Product Role Alopecia Health Professional Company Neurontin (Gabapentin) Haldol (Haloperidol) PS C Duration Manufacturer Route Representative Date:02/26/99ISR Number: 3410107-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980698 PT Report Source Product Role Nausea Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration (, QHS) Date:02/26/99ISR Number: 3410108-5Report Type:Periodic Age:73 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980701 PT Report Source Product Role Oedema Peripheral Health Professional Neurontin (Gabapentin) PS Oxycontin (Oxycodone Hydrochloride) Thyroid Supplement C C Duration 100 MG (, HS), PER ORAL 22-Aug-2005 Page: 87 2 DAY 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410109-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980703 PT Report Source Product Role Eye Discharge Visual Disturbance Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 1800 MG (, Visual Field Defect DAILY) Date:02/26/99ISR Number: 3410110-3Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980708 PT Report Source Product Role Face Oedema Health Professional Neurontin (Gabapentin) PS Lortab (Paracetamol, Hydrocone Bitartrate) C Duration ORAL 300 MG (100 MG, TID), PER ORAL Date:02/26/99ISR Number: 3410111-5Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980711 PT Report Source Product Role Breast Engorgement Breast Pain Health Professional Neurontin (Gabapentin) PS (Vitamin Nos) C Manufacturer Route Duration 900 MG (300 MG, TID), PER ORAL ORAL Date:02/26/99ISR Number: 3410112-7Report Type:Periodic Age:60 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980712 PT Report Source Product Role Nausea Vertigo Consumer Neurontin (Gabapentin) PS Norflex (Orphenadrine Citrate) C Manufacturer Route Duration ORAL 200 MG (100 MG, BID), PER ORAL Date:02/26/99ISR Number: 3410113-9Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980713 PT Report Source Product Role Dyskinesia Loss Of Consciousness Consumer Neurontin (Gabapentin) PS 1800 MG (, Muscle Twitching DAILY), PER Tinnitus ORAL Vision Blurred 22-Aug-2005 Page: 88 Manufacturer Route Duration 10:40 AM (Baclofen) Prevacid (Lansoprazole) C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410114-0Report Type:Periodic Age:80 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980714 PT Report Source Product Role Coordination Abnormal Vision Blurred Consumer Neurontin (Gabapentin) PS Zantac (Ranitidine Hydrochloride) Tenormin (Atenolol) C C Manufacturer Route Duration ORAL PER ORAL Date:02/26/99ISR Number: 3410115-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980717 PT Report Source Product Role Drug Interaction Dyskinesia Consumer Health Neurontin Capsules 100 Mg (Gabapentin) PS Insomnia Professional Elavil (Amitriptyline Hydrochloride) SS Manufacturer Route Manufacturer Route Duration 1200 MG (400 MG, TID) Mania Polyuria Tremor 80 MG (, QHS) Xanax (Alprazolam) Klonopin (Clonazepam) Phenergan (Promethazine Hydrochloride) Imitrex (Sumatriptan) (Potassium) Date:02/26/99ISR Number: 3410565-4Report Type:Periodic Age:43 YR Gender:Male I/FU:I Outcome Dose C C C C C Company Report #001-0945-980494 PT Report Source Product Condition Aggravated Consumer Neurontin Duration Role Dyspepsia (Gabapentin) PS (Lorazepam) Lodine (Etodolac) C C ORAL 900 MG (300 Supraventricular MG, TID) , Extrasystoles PER ORAL Date:02/26/99ISR Number: 3410567-8Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980495 PT Report Source Product Role Amnesia Pain Consumer Neurontin (Gabapentin) PS 2400 MG (, Paralysis DAILY), PER ORAL Wellbutrin (Amfebutamone Hydrochloride) Ritalin (Methylphenidate Hydrochloride) Premarin (Estrogens Conjugated) Klonopin (Clonazepam) 22-Aug-2005 Page: 89 Manufacturer Route Duration 10:40 AM C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410570-8Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980497 PT Report Source Product Role Paraesthesia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Prozac (Fluoxetine Hydrochloride) Zyprexa (Olanzapine) C C Manufacturer Route Duration ORAL 1200 MG (300 MG, QID), PER ORAL Date:02/26/99ISR Number: 3410575-7Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980499 PT Report Source Product Role Pyrexia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 200 MG (,DAILY) , PER ORAL Unspecified Blood Pressure Medication Unspecified "Water Pill" Date:02/26/99ISR Number: 3410577-0Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980500 PT Report Source Product Role Feeling Abnormal Feeling Jittery Consumer Neurontin(Gabapentin ) PS Manufacturer Route Duration 900 MG (300 Irritability MG, TID) , C ORAL Muscle Contractions PER ORAL Involuntary Ambien (Zolpidem Tartrate) Valium (Diazepam) (Methadone) Tenormin (Atenolol) Premarin (Dstrogens Conjugated Docusate Sodium Multivatimins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, Calcium Acetaminophen (Paracetamol) Date:02/26/99ISR Number: 3410579-4Report Type:Periodic Age: Gender: I/FU:I Outcome Dose 22-Aug-2005 Page: 90 C C C C C C C C C Company Report #001-0945-980502 PT Report Source Product Convulsive Threshold Lowered Drug Interaction Health Professional Neurontin (Gabapentin) Decongestants/Antihi stamines Role Duration 10:40 AM PS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410581-2Report Type:Periodic Age:72 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980504 PT Report Source Product Role Blood Glucose Increased Gastrointestinal Disorder Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG, TID) , PER ORAL (Insulin) (Digoxin) (Hydrochlorothiazide ) (Potassium) Coumadin (Warfarin Sodium) Ambien (Zolpidem Tartrate) Date:02/26/99ISR Number: 3410582-4Report Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980505 PT Report Source Product Role Pain Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 2400 MG (800 MG, TID), PER ORAL (Baclofen) Pamelor (Nortriptyline Hydrochloride) Xanax (Alprazolam) Sinequan (Doxepin Hydrochloride) Elavil (Amitriptyline Hydrochloride) C C C C C ORAL Date:02/26/99ISR Number: 3410584-8Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980506 PT Report Source Product Role Movement Disorder Consumer Neurontin(Gabapentin ) PS Manufacturer Route Duration ORAL 3200 MG (800 MG, QID) , PER ORAL Effexor (Venlafaxine Hydrochloride) Xanax (Alprazolam) Unspecified Muscle Relaxant Date:02/26/99ISR Number: 3410586-1Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980507 PT Report Source Product Role White Blood Cell Count Decreased Consumer Health Neurontin (Gabapentin) PS Manufacturer Route Duration 800 - 1200 MG Professional ( WHEN NEEDED ) , PER ORAL 22-Aug-2005 Page: 91 C C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410591-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980508 PT Report Source Product Role Alopecia Dermatitis Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG (400 Skin Nodule MG, TID), PER ORAL Voltaren(Diclofenac Sodium) Vasoretic (Hydrochlorothiazide , Enalapril Maleate) Glucotrol (Glipizide) Xalatan(Latanoprost) Date:02/26/99ISR Number: 3410594-0Report Type:Periodic Age:18 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980509 PT Report Source Product Role Hallucination Health Professional Neurontin(Gabapentin ) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3410595-2Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980512 PT Report Source Product Role Depressed Level Of Consciousness Health Professional Neurontin(Gabapentin ) PS Dysphagia Company Dyspnoea Representative Duration 300 MG (100 MG, TID) , PER ORAL Muscular Weakness ORAL Date:02/26/99ISR Number: 3410596-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Pruritus Skin Nodule Consumer Neurontin (Gabapentin) PS Route Manufacturer Route Company Report #001-0945-980514 PT Report Source Product Role Keratoconjunctivitis Sicca Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Prozac (Fluoxetine Hydrochloride) C Duration 900 MG (300 MG, TID) , PER ORAL 22-Aug-2005 Page: 92 Manufacturer Duration Date:02/26/99ISR Number: 3410598-8Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980513 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410600-3Report Type:Periodic Age:33 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Balance Disorder Dizziness Feeling Drunk Gait Disturbance Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3410602-7Report Type:Periodic Age:59 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980515 Company Report #001-0945-980516 PT Report Source Product Role Dizziness Dysarthria Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Duration ORAL 2400 MG (800 Hypoaesthesia MG, TID) , Sedation PER ORAL Vision Blurred Date:02/26/99ISR Number: 3410604-0Report Type:Periodic Age:48 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980519 PT Report Source Product Role Dysarthria Overdose Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 2400 MG Urinary Retention (,DAILY), PER ORAL Topamax (Topiramate) Tenormin (Atenolol) Hytrin (Terazosin Hydrochloride) Colace (Docusate Sodium) C C C C ORAL Date:02/26/99ISR Number: 3410605-2Report Type:Periodic Age:89 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980520 PT Report Source Product Role Sedation Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (, DAILY) , PER ORAL Date:02/26/99ISR Number: 3410607-6Report Type:Periodic Age:67 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980521 PT Report Source Product Role Convulsion Drug Interaction Consumer Neurontin (Gabapentin) PS Sulfa (Sulfaguanidine, Papaverine Hydrochloride, Clioquinol, Vitamins Lozol (Indapamide) (Spironolactone) SS C C 1200 MG Gait Disturbance (,DAILY), PER ORAL 22-Aug-2005 Page: 93 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Vitamins Nos) Asa (Acetylsalicylic Acid) Date:02/26/99ISR Number: 3410608-8Report Type:Periodic Age:76 YR Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980463 PT Report Source Product Role Abdominal Pain Upper Nausea Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 100-300 Nervousness DAILY, PER ORAL Mylanta Prilosec (Omeprazole) Xanax (Alprazolam) Date:02/26/99ISR Number: 3410610-6Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980464 PT Report Source Product Role Balance Disorder Blood Pressure Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 800 MG Fluctuation (,QHS), PER Dizziness ORAL Fatigue Feeling Abnormal Lethargy Premarin (Estrogens Conjugated) Provera (Medroxyprogesterone Acetate) Darvocet -N (Paracetamol, Dextrepropxyphene) Lotensin (Benazepril Hydrochloride) C C C C ORAL Dyazide (Hydrochlorothiazide , Triamterene) Date:02/26/99ISR Number: 3410612-XReport Type:Periodic Age:29 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980465 PT Report Source Product Role Constipation Convulsion Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 4300 MG (, Diarrhoea DAILY), PER Dyspepsia ORAL Ear Infection Increased Appetite Lip Dry Overdose Tympanic Membrane Perforation Vaginal Candidiasis Weight Decreased 22-Aug-2005 Page: 94 C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410618-0Report Type:Periodic Age:31 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980466 PT Report Source Product Role Arthralgia Gastritis Consumer Health Neurontin (Gabapentin) PS Upper Respiratory Tract Professional Manufacturer Route Duration ORAL 1800 MG (,DAILY), PER Infection ORAL Percocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone Meclizine (Meclozine Hydrochloride) Colace (Docusate Sodium) Date:02/26/99ISR Number: 3410623-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980467 PT Report Source Product Dermatitis Drug Interaction Health Professional Neurontin (Gabapentin) Amitriptyline (Amitriptyline) Role Manufacturer Route Manufacturer Route PS SS Company Report #001-0945-980468 PT Report Source Product Role Asthenia Balance Disorder Consumer Neurontin (Gabapentin) PS Duration 900 MG (300 Dizziness MG TID), PER C Duration Date:02/26/99ISR Number: 3410626-XReport Type:Periodic Age:72 YR Gender:Male I/FU:I Outcome Dose SS ORAL Fall ORAL Insomnia Peripheral Coldness Zestril (Lisinopril) (Insulin) (Atenolol) Enteric Coated Aspirin (Acetylsalicyclic Acid) Date:02/26/99ISR Number: 3410631-3Report Type:Periodic Age:81 YR Gender:Male I/FU:I Outcome Dose C C C C Company Report #001-0945-980471 PT Report Source Product Role Feelings Of Worthlessness Hyperhidrosis Consumer Neurontin (Gabapentin) PS (Digoxin) (Quinidine) C C 100 MG (, Mental Impairment DAILY), PER Pain In Extremity ORAL Sedation 22-Aug-2005 Page: 95 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410634-9Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980472 PT Report Source Product Role Cardiac Disorder Feeling Abnormal Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 100 - 200 MG (,HS PRN) Neurontin (Gabapentin) Estrace (Estradiol Lopressor (Metrprolol Tartrate) Motrin (Ibuprofen) Zyrtec (Certirizine Hydrochloride) Tylenol (Paracetamol) Vitamins Date:02/26/99ISR Number: 3410638-6Report Type:Periodic Age:84 YR Gender:Male I/FU:I Outcome Dose SS C C C C C C Company Report #001-0945-980475 PT Report Source Product Role Bipolar I Disorder Depression Health Professional Neurontin (Gabapentin) PS Duration ORAL 300 MG (, ONE Nervousness DOSE TAKEN) , Schizophrenia PER ORAL Date:02/26/99ISR Number: 3410643-XReport Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980476 PT Report Source Product Alopecia Consumer Neurontin Duration Role Manufacturer Route (Gabapentin) PS Prozac (Fluoxetine Hydrochloride) Xanax (Alprazolam) C C ORAL 1200 MG (300 MG QID) PER ORAL Date:02/26/99ISR Number: 3410649-0Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980479 PT Report Source Product Role Manufacturer Route Cataract Feeling Abnormal Health Professional Neurontin (Gabapentin) PS ORAL Neurontin (Gabapentin) SS ORAL Vicodin (Parametamol, Hydrocodone Bitartrate) (Nortriptyline) Norco C C C Duration 2700 MG (900 Headache MG, TID), PER Medication Error ORAL 900 MG (300 MG, TID), PER ORAL 22-Aug-2005 Page: 96 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Bitolterol) Date:02/26/99ISR Number: 3410654-4Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose PT Report Source Product Role Hair Disorder Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Company Report #001-0945-980482 PT Report Source Product Dry Skin Pigmentation Disorder Health Professional Neurontin (Gabapentin) Tegretol (Carbamazepine) Role Duration Date:02/26/99ISR Number: 3410665-9Report Type:Periodic Age:64 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980481 Duration Date:02/26/99ISR Number: 3410659-3Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose C PS C Company Report #001-0945-980483 PT Report Source Product Role Bone Marrow Depression White Blood Cell Count Health Professional Neurontin (Gabapentin) PS Unspecified Medication Chemotherapeutic SS Duration 900 MG (, Decreased DAILY), PER ORAL Date:02/26/99ISR Number: 3410667-2Report Type:Periodic Age:53 YR Gender:Male I/FU:I Company Report #001-0945-980484 ORAL Outcome Dose PT Report Source Product Role Coordination Abnormal Dizziness Consumer Neurontin Capsules 400 Mg (Gabapentin) PS (Ibuprofen) C Manufacturer Route Duration ORAL 3600 MG (1200 Vision Blurred MG, TID) PER Weight Increased ORAL Date:02/26/99ISR Number: 3410669-6Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980485 PT Report Source Product Role Anorgasmia Health Professional Neurontin (Gabapentin) PS Klonopin (Clonazepam) C 1500 MG, PER ORAL 22-Aug-2005 Page: 97 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410670-2Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980487 PT Report Source Product Role Arthralgia Dyspnoea Consumer Neurontin Capsules 400 Mg (Gabapentin) PS ORAL Peganone (Ethotoin) SS ORAL Chlorate Haldol (Haloperidol) Zoloft (Sertraline Hydrochloride) C C Manufacturer Route Duration 3200 MG (800 Overdose MG, QID), PER Stupor ORAL Syncope 500 MG (, DAILY), PER ORAL Date:02/26/99ISR Number: 3410672-6Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980488 PT Report Source Product Role Anorgasmia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 300 MG (, QHS), PER ORAL Synthroid (Levothyroxine Sodium) Depakote (Valproate Semisodium) Serzone (Nefazodone Hydrochloride) C C C ORAL Date:02/26/99ISR Number: 3410674-XReport Type:Periodic Age:52 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980490 PT Report Source Product Role Alopecia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Neurontin Capsules 300 Mg (Gabapentin) SS Manufacturer Route Duration 450 MG (, 150 MG QAM; 300 MG ORAL 450 MG (, 150 MG QAM; 300 MG QHS), PER ORAL Date:02/26/99ISR Number: 3410677-5Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Blood Pressure Decreased Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 400 MG (, DAILY), PER ORAL 22-Aug-2005 Page: 98 Company Report #001-0945-980492 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410707-0Report Type:Periodic Age:75 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980402 PT Report Source Product Role Dizziness Dry Mouth Health Professional Neurontin (Gabapentin) PS Many Unspecified Medications C Manufacturer Route Duration ORAL SEE TEXT, PER Dry Throat ORAL Dysarthria Insomnia Vision Blurred Date:02/26/99ISR Number: 3410712-4Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980403 PT Report Source Product Role Haematuria Consumer Health Neurontin (Gabapentin) PS Zoloft Nolahist Vitamins Vitamin E Calcium C C C C C Manufacturer Route Duration ORAL 1200 MG (300 Professional MG, QID), PER ORAL Date:02/26/99ISR Number: 3410769-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980404 PT Report Source Product Role Amenorrhoea Health Professional Neurontin (Gabapentin) PS Duration Manufacturer Route Date:02/26/99ISR Number: 3410772-0Report Type:Periodic Age:43 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980405 PT Report Source Product Role Hallucination Health Professional Neurontin (Gabapentin) PS Calcium Quinine Elavil Zantac Nephrocaps Sodium Bicarbonate C C C C C C Manufacturer Route Duration ORAL 300 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3410774-4Report Type:Periodic Age: Gender: I/FU:I Outcome Dose PT Report Source Product Role Overdose Pleural Effusion Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 3600 MG Pneumonitis (DAILY), PER ORAL 22-Aug-2005 Page: 99 Company Report #001-0945-980406 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410777-XReport Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980407 PT Report Source Product Role Dysarthria Feeling Abnormal Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Gait Disturbance Company Urticaria Representative Prozac Klonopin Dilantin Phenergan Indocin C C C C C Manufacturer Route Duration ORAL 600 MG (300 MG, BID), PER ORAL Date:02/26/99ISR Number: 3410779-3Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980408 PT Report Source Product Role Dizziness Euphoric Mood Health Professional Neurontin (Gabapentin) PS Avapro Ticlid (Amitriptyline) C C C Manufacturer Route Duration ORAL 300 MG Feeling Drunk (DAILY), PER Hypertensive Crisis ORAL Date:02/26/99ISR Number: 3410781-1Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose 200 MG (100 Company Report #001-0945-980409 PT Report Source Product Role Disturbance In Attention Dry Mouth Consumer Company Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL Fatigue Representative MG, BID), PER ORAL Synthroid Paxil Norvasc Lipitor Lasix K-Dur Premarin (Isosorbide) Imdur Vicodin Relafen Date:02/26/99ISR Number: 3410784-7Report Type:Periodic Age:77 YR Gender:Male I/FU:I Outcome Dose C C C C C C C C C C C Company Report #001-0945-980410 PT Report Source Product Role Depression Dizziness Consumer Neurontin Capsules 100 Mg (Gabapentin) PS 100 MG (XL Sedation DOSE), PER ORAL Hytrin Pepcid Zestril (Hydrochlorothiazide ) 22-Aug-2005 Page: 100 Manufacturer Route Duration 10:40 AM C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410786-0Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980411 PT Report Source Product Role Convulsion Oedema Consumer Neurontin (Gabapentin) PS Dilantin Klonopin C C Manufacturer Route Duration ORAL 1200 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3410790-2Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980414 PT Report Source Product Role Headache Reflexes Abnormal Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Pepcid C Manufacturer Route Duration ORAL 900-1200 MG Sedation (DAILY), PER ORAL Date:02/26/99ISR Number: 3410794-XReport Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980415 PT Report Source Product Role Constipation Increased Appetite Health Professional Neurontin (Gabapentin) PS Lamictal (Lamotrigine) SS Manufacturer Route Duration 700 MG Keratoconjunctivitis (DAILY), PER Sicca ORAL Nausea ORAL Atarax Ativan Date:02/26/99ISR Number: 3410799-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980418 PT Report Source Product Role Menstruation Irregular Health Professional Company Representative Neurontin (Gabapentin) Contraceptive Nos PS C Route Manufacturer Route Company Report #001-0945-980419 PT Report Source Product Role Neuropathy Peripheral Consumer Neurontin 300 Mg (Gabapentin) PS Premarin Provera C C Duration 2700 MG (900 MG, TID), PER ORAL 22-Aug-2005 Page: 101 Manufacturer Duration Date:02/26/99ISR Number: 3410803-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410807-5Report Type:Periodic Age:31 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980424 PT Report Source Product Role Sedation Visual Disturbance Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Proventil Vancenase Deconsal C C C Manufacturer Route Duration ORAL 600 MG (300 MG, BID), PER ORAL Date:02/26/99ISR Number: 3410819-1Report Type:Periodic Age:26 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980425 PT Report Source Product Role Abdominal Pain Upper Aggression Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG Headache (DAILY), PER Insomnia ORAL Sedation Vomiting Date:02/26/99ISR Number: 3410826-9Report Type:Periodic Age:7 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Coagulation Time Prolonged Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 2400 MG Drug Interaction (DAILY), PER Ecchymosis ORAL Company Report #001-0945-980428 ORAL Overdose Robitussin (Guaifenesin) Triaminic (Mepyramine Maleate, Pheniramine Maleate, Phenylpropanolamine Hydrochloride) Date:02/26/99ISR Number: 3410833-6Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose SS SS Company Report #001-0945-980430 PT Report Source Product Role Neutrophil Count Decreased Health Professional Neurontin (Gabapentin) PS Adriamycin C Manufacturer Route Duration ORAL 1000 MG (500 MG, BID), PER ORAL Date:02/26/99ISR Number: 3410839-7Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980431 PT Report Source Product Role Abdominal Pain Crying Consumer Neurontin (Gabapentin) PS Levsin C 2700 MG Dyspnoea (DAILY), PER Hyperhidrosis ORAL Irritable Bowel Syndrome 22-Aug-2005 Page: 102 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) Propoxyphene Date:02/26/99ISR Number: 3410845-2Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980433 PT Report Source Product Role Decreased Appetite Weight Increased Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Klonopin C Manufacturer Route Duration ORAL 100 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3410898-1Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980761 PT Report Source Product Role Blood Glucose Abnormal Health Professional Neurontin(Gabapentin ) PS Manufacturer Route Duration ORAL 2400 MG (800 MG, TID), PER ORAL Glucophage(Metformin Hydrochloride) Restoril(Temazepam) Wellbutrin(Amfebutam one Hydrochloride) Date:02/26/99ISR Number: 3410902-0Report Type:Periodic Age:75 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980762 PT Report Source Product Joint Swelling Consumer Neurontin(Gabapentin Duration Role Manufacturer Route Paraesthesia ) PS ORAL 1100 MG(,DAILY), PER ORAL Ultram(Tramadol Hydrochloride) Xanax(Alprazolam) Vicodin(Paracetamol, Hydrocodone Bitartrate) Date:02/26/99ISR Number: 3410907-XReport Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980763 PT Report Source Product Role Faecal Incontinence Health Professional Neurontin(Gabapentin ) PS Zoloft(Sertraline Hydrochloride) Valium(Diazepam) C C 1200 MG(,DAILY), PER ORAL 22-Aug-2005 Page: 103 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410911-1Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose PT Report Source Product Role Vitamin K Deficiency Health Professional Neurontin(Gabapentin ) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3410913-5Report Type:Periodic Age:61 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980764 Company Report #001-0945-980766 PT Report Source Product Role Foot Fracture Hypoaesthesia Consumer Neurontin(Gabapentin ) PS Duration ORAL 1800 Paraesthesia MG(,DAILY), PER ORAL (Amoxicillin) Minocin(Minocycline) Calan(Verapamil Hydrochloride) Date:02/26/99ISR Number: 3410914-7Report Type:Periodic Age:71 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980767 PT Report Source Product Role Oedema Peripheral Health Professional Neurontin(Gabapentin ) PS Manufacturer Route Duration 1800 MG(,DAILY), PER ORAL Date:02/26/99ISR Number: 3410917-2Report Type:Periodic Age:57 YR Gender:Female I/FU:I Company Report #001-0945-980768 ORAL Outcome Dose PT Report Source Product Role Dermatitis Insomnia Consumer Neurontin Capsules 300 Mg(Gabapentin) PS (Clonazepam) C Manufacturer Route Duration ORAL 900 MG(300 Mental Disorder MG, TID), PER Oedema Peripheral ORAL Date:02/26/99ISR Number: 3410920-2Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose 22-Aug-2005 Page: 104 Company Report #001-0945-980769 PT Report Source Product Dizziness Drug Interaction Dyspnoea Vertigo Consumer Neurontin Capsules 100 Mg(Gabapentin) Septra Ds(Sulfamethoxazole, Trimethoprim) Levaquin(Levofloxaci n) (Meclofenamate Sodium) Oxycontin(Oxycodone Hydrochloride) Zoloft(Sertraline Hydrochloride) Claritin(Loratadine) (Alprazolam) Role Duration 10:40 AM PS SS C C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Oxycodone) Date:02/26/99ISR Number: 3410922-6Report Type:Periodic Age:71 YR Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980770 PT Report Source Product Role Dysarthria Fall Consumer Neurontin(Gabapentin ) PS Lopressor(Metoprolol Tartrate) C Manufacturer Route Duration ORAL 300 Sedation MG(,DAILY), PER ORAL Date:02/26/99ISR Number: 3410926-3Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980771 PT Report Source Product Role Unevaluable Event Health Professional Neurontin(Gabapentin ) PS Manufacturer Route Duration ORAL 900 MG(,DAILY), PER ORAL Date:02/26/99ISR Number: 3410930-5Report Type:Periodic Age:51 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980773 PT Report Source Product Role Hallucination, Visual Consumer Neurontin Capsules 300 Mg(Gabapentin) PS Manufacturer Route Duration 2700 MG (900 MG, TID), PER ORAL ORAL Humulin N(Insulin Human Injection, Isophane) Humulin R(Insulin Human) Calan(Verapamil Hydrochloride) Depakote(Valproate Semisodium) Prozac(Fluoxetine Hydrochloride) (Potassium) Date:02/26/99ISR Number: 3410932-9Report Type:Periodic Age:76 YR Gender:Male I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980774 PT Report Source Product Role Faecal Incontinence Gingival Bleeding Consumer Neurontin Capsules 100 Mg(Gabapentin) PS 600 MG(300 Gingivitis MG, BID), PER Urinary Incontinence ORAL Asa(Acetylsalicylic Acid) Monopril(Fosinopril Sodium) (Insulin) Glyburide(Glibenclam 22-Aug-2005 Page: 105 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ide) Date:02/26/99ISR Number: 3410936-6Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980777 PT Report Source Product Role Abdominal Pain Upper Faeces Discoloured Consumer Neurontin Capsules 300 Mg(Gabapentin) PS Avonex(Interferon Beta) C Manufacturer Route Duration ORAL 1200 MG (300 Gastric Haemorrhage MG, QID), PER Headache ORAL Myalgia Nausea Stomach Discomfort Date:02/26/99ISR Number: 3410941-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980778 PT Report Source Product Convulsion Cushingoid Cyanosis Drug Interaction Consumer Neurontin(Gabapentin ) Dilantin Infatabs 50 Mg(Phenytoin Sodium) Role Manufacturer Route Duration PS SS ORAL X2 (, QAM AND Peripheral Coldness QPM), PER ORAL Colace(Docusate Sodium) Date:02/26/99ISR Number: 3410945-7Report Type:Periodic Age:27 YR Gender:Female I/FU:I Outcome Dose SS Company Report #001-0945-980782 PT Report Source Product Paraesthesia Health Neurontin Capsules Duration Role Manufacturer Route Professional 300 Mg(Gabapentin) PS Zoloft(Sertraline Hydrochloride) (Trazodone) (Lithium) Ativan(Lorazepam) C C C C ORAL 600 MG (300 MG, BID), PER ORAL Date:02/26/99ISR Number: 3410948-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Dermatomyositis Consumer Health Professional Neurontin(Gabapentin ) PS 22-Aug-2005 Page: 106 Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3410953-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980784 Company Report #001-0945-980785 PT Report Source Product Role Oedema Peripheral Health Professional Neurontin(Gabapentin ) PS Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3410955-XReport Type:Periodic Age:73 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980786 PT Report Source Product Role Feeling Abnormal Consumer Neurontin(Gabapentin ) PS Manufacturer Route Duration ORAL 600 MG (,QHS), PER ORAL Hytrin(Terazosin Hydrochloride) Children'S Aspirin(Acetylsalicy lic Acid) Date:02/26/99ISR Number: 3410958-5Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980780 PT Report Source Product Role Hallucination Consumer Health Neurontin Capsules 100 Mg(Gabapentin) PS Manufacturer Route Duration 400 MG (100 Professional MG, QID), PER ORAL Lopressor(Metoprolol Tartrate) Vasotec(Enalapril Maleate) Zocor(Simvastatin) (Nortriptyline) Zantac(Ranitidine Hydrochloride) Premarin(Estrogens Conjugated) K-Dur(Potassium Chloride) Motrin(Ibuprofen) Lasix(Furosemide) C C C C C C C C C ORAL Date:02/26/99ISR Number: 3410963-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Haematuria International Normalised Ratio Increased Health Professional Neurontin(Gabapentin ) Coumadin(Warfarin Sodium) Role Route Manufacturer Route PS SS Company Report #001-0945-980731 PT Report Source Product Role Condition Aggravated Hyperthyroidism Consumer Neurontin(Gabapentin ) PS (Estrogen Nos) (Propranolol) C C Duration 1800 MG (600MG, TID) , PER ORAL 22-Aug-2005 Page: 107 Manufacturer Duration Date:02/26/99ISR Number: 3411003-8Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980781 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3411006-3Report Type:Periodic Age:18 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980733 PT Report Source Product Role Accommodation Disorder Consumer (Gabapentin) PS Blepharospasm Health Dystonia Professional Manufacturer Route Duration ORAL 600 MG (200 MG, TID) , PER ORAL Solu-Medrol (Methylprednisolone) Zanaflex (Tizanidine) (Clonidine) Date:02/26/99ISR Number: 3411008-7Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980734 PT Report Source Product Role Urticaria Consumer Neurontin(Gabapentin ) PS (Prednisone) C Manufacturer Route Duration ORAL SEE TEXT, PER ORAL Date:02/26/99ISR Number: 3411009-9Report Type:Periodic Age:28 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980735 PT Report Source Product Role Amnesia Coordination Abnormal Health Professional Neurontin (Gabapentin) PS (Seroquel) C Duration SEE TEXT, Hallucination UNKNOWN Manufacturer Route Date:02/26/99ISR Number: 3411011-7Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980736 PT Report Source Product Role Paraesthesia Health Professional Neurontin(Gabapentin ) PS Pamelor (Nortriptyline Hydrochloride)) C Manufacturer Route Duration ORAL 300 MG (, DAILY) , PER ORAL Date:02/26/99ISR Number: 3411013-0Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Deafness Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 900 MG (300 MG, TID) , PER ORAL 22-Aug-2005 Page: 108 Company Report #001-0945-980737 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3411014-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980739 PT Report Source Product Role Oedema Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 900 MG (300 Company MG, TID) Representative Date:02/26/99ISR Number: 3411019-1Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Risperdal (Risperidone) Prozac (Fluoxetine Hydrochloride) Wellbutrin (Amfebutamone Hydrochloride) C C C Company Report #001-0945-980740 PT Report Source Product Role Gingival Erosion Stomatitis Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Axid (Nizatidine) C Duration ORAL 200 MG (100 MG, BID) , PER ORAL Date:02/26/99ISR Number: 3411022-1Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Ejaculation Disorder Impaired Healing Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 900 MG ( , Libido Decreased DAILY) , PER Company Report #001-0945-980742 ORAL ORAL Luvox (Fluvoxamine Maleate) Klonopin (Clonazepam) Date:02/26/99ISR Number: 3411024-5Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980743 PT Report Source Product Role Nightmare Health Professional Neurontin (Gabapentin) PS PER ORAL Oxycodone Restoril (Temazepam) Prilosec (Omeprazole) Lorcet (Paracetamol, Hydrocodone Bitartrate Date:02/26/99ISR Number: 3411026-9Report Type:Periodic Age:65 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 109 Manufacturer Route Duration PT Dizziness Night Sweats 10:40 AM Company Report #011-0945-980744 C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Dose Report Source Product Role Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 400 MG (200 MG, BID) , PER ORAL St. John'S Wort (Hypericum Extract) Dilantin (Phenytoin Sodium) Date:02/26/99ISR Number: 3411027-0Report Type:Periodic Age:38 YR Gender:Female I/FU:I Outcome Dose PT C C Company Report #001-0945-980745 Report Source Product Role Neurontin (Gabapentin) PS Manufacturer Route Duration Bladder Pain Pollakiuria ORAL 300 MG Urethral Pain (100MG, TID) , PER ORAL Date:02/26/99ISR Number: 3411029-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980746 PT Report Source Product Role Arthropathy Fall Consumer Health Neurontin (Gabapentin) PS Injury Professional Zanzflex (Tizanidine) SS (Clonidine) C Duration 600 MG (200 MG, TID) Sedation Vision Blurred 2 MG ( , QHS) Manufacturer Route Medrol (Methylprednisolone) Date:02/26/99ISR Number: 3411030-0Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980750 PT Report Source Product Role Bronchospasm Chest Discomfort Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (100 Dyspnoea MG, TID) , PER ORAL Klonopin (Clonazepam) Imitrex (Sumatriptan Succinate) Date:02/26/99ISR Number: 3411031-2Report Type:Periodic Age:91 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980751 PT Report Source Product Role Asthenia Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 1800 MG (600 MG, THREE TIMES DAILY) , PER ORAL (Glyceryl 22-Aug-2005 Page: 110 C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trinitrate) Xanax (Alprazolam) Pepcid (Famotidine) Date:02/26/99ISR Number: 3411032-4Report Type:Periodic Age:71 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980753 PT Report Source Product Role Dry Mouth Stomatitis Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Zantac (Ranitidine Hydrochloride) C Manufacturer Route Duration ORAL 400 MG (200 MG, BID) , PER ORAL Date:02/26/99ISR Number: 3411034-8Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980754 PT Report Source Product Role Diarrhoea Flatulence Consumer Neurontin Capsules 300 Mg (Gabapentin) PS (Trazodone) C Manufacturer Route Duration ORAL 900 MG ( , NIGHTLY) , PER ORAL Date:02/26/99ISR Number: 3411035-XReport Type:Periodic Age:62 YR Gender:Male I/FU:I Outcome Dose 900 MG (300 Company Report #001-0945-980755 PT Report Source Product Role Arthralgia Joint Stiffness Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL MG , TID) , PER ORAL Avonex (Interferon Beta) (Baclofen) Xalatan (Latanoptost) Ocupress (Carteolol Hydrochloride) Alphagan (Brimonidine Tartrate) (Amantadine) Date:02/26/99ISR Number: 3411038-5Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose C C C C Company Report #001-0945-980756 PT Report Source Product Role Abnormal Behaviour Feeling Abnormal Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 400 MG (200 Hostility MG , BID) , Lethargy PER ORAL Malaise Nausea Paranoia Psychomotor Hyperactivity Thinking Abnormal 22-Aug-2005 Page: 111 C C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3411042-7Report Type:Periodic Age:76 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980757 PT Report Source Product Role Manufacturer Route Drug Effect Decreased Drug Interaction Consumer Neurontin(Gabapentin ) PS ORAL Mavik (Trandolapril) SS ORAL Duration 300 MG ( , Sleep Disorder HS) , PER ORAL 4 MG ( , DAILY) , PER ORAL Date:02/26/99ISR Number: 3412077-0Report Type:Periodic Age:79 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980818 PT Report Source Product Role Constipation Consumer Neurontin Capsules 400mg (Gabapetin) PS Manufacturer Route Duration 400 MG (DAILY) PER ORAL Sinemet(Levodopa, Carbidopa) Permax (Pergolide Mesilate) Ambien (Zolpidem Tartrate) Tylenol (Paracetamol) Aspirin (Acetylsalicylic Acid) Metamucil (Psyllium Hydrophilic Mucilloid) C C C C C C ORAL Date:02/26/99ISR Number: 3412078-2Report Type:Periodic Age:74 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980819 PT Report Source Product Role Oedema Health Professional Neurontin Capsules 300mg (Gabapetin) PS Manufacturer Route Duration ORAL 2400 MG (600 MG, QID) PER ORAL Date:02/26/99ISR Number: 3412080-0Report Type:Periodic Age:77 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980820 PT Report Source Product Role Eye Pain Consumer Neurontin (Gabapetin) PS Mavik (Trandolapril) C 200 MG (DAILY), PER ORAL 22-Aug-2005 Page: 112 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3412082-4Report Type:Periodic Age:51 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980821 PT Report Source Product Role Ageusia Anosmia Consumer Neurontin Capsules 100mg (Gabapetin) PS Manufacturer Route Duration ORAL 100 MG Deafness (DAILY) PER Ear Infection ORAL Sinus Congestion Tinnitus Rezulin(Troglitazone ) Glucophage (Metformin Hydrochloride) Trazodone Date:02/26/99ISR Number: 3412084-8Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980822 PT Report Source Product Role Hyperglycaemia Consumer Neurontin (Gabapetin) PS Manufacturer Route Duration ORAL 600 MG (DAILY), PER ORAL Nph Insulin (Insulin Injection, Isophane) Humulin Regular(Insulin Human) Date:02/26/99ISR Number: 3412086-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980823 PT Report Source Product Flatulence Consumer Neurontin Capsules Duration Role Manufacturer Route Headache 300mg (Gabapetin) PS Demulen (Mestranol, Etynodiol Diacetate) C ORAL 900 MG (300 MD, TID) PER ORAL Date:02/26/99ISR Number: 3412089-7Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980825 PT Report Source Product Role Anxiety Dyspnoea Health Professional Neurontin Capsules 100mg (Gabapetin) PS 400 MG (200 MG, BID) PER ORAL Flexeril (Cyclobenzaprine Hydrochloride) Prozac (Fluoxetine Hydrochloride) 22-Aug-2005 Page: 113 Manufacturer Route Duration 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3412090-3Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980826 PT Report Source Product Role Eczema Pain In Extremity Consumer Neurontin Capsules 400mg (Gabapetin) PS Manufacturer Route Duration ORAL 1600 MG (400 Paraesthesia MG, QID), PER ORAL Klonopin(Clonazepam) Ambien(Zolpidem Tartrate) Prozac(Fluoxetine Hydrochloride) Oral Contraceptive Nos Date:02/26/99ISR Number: 3412092-7Report Type:Periodic Age:18 YR Gender:Male I/FU:I Outcome Dose C C C C Company Report #001-0945-980828 PT Report Source Product Role Amnesia Drug Interaction Consumer Neurontin Capsules 100mg (Gabapetin) PS Feverfew(Herbal Extracts Nos) Nortriptyline SS C Manufacturer Route Duration ORAL 300 MG (100 MG, TID) PER ORAL Date:02/26/99ISR Number: 3412093-9Report Type:Periodic Age:58 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980834 PT Report Source Product Pancreatitis Consumer Neurontin Duration Role Manufacturer Route (Gabapetin) PS ORAL 800 MG (DAILY), PER ORAL Vicodin(Paracetamol, Hydrocodone Bitartrate) Darvocet (Paracetamol, Dextropropoxyphene) Date:02/26/99ISR Number: 3412095-2Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980835 PT Report Source Product Role Ecchymosis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Zoloft (Sertraline Hydrochloride) C 600 MG (300 MG, BID) PER ORAL 22-Aug-2005 Page: 114 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3412096-4Report Type:Periodic Age:30 YR Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980836 PT Report Source Product Role Sedation Health Professional Neurontin Capsules 300mg (Gabapetin) PS Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL Date:02/26/99ISR Number: 3412098-8Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980837 PT Report Source Product Role Disorientation Health Professional Neurontin(Gabapentin ) PS Tylenol W/Codeine No. 3(Codeine Phosphate, Paracetamol) SS Manufacturer Route Duration ORAL 1200 MG (300 MG, QID), PER ORAL Date:02/26/99ISR Number: 3412100-3Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose 1200 MG (600MG, Q12H), PER Company Report #001-0945-980841 PT Report Source Product Role Blood Glucose Increased Health Professional Neurontin(Gabapentin ) PS Manufacturer Route Duration ORAL ORAL Proventil Inhaler(Salbutamol) Zocor(Simvastatin) Trazodone Humalin N(Insulin) Date:02/26/99ISR Number: 3412102-7Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose C C C C Company Report #001-0945-980842 PT Report Source Product Role Vision Blurred Consumer Neurontin Capsules 300 Mg(Gabapentin) PS 300 MG (,QHS), PER ORAL Rezulin (Troglitazone) Lanoxin(Digoxin) Stomach Medicine Prednisone Glucotrol (Glipizide) 22-Aug-2005 Page: 115 Manufacturer Route Duration 10:40 AM C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3412103-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980843 PT Report Source Product Role Weight Decreased Health Professional Neurontin(Gabapentin ) PS Manufacturer Route Manufacturer Route Duration SEE TEXT, Date:02/26/99ISR Number: 3412105-2Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980845 PT Report Source Product Role Fatigue Muscle Spasms Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Duration ORAL 300 MG (100 Myalgia MG, TID) PER Nervousness ORAL Date:02/26/99ISR Number: 3412107-6Report Type:Periodic Age:33 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980846 PT Report Source Product Role Ear Pain Pain In Jaw Consumer Neurontin Capsules 100 Mg(Gabapentin) PS Advil(Ibuprofen) C Manufacturer Route Duration ORAL 300 MG (100 MG, TID) PER ORAL Date:02/26/99ISR Number: 3412108-8Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose PT Duration Company Report #001-0945-980847 Report Source Product Role Manufacturer Route Mouth Ulceration Health Professional Date:02/26/99ISR Number: 3412109-XReport Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Neurontin (Gabapentin) PS Company Report #001-0945-980848 PT Report Source Product Role Pruritus Urine Abnormality Consumer Neurontin Capsules 400 Mg(Gabapentin) PS Manufacturer Route Duration ORAL 800 MG (400 MG, BID) PER ORAL Date:02/26/99ISR Number: 3412115-5Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980787 PT Report Source Product Role Chest Pain Headache Consumer Neurontin (Gabapentin) PS Duration 900 MG (300 Nausea MG, TID), Monopril (Fosinopril Sodium) Klonopin (Clonazepam) Evista (Raloxifene) 22-Aug-2005 Page: 116 10:40 AM C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3412118-0Report Type:Periodic Age:25 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Chloasma Consumer Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3412121-0Report Type:Periodic Age:23 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980788 Company Report #001-0945-980789 PT Report Source Product Role Dizziness Fatigue Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration ORAL 1200 MG (, 300MG QAM & QNOON, 600MG QPM), PER ORAL Date:02/26/99ISR Number: 3412123-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Blood Glucose Abnormal Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3412124-6Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980791 Company Report #001-0945-980792 PT Report Source Product Weight Increased Consumer Neurontin Capsules Duration Role 300 Mg (Gabapentin) PS (Atenolol) Estrogens Zoloft (Sertraline Hydrochloride) Elavil (Amitriptyline Hydrochloride) Valium (Diazepam) (Acetylsalicylic Acid) C C ORAL 600 MG (300 MG, BID), PER ORAL Date:02/26/99ISR Number: 3412127-1Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose C C C C Company Report #001-0945-980793 PT Report Source Product Role Muscle Rigidity Myalgia Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Levothroid (Levothyroxine Sodium) (Lithium) (Chloral Hydrate) C C C 1200 MG (,QHS), PER ORAL 22-Aug-2005 Page: 117 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3412129-5Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #001-0945-980797 PT Report Source Product Role Oedema Health Professional Neurontin (Gabapentin) PS Unspecified Analgesics C Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration SEE TEXT Date:02/26/99ISR Number: 3412131-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Blister Dermatitis Health Professional Neurontin (Gabapentin) Daypro (Oxaprozin) Dyazide (Hydrochlorothiazide , Triamterene) 300 MG, PS SS SS Company Report #001-0945-980800 PT Report Source Product Role Vasculitis Health Professional Company Representative Neurontin (Gabapentin) PS Duration Date:02/26/99ISR Number: 3412135-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Role Duration Date:02/26/99ISR Number: 3412133-7Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #001-0945-980799 Company Report #001-0945-980802 PT Report Source Product Role Feeling Abnormal Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration ORAL DAILY, PER ORAL; 600 MG (300 MG, BID), PER Date:02/26/99ISR Number: 3412136-2Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980804 PT Report Source Product Role Nausea Skin Discolouration Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS 300 MG (, DAILY), PER ORAL Vicodin (Paracetamol, Hydrocodone Bitarttrate) Oxycontin (Oxycodone Hydrochloride) (Influenza Virus Vaccine Polyvalent) 22-Aug-2005 Page: 118 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3412137-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Chromaturia Health Professional Neurontin (Gabapentin) "Golden Seal" Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, Wellbutrin (Amfebutamone Hydrochloride) Role Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3412139-8Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #001-0945-980805 PS SS C C Company Report #001-0945-980806 PT Report Source Product Role Oedema Peripheral Overdose Health Professional Neurontin (Gabapentin) PS Duration 4800 MG (, DAILY), Date:02/26/99ISR Number: 3412141-6Report Type:Periodic Age:65 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980809 PT Report Source Product Role Dyspepsia Feeling Abnormal Consumer Health Neurontin(Gabapentin ) PS Oesophagitis Professional Duration 900 MG (300 MG, TID), PER ORAL Relafen (Nabumetone) Pravachol (Pravastatin Sodium) C C ORAL (Diazepam) Date:02/26/99ISR Number: 3412143-XReport Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980810 PT Report Source Product Role Tooth Disorder Consumer Neurontin(Gabapentin ) PS Klonopin (Clonazepam) C Manufacturer Route Duration ORAL 300 MG (150 MG, BID), PER ORAL Date:02/26/99ISR Number: 3412145-3Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980811 PT Report Source Product Role Balance Disorder Hyperhidrosis Consumer Neurontin Capsules 100 Mg (Gabapentin) PS 900 MG (300 Palpitations MG, TID), PER Skin Warm ORAL Weight Increased 22-Aug-2005 Page: 119 Manufacturer Route Duration 10:40 AM Unspecified Steroid (Acetylsalicylic C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acid) Fish Oil (Zinc) (Chondroitin Sulfate) (Glucosamine) Vitamin A (Retinol) Vitamin B6 (Pyridoxine Hydrochloride) Vitamin B12 (Cyanocobalamin) Endocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone (Calcium) Date:02/26/99ISR Number: 3412147-7Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose C C C C C C C C C C Company Report #001-0945-980812 PT Report Source Product Role Drug Withdrawal Syndrome Headache Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (,DAILY), PER ORAL Date:02/26/99ISR Number: 3412149-0Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose 400 MG (, DAILY), PER ORAL Company Report #001-0945-980815 PT Report Source Product Role Pruritus Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL Relafen (Nabumetone) Synthroid (Levothyroxine Sodium) (Vitamins Nos) Date:02/26/99ISR Number: 3412151-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980816 PT Report Source Product Role Dystonia Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Company Report #001-0945-980817 PT Report Source Product Role Weight Increased Consumer Neurontin (Gabapentin) PS Duration 1800 MG (600 MG, TID), PER ORAL Prempro 22-Aug-2005 Page: 120 C C Duration Date:02/26/99ISR Number: 3412152-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Medroxyprogesterone Acetate, Estrogens Conjugated) Paxil (Paroxetine Hydrochloride) Date:02/26/99ISR Number: 3413091-1Report Type:Periodic Age:56 YR Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980586 PT Report Source Product Role Anxiety Fatigue Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 100 MG Nausea (,DAILY), PER ORAL Zestril (Lisinopril) Aspirin (Acetylsalicylic Acid) Glyburide (Glibenclamide) Centrum Silver (Ascorbid Acid, Tocopheryl Acetate, Retinol, Zinc, Calcium, Vitamins Vitamin E (Tocopherol) Date:02/26/99ISR Number: 3413092-3Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose C C C C Company Report #001-0945-980590 PT Report Source Product Role Arrhythmia Electrocardiogram Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 300 MG Abnormal (,DAILY), PER Heart Rate Increased ORAL C ORAL Provera (Medroxy Progesterone Acetate) Humalog (Insulin Lispro) Monopril (Fosinopril Sodium) Propulsid (Cisapride) Premarin (Estrogens Conjugated) Wellbutrin (Amfebutamone Hydrochloride) Date:02/26/99ISR Number: 3413094-7Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 121 PT Asthma Coordination Abnormal Depression Disturbance In Attention 10:40 AM Company Report #001-0945-980594 C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Nausea Overdose Dose Report Source Product Role Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 4800 MG (UNK), PER ORAL Unspecified Thyroid Medication Unspecified Hormone Medication Date:02/26/99ISR Number: 3413095-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980595 PT Report Source Product Role Fatigue Feeling Hot Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration UNK, UNKNOWN Nausea Date:02/26/99ISR Number: 3413096-0Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980596 PT Report Source Product Role Coordination Abnormal Fall Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Duration 600 MG (200 Muscular Weakness MG, TID), PER ORAL Vitamin B12 (Cyanocobalamin) (Vitamins Nos) Levothroid (Levothyroxine C C ORAL Sodium) Date:02/26/99ISR Number: 3413097-2Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980598 PT Report Source Product Role Dry Skin Pruritus Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 1500 MG (300 MG, X 5 DAILY), UNKNOWN Demerol (Pethidine Hydrochloride) Inderal (Propranolol Hydrochloride) Valium (Diazepam) Lasix (Furosemide) Date:02/26/99ISR Number: 3413098-4Report Type:Periodic Age:30 YR Gender:Male I/FU:I Outcome Dose C C C Company Report #001-0945-980599 PT Report Source Product Role Dermatitis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration 600 MG (300 22-Aug-2005 Page: 122 C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG, BID), PER ORAL (Amikacin) (Imipenem) Morphine Dulcolax (Bisacodyl) Compazine (Prochlorperazine Edisylate) Colace (Docusate Sodium) Multivitamins (Ergocalciferol, Ascorbid Acid, Folic Acid, Thiamine Hydrochloride, (Ferrous Sulfate) Folic Acid Enoxaparin Sodium (Heparin-Fraction, Sodium Salt) Narcan (Naloxone Hydrochloride) Tylenol (Paracetamol) Date:02/26/99ISR Number: 3413101-1Report Type:Periodic Age:76 YR Gender:Male I/FU:I Outcome Dose C C C C C C C C C C C C Company Report #001-0945-980601 PT Report Source Product Role Blood Glucose Increased Dizziness Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 1200 MG (400 Oedema Peripheral MG, TID), PER Weight Increased ORAL Capozide (Hydrochlorothiazide , Captopril) Glucotrol (Glipizide) Persantine C C ORAL (Dipyridamole) Lanoxin (Digoxin) Multivitamins (Ergocalciferol, Ascorbid Acid, Folic Acid, Thiamine Hydrochloride, Hytrin (Terazosin Hydrochloride) Asa (Acetylsalicylic Acid) Date:02/26/99ISR Number: 3413102-3Report Type:Periodic Age:22 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 123 PT Alcohol Intolerance Asthenia Blood Glucose Abnormal Decreased Appetite 10:40 AM Company Report #001-0945-980602 C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Depression Hyperacusis Irritability Report Source Product Role Nasal Congestion Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG (,DAILY), PER ORAL Date:02/26/99ISR Number: 3413104-7Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980603 PT Report Source Product Role Bone Disorder Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 400 MG (,DAILY), PER ORAL (Thyroid) Unspecified Hormones Unspecified Allergy Medication Date:02/26/99ISR Number: 3413106-0Report Type:Periodic Age:57 YR Gender:Male I/FU:I Outcome Dose C C C Company Report #001-0945-980604 PT Report Source Product Role Platelet Count Decreased Consumer Health Neurontin Capsules 100 Mg (Gabapentin) PS Zoloft (Sertraline Hydrochloride) C Manufacturer Route Duration 300 MG (100 Professional MG, TID) PER ORAL ORAL Zantac (Ranitidine Hydrochloride) Cytotec (Misoprostol) Propulsid (Cisapride) Zyloprim (Allopurinol) Ativan (Lorazepam) Lamictal (Lamotrigine) (Colchicine) Date:02/26/99ISR Number: 3413107-2Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980605 PT Report Source Product Role Amnesia Consumer Health Neurontin (Gabapentin) PS Manufacturer Route Duration 600 MG Professional (,DAILY), PER ORAL 22-Aug-2005 Page: 124 C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3413109-6Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980610 PT Report Source Product Role Abnormal Behaviour Disorientation Consumer Neurontin (Gabapentin) PS Paxil (Paroxetine Hydrochloride) Nasalcort C C Manufacturer Route Duration ORAL 200 MG (100 Fatigue MG, BID), PER Headache ORAL Vision Blurred Date:02/26/99ISR Number: 3413111-4Report Type:Periodic Age:58 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980612 PT Report Source Product Role Urinary Tract Infection Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (,DAILY), PER ORAL Procardia Xl (Nifedipine) Aerobid (Flunisolide) Persantine (Dipyridamole) Date:02/26/99ISR Number: 3413112-6Report Type:Periodic Age:82 YR Gender:Male I/FU:I Outcome Dose 300 MG (, X1 C C C Company Report #001-0945-980619 PT Report Source Product Role Feeling Abnormal Stupor Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL DOSE), PER ORAL Lescol (Fluvastatin Sodium) Asa (Acetylsalicylic Acid) Hytrin (Terazosin Hydrochloride) Norvasc (Amlodipine Besilate) Date:02/26/99ISR Number: 3413114-XReport Type:Periodic Age:72 YR Gender:Male I/FU:I Outcome Dose C C C C Company Report #001-0945-980620 PT Report Source Product Role Erectile Dysfunction Faecal Incontinence Health Professional Neurontin (Gabapentin) PS 300 MG (,DAILY), PER ORAL Vitamin B12 (Cyanocobalamin-N) Ventolin (Salbutamol) 22-Aug-2005 Page: 125 Manufacturer Route Duration 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3413115-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980622 PT Report Source Product Role Unevaluable Event Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration UNK, UNKNOWN Date:02/26/99ISR Number: 3413116-3Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980624 PT Report Source Product Role Vertigo Health Professional Neurontin (Gabapentin) PS Duration ORAL 1200 MG (400 MG,TID), PER ORAL Date:02/26/99ISR Number: 3413117-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980625 PT Report Source Product Role Pneumonia Weight Increased Health Professional Neurontin (Gabapentin) PS Zoloft (Sertraline Hydrochloride) C Manufacturer Route Duration 2000 MG (400 MG, 5 TIMES A DAY), PER ORAL Date:02/26/99ISR Number: 3413118-7Report Type:Periodic Age: Gender:Male I/FU:I Company Report #001-0945-980626 ORAL Outcome Dose PT Report Source Product Role Skin Ulcer Weight Increased Health Professional Neurontin (Gabapentin) PS Darvocet (Paracetamol, Dextropoxyphene) Soma (Carisoprodol) C C Manufacturer Route Duration ORAL 1600 MG (400 MG, QID), PER ORAL Date:02/26/99ISR Number: 3413119-9Report Type:Periodic Age:41 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980290 PT Report Source Product Role Anorgasmia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 90MG (30MG, TID ) PER ORAL Date:02/26/99ISR Number: 3413120-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980291 PT Report Source Product Role Paraesthesia Consumer Health Neurontin (Gabapentin) PS Duration 240MG Professional (DAILY), 22-Aug-2005 Page: 126 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3413121-7Report Type:Periodic Age:79 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980293 PT Report Source Product Role Erythema Hypoaesthesia Consumer Neurontin (Gabapentin) PS Tenormin (Atenolol) C Manufacturer Route Duration ORAL 120MG (40MG, Paraesthesia TID) , PER ORAL Date:02/26/99ISR Number: 3413122-9Report Type:Periodic Age:74 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980295 PT Report Source Product Role Herpes Zoster Consumer Health Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 2400 MG (600 Professional MG, QID), PER ORAL Lipitor (Atorvastatin) Lopressor (Metoprolol Tartrate) Nortriptyline Asa (Acetylsalicylic Acid) Date:02/26/99ISR Number: 3413123-0Report Type:Periodic Age: Gender: I/FU:I Outcome Dose C C C C Company Report #001-0945-980296 PT Report Source Product Role Diarrhoea Food Interaction Health Professional Neurontin (Gabapentin) PS Duration Manufacturer Route Nausea Shellfish SS ORAL PER ORAL Vomiting Date:02/26/99ISR Number: 3413124-2Report Type:Periodic Age:47 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980297 PT Report Source Product Role Anxiety Balance Disorder Consumer Neurontin Capsules 100 Mg (Gabapentin) PS SEE TEXT, PER Drug Withdrawal Syndrome ORAL Ear Disorder Fatigue Nausea Tension Tinnitus Vision Blurred 22-Aug-2005 Page: 127 Manufacturer Route Duration 10:40 AM Advil (Ibuprofen) Floxin (Ofloxacin) Imitrex (Sumatriptan) Clozapine Nervous Tension Anxiety Nausea Withdrawal Symptoms C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3413125-4Report Type:Periodic Age:12 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Gastrointestinal Disorder Viral Infection Vomiting Consumer Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3413126-6Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980298 Company Report #001-0945-980301 PT Report Source Product Role Libido Decreased Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Wellbutrin (Amfebutamone Hydrochloride) C Duration ORAL 1200 MG (400 Company MG, TID), PER Representative ORAL Date:02/26/99ISR Number: 3413127-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Fatigue Sedation Consumer Neurontin (Gabapentin) Ativan (Lorazepam) PS C Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3413128-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980302 Company Report #001-0945-980303 PT Report Source Product Erectile Dysfunction Consumer Neurontin Duration Role (Gabapentin) PS ORAL 1200 MG (DAILY) PER ORAL Date:02/26/99ISR Number: 3413129-1Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980305 PT Report Source Product Role Gingivitis Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1 GM (DAILY) PER ORAL FEW WEEKS Haldol (Haloperidol) Klonopin (Clonazepam) Depakote (Valproate Semisodium) Date:02/26/99ISR Number: 3413130-8Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980306 PT Report Source Product Role Insomnia Sinusitis Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 400 MG 22-Aug-2005 Page: 128 C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (DAILY) PER ORAL Carafate (Sucralfate) Prilosec (Omeprazole) Gaviscon (Aluminium Hydroxide Gel, Dried, Magnesium Trisilicate) Date:02/26/99ISR Number: 3413131-XReport Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980309 PT Report Source Product Role Ageusia Amnesia Consumer Health Neurontin (Gabapentin) PS Condition Aggravated Professional Doxidan (Dantron, Docusate Calcium) C Manufacturer Route Duration ORAL 500 MG (,SEE TEXT), PER Dizziness ORAL Flatulence Date:02/26/99ISR Number: 3413132-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980310 PT Report Source Product Role Abnormal Behaviour Logorrhoea Consumer Neurontin (Gabapentin) PS Baclofen C Duration UNK, COUPLES OF WEEKS Date:02/26/99ISR Number: 3413133-3Report Type:Periodic Age:75 YR Gender:Male I/FU:I Company Report #001-0945-980314 Manufacturer Route Outcome Dose PT Report Source Product Role Condition Aggravated Fatigue Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 500 MG (100 Feeling Abnormal MG, FIVE Frequent Bowel Movements TIMES DAILY), Nausea PER ORAL Oedema Peripheral Paraesthesia Sedation Tylenol (Paracetamol) Zantac (Ranitidine Hydrochloride) Date:02/26/99ISR Number: 3413134-5Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-983015 PT Report Source Product Role Vision Blurred Visual Acuity Reduced Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Dilantin (Phenytoin Sodium) C 300 MG (,DAILY) , PER ORAL SEE TEXT 22-Aug-2005 Page: 129 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3413136-9Report Type:Periodic Age:25 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980316 PT Report Source Product Role Anxiety Insomnia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL SEE TEXT, PER Orgasm Abnormal ORAL Weight Increased Date:02/26/99ISR Number: 3413139-4Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-98317 PT Report Source Product Role Balance Disorder Condition Aggravated Consumer Neurontin(Gabapentin ) PS Betaseron (Glucose, Albumin Human, Interferon Beta) C Manufacturer Route Duration ORAL 900 MG Gait Disturbance (300MG, TID), Migraine PER ORAL Thinking Abnormal Date:02/26/99ISR Number: 3413140-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose 600 MG (,DAILY) , PER ORAL Company Report #001-0945-980319 PT Report Source Product Role Disorientation Drug Withdrawal Syndrome Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL Date:02/26/99ISR Number: 3413142-4Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980321 PT Report Source Product Role Convulsion Overdose Health Professional Neurontin (Gabapentin) PS 3000 MG (1000 MG, TID) PER ORAL Imuran (Azathioprine) Lorazepam Isordil (Isosorbide Dinitrate) Premarin (Estrogens) Lasix (Furosemide) Ranitidine Lescol (Fluvastatin Sodium) Norvasc (Amlodipine Besilate) Acyclovir (Aciclovir) Albuterol (Salbutamol) Atrovent (Fenoterol Hydrobromide, Ipratropium Bromide) Proventil (Salbutamol) 22-Aug-2005 Page: 130 Manufacturer Route Duration 10:40 AM C C C C C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ms Contin (Morphine Sulfate) Dilantin (Phenytoin Sodium) Date:02/26/99ISR Number: 3414411-4Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980555 PT Report Source Product Role Arthralgia Dizziness Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 2400 MG (800 Fatigue MG, TID), PER Feeling Jittery ORAL Headache Irritability Nausea Weight Increased Date:02/26/99ISR Number: 3414413-8Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980557 PT Report Source Product Role Eye Disorder Hypertension Consumer Neurontin (Gabapentin) PS Baclofen C Manufacturer Route Duration ORAL 2100 MG (700 MG, TID), PER ORAL Date:02/26/99ISR Number: 3414416-3Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report #001-0945-980560 Report Source Product Role Manufacturer Route Oral Mucosal Blistering Stomatitis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS ORAL SEE TEXT, PER ORAL Date:02/26/99ISR Number: 3414417-5Report Type:Periodic Age:51 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980561 PT Report Source Product Role Abdominal Pain Feeling Drunk Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 600 MG (300 Insomnia MG, BID), PER Vision Blurred ORAL Date:02/26/99ISR Number: 3414420-5Report Type:Periodic Age:68 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980563 PT Report Source Product Role Dermatitis Diarrhoea Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Klonopin (Clonazepam) C 900 MG Dizziness (,EVERY Emotional Distress NIGHT), PER Malaise ORAL Sedation Vision Blurred 22-Aug-2005 Page: 131 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamins Nos Asa (Acetylsalicyclic Acid) Date:02/26/99ISR Number: 3414422-9Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980564 PT Report Source Product Role Photosensitivity Reaction Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Company Report #001-0945-980565 PT Report Source Product Role Headache Consumer Neurontin (Gabapentin) PS Duration Date:02/26/99ISR Number: 3414426-6Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome Dose C Duration Date:02/26/99ISR Number: 3414424-2Report Type:Periodic Age:71 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980566 PT Report Source Product Role Anorgasmia Consumer Neurontin (Gabapentin) PS Rilutek (Riluzole) C Duration 2400 MG (,DAILY), PER ORAL Date:02/26/99ISR Number: 3414427-8Report Type:Periodic Age:27 YR Gender:Female I/FU:I Company Report #001-0945-980567 ORAL Outcome Dose PT Report Source Product Role Oedema Peripheral Paraesthesia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 100 MG (,X1 DOSE), PER ORAL Birth Control Pills Tegretol (Carbamazepine) Date:02/26/99ISR Number: 3414428-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980568 PT Report Source Product Role Back Pain Medication Error Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration 1200 MG (400 MG, TID), PER ORAL 22-Aug-2005 Page: 132 C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414432-1Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980639 PT Report Source Product Role Blood Pressure Increased Haematuria Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG DAILY Medication Error PER ORAL Renal Colic Therapeutic Response Unexpected (Baclofen) Aspirin (Acetylsalicylic Acid) Synthroid (Levothyroxine Sodium) Date:02/26/99ISR Number: 3414433-3Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980569 PT Report Source Product Blood Cholesterol Increased Blood Triglycerides Increased Health Professional Neurontin (Gabapentin) Insulin 70/30 (Insulin Human, Insulin Human Injection, Isophane) Albuterol (Salbutamol) Digoxin Zestril (Lisinopril) Serevent (Salmeterol Xinafoate) Pravachol (Pracastatin Sodium) Prednisone Rezulin (Troglitazone) Prempro (Medroxyprogesterone Acetate, Estrogens Conjugated) Nasalide Role Duration PS C C C C C C C C C Manufacturer Route (Flunisolide) Lasix (Furosemide) Citracal (Calcium Citrate) Vitamin E (Tocopherol) Zoloft (Sertraline Hydrochloride) Buspar (Buspirone Hydrochloride) Tegretol (Carbamazepine) Trazodone Xanax (Alprazolam) Pulmicort (Budesonide) 22-Aug-2005 Page: 133 10:40 AM C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414435-7Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980570 PT Report Source Product Role Liver Function Test Abnormal Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (,DAILY), PER ORAL Date:02/26/99ISR Number: 3414437-0Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980642 PT Report Source Product Role Oligomenorrhoea Weight Increased Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG TID) PER ORAL Date:02/26/99ISR Number: 3414438-2Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980572 PT Report Source Product Role Dysarthria Ecchymosis Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 300 MG Feeling Drunk (,DAILY), PER ORAL Amantadine Eskalith (Lithium Carbonate) Klonopin (Clonazepam) C C C ORAL Synthroid (Levothyroxine Sodium) Serax (Oxazepam) Zyprexa (Olanzapine) Date:02/26/99ISR Number: 3414440-0Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980574 PT Report Source Product Role Blindness Visual Disturbance Consumer Neurontin(Gabapentin ) PS 1200 MG (,DAILY), PER ORAL Prozac (Fluoxetine Hydrochloride) Wellbutrin (Amfebutamone Hydrochloride) Klonopin (Clonazepam) Premarin (Estrogens Conjugated) Ogen (Estropipate) 22-Aug-2005 Page: 134 Manufacturer Route Duration 10:40 AM C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414441-2Report Type:Periodic Age:88 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980643 PT Report Source Product Role Anuria Increased Appetite Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 400 MG (200 Lethargy MG BID) PER Nervousness ORAL Date:02/26/99ISR Number: 3414442-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980575 PT Report Source Product Role Insomnia Mania Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Wellbutrin (Amfebutamone Hydrochloride) C Manufacturer Route Manufacturer Route Duration 400 MG (, 100 Medication Error MG QAM; 300 Tachycardia QHS), UNKNOWN Thinking Abnormal Date:02/26/99ISR Number: 3414444-8Report Type:Periodic Age:75 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980576 PT Report Source Product Role Abdominal Pain Nausea Consumer Neurontin (Gabapentin) PS Fosamax (Alendronate Sodium) C Duration 100 MG Pharyngolaryngeal Pain (,DAILY), PER ORAL ORAL Tylenol #3 (Codeine Phosphate, Paracetamol) Date:02/26/99ISR Number: 3414445-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980644 PT Report Source Product Blood Creatine Phosphokinase Increased Muscular Weakness Health Professional Neurontin (Gabapentin) Rezulin (Troglitazone) (Insulin) Prandin (Repaglinide) (Verapamil) Role Route Manufacturer Route PS SS C C C Company Report #001-0945-980580 PT Report Source Product Role Arthralgia Myalgia Health Professional Neurontin (Gabapentin) PS Depakote (Valproate Semisodium) C Duration 2700 MG (,DAILY), 22-Aug-2005 Page: 135 Manufacturer Duration Date:02/26/99ISR Number: 3414447-3Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414448-5Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose PT Report Source Product Role Arthralgia Malaise Myalgia Systemic Lupus Erythematosus Health Professional Company Representative Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3414449-7Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980646 Company Report #001-0945-980583 PT Report Source Product Role Skin Odour Abnormal Consumer Health Neurontin(Gabapentin ) PS Duration ORAL 900 MG (300 Professional MG, TID), PER ORAL Date:02/26/99ISR Number: 3414450-3Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980647 PT Report Source Product Asthenia Drug Interaction Syncope Consumer Neurontin (Gabapentin) Nardil (Phenelzine Sulfate) Role Manufacturer Route Duration PS SS 75 MG DAILY PER ORAL Propulsid (Cisapride) Prilosec (Omeprazole) Estratest Hs (Methyltestosterone, Estrogens C C ORAL Esterified) Artane (Trihexyphenidyl Hydrochloride) Librium (Chlordiazepoxide Hydrochloride) (Perphenazine) (Oxazepam) Date:02/26/99ISR Number: 3414451-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C C C C Company Report #001-0945-980584 PT Report Source Product Role Back Pain Pain In Extremity Consumer Neurontin (Gabapentin) PS 900 MG (300 Sedation MG, TID), PER ORAL Atenolol Prinivil (Lisinopril) Voltaren (Diclofenac Sodium) Zantac (Ranitidine 22-Aug-2005 Page: 136 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) Mevacor (Lovastatin) Premarin (Estrogens Conjugated) Elavil (Amitriptyline Hydrochloride) Diazepam Vicodin (Paracetamol, Hydrocodone Bitartrate) Date:02/26/99ISR Number: 3414452-7Report Type:Periodic Age:73 YR Gender:Male I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980648 PT Report Source Product Role Drug Withdrawal Syndrome Consumer Neurontin (Gabapentin) PS Percocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone Eye Drops C C Manufacturer Route Duration ORAL 2700 MG (300 MG , 9X DAILY) PER ORAL Date:02/26/99ISR Number: 3414453-9Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980585 PT Report Source Product Drug Interaction Sedation Health Professional Company Representative Neurontin (Gabapentin) Tegretol (Carbamazepine) Elavil Role Duration PS SS Manufacturer Route (Amitriptyline Hydrochloride) Date:02/26/99ISR Number: 3414454-0Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose SS Company Report #001-0945-980651 PT Report Source Product Role Alopecia Health Professional Neurontin (Gabapentin) PS 1200 MG (600 MG BID) PER ORAL Serzone (Nefazodone Hydrochloride) Xanax (Alprazolam) Plaquenil (Hydroxychloroquine Phosphate) 22-Aug-2005 Page: 137 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414455-2Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980652 PT Report Source Product Role Sedation Health Professional Neurontin (Gabapentin) PS (Valproate Sodium) C Manufacturer Route Duration ORAL 900 MG (300 MG TID) PER ORAL Date:02/26/99ISR Number: 3414457-6Report Type:Periodic Age:67 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980653 PT Report Source Product Role Arthralgia Consumer Neurontin (Gabapentin) PS Unspecified Medications C Manufacturer Route Manufacturer Route Duration TID Date:02/26/99ISR Number: 3414458-8Report Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980654 PT Report Source Product Role Arthralgia Joint Stiffness Consumer Neurontin (Gabapentin) PS Duration 2700 MG (900 MG TID) PER ORAL Serax (Oxazepam) Pamelor (Nortriptyline Hydrochloride) (Morphine) C C C ORAL Date:02/26/99ISR Number: 3414459-XReport Type:Periodic Age:67 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980655 PT Report Source Product Role Back Pain Nausea Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (DAILY) PER ORAL Synthroid (Levothyroxine Sodium) Pravachol (Pravastatin Sodium) Date:02/26/99ISR Number: 3414460-6Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980657 PT Report Source Product Role Eyelid Oedema Mydriasis Consumer Company Neurontin (Gabapentin) PS Prozac (Fluoxetine Hydrochloride) C 300 MG (100 Representative MG TID) PER ORAL 22-Aug-2005 Page: 138 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414461-8Report Type:Periodic Age:33 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980658 PT Report Source Product Role Amnesia Chills Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 4000 MG Diarrhoea (DAILY) PER Drug Withdrawal Syndrome ORAL Dyspnoea Ear Pain Electroencephalogram Abnormal Erectile Dysfunction Fatigue Feeling Abnormal Headache Hypoaesthesia Libido Decreased Night Sweats Overdose Palpitations Pollakiuria Sleep Disorder Tremor Vision Blurred Zoloft (Sertraline Hydrochloride) Ativan (Lorazepam) Luvox (Fluvoxamine Maleate) Serzone (Nefazodone Hydrochloride) Klonopin (Clonazepam) Elavil (Amitriptyline Hydrochloride) Date:02/26/99ISR Number: 3414462-XReport Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980659 PT Report Source Product Role Weight Increased Health Professional Company Representative Neurontin (Gabapentin) PS Duration Date:02/26/99ISR Number: 3414463-1Report Type:Periodic Age: Gender:Unknown I/FU:I Company Report #001-0945-980660 Manufacturer Route Outcome Dose PT Report Source Product Role Alopecia Restlessness Health Professional Neurontin (Gabapentin) PS Unspecified Antipsychotic Medications C Manufacturer Route Duration ORAL 1200 - 1500 MG( DAILY) PER ORAL Date:02/26/99ISR Number: 3414464-3Report Type:Periodic Age:77 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980662 PT Report Source Product Role Sleep Walking Consumer Neurontin Capsules 300 Mg (Gabapentin) PS 900 MG (300 MG TID) PER ORAL (Clonidine) (Folic Acid) Serevent (Salmeterol Xinafoate) 22-Aug-2005 Page: 139 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Timoptic (Timolol Maleate) Date:02/26/99ISR Number: 3414465-5Report Type:Periodic Age:49 YR Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980667 PT Report Source Product Role Feeling Abnormal Mental Impairment Consumer Health Neurontin (Gabapentin) PS Sedation Professional Prilosec (Omeprazole) Unspecified Inhaler C C Manufacturer Route Duration ORAL 2500 MG DAILY PER ORAL Date:02/26/99ISR Number: 3414466-7Report Type:Periodic Age:66 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980668 PT Report Source Product Role Oedema Peripheral Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 300 MG QHS PER ORAL Vancenase (Beclometasone Dipropionate) Aerobid (Flunisolide) Atrovent (Fenoterol Hydrobromide, Ipratropium Bromide) Albuterol (Salbutamol) (Nortriptyline) (Cyproheptadine) Elmiron (Pentosan Polysulfate Sodium) C C C C C C C ORAL Date:02/26/99ISR Number: 3414467-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980669 PT Report Source Product Role Visual Disturbance Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS 900 MG (300 MG TID) PER ORAL Serzone (Nefazodone Hydrochloride) Buspar (Buspirone Hydrochloride) Date:02/26/99ISR Number: 3414468-0Report Type:Periodic Age:43 YR Gender:Male I/FU:I Outcome 22-Aug-2005 Page: 140 Manufacturer Route Duration PT Drug Effect Decreased Euphoric Mood Fatigue Paranoia 10:40 AM Company Report #001-0945-980386 C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Dose Report Source Product Role Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Klonopin (Clonazepam) (Valproic Acid) Zyprexa (Olanzapine) C C C Manufacturer Route Duration ORAL 1200 MG (300 MG, QID), PER ORAL Date:02/26/99ISR Number: 3414469-2Report Type:Periodic Age:76 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980388 PT Report Source Product Role Balance Disorder Change Of Bowel Habit Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 300 MG Dry Mouth (DAILY) (SEE Dysarthria IMAGE) Fall Flatulence Insomnia Vision Blurred Zostrix (Capsaicin) Tylenol Pm (Diphenhydramine, Paracetamol) Lodine (Etodolac) Date:02/26/99ISR Number: 3414470-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980393 PT Report Source Product Amnesia Anaemia Confusional State Parkinsonian Gait Consumer Neurontin (Gabapentin) Dilantin (Phenytoin Sodium) Role Duration PS C (Felbamate) Date:02/26/99ISR Number: 3414471-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980394 PT Report Source Product Role Back Pain Consumer Neurontin (Gabapentin) PS Dolobid (Diflunisal) Vitamins C C Manufacturer Route Duration ORAL 2400 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3414472-2Report Type:Periodic Age:77 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980395 PT Report Source Product Role Manufacturer Route Drug Interaction Nausea Consumer Neurontin (Gabapentin) PS ORAL Buspar (Buspirone Hydrochloride) SS ORAL Duration 200 MG (100 MG,BID), PER ORAL 20 MG (10 MG, 22-Aug-2005 Page: 141 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report BID), PER ORAL Procardia Xl (Nifedipine) Tenormin (Atenolol) (Allopurinol) Prilosec (Omeprazole) Coumadin (Warfarin Sodium) Propulsid (Cisapride) Date:02/26/99ISR Number: 3414473-4Report Type:Periodic Age:76 YR Gender:Female I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980397 PT Report Source Product Role Feeling Abnormal Feeling Hot Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 100 MG Pain (DAILY), PER Paraesthesia ORAL Vasodilatation Glucophage (Metformin Hydrochloride) Synthroid (Levothyroxine Sodium) Plendil (Felodipine) Coumadin (Warfarin Sodium) Xanax (Alprazolam) Macrodantin (Nitrofurantoin) Vitamin C (Ascorbic Acid) Vitamin E (Tocopherol) C C C C C C C C ORAL Date:02/26/99ISR Number: 3414474-6Report Type:Periodic Age:79 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980398 PT Report Source Product Role Dizziness Feeling Abnormal Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG Sedation (DAILY), PER ORAL Adalat (Nifedipine) Aspirin (Acetylsalicylic Acid) Date:02/26/99ISR Number: 3414475-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980399 PT Report Source Product Role Porphyrin Metabolism Disorder Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 100-200 MG (DAILY), PER ORAL 22-Aug-2005 Page: 142 C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Herbs Date:02/26/99ISR Number: 3414476-XReport Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980400 PT Report Source Product Convulsion Health Professional Company Representative Neurontin (Gabapentin) Dilantin (Phenytoin Sodium) Role Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3414477-1Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose C PS C Company Report #001-0945-980401 PT Report Source Product Role Lymphadenopathy Health Professional Neurontin (Gabapentin) PS Elavil (Amitriptyline Hydrochloride) C Duration ORAL 300 MG (100 MG, TID), PER ORAL Date:02/26/99ISR Number: 3414478-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980324 PT Report Source Product Role Neuropathy Peripheral Health Professional Neurontin (Gabapentin) Alcohol (Ethanol) PS SS Duration Date:02/26/99ISR Number: 3414479-5Report Type:Periodic Age:28 YR Gender:Female I/FU:I Company Report #001-0945-980325 Manufacturer Route Outcome Dose PT Report Source Product Role Anorgasmia Libido Decreased Other Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3414480-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose 22-Aug-2005 Page: 143 Company Report #001-0945-980329 PT Report Source Product Convulsion Drug Interaction Consumer Neurontin (Gabapentin) Carbocaine (Mepivacaine Hydrochloride) Lamictal (Lamotrigine) Role Duration 10:40 AM PS SS C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414481-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose PT Report Source Product Role Dermatitis Neuropathy Peripheral Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3414482-5Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980339 Company Report #001-0945-980330 PT Report Source Product Role Difficulty In Walking Fatigue Consumer Neurontin (Gabapentin) PS Topimax (Topiramate) C Duration ORAL 1200 MG (400 Sedation MG, TID), PER ORAL Date:02/26/99ISR Number: 3414483-7Report Type:Periodic Age:29 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980340 PT Report Source Product Role Extrapyramidal Disorder Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 1200 MG ( , DAILY--IN DIVIDED DOSES) , PER ORAL Date:02/26/99ISR Number: 3414484-9Report Type:Periodic Age: Gender:Female I/FU:I Company Report #001-0945-980333 ORAL Outcome Dose 10 PT Report Source Product Role Amnesia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration DAY (Valproate Sodium) Pamelor (Nortriptyline Hydrochloride) (Nortriptyline) Date:02/26/99ISR Number: 3414485-0Report Type:Periodic Age:62 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980343 PT Report Source Product Role Arthralgia Myalgia Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Trazodone C Duration ORAL 700 MG ( , DAILY) , PER ORAL Date:02/26/99ISR Number: 3414486-2Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Medication Error Weight Increased Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 900 MG (300 MG, TID), PER 22-Aug-2005 Page: 144 Company Report #001-0945-980334 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Prozac (Fluoxetine Hydrochloride) Date:02/26/99ISR Number: 3414487-4Report Type:Periodic Age:4 YR Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980335 PT Report Source Product Role Convulsion Insomnia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (100 Psychomotor Hyperactivity MG, TID), PER ORAL (Chloral Hydrate) Unisom (Doxylamine Succinate) Date:02/26/99ISR Number: 3414488-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980344 PT Report Source Product Role Manufacturer Route Drug Interaction Hallucination Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS ORAL Nardil Tablets 15 Mg (Phenelzine Sulfate) SS ORAL Duration 1800 MG ( , DAILY) , PER ORAL 45 MG (, DAILY) , PER ORAL (Lithium) Plaquenil (Hydroxy-Chloroquine Phosphate) C C Ambien (Zolpidem Tartate) Date:02/26/99ISR Number: 3414489-8Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980347 PT Report Source Product Role Blood Pressure Decreased Paraesthesia Consumer Neurontin(Gabapentin ) PS 400 MG (200 Speech Disorder MG, BID) , PER ORAL Dilantin (Phenytoin Sodium) Cardizem (Diltiazem Hydrochloride) Prilosec (Omeprazole) Zoloft (Sertraline Hydrochloride) Urispas (Florvoxate Hydrochloride) Ambien (Zolpidem Tartrate) (Atenolol) (Colchicine) 22-Aug-2005 Page: 145 Manufacturer Route Duration 10:40 AM C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414490-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980336 PT Report Source Product Role Memory Impairment Weight Increased Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (100 MG, TID), PER ORAL Date:02/26/99ISR Number: 3414491-6Report Type:Periodic Age:22 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980350 PT Report Source Product Role Amnesia Chest Pain Consumer Neurontin (Gabepentin) PS Dilantin(Phenytoin Sodium) (Folic Acid) C C Manufacturer Route Duration ORAL 1200 MG ( , Drug Level Below DAILY), PER Therapeutic ORAL Date:02/26/99ISR Number: 3414492-8Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980352 PT Report Source Product Role Flat Affect Panic Attack Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Klonopin (Clonazepam) C Manufacturer Route Duration 100 MG (, Tremor DAILY) , PER ORAL ORAL (Meprobamate) Date:02/26/99ISR Number: 3414493-XReport Type:Periodic Age:62 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980337 PT Report Source Product Role Weight Increased Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3414494-1Report Type:Periodic Age:25 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980353 PT Report Source Product Role Medication Error Mydriasis Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS 1200 MG (400 MG, TID) , PER ORAL Depakote (Valproate Semisodium) Cogentin (Benzatropine Mesilate) Ativan (Lorazepam) Prolixin (Fluphenazine 22-Aug-2005 Page: 146 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) Date:02/26/99ISR Number: 3414495-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980338 PT Report Source Product Role Drug Level Below Therapeutic Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL PER ORAL Date:02/26/99ISR Number: 3414496-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Company Report #001-0945-980355 Report Source Oedema Neurontin (Gabapentin) Wellbutrin (Amfebutamone Hydrochloride) Date:02/26/99ISR Number: 3414497-7Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Product Role Manufacturer Route Manufacturer Route Duration PS C Company Report #001-0945-980522 PT Report Source Product Role Dizziness Nausea Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Duration SEE TEXT, PER Tremor ORAL (Insulin) Inderal (Propranolol Hydrochloride) Ogen (Estropipate) Tegretol (Carbamazepine) Lasix (Furosemide) Betimol (Timolol) Pepcid (Famotidine) Cardizem (Diltiazem C C C C C C C ORAL Hydrochloride) Date:02/26/99ISR Number: 3414498-9Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980524 PT Report Source Product Role Depression Other Neurontin (Gabapentin) (Cocaine) PS C Route Manufacturer Route Company Report #001-0945-980525 PT Report Source Product Role Pollakiuria Polyuria Health Professional Neurontin (Gabapentin) PS Effexor (Venlafaxine Hydrochloride) C Duration 600 MG (300 MG, BID), PER ORAL 22-Aug-2005 Page: 147 Manufacturer Duration Date:02/26/99ISR Number: 3414499-0Report Type:Periodic Age:17 YR Gender:Female I/FU:I Outcome Dose C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414500-4Report Type:Periodic Age:31 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980361 PT Report Source Product Role Clumsiness Disorientation Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG (400 Fall MG, TID) , Fatigue PER ORAL Speech Disorder Tegretol (Carbamazepine) Paxil (Paroxetine Hydroochloride) Klonopin (Clonazepam) Date:02/26/99ISR Number: 3414501-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C C C Company Report #001-0945-980368 PT Report Source Product Role Diplopia Dizziness Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1800 MG ( , Dry Mouth DAILY), PER Dystonia ORAL Muscle Spasms Vomiting Date:02/26/99ISR Number: 3414502-8Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980526 PT Report Source Product Role Oedema Health Professional Neurontin (Gabapentin) PS Duration SEE TEXT Company Manufacturer Route Representative Date:02/26/99ISR Number: 3414503-XReport Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980369 PT Report Source Product Role Conjunctival Hyperaemia Ear Pain Consumer Neurontin (Gabapentin) PS 2100 MG (, Food Allergy DAILY ) , PER Keratoconjunctivitis ORAL Sicca Lymphadenopathy Medication Error Oral Mucosal Blistering Salivary Gland Enlargement Tongue Oedema 22-Aug-2005 Page: 148 Manufacturer Route Duration 10:40 AM Pepcid (Famotikine) Tylenol # 3 (Codeine Phosphate, Paracetamol) Sporanox (Itraconazole) Zoloft (Sertraline Hydrochloride) Soma (Carisoprodol) (Vitamins Nos) C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414504-1Report Type:Periodic Age:31 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980529 PT Report Source Product Role Eye Disorder Tic Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 300 MG (, 100 MG QAM, 200 MG QPM, UNKNOWN Date:02/26/99ISR Number: 3414505-3Report Type:Periodic Age:61 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980372 PT Report Source Product Role Oedema Weight Increased Consumer Neurontin(Gabapentin ) PS Duration ORAL 900 MG (300 MG, TID) , PER ORAL Date:02/26/99ISR Number: 3414506-5Report Type:Periodic Age:60 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980530 PT Report Source Product Hypoglycaemia Health Professional Neurontin (Gabapentin) Diabeta (Glibenclamide) Role Duration Date:02/26/99ISR Number: 3414507-7Report Type:Periodic Age:43 YR Gender:Male I/FU:I Company Report #001-0945-980374 PS C Manufacturer Route Outcome Dose PT Report Source Product Role Oedema Peripheral Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 2400 MG (800 MG, TID) , PER ORAL Date:02/26/99ISR Number: 3414508-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980531 PT Report Source Product Role Fatigue Lethargy Consumer Neurontin (Gabapentin) PS 1200 MG (400 MG, TID) , PER ORAL Coumadin (Warfarin Sodium) Hytrin (Terazosin Hydrochloride) Vasotec (Enlapril Maleate) Zyloprim (Allopurinol) 22-Aug-2005 Page: 149 Manufacturer Route Duration 10:40 AM C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414509-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980375 PT Report Source Product Role Arthralgia Asthenia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 Coordination Abnormal MG,TID) PER Flushing ORAL Date:02/26/99ISR Number: 3414510-7Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980376 PT Report Source Product Role Abdominal Pain Upper Constipation Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 450 MG (150 Diarrhoea MG, TID) , Dyspepsia PER ORAL Fatigue Flatulence Nausea Pyrexia Xanax (Alprazolam) Klonopin (Clonazepam) (Cortisone) Date:02/26/99ISR Number: 3414511-9Report Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose 300 MG (X1 DOSE), PER ORAL C C C Company Report #001-0945-980532 PT Report Source Product Role Feeling Abnormal Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL Date:02/26/99ISR Number: 3414512-0Report Type:Periodic Age:89 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980537 PT Report Source Product Role Sedation Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 300 MG (, DAILY), Date:02/26/99ISR Number: 3414513-2Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980377 PT Report Source Product Role Back Pain Hypoaesthesia Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Duration 100 MG Insomnia (,DAILY), PER Pain In Extremity ORAL Paraesthesia Date:02/26/99ISR Number: 3414514-4Report Type:Periodic Age:71 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 150 PT Asthenia Condition Aggravated Confusional State Convulsion 10:40 AM Company Report #001-0945-980538 ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Difficulty In Walking Drug Level Above Therapeutic Dose Report Source Product Role Consumer Neurontin (Gabapentin) PS ORAL Dilantin (Phenytoin Sodium) SS ORAL Asa (Acetylsalicylic Acid) (Calcium) (Vitamins Nos) Unspecified Spray C C C C Manufacturer Route Duration Fall Sedation 1200 MG Urinary Incontinence (,DAILY) PER ORAL 300 MG (100 MG, TID) PER ORAL Date:02/26/99ISR Number: 3414515-6Report Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980383 PT Report Source Product Role Flatulence Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 900 MG (,300 MG TID), PER ORAL Glucophage (Metformin Hydrochloride) Paxil (Paroxetine Hydrochloride) Glucomide (Metformin Hydrochloride, Glibenclamide) C C C ORAL Date:02/26/99ISR Number: 3414516-8Report Type:Periodic Age:76 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980720 PT Report Source Product Role Anxiety Dyspnoea Consumer Neurontin (Gabapentin) PS 900 MG (300 Nervousness MG, TID), PER ORAL Valium (Diazepam) Darvocet-N (Paracetamol, Dextropropoxyphene) (Thyroid) Lopid(Gemfibrozil) Dyazide (Hydrochlorothiazide , Triamterene) Inderal (Propranolol Hydrochloride) 22-Aug-2005 Page: 151 Manufacturer Route Duration 10:40 AM C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414517-XReport Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980384 PT Report Source Product Role Amnesia Consumer Neurontin (Gabapentin) PS Zocof (Simvastatin) Baby Aspirin C C Manufacturer Route Duration ORAL 3600 MG (,DAILY), PER ORAL Date:02/26/99ISR Number: 3414518-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980385 PT Report Source Product Role Oedema Peripheral Pain Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 600 ,G (,DAILY), PER ORAL Tenormin (Atenolol) (Allopurinol) Procardia Xl (Nifedipine) Prilosec (Omeprazole) Propulsid (Cisapride) Coumadin (Warfarin Sodium) Date:02/26/99ISR Number: 3414519-3Report Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose PT Duration C C C C C C Company Report #001-0945-980721 Report Source Product Role Manufacturer Route Blood Creatinine Increased Health Professional Neurontin (Gabapentin) PS 200 MG (100 Oedema Peripheral MG, BID), PER Weight Increased ORAL Depakote (Valproate Semisodium) Prilosec (Omeprazole) Plavix (Clopidogrel) Synthroid (Levothyroxine Sodium) Miacalcin Nasal Spray (Calcitonin, Salmon) Feosol (Ferrous Sulfate) Cardizem (Diltiazem Hydrochloride) Tylenol (Paracetamol) 22-Aug-2005 Page: 152 10:40 AM C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3414520-XReport Type:Periodic Age:62 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980722 PT Report Source Product Role Eczema Consumer Neurontin (Gabapentin) PS Tegretol (Carbamazepine) Vitamins C C Manufacturer Route Duration ORAL 1200 MG (400 MG, TID, PER ORAL Date:02/26/99ISR Number: 3414521-1Report Type:Periodic Age:66 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980723 PT Report Source Product Role Depression Dizziness Consumer Neurontin (Gabapentin) PS Halcion (Triazolam) Viracept Azt (Zidovudine) Epivir (Lamivudine) (Levocarnitine) C C C C C Manufacturer Route Duration ORAL 300 MG (, Epistaxis DAILY) PER Feeling Abnormal ORAL Lethargy Weight Decreased Date:02/26/99ISR Number: 3414522-3Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980724 PT Report Source Product Role Micturition Urgency Muscle Spasms Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration SEE TEXT, PER ORAL ORAL Date:02/26/99ISR Number: 3414523-5Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980725 PT Report Source Product Role Diarrhoea Gingivitis Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 3600 MG Weight Decreased (,DAILY) PER ORAL Dilantin (Phenytoin Sodium) Cardizem (Diltiazem Hydrochloride) Isordil (Isosorbide Dinitrate) Date:02/26/99ISR Number: 3414524-7Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980726 PT Report Source Product Role Hallucination, Visual Health Professional Neurontin (Gabapentin) PS (Trazodone) C 900 MG (300 MG, TID) PER ORAL 22-Aug-2005 Page: 153 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vicodin (Paracetamol, Hydrocodone Bitartrate) Date:02/26/99ISR Number: 3414525-9Report Type:Periodic Age:91 YR Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980727 PT Report Source Product Role Pancytopenia Consumer Health Neurontin (Gabapentin) PS Cardura (Doxazosin Mesilate) C Manufacturer Route Duration ORAL 900 MG (300 Professional MG, TID) PER ORAL Date:02/26/99ISR Number: 3414526-0Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980728 PT Report Source Product Role Constipation Fluid Retention Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 200 MG (100 Increased Appetite MG, BID), PER Insomnia ORAL Nausea Obsessive Thoughts Weight Increased Date:02/26/99ISR Number: 3414527-2Report Type:Periodic Age:36 YR Gender:Male I/FU:I Ultram (Tramadol Hydrochloride) Carafate (Sucralfrate) Paxil (Paroxetine Hydrochloride) Company Report #001-0945-980730 C C C ORAL Outcome Dose PT Report Source Product Role Libido Decreased Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 2700 MG (900 MG, TID), PER ORAL Claritin (Loratadine) Prilosec (Omeprazole) Date:02/26/99ISR Number: 3416247-7Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980434 PT Report Source Product Role Tic Health Professional Neurontin (Gabapentin) PS Zyprexa C 600 MG (DAILY), PER ORAL 22-Aug-2005 Page: 154 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416251-9Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose 400 Company Report #001-0945-980435 PT Report Source Product Role Swelling Weight Increased Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Antivert Percocet Sleeping Pill C C C Manufacturer Route Duration ORAL MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3416261-1Report Type:Periodic Age:43 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980436 PT Report Source Product Role Gingival Pain Gingivitis Consumer Neurontin (Gabapentin) PS (Methadone) Valium C C Manufacturer Route Duration ORAL 1200 MG (300 MG, QID), PER ORAL Date:02/26/99ISR Number: 3416823-1Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980086 PT Report Source Product Role Manufacturer Route Weight Increased Consumer Neurontin Capsules 300 Mg (Gabapentin) PS ORAL SS ORAL Duration 2700 MG (DAILY) (Trazodone) Synthroid (Levothyroxine Sodium) (Insulin) Date:02/26/99ISR Number: 3416824-3Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980090 PT Report Source Product Role Tremor Weight Increased Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1800 MG (DAILY) Xanax (Alprazolam) Wellbutrin (Amfebutamone Hydrochloride) Date:02/26/99ISR Number: 3416825-5Report Type:Periodic Age:47 YR Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980091 PT Report Source Product Role Dizziness Feeling Abnormal Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Serzone (Nefazodone Hydrochloride) C 1800 MG (600 MG, TID) 22-Aug-2005 Page: 155 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416826-7Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980092 PT Report Source Product Role Blood Glucose Increased Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 2700 MG (900 MG, TID) Date:02/26/99ISR Number: 3416827-9Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980094 PT Report Source Product Role Eye Discharge Eyelid Oedema Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG, (100 Laryngitis MG, TID) Nasal Congestion Vision Blurred Paxil (Paroxetine Hydrochloride) Klonopin (Clonazepam) Risperdal (Risperidone) Date:02/26/99ISR Number: 3416828-0Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980095 PT Report Source Product Role Transient Ischaemic Attack Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3416829-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C PT Duration Company Report #001-0945-980096 Report Source Product Role Bruxism Tongue Oedema Consumer Neurontin Capsules 300 Mg (Gabapentin) PS ORAL 1200 MG (600 MG, BID) Artane (Trihexyphenidylhydr ochloride) Stelazine (Trifluoperazine Hydrochloride) Tegretol (Carbamazepine) Elavil (Amitriptyline Hydrochloride) Tranxene (Clorazepate Dipotassium) Date:02/26/99ISR Number: 3416830-9Report Type:Periodic Age:62 YR Gender:Female I/FU:I Outcome Dose 22-Aug-2005 Page: 156 SS C C C C Company Report #001-0945-980097 PT Report Source Product Role Libido Increased Consumer Neurontin (Gabapentin) (Seroquel) PS C Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Konopin (Clonazepam) Premarin (Estrogens Conjugated) Vitamins Date:02/26/99ISR Number: 3416831-0Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C C C Company Report #001-0945-980098 PT Report Source Product Role Alopecia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 600 MG (DAILY) Date:02/26/99ISR Number: 3416832-2Report Type:Periodic Age:57 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980100 PT Report Source Product Role Palpitations Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration ORAL 1800 MG (DAILY) Date:02/26/99ISR Number: 3416833-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980104 PT Report Source Product Role Amenorrhoea Consumer Neurontin (Gabapentin) PS Duration Date:02/26/99ISR Number: 3416834-6Report Type:Periodic Age:23 YR Gender:Male I/FU:I Company Report #001-0945-980105 Manufacturer Route Outcome Dose PT Report Source Product Role Sedation Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 600 MG (300 MG, BID) Date:02/26/99ISR Number: 3416835-8Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980109 PT Report Source Product Role Flatulence Gastrointestinal Pain Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Percocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone Ativan (Lorazepam) C C 300 MG (DAILY) 22-Aug-2005 Page: 157 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416836-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-945-980110 PT Report Source Product Role Myopathy Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 3600 MG Company (DAILY) Representative Date:02/26/99ISR Number: 3416837-1Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980113 PT Report Source Product Role Flatulence Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Duration ORAL 2400 MG (600 MG, QID) Klonopin (Clonazepam) Ultram (Tramadol Hydrochloride) Seroquel (Quetiapine Fuarate) Midrin (Paracetamol, Dichloralphenazone, Isometheptene) Effexor (Venlafaxine Hydrochloride) Date:02/26/99ISR Number: 3416838-3Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose 2400 MG C C C C C Company Report #001-0945-980118 PT Report Source Product Role Alopecia Consumer Health Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL Professional (DAILY) Effexor (Venlafaxine Hydrochloride) Hytrin (Terazosin Hydrochloride) Propulsid (Cisapride) Navane (Tiotixene) Prozac (Fluoxetine Hydrochloride) Date:02/26/99ISR Number: 3416839-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C C C C Company Report #001-0945-980122 PT Report Source Product Role Convulsion Drug Interaction Consumer Neurontin Capsules 300 Mg (Gabapentin) PS 900 MG Tooth Abscess (DAILY) Biaxin (Clarithromycin) (Phenobarbital) Estrogens) Zantac (Ranitidine Hydrochloride) Reglan 22-Aug-2005 Page: 158 Manufacturer Route Duration 10:40 AM SS C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metoclopramide) Colace (Docusate Sodium) Date:02/26/99ISR Number: 3416840-1Report Type:Periodic Age:77 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980123 PT Report Source Product Rosacea Consumer Neurontin (Gabapentin) Prinivil (Lisinopril) (Allopurinol) Lopid (Gemfibrozil) Role Manufacturer Route PS ORAL C C C Company Report #001-0945-980124 PT Report Source Product Role Hyperglycaemia Health Professional Company Representative Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3416842-5Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose C Duration Date:02/26/99ISR Number: 3416841-3Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C Company Report #001-0945-980125 PT Report Source Product Role Pollakiuria Urinary Incontinence Consumer Neurontin (Gabapentin) PS Duration ORAL 600 MG (300 MG, BID) "Norco" Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C C ORAL Date:02/26/99ISR Number: 3416843-7Report Type:Periodic Age:11 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980246 PT Report Source Product Role Feeling Cold Muscle Twitching Health Professional Neurontin (Gabapentin) PS 1500 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3416844-9Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 159 Manufacturer Route Duration PT Blister Burning Sensation Dysuria Erythema Eyelid Oedema Gingival Bleeding 10:40 AM Company Report #001-0945-980247 ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Urticaria Dose Report Source Product Role Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Effexor (Venlafaxine Hydrochloride) C Manufacturer Route Duration ORAL SEE TEXT, PER ORAL Date:02/26/99ISR Number: 3416845-0Report Type:Periodic Age:27 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980248 PT Report Source Product Role Pityriasis Rosea Health Professional Neurontin Capsules 300 Mg(Gabapentin) PS Motrin (Ibuprofen) C Manufacturer Route Duration ORAL 1200 MG (300 MG, QID), PER ORAL Date:02/26/99ISR Number: 3416846-2Report Type:Periodic Age:40 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Suicidal Ideation Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3416847-4Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980872 Company Report #001-0945-980015 PT Report Source Product Hypoaesthesia Consumer Neurontin Capsules Duration Role Nervousness 400 Mg (Gabapentin) PS 3600 MG DAILY Oedema Peripheral PER ORAL Pain In Extremity Speech Disorder Vision Blurred Weight Increased Prevacid (Lansoprazole) Dilantin (Phenytoin Sodium) (Trazodone) Carafate (Sucralfate) Propulsid (Cisapride) Questran (Colestyramine) Imodium (Loperamide Hydrochloride) Pancreatic Enzyme (Unspecified) Estrogens (Estrogen Nos) Date:02/26/99ISR Number: 3416848-6Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 160 PT Tremor 10:40 AM Company Report #001-0945-980249 Report Source Health Professional C C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Dose Product Role Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL Aerobid (Flunisolide) Serevent (Salmeterol Xinafoate) Amitriptyline Proamatine (Midodrine Hydrochloride) Date:02/26/99ISR Number: 3416849-8Report Type:Periodic Age:28 YR Gender:Male I/FU:I Outcome Dose C C C C Company Report #001-0945-980027 PT Report Source Product Role Abdominal Pain Upper Anxiety Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Mebaral (Methylphenobarbital ) (Allopurinol) C C Manufacturer Route Duration ORAL 1200 MG (300 Eye Disorder MG, QID) PER Flushing ORAL Headache Hyperhidrosis Date:02/26/99ISR Number: 3416850-4Report Type:Periodic Age:65 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980250 PT Report Source Product Clonic Convulsion Health Neurontin Capsules Duration Role Manufacturer Route Sedation Professional Tremor Company 300 Mg(Gabapentin) PS Alprazolam Diazepam Fentanyl Prilosec (Omeprazole) Humulin Nph (Insulin Human Injection, Isophane) Morphine Sulfate Thiamin (Thiamine Hydrochloride) Human Regular (Insulin Human) Cozaar (Losartan Potassium) Coumadin (Warfarin Sodium) Cefalexin Toprol Xl (Metoprolol Succinate) Aspirin SS SS C 300 MG (DAILY), PER Representative ORAL 22-Aug-2005 Page: 161 10:40 AM C C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Acetylsalicyclic Acid) Trental (Pentoxyifylline) Darvocet (Paracetamol, Dextropropoxyphene) Xanax (Alprazolam) Dulcolax (Bisacodyl) Nitro (Glyceryl Trinitrate) Propulsid (Cisapride) Nephron Fa Date:02/26/99ISR Number: 3416851-6Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose PT C C C C C C C C Company Report #001-0945-980028 Report Source Product Role Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration Pityriasis Rosea ORAL 1600 MG (800 MG BID) PER ORAL Date:02/26/99ISR Number: 3416852-8Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose 6 Company Report #001-0945-980251 PT Report Source Product Role Drug Withdrawal Syndrome Fatigue Health Professional Neurontin(Gabapentin ) PS Duration MON Influenza Like Illness Myalgia Date:02/26/99ISR Number: 3416853-XReport Type:Periodic Age: Gender:Male I/FU:I Company Report #001-0945-980030 Manufacturer Route Outcome Dose PT Report Source Product Role Blister Confusional State Gait Disturbance Vision Blurred Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Date:02/26/99ISR Number: 3416854-1Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Route Manufacturer Route Company Report #001-0945-980253 PT Report Source Product Role Arthralgia Chest Pain Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Coumadin (Warfarin Sodium) C Duration 900 MG (300 Company MG, TID), PER Representative ORAL 22-Aug-2005 Page: 162 Manufacturer Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416855-3Report Type:Periodic Age:81 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980032 PT Report Source Product Role Dizziness Embolism Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Couadin (Warfarin Sodium) C Manufacturer Route Duration ORAL 600 MG (300 Weight Increased MG, BID) PER ORAL Date:02/26/99ISR Number: 3416856-5Report Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980257 PT Report Source Product Role Hangover Sedation Consumer Health Neurontin (Gabapentin0 PS Manufacturer Route Duration 300 MG (100 Professional MG, TID), PER ORAL Buspar (Buspirone Hydrochloride) Humulin Nph (Insulin Human Injection, Isophane) Humulin Reg. (Insulin Human) Moduretic (Hydrochlorothiazide , Amiloride Hydrochloride) Date:02/26/99ISR Number: 3416857-7Report Type:Periodic Age:49 YR Gender:Female I/FU:I Company Report #001-0945-980033 C C C C ORAL Outcome Dose PT Report Source Product Role Alopecia Hair Growth Abnormal Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (100 Hair Texture Abnormal MG TID) PER ORAL Sinemet (Levodopa, Carbidopa) Tegretol (Carbamazepine) Date:02/26/99ISR Number: 3416858-9Report Type:Periodic Age:51 YR Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980258 PT Report Source Product Role Pain Consumer Neurontin Capsules 300 Mg (Gabapentin) PS 900 MG (300 MG, TID), PER ORAL Tylenol W/Codeine No. 3 (Codeine Phosphate, Paracetamol) Lescol (Fluvastatin Sodium) Micronase 22-Aug-2005 Page: 163 Manufacturer Route Duration 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Glibenclamide) Potassium Chloride Date:02/26/99ISR Number: 3416859-0Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980034 PT Report Source Product Role Diplopia Keratoconjunctivitis Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL SEE TEXT, PER Sicca ORAL Photophobia Vision Blurred (Phentermine) Accutane (Isotretinoin) Soma (Carisoprodol) Percocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone Date:02/26/99ISR Number: 3416860-7Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose C C C C Company Report #001-0945-980259 PT Report Source Product Role Diplopia Consumer Health Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration 200 MG (100 Professional MG, BID), PER ORAL Insulin Oxycontin (Oxycodone Hydrochloride) Date:02/26/99ISR Number: 3416861-9Report Type:Periodic Age:68 YR Gender:Female I/FU:I Company Report #001-0945-980035 C C ORAL Outcome Dose PT Report Source Product Role Back Pain Blood Glucose Increased Consumer Neurontin Capsules 300 Mg (Gabapentin) PS 900 MG (300 Diarrhoea MG TID) PER Fatigue ORAL Weight Increased 22-Aug-2005 Page: 164 Manufacturer Route Duration 10:40 AM Maalox (Magnesium Hydroxide, Aluminum Hydroxide Gel) Rezulin (Troglitazone) (Troglitazone) Humulin R (Insulin Human) Humulin Nph (Insulin Human Injection, Isophane) Glucophage (Metformin Hydrochloride) (Furosemide) Cycrin (Medroxyprogesterone Acetate) Premarin (Estrogens C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Conjugated) Asa (Acetylsalicylic Acid) (Calcium) K-Dur (Potassium Chloride) Magnesium Date:02/26/99ISR Number: 3416862-0Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose C C C C C Company Report #001-0945-980260 PT Report Source Product Role Ageusia Sedation Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 Tongue Oedema MG, TID), PER ORAL Interferon Pamelor (Nortriptyline Hydrochloride) Date:02/26/99ISR Number: 3416863-2Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C C Company Report #001-0945-980038 PT Report Source Product Role Benign Prostatic Hyperplasia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 100 - 200 MG Dysuria DAILY Irritable Bowel Syndrome Date:02/26/99ISR Number: 3416864-4Report Type:Periodic Age:60 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report #001-0945-980261 Report Source Product Role Alopecia Health Professional Neurontin (Gabapentin) PS ORAL 900 MG (300 MG, TID) , PER ORAL Dyazide (Hydrochlorothiazide , Triamterene) Hydrochlorothiazide Premarin (Estrogens Conjugated) Synthroid (Levothyroxine Sodium) Date:02/26/99ISR Number: 3416865-6Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose 22-Aug-2005 Page: 165 C C C C Company Report #001-0945-980263 PT Report Source Product Role Psychotic Disorder Health Professional Neurontin (Gabapentin) PS Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416866-8Report Type:Periodic Age:60 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980039 PT Report Source Product Role Anosmia Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration 1200 MG (400 Company MG TID) Representative Date:02/26/99ISR Number: 3416867-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980264 PT Report Source Product Role Breast Engorgement Breast Tenderness Health Professional Neurontin (Gabapentin) PS Duration 800 MG (400 Company MG, BID), Representative UNKNOWN 4 WK Date:02/26/99ISR Number: 3416868-1Report Type:Periodic Age:70 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980040 PT Report Source Product Role Blood Glucose Increased Sedation Consumer Neurontin (Gabapentin) PS Duration 400 MG (QHS) Stupor PER ORAL Insulin (Insulin) Vasotec (Enalapril Maleate) Norvasc (Amlodipine Besilate) Lasix (Furosemide) Epogen (Epoetin Alfa) C C C C C ORAL Peri-Colace (Docusate Sodium, Casanthranol) (Sorbitol) (Calcium) (Iron) Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, Date:02/26/99ISR Number: 3416869-3Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C Company Report #001-0945-980265 PT Report Source Product Role Muscle Spasms Health Professional Neurontin (Gabapentin) PS Duration 900 MG (DAILY), UNKNOWN 22-Aug-2005 Page: 166 C C C C 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416870-XReport Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980041 PT Report Source Product Role Bladder Pain Condition Aggravated Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL PER ORAL Surmontil (Trimipramine) Urispas (Flavoxate Hydrochloride) Tylenol (Paracetamol) Ativan (Lorazepam) Claritin (Loratadine) Estraderm (Estradiol) Date:02/26/99ISR Number: 3416871-1Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980266 PT Report Source Product Role Blood Pressure Increased Palpitations Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration SEE TEXT Company Representative Date:02/26/99ISR Number: 3416872-3Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980267 PT Report Source Product Role Muscle Spasms Consumer Health Neurontin (Gabapentin) PS Duration 200 MG (AT Professional HS), PER ORAL ORAL Date:02/26/99ISR Number: 3416873-5Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980043 PT Report Source Product Role Headache Insomnia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS 600 MG (300 Nausea MG BID) PER Sedation ORAL Capoten (Captopril) Lanoxin (Digoxin) (Triazolam) Soma (Carisoprodol) Vicodin (Paracetamol, Hydrocodone Bitartrate) Trental (Pentoxifylline) 22-Aug-2005 Page: 167 Manufacturer Route Duration 10:40 AM C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416874-7Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980268 PT Report Source Product Role Blood Pressure Increased Palpitations Health Professional Neurontin(Gabapentin ) PS Manufacturer Route Manufacturer Route Duration SEE TEXT Company Representative Date:02/26/99ISR Number: 3416875-9Report Type:Periodic Age:27 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980047 PT Report Source Product Role Eye Movement Disorder Memory Impairment Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Wellbutrin (Amfebutamone Hydrochloride) C Duration ORAL 900 MG (300 Nystagmus MG TID) PER ORAL Date:02/26/99ISR Number: 3416876-0Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Company Report #001-0945-980269 PT Report Source Product Role Blood Pressure Increased Palpitations Health Professional Neurontin(Gabapentin ) PS Duration SEE TEXT Company Representative Date:02/26/99ISR Number: 3416877-2Report Type:Periodic Age: Gender:Unknown I/FU:I Company Report #001-0945-980270 Manufacturer Route Outcome Dose PT Report Source Product Role Blood Pressure Increased Palpitations Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration SEE TEXT Company Representative Date:02/26/99ISR Number: 3416878-4Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980048 PT Report Source Product Role Alopecia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Wellbutrin (Amfebutamone Hydrochloride) Soma (Carisoprodol) (Lorazepam) C C C Duration 900 MG (300 MG TID) PER ORAL 22-Aug-2005 Page: 168 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416879-6Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980049 PT Report Source Product Role Blood Pressure Decreased Drug Withdrawal Syndrome Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration 1800 MG (600 Flushing MG TID) Headache Malaise Date:02/26/99ISR Number: 3416880-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980051 PT Report Source Product Role Urinary Incontinence Consumer Neurontin (Gabapentin) PS Duration 200 MG DAILY Date:02/26/99ISR Number: 3416881-4Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980054 PT Report Source Product Role Dermatitis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS (Morphine) C Duration 1800 MG (600 MG TID) PER ORAL ; 200 MG (100 MG BID) PER ORAL ORAL Date:02/26/99ISR Number: 3416882-6Report Type:Periodic Age:73 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980055 PT Report Source Product Role Asthenia Sedation Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG TID) PER ORAL Lanoxin (Digoxin) Rythmol (Propafenone) Norvasc (Amlodipine Besilate) Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, Date:02/26/99ISR Number: 3416883-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose 22-Aug-2005 Page: 169 C C C C Company Report #001-0945-980057 PT Report Source Product Role Urinary Tract Infection Consumer Health Professional Company Representative Neurontin (Gabapentin) PS Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416884-XReport Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980058 PT Report Source Product Role Breast Engorgement Breast Tenderness Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 Night Sweats MG, TID), PER ORAL Estrostep (Ethinyl-Estradiol, Norethisterone) Dyazide (Hydrochlorothiazide , Triamterene) Voltaren (Diclofenac Sodium) Date:02/26/99ISR Number: 3416885-1Report Type:Periodic Age:94 YR Gender:Female I/FU:I Outcome Dose 900 MG (300 C C Company Report #001-0945-980059 PT Report Source Product Medication Error Sleep Disorder Consumer Neurontin (Gabapentin) Fioricet (Caffeine, Butalbital, Paracetamol) Xanax (Alprazolam) Klonopin (Clonazepam) Role Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3416886-3Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose C PS C C C Company Report #001-0945-980060 PT Report Source Product Role Alopecia Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration ORAL MG TID), PER ORAL Remeron (Mirtazapine) (Trazodone) Ativan (Lorazepam) (Prednisone0 Florinef (Fludrocortisone Acetate) Dexedrine (Dexamfetamine Sulfate) Depakote (Valproate Semisodium) Date:02/26/99ISR Number: 3416887-5Report Type:Periodic Age:28 YR Gender:Female I/FU:I Outcome Dose 22-Aug-2005 Page: 170 C C C C C C C Company Report #001-0945-980061 PT Report Source Product Role Cutaneous Lupus Erythematosus Health Professional Neurontin (Gabapentin) Tegretol PS Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Carbamazepine) Date:02/26/99ISR Number: 3416888-7Report Type:Periodic Age:60 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980062 PT Report Source Product Role Increased Appetite Weight Increased Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1800 MG (, DAILY), PER ORAL Klonopin (Clonazepam) Synthroid (Levothyroxine Sodium) Date:02/26/99ISR Number: 3416889-9Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980066 PT Report Source Product Role Medication Error Periodontal Disease Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 600 MG (300 Sleep Walking MG, BID), PER ORAL (Amitriptyline) Synthroid (Levothyroxine Sodium) Capoten (Captopril) Macrodantin (Nitrofurantoin) Pravachol (Pravastatin Sodium) Premarin (Estrogens Conjugated) Lasix (Furosemide) C C C C C C C ORAL Slow-Mag (Magnesium Chloride Anhydrous) Insulin (Insulin) Date:02/26/99ISR Number: 3416890-5Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980067 PT Report Source Product Role Toothache Consumer Neurontin Capsules 100 Mg (Gabapentin) PS 900 MG (300 MG, TID), PER ORAL Pamelor (Nortriptyline Hydrochloride) Ms Contin (Morphine Sulfate) 22-Aug-2005 Page: 171 Manufacturer Route Duration 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416891-7Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose PT Report Source Product Drug Interaction International Normalised Ratio Decreased Consumer Neurontin (Gabapentin) Coumadin (Warfarin Sodium) Role Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3416892-9Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980126 PS SS Company Report #001-0945-980068 PT Report Source Product Role Hypoaesthesia Sedation Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Duration 900 MG (300 MG, TID), PER ORAL Calan (Verapamil Hydrochloride) Synthroid (Levothyroxine Sodium) Zoloft (Sertraline Hydrochloride) Estrace (Estradiol) Vicodin (Paracetamol, Hydrocodone Bitartrate) Elavil (Amitriptyline Hydrochloride) (Carisoprodol) Date:02/26/99ISR Number: 3416893-0Report Type:Periodic Age:20 YR Gender:Female I/FU:I Company Report #001-0945-980070 C C C C C C C ORAL Outcome Dose PT Report Source Product Role Fatigue Hair Growth Abnormal Consumer Neurontin (Gabapentin) PS Date:02/26/99ISR Number: 3416894-2Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Manufacturer Route Manufacturer Route Duration Company Report #001-0945-980129 PT Report Source Product Role Menorrhagia Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Asthma Meds C Duration ORAL 1200 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3416895-4Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Confusional State Convulsion Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 600 - 1200 MG Malaise (DAILY), PER 22-Aug-2005 Page: 172 Company Report #001-0945-980130 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Tegretol (Carbamazepine) Topamax (Topiramate) Ritalin (Methylphenidate Hydrochloride) Decadron (Dexamethasone) Date:02/26/99ISR Number: 3416896-6Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose C C C C Company Report #001-0945-980071 PT Report Source Product Role Hypertension Influenza Health Professional Neurontin (Gabapentin) PS Olanzapine (Olanzapine) C Manufacturer Route Duration ORAL 1800 MG (600 MG, TID), PER ORAL Date:02/26/99ISR Number: 3416897-8Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose PT Report Source Product Role Bone Marrow Depression Health Professional Neurontin (Gabapentin) PS 900 MG (300 Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3416898-XReport Type:Periodic Age:45 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980073 Company Report #001-0945-980075 PT Report Source Product Role Difficulty In Walking Feeling Hot Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Duration ORAL Paralysis MG, TID), PER ORAL Date:02/26/99ISR Number: 3416899-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980135 PT Report Source Product Role Anxiety Chest Pain Consumer Neurontin (Gabapentin) PS Tylenol With Codeine No. 3 (Codeine Phosphate Paracetamol) C 4200 MG Confusional State (DAILY), PER Dermatitis ORAL Disturbance In Attention Dizziness Eye Movement Disorder Fatigue Nervousness Vision Blurred 22-Aug-2005 Page: 173 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416900-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980077 PT Report Source Product Role Menstruation Irregular Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS (Oral Contraceptive Nos) Duract SS SS Manufacturer Route Manufacturer Route Duration 900 MG (300 MG, TID) Date:02/26/99ISR Number: 3416901-7Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980078 PT Report Source Product Role Alopecia Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Duration ORAL 200 MG (100 MG, BID), PER ORAL Zoloft (Sertraline Hydrochloride) Prilosec (Omeprazole) Ogen (Estropipate) Date:02/26/99ISR Number: 3416902-9Report Type:Periodic Age:62 YR Gender:Female I/FU:I Outcome Dose 2600 MG (DAILY), PER C C C Company Report #001-0945-980144 PT Report Source Product Role Tinnitus Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL ORAL Inderal (Propranolol Hydrochloride) (Codeine) Tranxene (Clorazepate Dipotassium) Miacalcin (Calcitonin, Salmon) Date:02/26/99ISR Number: 3416903-0Report Type:Periodic Age:45 YR Gender:Male I/FU:I Outcome Dose C C C C Company Report #001-0945-980145 PT Report Source Product Role Sedation Consumer Neurontin Capsules 100 Mg (Gabapentin) PS 900 MG (300 MG, TID), PER ORAL Rythmol (Propafenone) Baby Aspirin (Acetylsalicylic Acid) St. John'S Wort (Hypericum Extract) 22-Aug-2005 Page: 174 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416904-2Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980079 PT Report Source Product Role Arthralgia Gingivitis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 2400 MG (600 Hyperhidrosis MG, QID), PER Myalgia ORAL (Trazodone) (Insulin) (Atenolol) Vicodin (Paracetamol, Hydrocodone Bitartrate( Posicor (Mibefradil) Valium (Diazepam) Date:02/26/99ISR Number: 3416905-4Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose SS C C C C C Company Report #001-0945-980080 PT Report Source Product Role Oedema Peripheral Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration 900 MG (300 MG, TID) (Insulin) (Prednisone) Cyclosporin (Ciclosporin) Imuran (Azathioprine) Lasix (Furosemide) Normodyne (Labetalol Hydrochloride) Cardene (Nicardipine Hydrochloride) Coumadin (Warfarin Sodium) C C C C C C C C Manufacturer Route Provera (Medroxyprogesterone Acetate) Date:02/26/99ISR Number: 3416906-6Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980146 PT Report Source Product Role Asthenia Dizziness Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Xanax (Alprazolam) C Manufacturer Route Duration ORAL 900 MG (300 Fatigue MG, TID), PER ORAL Date:02/26/99ISR Number: 3416907-8Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Influenza Like Illness Psychotic Disorder Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration 900 MG (300 MG, TID) 22-Aug-2005 Page: 175 Company Report #001-0945-980082 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dilantin (Phenytoin Sodium) Haldol (Haloperidol) Cogentin (Benzatropine Mesilate) Antibiotics (Unspecified) Date:02/26/99ISR Number: 3416908-XReport Type:Periodic Age: Gender: I/FU:I Outcome Dose C C Company Report #001-0945-980147 PT Report Source Product Role Influenza Like Illness Health Professional Company Representative Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3416909-1Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980084 PT Report Source Product Role Disturbance In Attention Memory Impairment Consumer Neurontin (Gabapentin) PS Dilantin (Phenytoin Sodium) C Duration ORAL 200 MG (, DAILY), PER ORAL Date:02/26/99ISR Number: 3416910-8Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980152 PT Report Source Product Agitation Consumer Neurontin Duration Role Manufacturer Route Anxiety (Gabapentin) PS Chest Pain Feeling Jittery Effexor (Venlafaxine Hydrochloride) (Imipramine) C C ORAL PER ORAL Date:02/26/99ISR Number: 3416911-XReport Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980153 PT Report Source Product Role Glossodynia Health Professional Neurontin (Gabapentin) PS 2700 MG, (900 MG,TID), PER ORAL Paxil (Paroxetine Hydrochloride) Synthroid (Levothyroxine Sodium) (Thioridazine) Humibid (Guaifenesin) Decongestant (Unspecified) 22-Aug-2005 Page: 176 Manufacturer Route Duration 10:40 AM C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416912-1Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980085 PT Report Source Product Role Diplopia Eye Disorder Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 2400 MG (, Eye Movement Disorder DAILY) Eye Pain Eyelid Oedema Facial Pain Lacrimation Increased Pain Paraesthesia Zoloft (Sertraline Hydrochloride) Indocin (Indometacin) (Verapamil) Nitro Patch (Glyceryl Trinitrate) Thyroid Medication Date:02/26/99ISR Number: 3416913-3Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose C C C C C Company Report #001-0945-980272 PT Report Source Product Role Ventricular Extrasystoles Health Professional Neurontin (Gabapentin) PS Duration ORAL 3200 MG (800 Company MG, QID), PER Representative ORAL Zoloft (Sertraline Hydrochloride) Buspar (Buspirone Hydrochloride) Date:02/26/99ISR Number: 3416914-5Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980274 PT Report Source Product Dizziness Consumer Neurontin Capsules Duration Role Manufacturer Route Feeling Cold 400 Mg (Gabapentin) PS ORAL 1200 MG (400 MG, TID), PER ORAL Allegra(Fexofenadine Hydrochloride) Imitrex (Sumatriptan) Date:02/26/99ISR Number: 3416915-7Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980276 PT Report Source Product Role Dyspnoea Muscle Contractions Health Professional Neurontin (Gabapentin) PS Premarin(Estrogens Conjugated) C 600 MG Involuntary (,DAILY), PER ORAL 22-Aug-2005 Page: 177 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416916-9Report Type:Periodic Age:40 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980279 PT Report Source Product Role Anxiety Testicular Pain Health Professional Neurontin (Gabapentin) PS Zoloft(Sertraline Hydrochloride) Klonopin(Clonazepam) C C Manufacturer Route Duration ORAL 1800 MG (,DAILY), PER ORAL Date:02/26/99ISR Number: 3416917-0Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980280 PT Report Source Product Role Dysphagia Pharyngeal Oedema Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 1800 MG (300 MG, SIX TIMES DAILY), PER ORAL Premarin (Estrogens Conjugated) Multivitamins(Ergoca lciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, Oscal (Calcium Carbonate) Date:02/26/99ISR Number: 3416918-2Report Type:Periodic Age:39 YR Gender:Female I/FU:I Company Report #001-0945-980155 C C C ORAL Outcome Dose PT Report Source Product Role Alopecia Hirsutism Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1800 MG (300 MG, X6), PER ORAL (Baclofen) Synthroid (Levothyroxine Sodium) Lasix (Furosemide) (Methadone) Prozac (Fluoxetine Hydrochloride) Date:02/26/99ISR Number: 3416919-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose 14 C C C C C Company Report #001-0945-980156 PT Report Source Product Role Blood Amylase Increased Lipase Increased Health Professional Neurontin (Gabapentin) PS Duration DAY (Lorazepam) Dilantin (Phenytoin Sodium) Phenobarb (Phenobarbital 22-Aug-2005 Page: 178 10:40 AM C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) (Pyridoxine) Date:02/26/99ISR Number: 3416920-0Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980282 PT Report Source Product Role Fatigue Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 400 MG (100 MG, QID), PER ORAL Glucotrol (Glipizide) Lipitor (Atorvastatin) Unspecified Blood Pressure Pill Date:02/26/99ISR Number: 3416921-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C C C Company Report #001-0945-980168 PT Report Source Product Role Dizziness Hemiparesis Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration 1200 MG (400 MG, TID), PER ORAL Lortab (Paracetamol, Hydrocodone Bitartrate) Parafon Forte (Chloroxazone, Paracetamol) Dilacor (Digoxin) C C C ORAL Date:02/26/99ISR Number: 3416922-4Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980284 PT Report Source Product Role Hypersensitivity Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL PER ORAL Date:02/26/99ISR Number: 3416923-6Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980169 PT Report Source Product Role Migraine Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Rhinocort (Budesonide) C 900 MG (300 MG, TID), PER ORAL 22-Aug-2005 Page: 179 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416924-8Report Type:Periodic Age:78 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980287 PT Report Source Product Role Abdominal Pain Upper Vomiting Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (,DAILY), PER ORAL Lanoxin (Digoxin) Capoten (Captopril) Vitamin C (Ascorbic Acid) Ativan (Lorazepam) Vicodin (Paracetamol, Hydrocodone Bitartrate) (Zinc) (Folic Acid) Date:02/26/99ISR Number: 3416925-XReport Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose C C C C C C C Company Report #001-0945-980171 PT Report Source Product Role Balance Disorder Blister Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 1800 MG (600 Dermatitis MG, TID) PER Dry Mouth ORAL Ecchymosis Headache Nausea Pruritus Rash Papular Sedation Skin Ulcer Dilantin (Phenytoin Sodium) Valium (Diazepam) Fioricet (Caffeine, Butalbital, Paracetamol) C C C ORAL Date:02/26/99ISR Number: 3416926-1Report Type:Periodic Age:62 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980288 PT Report Source Product Role Nasal Congestion Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 3600 MG (,DAILY), PER ORAL Date:02/26/99ISR Number: 3416927-3Report Type:Periodic Age:69 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Disorientation Feeling Jittery Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration THREE Headache CAPSULES (1 Heart Rate Increased CAPSULE, Mental Impairment TID), PER Mood Altered ORAL 22-Aug-2005 Page: 180 Company Report #001-0945-980173 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416928-5Report Type:Periodic Age:66 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980289 PT Report Source Product Role Discomfort Oedema Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (,DAILY), PER ORAL Klonopin (Clonazepam) (Estradiol) Baby Asa (Acetylsalicylic Acid) Date:02/26/99ISR Number: 3416929-7Report Type:Periodic Age:60 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980177 PT Report Source Product Role Bronchospasm Dyspnoea Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (100 MG, TID), PER ORAL Ativan (Lorazepam) (Prednisone) Calan (Verapamil Hydrochloride) (Skullcap) L-Taurene Date:02/26/99ISR Number: 3416930-3Report Type:Periodic Age:24 YR Gender:Female I/FU:I Outcome Dose PT Duration C C C C C Company Report #001-0945-980180 Report Source Product Role Manufacturer Route Dermatitis Hearing Impaired Consumer Neurontin Capsules 300 Mg (Gabapentin) PS ORAL 900 MG (300 Photopsia MG, TID), PER Vision Blurred ORAL Neupogen (Filgrastim) Dextrostat (Dexamfetamine Sulfate) Date:02/26/99ISR Number: 3416931-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980864 PT Report Source Product Role Vision Blurred Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Company Report #001-0945-980181 PT Report Source Product Role Drug Interaction Drug Level Above Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration 900 MG (300 Therapeutic MG, TID), PER 22-Aug-2005 Page: 181 C Duration Date:02/26/99ISR Number: 3416932-7Report Type:Periodic Age:63 YR Gender:Male I/FU:I Outcome Dose C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL/ 600 MG (300 MG, DAILY), PER (Lithium) SS ORAL 900 MG (300 MG, TID), PER ORAL Depakote (Valproate Semisodium) Synthroid (Levothyroxine Sodium) Date:02/26/99ISR Number: 3416933-9Report Type:Periodic Age:73 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980865 PT Report Source Product Role Manufacturer Route Sedation Consumer Neurontin (Gabapentin) PS ORAL Neurontin (Gabapentin) SS ORAL Duration 300 MG (, ONE DOSE), PER ORAL 100 MG (, ONE DOSE), PER ORAL Dyazide (Hydrochlorothiazide , Triamterene) Mellaril (Thioridazine Hydrochloride) Antivert (Nicotinic Acid, Meclozine Hydrochloride) C C C Nerve Pill Date:02/26/99ISR Number: 3416934-0Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980182 PT Report Source Product Role Hallucination Hostility Health Professional Neurontin (Gabapentin) PS Duration 1100 MG (DAILY) Elavil (Amitriptyline Hydrochloride) Prilosec (Omeprazole) Propulsid (Cisapride) Peri-Colace (Docusate Sodium, Casanthranol) Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, 22-Aug-2005 Page: 182 10:40 AM C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416935-2Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980866 PT Report Source Product Role Abdominal Pain Upper Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (, QHS), PER ORAL Elavil (Amitriptyline Hydrochloride) (Salsalate) Ativan (Lorazepam) Lortab (Paracetamol, Hydrocodone Bitartrate) Ogen (Estropipate) Tylenol (Paracetamol) Date:02/26/99ISR Number: 3416936-4Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980867 PT Report Source Product Role Migraine Multiple Sclerosis Consumer Health Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 900 MG (300 Professional MG, TID), PER ORAL Imitrex (Sumatriptan) Fioricet (Caffeine, Butalbital, Paracetamol) C C ORAL Date:02/26/99ISR Number: 3416937-6Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980868 PT Report Source Product Role Coordination Abnormal White Blood Cell Count Consumer Neurontin (Gabapentin) PS (Vitamins Nos) C Manufacturer Route Duration ORAL 200 MG (100 Decreased MG, BID), PER ORAL Date:02/26/99ISR Number: 3416938-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Arthralgia Haematuria Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 600 MG Joint Swelling (,DAILY), PER Polyuria ORAL 22-Aug-2005 Page: 183 Company Report #001-0945-980871 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416939-XReport Type:Periodic Age:49 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980873 PT Report Source Product Role Abdominal Distension Vomiting Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Depakote (Valproate Semisodium) C Manufacturer Route Duration ORAL 1200 MG (400 MG, TID), PER ORAL Date:02/26/99ISR Number: 3416940-6Report Type:Periodic Age:13 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980875 PT Report Source Product Role Epistaxis Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS (Lithium) C Manufacturer Route Duration ORAL 300 MG (100 MG, TID), PER ORAL Date:02/26/99ISR Number: 3416941-8Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980876 PT Report Source Product Role Dizziness Dysarthria Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 1200 MG Gait Disturbance (,DAILY), PER Sedation ORAL Flomax ORAL (Morniflumate) SS ORAL Ativan (Lorazepam) SS ORAL Elavil (Amitriptyline Hydrochloride) SS ORAL 0.4 MG (,DAILY), PER ORAL 1 MG (,DAILY), PER ORAL 100 MG (,DAILY), PER ORAL Date:02/26/99ISR Number: 3416942-XReport Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980877 PT Report Source Product Role Dizziness Drug Interaction Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Imitrex (Sumatriptan Succinate) SS Hyzaar (Hydrochlorothiazide , Losartan Potassium) C 1200 MG (300 Libido Decreased MG, QID), PER Nausea ORAL INTRAMUSCULAR WHEN NEEDED, INTRAMUSCULAR 22-Aug-2005 Page: 184 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416943-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980903 PT Report Source Product Role Coordination Abnormal Lethargy Consumer Neurontin (Gabapentin) PS Nardil (Phenelzine Sulfate) (Lithium) C C Manufacturer Route Manufacturer Route Duration 400 MG Tremor (,DAILY), Date:02/26/99ISR Number: 3416944-3Report Type:Periodic Age:32 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980905 PT Report Source Product Role Hair Growth Abnormal Medication Error Consumer Neurontin 300 Mg (Gabapentin) PS Duration ORAL 900 MG (300 MG, TID), PER ORAL Ultram (Tramadol Hydrohcloride) Darvocet N (Paracetamol Dextropropoxyphene) Date:02/26/99ISR Number: 3416945-5Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose 3600 MG (,DAILY), C C Company Report #001-0945-980908 PT Report Source Product Role Oedema Peripheral Health Professional Neurontin (Gabapentin) PS Duration Manufacturer Route SEVERAL MONTHS AGO - Date:02/26/99ISR Number: 3416946-7Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980909 PT Report Source Product Role Fatigue Medication Error Consumer Neurontin Capsules 100 Mg(Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG,TID), PER ORAL Klonopin (Clonazepam) Remeron (Mirtazapine) Date:02/26/99ISR Number: 3416947-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980910 PT Report Source Product Role Medication Error Myalgia Consumer Neurontin Capsules 100 Mg(Gabapentin) PS Remeron (Mirtazapine) C 900 MG (300 MG, TID, ) PER ORAL 22-Aug-2005 Page: 185 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin (Clonazepam) Date:02/26/99ISR Number: 3416948-0Report Type:Periodic Age:29 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980911 PT Report Source Product Role Chest Pain Fatigue Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 Influenza Like Illness MG, TID, PER Myalgia ORAL) Date:02/26/99ISR Number: 3416949-2Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose PT Report Source Product Tongue Geographic Health Professional Neurontin (Gabapentin) Premarin (Estrogens Conjugated) Provera (Medroxyprogesterone Acetate) Synthroid (Levothyroxine Sodium) Role Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3416951-0Report Type:Periodic Age:87 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980913 PS C C C Company Report #001-0945-980916 PT Report Source Product Role Asthenia Headache Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Duration 100 MG (, ONE ORAL Palpitations DOSE), PER ORAL Date:02/26/99ISR Number: 3416952-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980917 PT Report Source Product Role Joint Stiffness Consumer Neurontin Capsules 300 Mg (Gabapentin) PS (Nortriptyline) C Manufacturer Route Duration ORAL 300 MG, PER ORAL Date:02/26/99ISR Number: 3416954-6Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980918 PT Report Source Product Role Alopecia Consumer Neurontin (Gabapentin) PS Lamictal (Lamotrigine) C 800 MG (400 MG, BID), PER ORAL 22-Aug-2005 Page: 186 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416956-XReport Type:Periodic Age:78 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-990005 PT Report Source Product Role Hypervigilance Consumer Neurontin Capsules 300 Mg(Gabapentin) PS Manufacturer Route Duration ORAL 300 MG, (,QHS), PER ORAL Date:02/26/99ISR Number: 3416957-1Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-990006 PT Report Source Product Role Hypervigilance Consumer Neurontin Capsules 300 Mg(Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (,QHS), PER ORAL Synthroid (Levothyroxine Sodium) Macrodantin (Nitrofurantoin) Zocor (Simvastatin) Maxzide (Hydrochlorothiazide , Triamterene) Date:02/26/99ISR Number: 3416959-5Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose 2800 MG (, C C C C Company Report #001-0945-990007 PT Report Source Product Role Arthralgia Joint Swelling Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 800 MG TID, 400 MGQHS), PER ORAL Triphasil (Ethinylestradiol, Levonorgestrel) Effexor (Venlafaxine Hydrochloride) Date:02/26/99ISR Number: 3416961-3Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-990009 PT Report Source Product Role Blood Pressure Decreased Sedation Consumer Neurontin (Gabapentin) PS 600 MG (,QHS), PER ORAL Synthroid (Levothyroxine Sodium) Klonopin (Clonazepam) 22-Aug-2005 Page: 187 Manufacturer Route Duration 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3416967-4Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-990010 PT Report Source Product Role Fatigue Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 3600 MG (,1200 MG QAM, 2400 MG QHS), PER ORAL Synthroid (Levothyroxine Sodium) Klonopin (Clonazepam) Paxil (Paroxetine Hydrochloride) Date:02/26/99ISR Number: 3416968-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-990016 PT Report Source Product Role Haematochezia Visual Disturbance Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 300 MG Vomiting (,DAILY), Date:02/26/99ISR Number: 3416970-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose 2700 MG Company Report #001-0945-990022 PT Report Source Product Role Abdominal Distension Hyponatraemic Syndrome Consumer Neurontin (Gabapentin) PS Duration (,DAILY), Calan St (Verapamil Hydrochloride) Soma (Carisoprodol) Lasix (Furosemide) Estraderm (Estradiol) Prevacid (Lansoprazole) Naprosyn (Naproxen Sodium) Date:02/26/99ISR Number: 3416973-XReport Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C C C Company Report #001-0945-990092 PT Report Source Product Role Amnesia Health Professional Neurontin (Gabapentin) .. PS C Duration Date:02/26/99ISR Number: 3416975-3Report Type:Periodic Age: Gender:Male I/FU:F Outcome 22-Aug-2005 Page: 188 C C C PT Convulsion Dizziness 10:40 AM Company Report #001-0945-950323 Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dizziness Postural Epididymitis Haematuria Report Source Product Role Headache Consumer Neurontin Capsules 300 Mg(Gabapentin) PS ORAL Dilantin (Phenytoin Sodium) SS ORAL Manufacturer Route Duration SEE TEXT, PER ORAL SEE TEXT, PER ORAL Date:02/26/99ISR Number: 3416977-7Report Type:Periodic Age:58 YR Gender:Male I/FU:F Outcome Dose Company Report #001-0945-970439 PT Report Source Product Role Fatigue Hypoaesthesia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG Paraesthesia (,DAILY), PER Tremor ORAL Humulin Nph (Insulin Human Injection, Isophane) Lipitor (Atorvastatin) Date:02/26/99ISR Number: 3417009-7Report Type:Periodic Age:41 YR Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980183 PT Report Source Product Role Amnesia Drug Interaction Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 2000 MG Hyporeflexia (DAILY) PER C ORAL Pain ORAL Lamisil (Terbinafine Hydrochloride) SS 250 MG (DAILY) UNKNOWN Levsin (Hyoscyamine Sulfate) Imodium (Loperamide Hydrochloride) Elavil (Amitriptyline Hydrochloride ) Ultram (Tramadol Hydrochloride) Date:02/26/99ISR Number: 3417010-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C C C C Company Report #001-0945-980185 PT Report Source Product Role Drug Interaction Muscular Weakness Consumer Neurontin (Gabapentin) PS Magnesium SS Duration UNK, UNKNOWN UNK, UNKNOWN 22-Aug-2005 Page: 189 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417013-9Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose 900 MG Company Report #001-0945-980186 PT Report Source Product Role Connective Tissue Disorder Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Duration (300 MG QAM, 600 MG QPM), UNKNOWN Estrace (Estradiol) Synthroid (Levothyroxine Sodium) Lobutrin Date:02/26/99ISR Number: 3417015-2Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome Dose C C C Company Report # 001-0945-980187 PT Report Source Product Role Tinnitus Health Professional Neurontin (Gabapentin) PS Duration ORAL 300 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3417018-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Cerebrovascular Disorder Dizziness Consumer Neurontin (Gabapentin) PS Duration 4000 MG Fall (DAILY) Company Report #001-0945-980190 Manufacturer Route Oral Pain UNKNOWN Synthroid (Levothyroxine Sodium) Effexor (Venlafaxine Hydrochloride) Date:02/26/99ISR Number: 3417019-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose C C Company Report #001-0945-980191 PT Report Source Product Role Blood Glucose Increased Dry Mouth Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (100 Vision Blurred MG, TID) PER ORAL Date:02/26/99ISR Number: 3417021-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980192 PT Report Source Product Role Constipation Flatulence Consumer Neurontin Capsules 100 Mg (Gabapentin) PS 300 MG (100 MG, TID) PER ORAL Xanax (Alprazolam) Synthroid (Levothyroxine 22-Aug-2005 Page: 190 Manufacturer Route Duration 10:40 AM C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) Premarin (Estrogens Conjugated) Cozaar (Losartan Potassium) Date:02/26/99ISR Number: 3417024-3Report Type:Periodic Age:59 YR Gender:Male I/FU:I Outcome Dose C C C Company Report #001-0945-980193 PT Report Source Product Role Feeling Abnormal Sedation Consumer Health Neurontin Capsules 300 Mg (Gabapentin) PS Vision Blurred Professional Manufacturer Route Duration ORAL SEE TEXT, PER ORAL Zocor (Simvastatin) Aspirin (Acetylsalicylic Acid) Paxil (Paroxetine Hydrochloride) Date:02/26/99ISR Number: 3417026-7Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C C C Company Report #001-0945-980194 PT Report Source Product Role Ammonia Increased Drug Ineffective Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration UNK, UNKNOWN Company Representative Date:02/26/99ISR Number: 3417028-0Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose 1800 MG Company Report #001-0945-980195 PT Report Source Product Role Dry Skin Skin Disorder Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration Skin Exfoliation (DAILY) , Urinary Incontinence UNKNOWN Phenobarbital Date:02/26/99ISR Number: 3417030-9Report Type:Periodic Age:78 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980196 PT Report Source Product Role Blood Pressure Increased Flushing Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Duration 100 MG (TOOK Headache ONE DOSE), Nervousness UNKNOWN Hytrin (Terazosin Hydrochloride) Isoptin Sr (Verapamil Hydrochloride) Ecotrin (Acetylsalicylic Acid) Potassium 22-Aug-2005 Page: 191 10:40 AM C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417032-2Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980198 PT Report Source Product Role Drug Interaction Dyskinesia Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Fosamax (Alendronate Sodium) SS Manufacturer Route Duration ORAL 1200 MG (400 MG , TID) PER ORAL 10 MG (UNK) UNKNOWN Pamelor (Nortriptyline Hydrochloride) Synthroid (Levothyroxine Sodium) Premarin (Estrogens Conjugated) Provera (Medroxyprogesterone Acetate) Tenormin (Atenolol) Asa (Acetylsalicylic Acid) Date:02/26/99ISR Number: 3417033-4Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C C C C C C Company Report #001-0945-980199 PT Report Source Product Role Drug Interaction International Normalised Health Professional Neurontin (Gabapentin) PS Coumadin (Warfarin Sodium) SS Duration UNK, UNKNOWN Ratio Increased UNK, UNKNOWN Manufacturer Route Date:02/26/99ISR Number: 3417035-8Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980200 PT Report Source Product Role Alanine Aminotransferase Increased Health Professional Neurontin (Gabapentin) PS Depakote (Valproate Semisodium) SS Manufacturer Route Manufacturer Route Duration 1200 MG Aspartate (DAILY), Aminotransferase UNKNOWN Increased Nausea UNK, UNKNOWN Pain In Extremity Date:02/26/99ISR Number: 3417037-1Report Type:Periodic Age:26 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980205 PT Report Source Product Role Dyskinesia Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Duration 100 MG (QHS), PER ORAL Lorcet (Paracetamol, Hydrocodone) Zantac (Ranitidine Hydrochloride) 22-Aug-2005 Page: 192 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417039-5Report Type:Periodic Age:28 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980208 PT Report Source Product Role Eyelid Function Disorder Nightmare Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (100 Tremor MG, TID) PER ORAL Fioricet (Cafeine Butalbital, Paracetamol) Dilantin (Phenytoin Sodium) Mysoline (Primidone) Propulsid (Cisapride) Prilosec (Omeprazole) Date:02/26/99ISR Number: 3417041-3Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose C C C C C Company Report #001-0945-980211 PT Report Source Product Role Condition Aggravated Dysgeusia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Arthrotec (Diclofenac Sodium, Misoprostol) SS Manufacturer Route Duration 300 MG Urinary Tract Infection (DAILY) PER ORAL UNK, UNKNOWN Axid (Nizatidine) Bentyl (Dicycloverine Hydrochloride) Lactaid (Tilactase) C C C ORAL Date:02/26/99ISR Number: 3417042-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980212 PT Report Source Product Role Anxiety Insomnia Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 100 MG (DAILY), PER ORAL Xanax (Alprazolam) Premarin (Estrogens Conjugated) Date:02/26/99ISR Number: 3417043-7Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980214 PT Report Source Product Role Vision Blurred Vitreous Floaters Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Ativan (Lorazepam) C 900 - 1200 MG (DAILY), PER ORAL 22-Aug-2005 Page: 193 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417044-9Report Type:Periodic Age:74 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980215 PT Report Source Product Role Dry Mouth Sedation Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 600 MG (200 Sensation Of Heaviness MG, TID) PER ORAL Dilatin (Phenytoin Sodium) Phenobarb (Phenobarbital Sodium) Synthroid (Levothyroxine Sodium) Premarin (Estrogens Conjugated) Calcium Date:02/26/99ISR Number: 3417045-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C C C C Company Report #001-0945-980217 PT Report Source Product Role Manufacturer Route Confusional State Delusion Consumer Neurontin Capsules 300 Mg (Gabapentin) PS ORAL Neurontin Capsules 300 Mg (Gabapentin) SS ORAL Duration 1800 MG (600 MG, TID), PER ORAL 1200 MG (600 MG, BID), PER ORAL Elavil (Amitriptyline Hydrochloride) Valium (Diazepam) Laxatives Date:02/26/99ISR Number: 3417046-2Report Type:Periodic Age:60 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980218 PT Report Source Product Role Peripheral Coldness Consumer Neurontin Capsules 300 Mg (Gabapentin) PS 2100 MG (, 900 MG BID, 300 MG AT NIGHT), PER ORAL Synthroid (Levothyroxine Sodium) Zocor (Simvastatin) Provera(Medroxyproge sterone) Ogen (Estropipate) Levbid (Hyoscyamine Sulfate) 22-Aug-2005 Page: 194 Manufacturer Route Duration 10:40 AM C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417047-4Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980220 PT Report Source Product Role Erythema Consumer Neurontin (Gabapentin) PS Prozac (Fluoxetine Hydrochloride) C Manufacturer Route Duration ORAL 600 MG (300 MG, BID), PER ORAL Date:02/26/99ISR Number: 3417048-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980223 PT Report Source Product Role Fatigue Muscle Rigidity Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1800 MG (600 Palpitations MG, TID), PER Sedation ORAL Date:02/26/99ISR Number: 3417049-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980226 PT Report Source Product Role Burning Sensation Drug Interaction Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Zostrix (Capsaicin) SS Manufacturer Route Duration 900 MG (300 Oedema Peripheral MG, TID), PER ORAL ORAL Date:02/26/99ISR Number: 3417050-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Breast Disorder Calcinosis Consumer Neurontin (Gabapentin) Fosamax (Alendronate Sodium) Theodur (Theophylline) Synthroid (Levothyroxine Sodium) Role Route Manufacturer Route PS C C C Company Report #001-0945-980229 PT Report Source Product Role Amnesia Asthenia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS (Tamoxifen) C Duration 900 MG (300 MG, TID), PER ORAL 22-Aug-2005 Page: 195 Manufacturer Duration Date:02/26/99ISR Number: 3417051-6Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980227 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417053-XReport Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose PT Report Source Product Role Hyperglycaemia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3417054-1Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980230 Company Report #001-0945-980231 PT Report Source Product Role Drug Interaction Muscle Twitching Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS ORAL (Nortriptyline) SS ORAL Duration 300 MG (100 MG, TID), PER ORAL 50 MG (, QHS), PER ORAL Date:02/26/99ISR Number: 3417056-5Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980232 PT Report Source Product Role Headache Tinnitus Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 900 MG (300 MG, TID), PER ORAL Excedrin (Acetylsalicylic Acid, Caffeine, Salicylamide, ORAL Paracetamol) Toprol Xl (Metoprolol Succinate) Prilosec (Omeprazole) Lipitor (Atorvastatin) Date:02/26/99ISR Number: 3417057-7Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose C C C C Company Report #001-0945-980233 PT Report Source Product Role Blood Bilirubin Increased Depression Consumer Neurontin Capsules 100 Mg (Gabapentin) PS 300 MG (100 Drug Interaction MG, TID), PER Gallbladder Disorder ORAL Sedation 22-Aug-2005 Page: 196 Manufacturer Route Duration 10:40 AM Risperdal (Risperidone) Paxil (Paroxetine Hydrochloride) Klonopin (Clonazepam) SS C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417058-9Report Type:Periodic Age:19 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980234 PT Report Source Product Role Amnesia Pregnancy Consumer Neurontin (Gabapentin) PS Prenatal Vitamins (Ergocalcierol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL Date:02/26/99ISR Number: 3417059-0Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Fatigue Steatorrhoea Weight Decreased Health Professional Neurontin (Gabapentin) Dextroamphetamine-(D examethasone Sulfate) Role Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3417060-7Report Type:Periodic Age:75 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980235 PS C Company Report #001-0945-980236 PT Report Source Product Role Dyskinesia Dystonia Health Professional Neurontin (Gabapentin) PS Duration Date:02/26/99ISR Number: 3417061-9Report Type:Periodic Age:51 YR Gender:Female I/FU:I Company Report #001-0945-980237 Outcome Dose PT Report Source Product Role Joint Swelling Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL (Atenolol) Estrace (Estradiol) Ativan (Lorazepam) Maxzide (Hydrochlorothiazide , Triamterene) (Trazodone) Klonopin (Clonazepam) (Ibuprofen) (Amoxapine) Date:02/26/99ISR Number: 3417062-0Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose C C C C C Company Report #001-0945-980238 PT Report Source Product Role Migraine Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 4500 MG (,DAILY), PER 22-Aug-2005 Page: 197 C C C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL "Many" Unspecified Date:02/26/99ISR Number: 3417063-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980239 PT Report Source Product Role Feeling Abnormal Weight Increased Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 2400 MG (300 MG, EVERY 3 HOURS), PER ORAL Date:02/26/99ISR Number: 3417064-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Dyskinesia Health Professional Neurontin (Gabapentin) Dilantin (Phenytoin Sodium) Role Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3417065-6Report Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980240 PS C Company Report #001-0945-980244 PT Report Source Product Role Eye Movement Disorder Nausea Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Duration 1800 MG (600 Oedema Peripheral MG, TID), PER ORAL Roxicet ORAL (Paracetamol, Oxycodone Hydrochloride) (Calcium) Date:02/26/99ISR Number: 3417066-8Report Type:Periodic Age:73 YR Gender:Female I/FU:I Outcome Dose PT C C Company Report #001-0945-980245 Report Source Product Role Neurontin (Gabapentin) PS Dermatitis Urinary Incontinence ONE CAPSULE IN AM; ONE CAPSULE IN AM; ONE CAPSULE AT HS Alphagan (Brimonidine Tartrate) Timoptic Xe (Timolol Maleate) Risperdal (Risperidone) Ativan (Lorazepam) Xalatan (Latanoprost) 22-Aug-2005 Page: 198 Manufacturer Route Duration 10:40 AM C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417067-XReport Type:Periodic Age:65 YR Gender:Male I/FU:F Outcome Dose Company Report #001-0945-970625 PT Report Source Product Role Cerebrovascular Accident Sedation Health Professional Neurontin 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1800 MG (600 MG, TID) PER ORAL Rezulin (Troglitazone) Lipitor (Atorvastatin) Cozaar (Losartan Potassium) Glucophage (Metformin Hydrochloride) Toprol (Metoprolol Succinate) Norvasc (Amlodipine Besilate) (Insulin) Ecotrin (Acetylsalicylic Acid) Elavil (Amitriptyline Hydrochloride) Date:02/26/99ISR Number: 3417068-1Report Type:Periodic Age:40 YR Gender:Male I/FU:F Outcome Dose C C C C C C C C Company Report #001-0945-970665 PT Report Source Product Role Clumsiness Disturbance In Attention Consumer Neurontin 300 Mg (Gabapentin) PS Manufacturer Route Duration 900 MG (300 Visual Disturbance MG, TID), PER ORAL C ORAL Azmacort (Triamcinolone Acetonide) Date:02/26/99ISR Number: 3417069-3Report Type:Periodic Age:13 YR Gender:Female I/FU:F Outcome Dose C Company Report #001-0945-970686 PT Report Source Product Role Abdominal Pain Upper Gallbladder Disorder Consumer Health Neurontin Capsules 100 Mg (Gabapentin) PS Polyp Professional Veetids (Phenoxymethylpenici llin Potassium) C 400 MG (, 100 MG QAM, 100 MG QPM,200 MG QHS), PER ORAL 22-Aug-2005 Page: 199 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417070-XReport Type:Periodic Age:51 YR Gender:Female I/FU:F Outcome Dose Company Report #001-0945-970703 PT Report Source Product Role Fatigue Nausea Health Professional Neurontin 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG (300 Pancreatitis MG, QID), PER ORAL Prosom (Estazolam) Doxepin Diazepam Hydroxyzine Surmontil (Trimipramine) Date:02/26/99ISR Number: 3417071-1Report Type:Periodic Age:32 YR Gender:Female I/FU:F Outcome Dose C C C C C Company Report #001-0945-970708 PT Report Source Product Role Dyspnoea Health Professional Neurontin (Gabapentin) PS Amitriptyline Verapamil C C Manufacturer Route Duration ORAL 1800 MG (600 MG, TID), PER ORAL Date:02/26/99ISR Number: 3417072-3Report Type:Periodic Age:35 YR Gender:Unknown I/FU:F Outcome Dose Company Report #001-0945-970709 PT Report Source Product Role Facial Palsy Health Professional Neurontin (Gabapentin) PS Duration Manufacturer Route Date:02/26/99ISR Number: 3417073-5Report Type:Periodic Age:35 YR Gender:Unknown I/FU:F Outcome Dose PT Report Source Product Role Facial Palsy Health Professional Neurontin (Gabapentin) PS 22-Aug-2005 Page: 200 Route Manufacturer Route Manufacturer Route Company Report #001-0945-970711 PT Report Source Product Role Polymenorrhoea Health Professional Neurontin (Gabapentin) PS Duration Date:02/26/99ISR Number: 3417075-9Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Manufacturer Duration Date:02/26/99ISR Number: 3417074-7Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Company Report #001-0945-970710 Company Report #001-0945-970712 PT Report Source Product Role Menstruation Irregular Health Professional Neurontin (Gabapentin) PS Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417076-0Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose PT Report Source Product Role Menstrual Disorder Health Professional Neurontin (Gabapentin) PS Route Manufacturer Route Manufacturer Route Manufacturer Route Company Report #001-0945-970714 PT Report Source Product Role Polymenorrhoea Health Professional Neurontin (Gabapentin) PS Duration Date:02/26/99ISR Number: 3417078-4Report Type:Periodic Age:42 YR Gender:Male I/FU:F Outcome Dose Manufacturer Duration Date:02/26/99ISR Number: 3417077-2Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Company Report #001-0945-970713 Company Report #001-0945-970716 PT Report Source Product Role Influenza Like Illness Health Professional Neurontin (Gabapentin) PS Duration 200 MG (AT HS), UNKNOWN Date:02/26/99ISR Number: 3417079-6Report Type:Periodic Age:31 YR Gender:Male I/FU:F Outcome Dose Company Report #001-0945-970719 PT Report Source Product Role Drug Interaction Vomiting Health Professional Neurontin 300 Mg (Gabapentin) PS Novocain (Procaine Hydrochloride) SS Duration 900 MG (300 MG, TID) , PER ORAL ORAL Synthroid (Levothyroxine Sodium) Humalog (Insulin Lispro) Date:02/26/99ISR Number: 3417080-2Report Type:Periodic Age:67 YR Gender:Female I/FU:F Outcome Dose C Company Report #001-0945-973007 PT Report Source Product Role Delirium Sepsis Health Professional Company Representative Neurontin (Gabapentin) PS Route PT Manufacturer Route Company Report #001-0945-973020 Report Source Product Role Neurontin (Gabapentin) PS Klonopin (Clonazepam) C Duration Platelet Count Decreased 300 MG (DAILY), UNKNOWN 22-Aug-2005 Page: 201 Manufacturer Duration Date:02/26/99ISR Number: 3417081-4Report Type:Periodic Age:50 YR Gender:Male I/FU:F Outcome Dose C 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vistaril (Hydroxyzine Embonate) Ativan (Lorazepam) Date:02/26/99ISR Number: 3417082-6Report Type:Periodic Age:50 YR Gender:Female I/FU:F Outcome Dose C C Company Report #001-0945-973031 PT Report Source Product Role Hallucination, Visual Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Elavil (Amitriptyline Hydrochloride) C Manufacturer Route Duration ORAL 900 MG (,300 Company MG TID), PER Representative ORAL Date:02/26/99ISR Number: 3417083-8Report Type:Periodic Age:54 YR Gender:Female I/FU:F Outcome Dose Company Report #001-0945-973036 PT Report Source Product Role Dizziness Epistaxis Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 400 MG (200 Nasal Discomfort MG BID), PER Throat Irritation ORAL Fosamax (Alendronate Sodium) Prempro (Medroxyprogesterone Acetate, Estrogens Conjugated) C C ORAL Date:02/26/99ISR Number: 3417084-XReport Type:Periodic Age:50 YR Gender:Female I/FU:F Outcome Dose Company Report #001-0945-973043 PT Report Source Product Role Constipation Hirsutism Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration 600 MG (300 MG, BID) UNKNOWN Prozac (Fluoxetine Hydrochloride) Claritin (Loratadine) Nasacort Inhaler (Triamcinolone Acetate) Aygestin (Norethisterone Acetate) Darvocet (Paracetamol, Dextropropoxyphene) Skelaxin (Metaxalone) Voltaren (Diclofenac Sodium) Ultram (Tramadol 22-Aug-2005 Page: 202 10:40 AM C C C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) Humibid (Guaifenesin, Dextromethorphan Hydrobromide) Date:02/26/99ISR Number: 3417085-1Report Type:Periodic Age:12 YR Gender:Male I/FU:F Outcome Dose C C Company Report #001-0945-973044 PT Report Source Product Role Decreased Appetite Food Craving Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 900 MG (300 Weight Increased MG, TID) UNKNOWN Prozac (Fluoxetine Hydrochloride) Tofranil (Imipramine Hydrochloride) Sudafed (Pseudoephedrine Hydrochloride) Date:02/26/99ISR Number: 3417086-3Report Type:Periodic Age:55 YR Gender:Female I/FU:F Outcome Dose C C C Company Report #001-0945-980004 PT Report Source Product Role Depression Oedema Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration 900 MG (300 MG, TID), PER ORAL Zyprexa (Olanzapine) Prozac (Fluxoxetine Hydrochloride) Depakote (Valproate Semisodium) Adderall (Amfetamine C C C ORAL Sulfate) Date:02/26/99ISR Number: 3417087-5Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose C Company Report #001-0945-980880 PT Report Source Product Role Burning Sensation Paraesthesia Health Professional Neurontin Capsules 100mg (Gabapentin) PS Prozac (Fluoxetine Hydrochloride) C Manufacturer Route Duration ORAL 100MG DAILY Rash Pruritic PER ORAL Date:02/26/99ISR Number: 3417088-7Report Type:Periodic Age:8 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980881 PT Report Source Product Role Weight Increased Consumer Neurontin Capsules 300mg (Gabapentin) PS 2400MG IN DIVIDED DOSES PER ORAL Lithium Tenex (Guanfactine 22-Aug-2005 Page: 203 Manufacturer Route Duration 10:40 AM C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) Date:02/26/99ISR Number: 3417089-9Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose C Company Report #001-0945-980882 PT Report Source Product Role Burning Sensation Hypoaesthesia Consumer Neurontin Capsules 300mg (Gabapentin) PS Manufacturer Route Duration ORAL 300MG X1 DOSE Muscle Twitching PER ORAL Paraesthesia Tongue Oedema Date:02/26/99ISR Number: 3417090-5Report Type:Periodic Age:68 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980883 PT Report Source Product Role Blood Pressure Increased Dizziness Consumer Neurontin Capsules 300mg (Gabapentin) PS Manufacturer Route Duration ORAL SEE IMAGE Fatigue Herpes Zoster Keratoconjunctivitis Sicca Migraine Darvocet-N (Paracetamol) Dextropropoxyphene Imitrex (Sumatriptan) Herbal Preparation Date:02/26/99ISR Number: 3417091-7Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose C C C C Company Report #001-0945-980884 PT Report Source Product Role Hearing Impaired Tinnitus Consumer Neurontin Capsules 300mg (Gabapentin) PS Manufacturer Route Duration 900MG DAILY PER ORAL Estrace (Estradiol) Provera C ORAL (Medroxyprogesterone Acetate) Imodium (Loperamide Hydrochloride) Allerga (Fexofenadine Hydrochloride) Date:02/26/99ISR Number: 3417092-9Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #001-0945-980885 PT Report Source Product Role Drug Ineffective Drug Interaction Consumer Neurontin (Gabapentin) PS Lorazepam SS Rocephin (Cefriaxone Sodium) C Manufacturer Route Duration SEE TEXT 2MG 1MG BID PER ORAL 22-Aug-2005 Page: 204 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417093-0Report Type:Periodic Age:69 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980887 PT Report Source Product Role Condition Aggravated Tremor Consumer Neurontin Capsules 400mg (Gabapentin) PS Sinemet (Levodopa, Carbidopa) C Manufacturer Route Duration ORAL 400MG DAILY PER ORAL Date:02/26/99ISR Number: 3417094-2Report Type:Periodic Age:43 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980889 PT Report Source Product Role Urticaria Consumer Neurontin Capsules 300mg (Gabapentin) PS Manufacturer Route Duration ORAL 300MG DAILY PER ORAL Date:02/26/99ISR Number: 3417095-4Report Type:Periodic Age:76 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980890 PT Report Source Product Role Constipation Fall Consumer Neurontin Capsules 100mg (Gabapentin) PS Manufacturer Route Duration ORAL 800MG (400MG BID) PER ORAL Date:02/26/99ISR Number: 3417096-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980891 PT Report Source Product Diabetes Mellitus Health Neurontin Duration Role Manufacturer Route Professional Date:02/26/99ISR Number: 3417097-8Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose PS C Company Report #001-0945-980892 PT Report Source Product Role Purpura Health Professional Neurontin (Gabapentin) PS Route Manufacturer Route Company Report #001-0945-980893 PT Report Source Product Role Balance Disorder Decreased Activity Consumer Neurontin Capsules 100mg (Gabapentin) PS Duration 300MG (100MG Dizziness TID) PER ORAL Mental Impairment 22-Aug-2005 Page: 205 Manufacturer Duration Date:02/26/99ISR Number: 3417098-XReport Type:Periodic Age:71 YR Gender:Female I/FU:I Outcome Dose (Gabapentin) Dilantin (Phenytoin Sodium) 10:40 AM Aldactone (Spironolactone) K-Dur (Potassium Chloride) Lasix (Furosemide) Aspirin (Acetylsalicylic Acid) C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Magnesium Ismo (Isosorbide Mononitrate) Date:02/26/99ISR Number: 3417099-1Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980894 PT Report Source Product Role Aphonia Chest Pain Consumer Neurontin Capsules 300mg (Gabapentin) PS Prozac (Fluoxetine Hydrochloride0 Clonazepam C C Manufacturer Route Duration ORAL 3600MG (900 Dyspnoea MG QID) PER Pharyngolaryngeal Pain ORAL Weight Increased Date:02/26/99ISR Number: 3417100-5Report Type:Periodic Age:52 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980895 PT Report Source Product Role Condition Aggravated Fatigue Health Professional Neurontin (Gabapentin) PS Ultram (Tramadol Hydrochloride) C Manufacturer Route Duration ORAL 700MG DAILY PER ORAL Date:02/26/99ISR Number: 3417101-7Report Type:Periodic Age:9 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980897 PT Report Source Product Role Rectal Haemorrhage Health Professional Neurontin Capsules 300mg (Gabapentin) PS Manufacturer Route Duration 2700MG (900MG ORAL TID) PER ORAL Date:02/26/99ISR Number: 3417102-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Face Oedema Oedema Mouth Stomatitis Health Professional Neurontin (Gabapentin) PS Route Manufacturer Route Company Report #001-0945-980899 PT Report Source Product Role Cataract Night Blindness Consumer Health Neurontin (Gabapentin) PS Voltaren (Diclofenac Sodium) C Duration 1200MG (600MG Professional BID) 22-Aug-2005 Page: 206 Manufacturer Duration Date:02/26/99ISR Number: 3417103-0Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980898 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417104-2Report Type:Periodic Age:75 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980900 PT Report Source Product Role Headache Health Professional Neurontin Capsules 300mg (Gabapentin) PS Manufacturer Route Duration ORAL 300MG (ONE DOSE) PER ORAL Date:02/26/99ISR Number: 3417105-4Report Type:Periodic Age:69 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980901 PT Report Source Product Role Fatigue Increased Appetite Consumer Neurontin Capsules 300mg (Gabapentin) PS Manufacturer Route Duration ORAL 300MG (X ONE DOSE) PER ORAL Date:02/26/99ISR Number: 3417106-6Report Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980902 PT Report Source Product Role Keratoconjunctivitis Sicca Consumer Neurontin Capsules 100mg (Gabapentin) PS Cozaar (Losartan Potassium) C Manufacturer Route Duration 400MG DAILY PER ORAL Date:02/26/99ISR Number: 3417321-1Report Type:Periodic Age:17 YR Gender:Female I/FU:F Company Report #001-0945-980009 ORAL Outcome Dose PT Report Source Product Role Alopecia Dry Mouth Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Klonopin (Clonazepam) Steroid Injections SS C Manufacturer Route Duration ORAL 900 MG (300 Fatigue MG, TID), PER Headache ORAL Mood Swings Nausea Sedation Tremor Date:02/26/99ISR Number: 3417323-5Report Type:Periodic Age:22 YR Gender:Male I/FU:F Outcome Dose Company Report #001-0945-980010 PT Report Source Product Role Asthma Health Professional Neurontin Capsules 300 Mg(Gabapentin) PS 600 MG (300 MG, BID), PER ORAL Date:02/26/99ISR Number: 3417324-7Report Type:Periodic Age:61 YR Gender:Female I/FU:F Outcome 22-Aug-2005 Page: 207 Manufacturer Route Duration PT Dry Mouth Eye Irritation Fluid Retention 10:40 AM Company Report #001-0945-980012 ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervousness Nightmare Oedema Peripheral Dose Report Source Product Role Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Inderal (Codeine) Tranxene Magnesium Estrace (Progesterone) C C C C C C Manufacturer Route Duration Sedation Sleep Disorder ORAL 1800 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3417326-0Report Type:Periodic Age:43 YR Gender:Male I/FU:F Outcome Dose Company Report #001-0945-980019 PT Report Source Product Role Diplopia Dizziness Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Dilantin C Manufacturer Route Duration ORAL 1200 MG (300 Flatulence MG, QID), PER Headache ORAL Increased Bronchial Secretion Nasal Congestion Sedation Date:02/26/99ISR Number: 3417329-6Report Type:Periodic Age:57 YR Gender:Male I/FU:F Outcome Dose 2900 MG Company Report #001-0945-980020 PT Report Source Product Role Amnesia Dizziness Health Professional Neurontin (Gabapentin) PS Duration Manufacturer Route Erectile Dysfunction (DAILY) Fatigue Vision Blurred Glucophage Humulin N Humulin Nph Date:02/26/99ISR Number: 3417332-6Report Type:Periodic Age: Gender:Male I/FU:F Outcome Dose Company Report #001-0945-980023 PT Report Source Product Role Platelet Count Decreased Health Professional Neurontin (Gabapentin) Toprol Ambien PS C C Route Manufacturer Route Company Report #001-0945-980024 PT Report Source Product Role Dermatitis Health Professional Neurontin (Gabapentin) PS Lioresal Betaseron C C Duration 1200 MG (400 MG, TID), PER ORAL 22-Aug-2005 Page: 208 Manufacturer Duration Date:02/26/99ISR Number: 3417337-5Report Type:Periodic Age:53 YR Gender:Male I/FU:F Outcome Dose C C C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417339-9Report Type:Periodic Age: Gender: I/FU:I Outcome Dose PT Report Source Product Role Abdominal Pain Upper Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3417342-9Report Type:Periodic Age:5 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980541 Company Report #001-0945-980542 PT Report Source Product Role Psychomotor Hyperactivity Consumer Neurontin (Gabapentin) PS Duration ORAL 900 MG (300 MG, TID), PER ORAL Date:02/26/99ISR Number: 3417344-2Report Type:Periodic Age:18 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980544 PT Report Source Product Role Joint Contracture Health Professional Neurontin (Gabapentin) PS Atrovent Relafen C C Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL 7 DAY Date:02/26/99ISR Number: 3417345-4Report Type:Periodic Age: Gender: I/FU:I Outcome Dose PT Duration Company Report #001-0945-980546 Report Source Product Role Manufacturer Route Anxiety Depression Health Professional Neurontin (Gabapentin) PS ORAL SEE TEXT, PER Tremor ORAL Date:02/26/99ISR Number: 3417347-8Report Type:Periodic Age:14 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980547 PT Report Source Product Role Hypoaesthesia Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL Date:02/26/99ISR Number: 3417349-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Diarrhoea Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 300 MG (QHS), PER ORAL 22-Aug-2005 Page: 209 Company Report #001-0945-980548 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3417351-XReport Type:Periodic Age:40 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980549 PT Report Source Product Role Confusional State Dizziness Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Synthroid Serzone C C Manufacturer Route Duration ORAL 900 MG (300 Hypoaesthesia MG IN AM, 600 MG IN PM), PER ORAL Date:02/26/99ISR Number: 3417360-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Back Pain Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/26/99ISR Number: 3417361-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980551 Company Report #001-0945-980552 PT Report Source Product Role Disorientation Dizziness Consumer Health Neurontin Capsules 300 Mg (Gabapentin) PS Medication Error Professional Daypro Vitamin E Belphenergots C C C Duration 1200 MG (300MG QAM, Pain 300 MG QPM, Sedation 600MG QHS) Date:02/26/99ISR Number: 3417363-6Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980554 PT Report Source Product Role Abdominal Distension Ecchymosis Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration SEE TEXT Weight Increased Date:02/26/99ISR Number: 3423642-9Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980849 PT Report Source Product Role Urinary Incontinence Consumer Neurontin (Gabapentin) PS Duration 1600 MG (400 MG, QID), PER ORAL Unspecified Antidepresants Vicodin (Paracetamol, Hydrocodone Bitartrate) Tylenol #3 (Codeine Phosphate, Paracetamol) 22-Aug-2005 Page: 210 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3423643-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Dermatitis Health Professional Neurontin (Gabapentin) PS Route Manufacturer Route Manufacturer Route Company Report #001-0945-980851 PT Report Source Product Diarrhoea Myasthenia Gravis Health Professional Company Representative Neurontin (Gabapentin) Mestinon (Pyridostigmine Bromide) Role Duration Date:02/26/99ISR Number: 3423646-6Report Type:Periodic Age:80 YR Gender:Male I/FU:I Outcome Dose Manufacturer Duration Date:02/26/99ISR Number: 3423644-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980850 PS C Company Report #001-0945-980852 PT Report Source Product Role Abdominal Distension Flatulence Consumer Neurontin (Gabapentin) PS Duration 1500 MG (500 MG, TID), PER ORAL Coumadin (Warfarin Sodium) Vasotec (Enalapril Maleate) Lasix (Furosemide) K-Dur (Potassium Chloride) Date:02/26/99ISR Number: 3423648-XReport Type:Periodic Age: Gender:Male I/FU:I Company Report #001-0945-980853 C C C C ORAL Outcome Dose PT Report Source Product Role Gynaecomastia Health Professional Neurontin (Gabapentin) PS Date:02/26/99ISR Number: 3423651-XReport Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Route Manufacturer Route Company Report #001-0945-980855 PT Report Source Product Role Amnesia Coeliac Disease Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Duration 600 MG (300 Joint Swelling MG, BID), PER ORAL Premarin (Estrogens Conjugated) Unspecified Oral Antihyperglycemic Med 22-Aug-2005 Page: 211 Manufacturer Duration 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3423652-1Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980857 PT Report Source Product Role Vaginal Haemorrhage Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1400 MG (DAILY), PER ORAL Prozac (Fluoxetine Hydrochloride) Risperdal (Risperidone) Date:02/26/99ISR Number: 3423655-7Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose C C Company Report #001-0945-980858 PT Report Source Product Role Diarrhoea Nausea Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG Sedation (DAILY), PER Urticaria ORAL Paxil (Paroxetine Hydrochloride) Premarin (Estrogens Conjugated) Depakote (Valproate Semisodium) Relafen (Nabumetone) Date:02/26/99ISR Number: 3423658-2Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose C C C C Company Report #001-0945-980862 PT Report Source Product Myalgia Consumer Neurontin Capsules Duration Role Manufacturer Route Health 400 Mg (Gabapentin) PS ORAL 1200 MG (400 Professional MG, TID), PER ORAL Tegretol (Carbamazepine) Paxil (Paroxetine Hydrochloride) (Lorazepam) Date:02/26/99ISR Number: 3423659-4Report Type:Periodic Age:45 YR Gender:Male I/FU:I Outcome Dose C C C Company Report #001-0945-980863 PT Report Source Product Role Bradykinesia Tremor Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS 800 MG (400 MG, BID), PER ORAL Prolixin (Fluphenazine Hydrochloride) Risperdal (Risperidone) Depakote (Valproate Semisodium) 22-Aug-2005 Page: 212 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3424030-1Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980627 PT Report Source Product Role Dyspnoea Nystagmus Consumer Neurontin (Gabapentin) PS Asa Depakote Paxil Dalmane C C C C Manufacturer Route Duration ORAL 1200 MG Syncope (DAILY), PER ORAL Date:02/26/99ISR Number: 3424032-5Report Type:Periodic Age:70 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980628 PT Report Source Product Role Abdominal Pain Upper Headache Consumer Neurontin (Gabapentin) PS Robaxin C Manufacturer Route Duration ORAL 300 MG Stomatitis (DAILY), PER ORAL Date:02/26/99ISR Number: 3424033-7Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose 2700 MG (DAILY), PER ORAL Company Report #001-0945-980630 PT Report Source Product Role Dysarthria Hypoaesthesia Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL Klonopin Date:02/26/99ISR Number: 3424042-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980632 PT Report Source Product Water Intoxication Consumer Neurontin (Gabapentin) Tagamet Hb 200 (Cimetidine) Role Route Manufacturer Route PS SS Company Report #001-0945-980633 PT Report Source Product Role Headache Myalgia Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Zoloft Vistaril Motrin C C C Duration 100 MG (DAILY), PER ORAL 22-Aug-2005 Page: 213 Manufacturer Duration Date:02/26/99ISR Number: 3424044-1Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3424046-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980634 PT Report Source Product Role Alopecia Burning Sensation Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 500 MG Lip Disorder (DAILY), PER Muscle Twitching ORAL Nail Disorder Date:02/26/99ISR Number: 3424048-9Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980635 PT Report Source Product Role Anorgasmia Drug Interaction Consumer Neurontin (Gabapentin) PS Propoxyphene Napsylate With Apap (Paracetamol, Dextropropoxyphene Napsilate) SS Fiorinal C Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL 2 TABS (AS NEEDED) Date:02/26/99ISR Number: 3424050-7Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980636 PT Report Source Product Amnesia Consumer Neurontin Duration Role Manufacturer Route Blood Pressure Increased (Gabapentin) PS ORAL 400 MG Crying (DAILY), PER Dyspnoea ORAL Erythema Feeling Abnormal Flushing Medication Error Date:02/26/99ISR Number: 3424051-9Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980637 PT Report Source Product Role Dizziness Pallor Consumer Neurontin (Gabapentin) PS Copaxone Klonopin Cylert Pamelor C C C C Manufacturer Route Duration ORAL 400 MG (100 MG, QID) PER ORAL Date:02/26/99ISR Number: 3424053-2Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Dizziness Nausea Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration 200 MG (100 22-Aug-2005 Page: 214 Company Report #001-0945-980638 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG, BID), PER ORAL Luvox (Fluvoxamine Maleate) SS Prozac Synthroid Ativan C C C ORAL 100 MG (QHS), PER ORAL Date:02/26/99ISR Number: 3424055-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose 2800 Company Report #001-0945-980437 PT Report Source Product Role Dizziness Overdose Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL MG Photosensitivity Reaction (DAILY), PER Sedation ORAL Syncope Date:02/26/99ISR Number: 3424057-XReport Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose 2400 Company Report #001-0945-980438 PT Report Source Product Role Drug Interaction Grand Mal Convulsion Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration MG Company (1200 MG, Representative BID), PER ORAL Wellbutrin (Amfebutamone ORAL Hydrochloride) SS Prozac Klonopin C C ORAL 375 (DAILY), PER ORAL Date:02/26/99ISR Number: 3424059-3Report Type:Periodic Age:26 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980439 PT Report Source Product Role Amnesia Condition Aggravated Consumer Neurontin (Gabapentin) PS Tegretol Synthroid C C Manufacturer Route Duration ORAL 900 MG Convulsion (DAILY), PER Ear Infection ORAL Date:02/26/99ISR Number: 3424061-1Report Type:Periodic Age:69 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980442 PT Report Source Product Role Erectile Dysfunction Loss Of Libido Consumer Neurontin (Gabapentin) PS Norvasc (Quinapril) (Ibuprofen) Prozac C C C C 2100 MG (DAILY), PER ORAL 22-Aug-2005 Page: 215 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serax (Lithium) Micronase Date:02/26/99ISR Number: 3424063-5Report Type:Periodic Age:80 YR Gender:Male I/FU:I Outcome Dose C C C Company Report #001-0945-980443 PT Report Source Product Role Abdominal Pain Nausea Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 100 MG (HS), PER ORAL Date:02/26/99ISR Number: 3424064-7Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980444 PT Report Source Product Role Dyskinesia Tremor Consumer Neurontin (Gabapentin) PS Voltaren Zantac (Atenolol) C C C Manufacturer Route Duration ORAL 600 MG (DAILY), PER ORAL Date:02/26/99ISR Number: 3424067-2Report Type:Periodic Age:68 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980445 PT Report Source Product Role Diarrhoea Uterine Haemorrhage Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 1200 MG (400 MG, TID), PER ORAL ORAL Date:02/26/99ISR Number: 3424069-6Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980446 PT Report Source Product Role Abdominal Distension Hair Texture Abnormal Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1800 MG (600 Increased Appetite MG, TID), PER Oedema Peripheral ORAL Weight Increased Date:02/26/99ISR Number: 3424071-4Report Type:Periodic Age: Gender: I/FU:I Outcome Dose 22-Aug-2005 Page: 216 Company Report #001-0945-980448 PT Report Source Product Role Systemic Lupus Erythematosus Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3424072-6Report Type:Periodic Age:80 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980452 PT Report Source Product Role Liver Function Test Abnormal Health Professional Neurontin (Gabapentin) PS Bactrim Ds (Sulfamethoxazole, Trimethoprim) SS Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL (BID) Date:02/26/99ISR Number: 3424075-1Report Type:Periodic Age:43 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980453 PT Report Source Product Role Sedation Consumer Neurontin (Gabapentin) PS Cardura Klonopin Hyzaar (Verapamil) Effexor Xr Atarax Dexacort C C C C C C C Manufacturer Route Duration ORAL 1200 MG (SEE TEXT), PER ORAL Date:02/26/99ISR Number: 3424076-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #001-0945-980454 PT Report Source Product Urine Analysis Abnormal Health Neurontin Duration Role Manufacturer Route Professional Date:02/26/99ISR Number: 3424077-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose 22-Aug-2005 Page: 217 Company Report #001-0945-980456 PT Report Source Product Role Cardiac Failure Oedema Peripheral Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Company Report #001-0945-980457 PT Report Source Product Role Myalgia Consumer Neurontin (Gabapentin) PS Duration Date:02/26/99ISR Number: 3424079-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PS C C Duration Date:02/26/99ISR Number: 3424078-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose (Gabapentin) Trazodone Inderal Company Report #001-0945-980459 PT Report Source Product Role Libido Decreased Health Professional Neurontin (Gabapentin) PS Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3424080-5Report Type:Periodic Age:66 YR Gender:Female I/FU:I Outcome Dose Company Report #001-0945-980461 PT Report Source Product Role Blood Glucose Increased Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Glyburide (Furosemide) (Potassium) Prozac Anturane C C C C C Manufacturer Route Duration ORAL 1200 MG (300 MG, QID), PER ORAL Date:02/26/99ISR Number: 3424081-7Report Type:Periodic Age:72 YR Gender:Male I/FU:I Outcome Dose Company Report #001-0945-980462 PT Report Source Product Role Skin Odour Abnormal Consumer Neurontin (Gabapentin) PS Hytrin Mevacor Prozac C C C Manufacturer Route Duration 400 MG (QHS) Date:03/01/99ISR Number: 3208259-3Report Type:Direct Age:24 YR Gender:Female I/FU:I Outcome Dose Duration Death 300 MG / TID Company Report # PT Report Source Product Role Manufacturer Route Cardiac Arrest Health Neurontin PS Parke-Davis ORAL Haldol Benadryl Cogentin Zyprexa C C C C Professional / ORAL 1 WK Klonopin Date:03/01/99ISR Number: 3218648-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 150 MG/TWICE Initial or Prolonged PER DAY/ORAL C Company Report #A0077155 PT Report Source Product Role Manufacturer Route Stevens-Johnson Syndrome Health Zyban Tablet - Zyban PS ORAL Gabapentin Capsule SS ORAL Professional Date:03/02/99ISR Number: 3210320-4Report Type:Expedited (15-DaCompany Report #001-0945-980783 Age:51 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG (100 PT Report Source Product Role Diabetes Mellitus Diarrhoea Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Dizziness MG, QID), PER Nervous System Disorder ORAL Orthostatic Hypotension Renal Disorder 22-Aug-2005 Page: 218 10:40 AM Cozaar (Losartan Potassium) (Insulin) Nph Insulin (Insulin Injection, Isophane) Proamatine C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Midodrine Hydrochloride) Lasix (Furosemide) Date:03/03/99ISR Number: 3210649-XReport Type:Direct Age:86 YR Gender:Male I/FU:I Outcome Dose Death PT C C Company Report # Report Source Product Role Gabapentin Carbamazepine Lamotrigine PS SS SS Manufacturer Route Manufacturer Route Duration Death Date:03/03/99ISR Number: 3211629-0Report Type:Expedited (15-DaCompany Report #001-0945-980676 Age:59 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Fall Gout Consumer Neutrontin (Gabapentin) PS Colchicine Coumadin Isosorbide Norvasc Hytrin Lanoxin Prinivil Lasix Levodopa K-Dur C C C C C C C C C C Duration ORAL 900 MG (300 Weight Decreased MG, TID) PER ORAL Date:03/04/99ISR Number: 3212859-4Report Type:Expedited (15-DaCompany Report #001-0945-990133 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Convulsion Health Neurontin Capsules Duration Role Manufacturer Route Drug Effect Decreased Professional 300 Mg (Gabapentin) PS 900 MG (300 MG, TID), UNKNOWN Date:03/05/99ISR Number: 3214125-XReport Type:Direct Age:75 YR Gender:Male I/FU:I Outcome Dose Other PO PT Company Report # Report Source Product Role Chest Pain Neurontin PS Convulsion Cough Drug Level Below Therapeutic Dilantin SS Date:03/05/99ISR Number: 3214470-8Report Type:Expedited (15-DaCompany Report #A0082673 Age:44 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 219 Manufacturer Route Duration 10:40 AM PT Agitation Drug Level Above Therapeutic ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Drunk Nausea Tremor Dose Report Source Product Role Manufacturer Route Health Wellbutrin Tablet PS ORAL Professional Other Lithium Carbonate Tablet SS ORAL Olanzapine Tablet SS ORAL Benzatropine Tablet SS ORAL Gabapentin Tablet SS ORAL Clonazepam Tablet SS ORAL Zolpidem Tartrate Tablet SS ORAL Sertraline Hydrochloride Tablet SS ORAL Duration ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL Date:03/08/99ISR Number: 3216166-5Report Type:Direct Age:72 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 300 MG TID Initial or Prolonged PT Report Source Product Role Coordination Abnormal Health Gabapentin PS Mental Disorder Professional Esgic C Date:03/09/99ISR Number: 3216360-3Report Type:Direct Age:32 YR Gender:Male I/FU:I Outcome Dose Other Company Report # PT Manufacturer Route Route Company Report # Report Source Product Role Manufacturer Drug Level Below Therapeutic Neoral (Cyclosporine) PS Novartis Graft Versus Host Disease Neurontin Duration CAPSULE Medication Error (Gabapentin) SS Parke-Davis Manufacturer CAPSULES Date:03/10/99ISR Number: 3216642-5Report Type:Expedited (15-DaCompany Report #001-0945-990120 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 Other MG, TID), PER PT Report Source Product Role Cardiac Failure Congestive Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Condition Aggravated Depression ORAL Haematocrit Decreased Haemoglobin Decreased Personality Disorder Post-Traumatic Stress Disorder Psychotic Disorder Red Blood Cell Count Decreased 22-Aug-2005 Page: 220 10:40 AM Mellaril (Thiorida Zine Hydrochloride) (Clonidine) Anafranil (Clomipramine Hydrochloride) Robitussin (Guaifenesin) Peri-Colace (Docusate Sodium, Casanthranol) Seroquel (Quetiapine Fumarate) (Trazodone) C C C C C C C Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/99ISR Number: 3218193-0Report Type:Expedited (15-DaCompany Report #001-0945-990126 Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Blood Glucose Increased Glycosuria Consumer Neurontin Capsules (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG, TID) PER ORAL Date:03/11/99ISR Number: 3218768-9Report Type:Direct Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1200MG PO TID Initial or Prolonged PTA CONT AT PT Company Report # Report Source Abnormal Behaviour Product Role Neurontin PS Ativan Neutontin Srytin Lortab C C C C Manufacturer Route ORAL Appetite Disorder Confusional State DISCHARGE Hallucination LOWER DOSE Movement Disorder Date:03/12/99ISR Number: 3219027-0Report Type:Expedited (15-DaCompany Report #001-0945-990153 Age:68 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Blood Glucose Decreased Convulsion Consumer Neurontin Capsules 300 Mg (Gabapentin) PS 300 MG Movement Disorder (,DAILY), PER Tremor ORAL Manufacturer Route Duration ORAL Nph Insulin (Insulin Injection, Isophane) (Insulin) Zoloft (Sertraline Hydrochloride) Creon (Pancreatin) (Furosemide) Accupril (Quinapril Hydrochloride) Miacalcin 9calcitonin, Salmon) C C C C C C C Date:03/12/99ISR Number: 3219309-2Report Type:Expedited (15-DaCompany Report #201427 Age:48 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Ecchymosis Initial or Prolonged Haematocoele Female Required Injury 20 DOSE FORM Intervention to Thyroid Disorder DAILY ORAL Prevent Permanent SUBCUTANEOUS 20 MG DAILY Impairment/Damage SUBCUTANEOUS Report Source Product Role Manufacturer Route Foreign Other Rivotril (Clonazepam) 2.5 Mg/Ml PS Copaxone (Copaxone) SS Mysoline (Primidone) 250 Mg SS ORAL Atarax (Hydroxyzine Hydrochloride) 25mg SS ORAL ORAL 250 MG DAILY ORAL 50 MG DAILY ORAL Anafranil 22-Aug-2005 Page: 221 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clomipramine Hydrochloride) 75 Mg SS ORAL Neurontin (Gabapentin) 300 Mg SS ORAL Xatral Topalgic C C 75 MG DAILY ORAL 900 MG DAILY ORAL Date:03/12/99ISR Number: 3219479-6Report Type:Expedited (15-DaCompany Report #033-0945-990018 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG PT Report Source Product Role Ecchymosis Thyroid Disorder Foreign Health Neurontin (Gabapentin) PS Manufacturer Route ORAL Professional (DAILY) PER ORAL Anafranil (Clomipamine Hydrochloride) Rivoril (Clonazepam) Atarax (Hydroxyzine) Mysoline (Primidone) Xatral Lp (Alfuzosin) Copaxone (Copolymer) Topalgic C C C C C C C Date:03/15/99ISR Number: 3221115-XReport Type:Expedited (15-DaCompany Report #001-0945-990130 Age:27 YR Gender:Female I/FU:I Outcome Dose Other 1800 MG PT Report Source Product Role Abortion Spontaneous Health Neurontin PS Duration Manufacturer Route Professional (,DAILY), UNKNOWN Prenatal Vitamins Folic Acid C C Date:03/15/99ISR Number: 3221209-9Report Type:Expedited (15-DaCompany Report #001-0991-990448 Age:34 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Complications Of Maternal Consumer Rezulin (Troglitazone) PS 400 MG Exposure To Therapeutic (,DAILY), PER Drugs ORAL Drug Ineffective 22-Aug-2005 Page: 222 Manufacturer Route Duration 10:40 AM Lipitor (Atorvastatin) Neurontin (Gabapentin) Wellbutrin Humulin N Lipitor Neurontin Humulin N Humulin R SS SS C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/99ISR Number: 3222091-6Report Type:Expedited (15-DaCompany Report #001-0945-990140 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization 900 MG (300 Initial or Prolonged MG, TID) PT Report Source Product Role Drug Interaction Hepatic Necrosis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Hepatotoxicity Multi-Organ Failure (Ciclosporin) (Azathioprine) (Prednisone) (Ranitidine) (Baclofen) (Atorvastatin) (Ketoconazole) Acetaminophen (Paracetamol) Niacin (Nicotinic Acid) Dilaudid (Hydromorphone Hydrochloride) (Alprazolam) (Losartan) (Atenolol) (Diltiazem) SS SS SS SS SS SS SS SS SS SS SS SS SS C Date:03/17/99ISR Number: 3222507-5Report Type:Expedited (15-DaCompany Report #001-0945-990170 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG QAM; AND 200 MG QPM (,DAILY),PER ORAL PT Report Source Product Role Medication Error Health Professional Neurontin Capsules 100 Mg(Gabapentin) PS ORAL Date:03/17/99ISR Number: 3222551-8Report Type:Expedited (15-DaCompany Report #001-0945-990142 Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Other 1200 MG (300 PT Report Source Product Role Hyperprolactinaemia Health Neurontin PS Pituitary Tumour Professional Manufacturer Route ORAL MG, QID), PER ORAL Date:03/17/99ISR Number: 3222574-9Report Type:Expedited (15-DaCompany Report #001-0945-990141 Age:8 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG (DAILY), PER ORAL 22-Aug-2005 Page: 223 10:40 AM PT Report Source Product Role Ear Infection Influenza Like Illness Consumer Neurontin (Gabapentin) PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/99ISR Number: 3223501-0Report Type:Expedited (15-DaCompany Report #99F--10195 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 75 MG, DAILY, Initial or Prolonged ORAL PT Report Source Product Role Ecchymosis Foreign Anafranil PS ORAL Haematocoele Health Mysoline SS ORAL Atarax SS ORAL Rivotril SS ORAL Gabapentin SS ORAL Copaxone SS Professional Manufacturer Route 250 MG, Other DAILY, ORAL 50 MG, DAILY, ORAL 20 DRP, DAILY, ORAL 900 MG, DAILY, ORAL SUBCUTANEOUS SUBCUTANEOUS 20 MG, DAILY, 5 MON Date:03/22/99ISR Number: 3224033-6Report Type:Expedited (15-DaCompany Report #002-0945-990011 Age:30 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Dizziness Drug Withdrawal Syndrome Foreign Health Neurontin (Gabapentin) PS Hypoaesthesia Professional 900 MG (DAILY), PER Multiple Sclerosis ORAL/600 MG DAILY/300 MG Manufacturer Route Duration ORAL DAILY Date:03/22/99ISR Number: 3224087-7Report Type:Expedited (15-DaCompany Report #001-0945-990062 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Convulsion Health Professional Company Representative Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:03/23/99ISR Number: 3224779-XReport Type:Expedited (15-DaCompany Report #034-0945-990005 Age:60 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 400 MG (TAKEN Initial or Prolonged ONCE), PER PT Report Source Product Role Anxiety Coma Foreign Health Neurontin Capsules 400mg (Gabapentin) PS Logorrhoea Professional Fluvoxamine C ORAL ORAL Date:03/25/99ISR Number: 3226575-6Report Type:Expedited (15-DaCompany Report #001-0945-990217 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100MG PT Report Source Product Role Abdominal Pain Dehydration Consumer Neurontin Capsules 100mg (Gabapentin) PS Corgard Estrace Pamelor C C C Retching Vomiting 22-Aug-2005 Page: 224 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/99ISR Number: 3229046-6Report Type:Expedited (15-DaCompany Report #JAUSA-36661 Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Bronchitis Chills Csf Protein Increased Gingival Bleeding Health Professional Sporanox (Itraconazole), Janssen, Capsules 100 Mg PS Janssen ORAL Neurontin (Gabapentin) SS Ibuprofen Skelaxin C C 400 MG PULSE Influenza Like Illness ORAL, 200 MG Leukopenia BID, ONE WEEK Pyrexia ON, THREE Thrombocytopenia WEEKS OFF, ORAL ORAL Date:03/30/99ISR Number: 3229662-1Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other Company Report #9818651 PT Report Source Product Role Drug Interaction Unevaluable Event Health Professional Diflucan Tablets Zyrtec Neurontin Tegretol PS SS SS SS Manufacturer Route Duration ORAL ORAL Date:03/30/99ISR Number: 3229952-2Report Type:Expedited (15-DaCompany Report #001-0945-990085 Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG PT Report Source Product Role Hypertonia Movement Disorder Health Professional Neurontin Capsules (Gabapentin) PS Manufacturer Route ORAL (,TAKEN ONCE), PER ORAL Baclofen C Date:03/31/99ISR Number: 3231005-4Report Type:Expedited (15-DaCompany Report #001-0945-990255 Age:75 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG DAILY Initial or Prolonged PER ORAL PT Report Source Product Role Balance Disorder Consumer Neurontin PS Vasotec Procardia Ritalin C C C Coordination Abnormal Depression Diplopia Dizziness Fall Fatigue Foot Fracture Speech Disorder Tremor Date:03/31/99ISR Number: 3418509-6Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 225 PT Coordination Abnormal Drug Interaction 10:40 AM Company Report #318753 Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Dose Report Source Product Role Manufacturer Route Health Professional Asacol Tablets, 400 Mg (Mesalamine) PS ORAL Neurontin (Gabapentin) SS ORAL Neurontin (Gabapentin) C Duration 2400 MG DAILY; ORAL ORAL Date:04/01/99ISR Number: 3231735-4Report Type:Expedited (15-DaCompany Report #044-0945-990005 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1.2 GM PT Report Source Product Role Manufacturer Route C-Reactive Protein Increased Foreign Health Neurontin (Gabapentin) PS ORAL Clavicle Fracture Professional Valproate Sodium SS ORAL (DAILY) PER Confusional State ORAL Convulsion 2 GM (DAILY) Facial Bones Fracture PER ORAL Hyponatraemia YEARS AGO Malaise Nausea Osteoporosis Urinary Tract Infection Weight Increased Date:04/01/99ISR Number: 3231738-XReport Type:Expedited (15-DaCompany Report #001-0945-990220 Age:6 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Dermatitis Haemoglobin Decreased Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Paxil Ritalin Zantac C C C Manufacturer Route ORAL Hyperkalaemia MG, TID) PER Hyponatraemia ORAL Sepsis Stevens-Johnson Syndrome White Blood Cell Count Decreased Date:04/01/99ISR Number: 3231739-1Report Type:Expedited (15-DaCompany Report #001-0945-990120 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 Other MG, TID), PER PT Report Source Product Role Cardiac Failure Congestive Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Mellaril Clonidine Anafranil Robitussin Peri-Colace Seroquel Trazondone C C C C C C C Condition Aggravated Depression ORAL Haematocrit Decreased Haemoglobin Decreased Personality Disorder Post-Traumatic Stress Disorder Psychotic Disorder Red Blood Cell Count Decreased 22-Aug-2005 Page: 226 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/99ISR Number: 3232142-0Report Type:Expedited (15-DaCompany Report #046-0945-990003 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1600 MG PT Report Source Product Role Manufacturer Route Anaemia Antibody Test Positive Foreign Health Neurontin Capsules 400 Mg (Gabapentin) PS ORAL Antinuclear Antibody Professional Arthralgia Blood Albumin Decreased Sabrilex (Vigabatrin) SS ORAL Dyskinesia Glomerular Filtration Rate Decreased Oedema Peripheral Polyarthritis Spirometry Abnormal Systemic Lupus Erythematosus Tremor Orfiril Polyfarmaci C C (DAILY) PER Positive ORAL PER ORAL Date:04/02/99ISR Number: 3233035-5Report Type:Direct Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Required 100MG TID PO Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Dermatitis Gabapentin 100mg Cap PS Pruritus Amitriptyline Fluoxetine Generic Mylanta Lansoprazole Cetirizine Amoxicillin Acetaminophen Sumatriptan Lorazeparn Buspar Fosmax Naproxen Beconase Nasal Inh C C C C C C C C C C C C C Manufacturer Route ORAL Date:04/06/99ISR Number: 3233969-1Report Type:Expedited (15-DaCompany Report #001-0945-990231 Age:1 DY Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Bronchiolitis Initial or Prolonged Complications Of Maternal TRANSPLACENTAL SEE TEXT, Congenital Anomaly Exposure To Therapeutic PLACENTAL; Drugs IN UTERO Congenital Eye Disorder EXPOSURE Congenital Hearing TRANSPLACENTAL SEE TEXT, Disorder PLACENTAL; Congenital Tracheomalacia IN UTERO Diarrhoea EXPOSURE Hypotonia Nasopharyngitis TRANSPLACENTAL SEE TEXT, Prader-Willi Syndrome PLACENTAL; Respiratory Disorder IN UTERO Staring EXPOSURE Visual Disturbance Vomiting Weight Gain Poor 22-Aug-2005 Page: 227 10:40 AM Report Source Product Role Health Professional Neurontin (Gabapentin) PS Gabitril (Tiagabine) SS Tegretol (Carbamazepine) SS Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acid, Thiamine Hydrochloride, Date:04/08/99ISR Number: 3234626-8Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Death PT C Company Report # Report Source Product Role Gabapentin (Neurontin) PS Fluoxetine Methylphenidate Codeine Morphine Diphenhydramine Ranitidine Acetaminophen Ceftazidime Silvadene Nafcillin Prednisolone Dopamine Amphotericin B C C C C C C C C C C C C C Manufacturer Route Duration Blister Condition Aggravated ORAL 300MG TID Dermatitis ORAL Enterococcal Bacteraemia Erythema Escherichia Infection Mouth Ulceration Pain Rash Pruritic Sepsis Staphylococcal Infection Stevens-Johnson Syndrome Systemic Candida Date:04/12/99ISR Number: 3238493-8Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Other 50 MG PO Q BID Company Report # PT Report Source Product Role Dermatitis Exfoliative Health Lamotrigine PS ORAL 8 Route Dry Skin Professional Gabapentin SS ORAL Gabapentin Haldol Klonoprin Valproic Acid C C C C MON Rash Erythematous 300 MG PO Q Rash Maculo-Papular HS Manufacturer Duration 12 DAY Cogentin C Date:04/13/99ISR Number: 3239116-4Report Type:Expedited (15-DaCompany Report #001-0945-990270 Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Other MG TID), PER PT Report Source Product Role Blood Glucose Increased Weight Increased Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Glucotrol Lithium C C ORAL Date:04/13/99ISR Number: 3239176-0Report Type:Expedited (15-DaCompany Report #001-0945-990134 Age:20 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 228 10:40 AM PT Bipolar Disorder Convulsion Dizziness Drug Interaction Drug Level Below Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Headache Lethargy Mania Dose Report Source Product Role Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration Status Epilepticus ORAL 2700 MG (900 MG, TID), PER ORAL (Lithium) (Seroquel) Ambien (Zolpidem Tartrate Date:04/14/99ISR Number: 3239787-2Report Type:Direct Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO; FOR A Initial or Prolonged SHORT TIME PT SS SS C Company Report # Report Source Dyspnoea Product Role Neurontin PS Phenobardital C Manufacturer Route ORAL Fatigue Lethargy Date:04/14/99ISR Number: 3239814-2Report Type:Expedited (15-DaCompany Report #9912253 Age: Gender:Male I/FU:I Outcome Dose Duration Required 20.00 MG Intervention to TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage 1500.00 PT Report Source Product Role Blood Glucose Increased Consumer Feldene Capsules PS ORAL Route Neurontin SS ORAL Blood Triglycerides Increased Haemoglobin Increased Road Traffic Accident TOTAL:DAILY:O Manufacturer RAL Glyburide Metformin Lopid Misoprostol Tens Unit C C C C C Date:04/14/99ISR Number: 3240042-5Report Type:Expedited (15-DaCompany Report #001-0945-990266 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 4 TABLET PT Report Source Product Role Ear Pain Headache Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Hypersensitivity (,UNK) Pain In Jaw Date:04/15/99ISR Number: 3240719-1Report Type:Expedited (15-DaCompany Report #001-0945-990311 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Complications Of Maternal Health Professional Neurontin (Gabapentin) PS (Phenobarbital Sodium) SS Duration 2800MG Exposure To Therapeutic (DAILY) Drugs 230MG (DAILY) 22-Aug-2005 Page: 229 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/99ISR Number: 3240722-1Report Type:Expedited (15-DaCompany Report #001-0945-990283 Age:32 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Chromosome Abnormality Health Professional Neurontin (Gabapentin) PS (Phenobarbital Sodium) SS Ergocalciferol Ascorbic Acid Folic Acid Thiamine Hydrochloride Retinol Riboflavin Nicotinamide Panthenol C C C C C C C C C Manufacturer Route Manufacturer Route Duration 2800MG Complications Of Maternal (DAILY) Exposure To Therapeutic Drugs 230MG, (DAILY) Date:04/20/99ISR Number: 3243285-XReport Type:Expedited (15-DaCompany Report #001-0991-990448 Age:34 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Drug Ineffective Health Professional Rezulin (Troglitazone) PS Duration 400 MG Glycosylated Haemoglobin (DAILY) PER Increased ORAL Lipitor (Atorvastatin) Neurontin (Gabapentin) Wellbutrin Humulin N Neurontin Humulin N SS SS C C C C ORAL Humulin R Date:04/20/99ISR Number: 3320078-6Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose Company Report #1998SUS0286 PT Report Source Product Role Acne Drug Interaction Consumer Sustiva Celexa Neurontin PS SS SS Route Manufacturer Route Company Report # PT Report Source Product Role Abnormal Behaviour Consumer Neurontin PS Carisprodol Diclofenac Midrin C C C Duration Aggression INCREASED Feeling Abnormal DOSES-PROB Hypersensitivity STARTED ON 1ST DAY OF 22-Aug-2005 Page: 230 Manufacturer Duration Date:04/22/99ISR Number: 3244510-1Report Type:Direct Age:42 YR Gender:Male I/FU:I Outcome Dose Other GRAD C 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/99ISR Number: 3244511-3Report Type:Direct Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Company Report # PT Report Source Product Encephalopathy Health Baclofen PS ORAL Hospitalization Multiple Sclerosis 300MG MWF 10 DAY Initial or Prolonged Respiratory Acidosis Sepsis 10 MG PO TID 2 Professional Date:04/23/99ISR Number: 3245256-6Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Other 300 MG QHS Role Manufacturer Route Manufacturer Route Manufacturer Route DAY Neurontin SS Synthroid Colace Phos-Lo Nephron Caps Cortisone Senokot Prevacid Restoril Ventolin Atrovent Calcitonin Vicodin C C C C C C C C C C C C Company Report # PT Report Source Product Role Vomiting Health Neurontin PS Duration 8 MON Professional Date:04/26/99ISR Number: 3250747-8Report Type:Periodic Age:76 YR Gender:Male I/FU:I Outcome Dose Other 50.00 MG Company Report #9901371 PT Report Source Product Role Drug Ineffective Consumer Viagra Tablets PS Duration ORAL Neuropathy Peripheral Health TOTAL:PRN:ORA Professional L Neurontin SS Serevent Flovent Hydrocodone Temazepam C C C C ORAL TID:ORAL Date:04/27/99ISR Number: 3247383-6Report Type:Expedited (15-DaCompany Report #033-0945-990026 Age:1 DY Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Foreign Health Neurontin (Gabapentin) PS Drugs Skull Malformation Professional Depakine C Manufacturer Route Manufacturer Route PLACENTAL Date:04/27/99ISR Number: 3247395-2Report Type:Expedited (15-DaCompany Report #044-0945-990036 Age:28 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Anaphylactic Reaction Chest Discomfort Foreign Health Neurontin (Gabapentin) PS Peak Expiratory Flow Rate Professional Amitriptyline Tramadol C C Duration 300 MG (,DAILY), Decreased UNKNOWN Rash Erythematous 22-Aug-2005 Page: 231 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diclofenac C Date:04/27/99ISR Number: 3247398-8Report Type:Expedited (15-DaCompany Report #033-0945-990024 Age:1 DY Gender: I/FU:I Outcome Dose Duration Death PARENTERAL UNK, Life-Threatening PLACENTAL / Congenital Anomaly IN UTERO PT Report Source Product Role Coarctation Of The Aorta Foreign (Gabapentin) PS Complications Of Maternal Health Exposure To Therapeutic Professional Manufacturer Route Manufacturer Route Drugs EXPOSURE Heart Disease Congenital Small For Dates Baby Ultrasound Antenatal Screen Abnormal Ventricular Septal Defect Acquired Date:04/28/99ISR Number: 3248878-1Report Type:Expedited (15-DaCompany Report #001-0945-990153 Age:68 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Clonic Convulsion Convulsion Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Nph Insulin Insulin Zoloft Creon Furosemide Accurpil Miacalcin C C C C C C C Duration 300 MG DAILY Diabetes Mellitus PER ORAL Inadequate Control Feeling Abnormal Tremor ORAL Date:04/29/99ISR Number: 3249873-9Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Required 300MG TID; Intervention to 100MG TID Prevent Permanent Impairment/Damage PT Company Report # Report Source Angina Pectoris Product Role Neurontin 300mg PS Manufacturer Route Manufacturer Route Date:04/29/99ISR Number: 3249986-1Report Type:Expedited (15-DaCompany Report #001-0945-990142 Age:35 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Blood Prolactin Increased Pituitary Tumour Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration 1200 MG (300 MG, QID) PER ORAL Date:04/29/99ISR Number: 3249987-3Report Type:Expedited (15-DaCompany Report #001-0945-990140 Age:55 YR Gender:Female I/FU:F Outcome Death Hospitalization 22-Aug-2005 Page: 232 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Dose PT Report Source Product Role Drug Interaction Hepatic Necrosis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 900 MG (300 Hepatotoxicity MG, TID) Multi-Organ Failure Ciclosporin Azathioprine Prednisone Losartan Atenolol Diltiazem Ranitidine Alprazolam Baclofen Dilaudid (Hydromorphone Hydrochloride) Atorvastatin Niacin (Nicotinic Acid) Ketoconazole Acetaminophen (Paracetamol) Ambien Aspirin Dicyclomine Lasix Lonox Nizoral Vitamin E Niaspan Erythromycin Tylenol SS SS SS SS SS SS SS SS SS SS SS SS SS SS C C C C C C C C C C Date:04/29/99ISR Number: 3249988-5Report Type:Expedited (15-DaCompany Report #001-0945-990134 Age:20 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization - PT Report Source Product Bipolar Disorder Health Neurontin Capsules Role Initial or Prolonged 2700 MG (900 Convulsion Professional 300 Mg (Gabapentin) PS Eskalith (Lithium Carbonate) Seroquel Ambien SS SS C Dizziness MG, TID) PER Drug Interaction ORAL Headache Lethargy Status Epilepticus Date:04/29/99ISR Number: 3250001-4Report Type:Expedited (15-DaCompany Report #001-0073-990173 Age:45 YR Gender:Female I/FU:I Outcome Disability 22-Aug-2005 Page: 233 PT Alopecia Anxiety Arthralgia Blood Potassium Increased Confusional State Convulsion Disorientation 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Below Therapeutic Fall Dose Report Source Product Role Consumer Dilantin Kapseals 100 Mg (Phenytoin Sodium) PS Neurontin (Gabapentin) Prempro SS C Manufacturer Route Duration Gingival Hyperplasia Nausea Palpitations ORAL 300 MG (100 Parkinsonian Gait MG, TID), PER Tinnitus ORAL Visual Acuity Reduced Date:05/03/99ISR Number: 3251651-1Report Type:Direct Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Report Source Product Role Coordination Abnormal Dysarthria Gait Disturbance Health Professional Gabapentin Morphine Trazodone Fluoxetine PS SS C C Manufacturer Route Manufacturer Route Date:05/04/99ISR Number: 3253604-6Report Type:Expedited (15-DaCompany Report #001-0945-990361 Age:52 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Cough Groin Pain Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Daypro C Duration 900 MG (300 Headache MG, TID) PER Myocardial Infarction ORAL Nausea Vomiting ORAL Date:05/05/99ISR Number: 3254595-4Report Type:Expedited (15-DaCompany Report #001-0945-990367 Age:38 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Optic Neuritis Retinopathy Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Elavil Betaseron Copaxone Soma C C C C Manufacturer Route Duration ORAL 1200 MG (600 MG BID) PER ORAL Date:05/06/99ISR Number: 3255686-4Report Type:Expedited (15-DaCompany Report #001-0945-990343 Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Other Required ONE DOSE, PER Intervention to ORAL Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 234 10:40 AM PT Report Source Product Role Blood Glucose Decreased Coma Consumer Neurontin Capsules 100 Mg (Gabapentin) PS (Insulin) Lescol (Fluvastatin Sodium) (Atenolol) Vasotec (Enalapril C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) Lasix (Furosemide) Aspirin (Acetylsalicylic Acid) C C C Date:05/06/99ISR Number: 3255699-2Report Type:Expedited (15-DaCompany Report #001-0981-992736 Age:43 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Convulsion Health Professional Lipitor (Atorvastatin) Neurontin (Gabapentin ) Tegretol (Carbamazepine) Role Manufacturer Route Duration PS ORAL SS SS Date:05/07/99ISR Number: 3256537-4Report Type:Expedited (15-DaCompany Report #20615-009 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening Required Intervention to Prevent Permanent Impairment/Damage 3-9 MCG/HR IT PT Report Source Product Role Manufacturer Abdominal Distension Agitation Apnoea Blood Pressure Increased Coma Condition Aggravated Health Professional Duraclon Injection (Clonidine Hydrochloride), 1mg/10ml, Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. Gabapentin 100 Mg CapsulesParke-Davis SS Parke-Davis Emotional Distress Failure Of Implant Pain 200 MG Q8H PO Tachycardia Tonic Convulsion Urinary Retention Date:05/07/99ISR Number: 3261871-8Report Type:Periodic Age:42 YR Gender:Female I/FU:I Company Report #98USA10702 Route ORAL Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG, TID, PT Report Source Product Role Manufacturer Route Rash Maculo-Papular Health Professional Tegretol Tablet (Carbamazepine) PS ORAL Klonopin Unknown (Clonazepam) SS ORAL Neurontin Capsule (Gabapetin) SS ORAL Depakote Ganciclovir Solution C C ORAL 2 MG, DAILY, ORAL SEE IMAGE Date:05/11/99ISR Number: 3259107-7Report Type:Expedited (15-DaCompany Report #001-0945-990125 Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3 MON Other 22-Aug-2005 Page: 235 10:40 AM PT Report Source Product Role Bile Duct Obstruction Hepatic Enzyme Increased Health Professional Neurontin (Gabapentin) PS Jaundice Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/99ISR Number: 3259108-9Report Type:Expedited (15-DaCompany Report #001-0945-990255 Age:75 YR Gender:Female I/FU:F Outcome Dose Duration Death Hospitalization 600 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Balance Disorder Coma Consumer Neurontin (Gabapentin) PS Vasotec Procardia Ritalin C C C Manufacturer Route ORAL Coordination Abnormal Depression ORAL Diplopia Dizziness Drug Toxicity Fall Fatigue Foot Fracture Speech Disorder Tremor Date:05/11/99ISR Number: 3259109-0Report Type:Expedited (15-DaCompany Report #033-0945-980026 Age:67 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Fall Femoral Neck Fracture Foreign Health Neurontin (Gabapentin) PS Muscular Weakness Professional Lioresal C Manufacturer Route ORAL MG, TID), PER ORAL Date:05/12/99ISR Number: 3260114-9Report Type:Expedited (15-DaCompany Report #20615-009 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening Required PT Report Source Product Abdominal Distension Agitation Apnoea Health Professional Duraclon Inection (Clonidine Hydrochloride), Role Manufacturer Route Intervention to Prevent Permanent Impairment/Damage 3-9 MCG/HR IT Blood Pressure Increased Clonic Convulsion Coma 1mg/10ml, Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. Emotional Distress Mental Disorder Pain Gabapentin 100 Mg Capsules - Parke Davids SS Parke-Davids ORAL Manufacturer Route 200MG Q8H PO Tachycardia Urinary Retention Date:05/14/99ISR Number: 3262841-6Report Type:Expedited (15-DaCompany Report #001-0945-990101 Age: Gender:Female I/FU:F Outcome Dose Death 1200 MG PT Report Source Product Role Accidental Exposure Drowning Health Professional Neurontin (Gabapentin) PS Lamictal (Lamotrigine) Dilantin Drisdol Calcium Carbonate Docusate SS C C C C Duration (X1) PER ORAL 22-Aug-2005 Page: 236 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/99ISR Number: 3263532-8Report Type:Expedited (15-DaCompany Report #001-0945-990371 Age:45 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Optic Ischaemic Neuropathy Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 180 (600 MG TID) Date:05/19/99ISR Number: 3265131-0Report Type:Expedited (15-DaCompany Report #001-0945-990120 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 Other MG, TID), PER PT Report Source Product Role Cardiac Failure Congestive Health Professional Neurontin Capsules 300mg(Gabapentin) PS ORAL Depression Haematocrit Decreased ORAL Haemoglobin Decreased Major Depression Personality Disorder Post-Traumatic Stress Disorder Psychotic Disorder Red Blood Cell Count Decreased Mellaril(Thioridazin e Hydrochloride) (Clonidine) Anafranil(Clomiprami ne Hydrochloride) Robitussin(Guaifenes in) Peri-Colace(Docusate Sodium, Casanthranol) Seroquel (Quetiapine Fumarate) (Trazodone) Date:05/19/99ISR Number: 3330102-2Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose PT Duration C C C C C C C Company Report #S99-USA-00258-01 Report Source Product Role Manufacturer Route Dermatitis Consumer Celexa PS ORAL Celexa SS ORAL Sustiva Neurontin SS SS 20 MG DAILY Drug Interaction PO 30 MG DAILY PO Date:05/20/99ISR Number: 3265117-6Report Type:Expedited (15-DaCompany Report #99-05-0121 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Death 10MG TID ORAL Hospitalization 300MG MWF Initial or Prolonged ORAL PT Report Source Product Role Encephalopathy Health Baclofen Tablets PS ORAL Multiple Sclerosis Professional Neurontin Tablets SS ORAL Synthroid Colace Nephrocaps Cortisone Senokot Prevacid Restoril Ventolin Vicodin Atrovent Calcitonin C C C C C C C C C C C Respiratory Acidosis Sepsis 22-Aug-2005 Page: 237 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/99ISR Number: 3266113-5Report Type:Expedited (15-DaCompany Report #001-0945-990424 Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800MG (600MG PT Report Source Product Role Breast Mass Eosinophil Count Consumer Neurontin Capsules 300mg (Gabapentin) PS Wellbutrin Desyrel C C Manufacturer Route ORAL Increased TID) , PER Fatigue ORAL Haematoma Malaise Pyrexia White Blood Cell Count Increased Date:05/21/99ISR Number: 3268104-7Report Type:Expedited (15-DaCompany Report #001-0945-990363 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged (SEE TEXT) PT Report Source Product Role Bone Cyst Increased Tendency To Health Professional Neurontin (Gabapentin) PS Bruise 900 MG TWICE A DAY , 600 MG AT BEDTIME1500 Prozac Unspecified Tricyclic Antidepressant Date:05/25/99ISR Number: 3269477-1Report Type:Expedited (15-DaCompany Report #001-0945-990170 Age:32 YR Gender:Male I/FU:F C C Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged 500 MG(,300 PT Report Source Product Role Graft Versus Host Disease Medication Error Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS MG QAM AND 200 MG QPM), PER ORAL Date:05/25/99ISR Number: 3269481-3Report Type:Expedited (15-DaCompany Report #001-0073-990173 Age:45 YR Gender:Female I/FU:F Outcome Disability 22-Aug-2005 Page: 238 PT Abdominal Distension Abdominal Pain Alopecia Anxiety Arthralgia Blood Potassium Increased Condition Aggravated Confusional State Convulsion Drug Level Below Therapeutic Fall Gingival Hypertrophy Heart Rate Irregular Nausea Parkinsonian Gait 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tinnitus Visual Acuity Reduced Weight Increased Dose Report Source Product Role Consumer Dilantin Kapseal 100 Mg (Phenytoin Sodium) PS Manufacturer Route Duration ORAL 300 MG (100 MG, TID), PER ORAL Neurontin (Gabapentin) Prempro(Medroxyproge sterone Acetate, Estrogens Conjugated) SS C Date:05/26/99ISR Number: 3270270-4Report Type:Expedited (15-DaCompany Report #001-0945-990413 Age:79 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Alopecia Asthenia Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Spinal Epidural C Manufacturer Route Duration 1600 MG (400 Deafness MG, QID), PER Decreased Appetite ORAL Depression Dermatitis Dizziness Eructation Flatulence Hypersensitivity Hypoaesthesia Mucosal Ulceration Paraparesis Scab Skin Exfoliation Tremor Ulcer Visual Disturbance ORAL Vulvovaginal Discomfort Date:05/27/99ISR Number: 3270198-XReport Type:Expedited (15-DaCompany Report #001-0945-990442 Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 6400 MG (1600 PT Report Source Product Role Accident Complex Partial Seizures Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Drug Ineffective MG,QID) Injury Overdose Dilantin Experimental Seizure Medication C C Date:05/27/99ISR Number: 3270208-XReport Type:Expedited (15-DaCompany Report #001-0945-990412 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Drug Interaction International Normalised Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Ratio Increased MG TID) PER ORAL 22-Aug-2005 Page: 239 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coumadin (Warfarin Sodium) SS Premarin Compazine Aciclovir Dexamethasone Cisplatin Bcnu Anzemet C C C C C C C ORAL PER ORAL 7.5 MG Date:05/27/99ISR Number: 3271183-4Report Type:Expedited (15-DaCompany Report #001-0945-990419 Age:33 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Health Professional Neurontin (Gabapentin) PS Paxil (Paroxetine Hydrochloride) C Manufacturer Route Manufacturer Route Duration 600 MG, (DAILY), (06/ /98 PREGNANCY WEEK 5) Date:05/27/99ISR Number: 3271184-6Report Type:Expedited (15-DaCompany Report #001-0945-990421 Age:70 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Back Pain Encephalopathy Health Professional Neurontin (Gabapentin) PS Duration 300 MG ON Liver Function Test MON, WED & Abnormal FRI, UNKNOWN Mental Impairment (Baclofen) SS 30 MG (10 MG, Respiratory Acidosis TID) PER ORAL Sepsis 22-Aug-2005 Page: 240 10:40 AM Colace (Docusate Sodium) Phoslo (Calcium Acetate) (Cortisone) Nephrocaps (Folic Acid, Vitamins Nos) Prevacid (Lansoprazole) Restoril (Temazepam) (Calcitonin) Vicodin (Paracetamol, Hydrocodone Bitartrate) Senokot (Senna Fruit) Ventolin (Salbutamol) Atrovent (Ipratropium Bromide) Synthroid (Levothyroxine Sodium) C C C C C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cordarone (Amiodarone Hydrochloride) C Date:05/27/99ISR Number: 3271186-XReport Type:Expedited (15-DaCompany Report #JACGBR1999000063 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Hypokalaemia Foreign Health Professional Hismanal (Unspecified) (Astemizole) Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route SS Date:05/28/99ISR Number: 3271605-9Report Type:Expedited (15-DaCompany Report #002-0945-990014 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 500 MG (DAILY) 4 PT Report Source Product Role Anhedonia Catatonia Foreign Literature Neurontin (Gabapentin) PS Decreased Appetite Health Depressed Mood Depression Disturbance In Attention Hypomania Immobile Insomnia Lack Of Spontaneous Speech Muscle Rigidity Staring Tangentiality Tearfulness Thinking Abnormal Professional WK Date:05/28/99ISR Number: 3272789-9Report Type:Expedited (15-DaCompany Report #001-0945-990418 Age:50 YR Gender:Male I/FU:I ORAL Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Consumer Neurontin Capsules 300 Mg (Gabapentin) PS ORAL (Lithium) SS ORAL Ambien C Therapeutic MG, TID) PER Dry Mouth ORAL Dyskinesia 1800 MG (600 Parkinsonian Gait MG, TID), PER Sedation ORAL Vision Blurred Date:06/01/99ISR Number: 3274447-3Report Type:Expedited (15-DaCompany Report #12347/20246 Age:30 YR Gender:Female I/FU:I Outcome Disability Other 22-Aug-2005 Page: 241 PT Diplopia Dizziness Hysterectomy Iiird Nerve Paralysis Insomnia 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Migraine Mydriasis Nausea Report Source Product Role Ovarian Cyst Paraesthesia Peripheral Nerve Injury Health Professional Company Depo-Provera Contraceptive Injection (150 Mg) PS Sedation Sensation Of Foreign Body Visual Disturbance Representative Neurontin Tylenol SS SS Manufacturer Route Manufacturer Route Duration IM Date:06/02/99ISR Number: 3274552-1Report Type:Expedited (15-DaCompany Report #99-05-0121 Age:70 YR Gender:Male I/FU:F Outcome Dose Duration Death 10MG TID ORAL Hospitalization 300MG MWF Initial or Prolonged ORAL PT Report Source Product Role Encephalopathy Health Baclofen Tablets PS ORAL Mental Impairment Professional Neurontin Tablets SS ORAL Synthroid Colace Nephrocaps Cortisone Senokot Prevacid Restoril Ventolin Vicodin Atrovent Calcitonin C C C C C C C C C C C Respiratory Acidosis Sepsis Date:06/02/99ISR Number: 3279032-5Report Type:Expedited (15-DaCompany Report #001-0945-990125 Age:75 YR Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization 3 MON PT Report Source Product Role Bile Duct Obstruction Bile Duct Stenosis Health Professional Neurontin (Gabapentin) PS Manufacturer Route Initial or Prolonged Other Hepatic Enzyme Increased Jaundice Date:06/02/99ISR Number: 3283040-8Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG, Company Report #98USA10702 PT Report Source Product Role Manufacturer Route Rash Maculo-Papular Health Professional Tegretol Tablet (Carbamazepine) PS ORAL Neurontin Capsule (Gabapentin) SS ORAL Depakote Capsule Ganciclovir Solution Glipizide Tablet Phenobarbital C C C C DAILY, ORAL 1800 MG, DAILY, ORAL 22-Aug-2005 Page: 242 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3276035-1Report Type:Expedited (15-DaCompany Report #001-0981-992736 Age:43 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Convulsion Health Professional Lipitor (Atorvastatin) PS Manufacturer Route Duration ORAL PER ORAL Neurontin (Gabapentin) Tegretol (Carbamazepine) Date:06/08/99ISR Number: 3277497-6Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose PT SS SS Company Report # Report Source Product Role Gabapentin 300 Mg Cap PS Manufacturer Route Manufacturer Route Duration Sexual Dysfunction 300 MG QID Date:06/08/99ISR Number: 3277925-6Report Type:Expedited (15-DaCompany Report #001-0945-990471 Age:34 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Blood Gonadotrophin Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Lamictal C Duration ORAL 2400 MG, Increased DAILY, PER ORAL Date:06/09/99ISR Number: 3279012-XReport Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Manufacturer Route Hospitalization 25MG PO Q 6H Initial or Prolonged 300MG PO TID Accident At Home Baclofen PS Fall Gabapentin SS ORAL Sedation Date:06/10/99ISR Number: 3280402-XReport Type:Expedited (15-DaCompany Report #049-0945-990013 Age:75 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Bacterial Infection Dermatitis Foreign Health Neurontin Capsules 100 Mg (Gabapentin) PS Sepsis Professional 200 MG (,DAILY), PER Toxic Epidermal ORAL Necrolysis Phenhydan (Phenytoin) Novodigal (Digoxin) L-Thyroxin (Levothyroxine Sodium) Date:06/16/99ISR Number: 3284976-4Report Type:Expedited (15-DaCompany Report #001-0945-990491 Age:88 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 243 Manufacturer Route Duration 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose PT Report Source Product Role Atrial Fibrillation Confusional State Health Professional Neurontin Capsules 100 Mg(Gabapentin) PS Delirium Company Delusion Representative Manufacturer Route Duration ORAL 300 MG (100 MG, TID), PER ORAL Paranoia Urinary Tract Infection Lasix (Furosemide) Coumadin (Warfarin Sodium) (Potassium) (Digoxin) Augmentin(Clavulanat e Potassium, Amoxicillin Trihydrate) C C C C C Date:06/16/99ISR Number: 3286392-8Report Type:Expedited (15-DaCompany Report #9925406 Age:10 YR Gender:Male I/FU:I Outcome Dose Duration Required 200.00MG Intervention to TOTAL DAILY Prevent Permanent ORAL Impairment/Damage 300.00MG PT Report Source Product Role Abnormal Behaviour Health Zoloft Tablets PS ORAL Condition Aggravated Professional Neurontin SS ORAL Manufacturer Route Drug Interaction Sleep Disorder Suicidal Ideation TOTAL ORAL Date:06/17/99ISR Number: 3286241-8Report Type:Expedited (15-DaCompany Report #LBID002990002 Age:44 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization - PT Report Source Product Agitation Consumer Lithobid Tablets 300 Role Manufacturer Route Initial or Prolonged Drug Level Above Therapeutic Mg (Lithium Carbonate) PS ORAL Benzotropine (Benzatropine Mesilate) SS ORAL Neurontin (Gabapentin) SS ORAL Ambien (Zolpidem Tartrate) SS ORAL Buspar Lamictal Wellbutrin Zoloft Zyprexa C C C C C 1200 MG, PER Drug Toxicity ORAL Feeling Drunk Nausea Tremor PER ORAL PER ORAL PER ORAL Date:06/17/99ISR Number: 3286266-2Report Type:Expedited (15-DaCompany Report #A0094748 Age:31 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 244 10:40 AM PT Aggression Aspiration Electrocardiogram Qrs Complex Prolonged Intentional Misuse Lung Infiltration FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Suicide Attempt Tachypnoea Ventricular Tachycardia Report Source Product Role Vomiting Health Lamictal Tablet PS ORAL Professional Cabapentin Capsule SS ORAL Fluoxetine Hydrochloride Risperidone Methylphenidate Thioridazine Ethanol SS SS SS SS SS ORAL ORAL ORAL Manufacturer Route Duration SINGLE DOSE SINGLE DOSE ORAL Date:06/21/99ISR Number: 3288053-8Report Type:Expedited (15-DaCompany Report #001-0945-990505 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3600 MG (2400 Other QAM), 1200 MG PT Report Source Product Role Hallucination Logorrhoea Consumer Neurontin (Gabapentin) PS Many Unspecified Medications C Manufacturer Route ORAL Multiple Sclerosis QPM) PER ORAL Date:06/21/99ISR Number: 3288331-2Report Type:Expedited (15-DaCompany Report #049-0945-990013 Age:75 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Dermatitis Epidermolysis Bullosa Foreign Health Neurontin Capsules 100 Mg (Gabapentin) PS Liver Function Test Professional Phenhydan C Manufacturer Route Duration 200 MG (DAILY) PER Abnormal ORAL Sepsis ORAL Toxic Epidermal Necrolysis Novodigal L-Thyroxin C C Date:06/21/99ISR Number: 3288377-4Report Type:Expedited (15-DaCompany Report #001-0945-990371 Age:45 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Optic Ischaemic Neuropathy Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 1800 MG (600 Visual Disturbance MG, TID) Date:06/22/99ISR Number: 3287414-0Report Type:Direct Age:71 YR Gender:Female I/FU:I Outcome Dose Other 300 MG ONCE PT Company Report # Report Source Product Role Neurontin PS Quinapril Hydrochloride Hydrochlorothiazide Atenolol Valproic Acid C C C C Duration Angioneurotic Oedema PO 22-Aug-2005 Page: 245 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/99ISR Number: 3288919-9Report Type:Expedited (15-DaCompany Report #001-0945-990508 Age:81 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role International Normalised Ratio Increased Health Professional Neurontin (Gabapentin) PS Coumadin (Warfarin Sodium) SS Erythropoietin Insulin Cozaar Glipizide C C C C Manufacturer Route Manufacturer Route Manufacturer Route Duration 200 MG (AFTER Prothrombin Time EACH DIALYSIS Prolonged TREATMENT) 6 MG (AFTER EACH DIALYSIS TREATMENT) Date:06/22/99ISR Number: 3288921-7Report Type:Expedited (15-DaCompany Report #001-0945-990506 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Pulmonary Fibrosis Health Professional Company Representative Neurontin (Gabapentin) PS Duration Date:06/24/99ISR Number: 3290887-0Report Type:Expedited (15-DaCompany Report #001-0945-990547 Age:23 YR Gender:Female I/FU:I Outcome Dose Other 2700 MG, PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Health Professional Neurontin (Gabapentin) PS Duration Drugs DAILY Pre-Eclampsia Premature Baby Cyclosporine (Ciclosporin) Date:06/25/99ISR Number: 3296730-8Report Type:Periodic Age:32 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #9907622 PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Diabetes Mellitus Health Professional Glucotrol Xl Extended Release Tablets PS ORAL Gabapentin SS ORAL Metformin Naprosyn Multi-Vitamin Insulin C C C C Duration 10.00 MG Intentional Misuse TOTAL:BID:ORA Liver Function Test L Abnormal 1200.00 MG Medication Error TOTAL:DAILY:O Neuralgia RAL 22-Aug-2005 Page: 246 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/99ISR Number: 3342881-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #001-0981-992725 PT Report Source Product Role Drug Ineffective Drug Interaction Consumer Lipitor Tablets 20 Mg (Atorvastatin) PS Manufacturer Route Duration ORAL 60 MG (20 MG, TID) Zestril (Lisinopril) Betapace (Sotalol Hydrochloride) (Salsalate) Cardura (Doxazosin Mesilate) Neurontin (Gabapentin) Plavix (Clopidogrel) K-Dur (Potassium Chloride) (Furosemide) Z-Bec (Zinc Sulfate, Vitamins Nos) Oscal (Calcium Carbonate) (Temazepam) (Ranitidine) Lanoxin (Digoxin) (Amitriptyline) Vitamin E (Tocopherol) Synthroid (Levothyroxine Sodium) Propoxyphene-N (Dextropoxyphene) Hytrin (Terazosin Hydrochloride) Date:07/02/99ISR Number: 3351008-9Report Type:Periodic Age:78 YR Gender:Female I/FU:I Outcome Dose PT Duration SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS C Company Report #001-0981-992255 Report Source Product Role Manufacturer Route Chills Diarrhoea Malaise Nausea Consumer Health Professional Lipitor (Atorvastatin) Neurontin (Gabapentin) Date:07/06/99ISR Number: 3298103-0Report Type:Expedited (15-DaCompany Report #049-0945-990013 Age:75 YR Gender:Female I/FU:F Outcome Death 22-Aug-2005 Page: 247 PT Blister Blood Urea Increased Cardiac Failure Conjunctivitis Dermatitis Epidermolysis Bullosa Hyperkalaemia Leukocytosis Liver Function Test Abnormal 10:40 AM PS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Mouth Ulceration Oral Pain Pyrexia Report Source Product Role Sedation Sepsis Foreign Health Neurontin Capsules 300 Mg (Gabapentin) PS Toxic Epidermal Professional Phenhydan Novodigal L-Thyroxin Antra Aspirin Bronchoretard Zinacef Catapresan Paracetamol Berotec Pulmicort Rekawan C C C C C C C C C C C C Manufacturer Route Duration ORAL 600 MG (300 MG, BID), PER Necrolysis ORAL Urinary Tract Infection Date:07/06/99ISR Number: 3298522-2Report Type:Expedited (15-DaCompany Report #001-0945-990546 Age:1 DY Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Collapse Of Lung Complications Of Maternal Health Professional Neurontin (Gabapentin) PS Topamax (Topiramate) SS Felbatol (Felbamate) SS Duration PLACENTAL Exposure To Therapeutic IN UTERO Drugs EXPOSURE Premature Baby PLACENTAL IN UTERO EXPOSURE PLACENTAL Manufacturer Route IN UTERO EXPOSURE (Phenobarbital) SS (Folic Acid) Prenatal Vitamins (Ergocalciferol, Acorbic Acid, Pyridoxine Hidrochloride, C PLACENTAL IN UTERO EXPOSURE C Date:07/06/99ISR Number: 3298524-6Report Type:Expedited (15-DaCompany Report #001-0945-990412 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Manufacturer Route Drug Interaction International Normalised Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS ORAL Coumadin (Warfarin Sodium) SS ORAL Premarin (Estrogens Conjugated) (Aciclovir) C C Ratio Increased MG, TID), PER ORAL 1800 MG (600 MG, TID), PER ORAL 22-Aug-2005 Page: 248 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Campazine (Prochlorperazine Edisylate) (Dexamethasone) (Cisplatin) Bcnu (Carmustine) Anzemet (Dolasetron Mesilate) C C C C C Date:07/06/99ISR Number: 3298528-3Report Type:Expedited (15-DaCompany Report #001-0945-990592 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Complications Of Maternal Exposure To Therapeutic Drugs Health Professional Neurontin (Gabapentin) Felbatol (Felbamate) PS SS Manufacturer Route Manufacturer Route Duration Date:07/07/99ISR Number: 3298550-7Report Type:Expedited (15-DaCompany Report #044-0945-990044 Age:19 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Cachexia Cervical Myelopathy Foreign Health Neurontin (Gabapentin) PS Csf Protein Increased Professional Lamotrigine Carbamazepine C C ORAL (,QD), PER Nuclear Magnetic ORAL Resonance Imaging Abnormal Date:07/09/99ISR Number: 3299725-3Report Type:Direct Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to PT Eye Rolling Joint Stiffness Company Report # Report Source Product Prilosec #3 Tegretol Susp 100mg Role Manufacturer Route Prevent Permanent 8 MON Impairment/Damage Movement Disorder /5cc PS Neurontin Capsules Tegretol Susp 100mg /5cc Eyedrops SS SS C Date:07/09/99ISR Number: 3300470-6Report Type:Expedited (15-DaCompany Report #001-0945-990619 Age:25 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abdominal Pain Hepatitis Health Professional Neurontin (Gabapentin) PS Paxil C 900 MG (, Liver Function Test DAILY) , PER Abnormal ORAL 22-Aug-2005 Page: 249 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/99ISR Number: 3300471-8Report Type:Expedited (15-DaCompany Report #001-0945-990421 Age:70 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Alanine Aminotransferase Increased Health Professional Neurontin (Gabapentin) PS (Baclofen) SS Colace Phoslo Cortisone Nephrocaps Prevacid Restoril (Calcitonin) Vicodin Senokot Ventolin Atrovent Synthroid Cordarone C C C C C C C C C C C C C Manufacturer Route Duration 300 MG ON Aspartate MON, WED, & Aminotransferase FRI Increased ORAL 30 MG (10 MG, Encephalopathy TID), PER Mental Impairment ORAL Respiratory Acidosis Sepsis Date:07/12/99ISR Number: 3301817-7Report Type:Expedited (15-DaCompany Report #9912253 Age: Gender:Male I/FU:F Outcome Dose Duration Required 20.00 MG Intervention to TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage 900.00 MG PT Report Source Product Role Manufacturer Route Arthritis Consumer Feldene Capsules PS ORAL Blood Glucose Decreased Health Blood Glucose Increased Professional Blood Triglycerides Company Neurontin SS ORAL Increased Representative TOTAL:TID:ORA Diabetes Mellitus L Non-Insulin-Dependent Haemoglobin Increased Hyperlipidaemia Irritable Bowel Syndrome Low Density Lipoprotein Increased Muscle Spasms Musculoskeletal Disorder Pain Peptic Ulcer Polytraumatism Road Traffic Accident Date:07/13/99ISR Number: 3301729-9Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT C Company Report #081177 Report Source Product Role Manufacturer PS Msd SS Parke Davis Duration Medication Error 22-Aug-2005 Page: 250 Tens Unit 10:40 AM Noroxin 400mg (Norfloxacin) Neurontin 400mg (Gabapentin) Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/99ISR Number: 3302478-3Report Type:Expedited (15-DaCompany Report #001-0945-990363 Age:44 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE TEXT PT Report Source Product Role Bone Cyst Ecchymosis Health Professional Neurontin (Gabapentin) PS Prozac Unspecified Tricyclic Antidepressant Manufacturer Route Manufacturer Route C C Date:07/14/99ISR Number: 3303992-7Report Type:Expedited (15-DaCompany Report #A0094748 Age:31 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening SINGLE DOSE Hospitalization ORAL Initial or Prolonged SINGLE DOSE Other ORAL PT Report Source Product Role Aggression Health Lamictal Tablet PS ORAL Aspiration Professional Gabapentin Capsule SS ORAL Intentional Misuse Lung Infiltration Suicide Attempt Tachypnoea Fluoxetine Hydrochloride (Formulation Unknown) SS ORAL Ventricular Tachycardia Vomiting Risperidone (Formulation Unknown) SS ORAL Methylphenidate (Formulation Unknown) SS ORAL Thioridazine (Formulation Unknown) SS ORAL Electrocardiogram Qrs Complex Prolonged ORAL ORAL ORAL ORAL Ethanol (Formulation Unknown) SS ORAL ORAL Date:07/14/99ISR Number: 3304026-0Report Type:Expedited (15-DaCompany Report #A0094619 Age:31 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged SINGLE DOSE/ Other ORAL PT Report Source Product Role Aggression Health Lamictal Tablet PS ORAL Aspiration Professional Gabapentin SS ORAL Route Fluoxetine Hydrochloride Risperidone Thioridazine Methylphenidate Ethanol SS SS SS SS SS Electrocardiogram Qrs Complex Prolonged Intentional Misuse Lung Infiltration Suicide Attempt Ventricular Tachycardia Vomiting Date:07/15/99ISR Number: 3347794-4Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Manufacturer Company Report #990518-SK796 PT Report Source Product Role Manufacturer Route Headache Consumer Celebrex PS ORAL Pain Health Sedation Professional Fosamax SS ORAL Relafen (Usa) SS ORAL Neurontin SS ORAL Duration 200.000MG QD PO 5.000MG QD PO Tooth Disorder 1500.000MG QD PO 2400.000MG QD 22-Aug-2005 Page: 251 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Premarin SS Medroxyprogesterone Flunisolide Metronidazole C C C ORAL 1.000 TB QD PO Date:07/15/99ISR Number: 3349889-8Report Type:Periodic Age:84 YR Gender:Male I/FU:I Outcome Dose QD Company Report #990415-SK377 PT Report Source Product Role Manufacturer Route Myalgia Consumer Celebrex PS ORAL Health Neurontin SS ORAL Duration PO 3 DAY PO Professional Date:07/15/99ISR Number: 3350821-1Report Type:Periodic Age:71 YR Gender:Male I/FU:I Outcome Dose Company Report #990426-SK376 PT Report Source Product Role Manufacturer Route Sedation Consumer Celebrex PS ORAL Neurontin SS ORAL Soma SS ORAL Trazodone SS ORAL Buspirone Clonazepam Lansoprazole C C C Duration 200.000 MG QD Health PO Professional PO PO PO Date:07/16/99ISR Number: 3305704-XReport Type:Expedited (15-DaCompany Report #1324/11153 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 160 MG/DAY; Initial or Prolonged ORAL Other ORAL PT Report Source Product Role Manufacturer Route Thrombocytopenia Foreign Medrol Tablets PS ORAL Company Nifedipine SS ORAL Representative Neurontin SS ORAL Di-Antalvic (400 Mg) SS ORAL Vincristine Sulphate Carmustine Procarbazine Cisplatin Cytarabine Dacarbazine Hydroxycarbazine C C C C C C C Consumer ORAL 400 MG-6Q1DY; ORAL Date:07/21/99ISR Number: 3308028-XReport Type:Direct Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 300MG QID PO Hospitalization 1200MG QID PO Initial or Prolonged 22-Aug-2005 Page: 252 10:40 AM PT Company Report # Product Role Aplasia Carbamazepine PS ORAL Glossopharyngeal Gabapentin SS ORAL Neuralgia Report Source Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/99ISR Number: 3309025-0Report Type:Expedited (15-DaCompany Report #PRIUSA1999002537 Age:62 YR Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Blood Pressure Systolic Decreased Coma Completed Suicide Literature Health Professional Tylenol With Codeine (Unspecified) (Acetaminophen/Codei ne) PS ORAL Convulsion Fluid Overload Amitriptyline (Amitriptyline) SS ORAL Heart Rate Increased Valium (Diazepam) SS ORAL Hypotension Hypoxia Gabapentin (Gabapentin) SS ORAL ORAL ORAL OROPHARINGEAL ORAL Oxygen Saturation Abnormal Pulmonary Oedema Pupil Fixed Ventricular Tachycardia Date:07/22/99ISR Number: 3309155-3Report Type:Expedited (15-DaCompany Report #044-0945-990075 Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG DAILY PT Report Source Product Role Manufacturer Route Drug Interaction International Normalised Foreign Health Neurontin (Gabapentin) PS ORAL Ratio Increased Professional Warfarin SS ORAL Ciprofloxacin Fentanyl Co-Amilozide Sevredol C C C C PER ORAL VARIABLE PER ORAL Date:07/22/99ISR Number: 3309156-5Report Type:Expedited (15-DaCompany Report #001-0945-990632 Age:23 YR Gender:Male I/FU:I Outcome Dose Other 900 MG PT Report Source Product Role Anal Fissure Colitis Ulcerative Consumer Health Neurontin Capsules 300 Mg (Gabapentin) PS Condition Aggravated Professional Lamictal C Manufacturer Route Duration ORAL (300 MG TID) Enterocolitis PER ORAL Haemorrhagic Rectal Haemorrhage Date:07/22/99ISR Number: 3309267-4Report Type:Expedited (15-DaCompany Report #10048908 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 40 MILLIGRAM, Initial or Prolonged 2/DAY ORAL 22-Aug-2005 Page: 253 10:40 AM PT Report Source Product Role Blood Creatinine Study Omapatrilat PS Increased Health Blood Urea Increased Cardiac Failure Congestive Condition Aggravated Renal Impairment Professional Neurontin (Gabapentin) Vitamins + Minerals Lanoxin Furosemide Zaroxolyn Quinine Isosorbide Dinitrate SS C C C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amlodipine Premarin Alprazolam Aspirin Nph Insulin Insulin Sliding Scale Sublingual Nitroglycerin Tylenol Cimetidine Allopurinol Famotidine C C C C C C C C C C C Date:07/22/99ISR Number: 3309750-1Report Type:Expedited (15-DaCompany Report #044-0945-990080 Age: Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Abortion Induced Anal Atresia Foreign Health Neurontin (Gabapentin) PS Complications Of Maternal Professional Lamotrigine Clobazam C C 2900 MG (,DAILY), Exposure To Therapeutic PLACENTAL; IN Drugs UTERO Congenital Anomaly EXPOSURE Congenital Diaphragmatic Eventration Ectropion Exomphalos Kyphoscoliosis Limb Deformity Male Genital Tract Tuberculosis Pulmonary Hypoplasia Talipes Date:07/22/99ISR Number: 3309754-9Report Type:Expedited (15-DaCompany Report #001-0945-990626 Age:79 YR Gender:Female I/FU:I Manufacturer Route Outcome Dose Duration Death Hospitalization SEE TEXT, PER Initial or Prolonged ORAL PT Report Source Product Role Accidental Overdose Blood Creatinine Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route ORAL Increased Hypotension Date:07/22/99ISR Number: 3309757-4Report Type:Expedited (15-DaCompany Report #044-0945-990079 Age:25 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Foreign Health Neurontin (Gabapentin) PS Lamotrigine C 2900 MG Professional (,DAILY), PER ORAL 22-Aug-2005 Page: 254 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/99ISR Number: 3309938-XReport Type:Direct Age:43 YR Gender:Female I/FU:I Outcome Dose Duration Other 300MG QAM PO; PT Company Report # Report Source White Blood Cell Count Product Role Gabapentin PS Manufacturer Route ORAL Decreased 600MG QHS PO Date:07/23/99ISR Number: 3309909-3Report Type:Expedited (15-DaCompany Report #001-0945-990677 Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Other MG, TID), PER PT Report Source Product Role Manufacturer Route Cardiac Failure Congestive Consumer Neurontin (Gabapentin) PS ORAL Coumadin (Warfarin Sodium) SS ORAL Asa Prinivil Lasix Nifedipine Zaroxolyn Lanoxin Mevacor Vitamin B6 Vitamin C Vitamin E Centrum Folic Acid C C C C C C C C C C C C Influenza Like Illness International Normalised ORAL Ratio Increased 2.5 MG (,DAILY) , PER ORAL Date:07/23/99ISR Number: 3310441-1Report Type:Direct Age:17 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG QD Initial or Prolonged ORAL PT Company Report # Report Source Hangover Product Role Manufacturer Route Gabapentin PS ORAL Lorazepam SS ORAL Ativan Resperidol Benadryl C C C 1 MG Q 6H ORAL Date:07/26/99ISR Number: 3311025-1Report Type:Expedited (15-DaCompany Report #044-0945-990078 Age: Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Death Foreign Health Professional Neurontin (Gabapentin) PS Duration Date:07/27/99ISR Number: 3310631-8Report Type:Direct Age:57 YR Gender:Female I/FU:I Outcome Disability 22-Aug-2005 Page: 255 PT Aggression Amnesia 10:40 AM Company Report # Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Burning Sensation Depression Diplopia Dose Report Source Product Role Manufacturer Neurontin 300mg Parke Davis PS Parke Davis Heart Rate Irregular Labile Blood Pressure Celebrex 200mg Searle SS Searle Lethargy Nervous System Disorder Nightmare Peripheral Coldness Speech Disorder Thinking Abnormal Tremor Vision Blurred Armour Thryoid Xanax(Alprazolim) C C Route Duration Dysgraphia Fear 300MG 4 TIMES Formication DAY 200MG 1 TIME Date:07/27/99ISR Number: 3357442-5Report Type:Periodic Age:42 YR Gender:Male I/FU:F Outcome Dose PT Report Source Product Role Acne Drug Interaction Consumer Sustiva (Efavirenz) Ni (Citalopram) Neurontin (Gabapentin) PS SS 3DAYS;T TID Route PT Manufacturer Route SS Company Report # Report Source Product Role Neurontin PS Duration Blister Pruritus DAYS;T BID X Manufacturer Duration Date:07/28/99ISR Number: 3313411-2Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Other T QHS X3 Company Report #1998SUS0286 THEREAFTER Lortab Flexeril Trazadone Tylenol Alprazolam Midrin Triazolam Cyanocobalamin Omeprazole Metoclopramide Flonase Fluticasone Salmeterol Albuterol Diltiazem Xr Phenytoin Hydrochlorothiazine Corevert Flovent 22-Aug-2005 Page: 256 10:40 AM C C C C C C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/99ISR Number: 3314137-1Report Type:Expedited (15-DaCompany Report #8250574 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Bowel Sounds Abnormal Bradycardia Breath Sounds Decreased Coma Drug Level Above Therapeutic Drug Toxicity Haematoma Haemodialysis Hypotension Miosis Pneumonia Aspiration Procedural Site Reaction Respiratory Disorder Shock Suicide Attempt Thrombocytopenia Literature Health Professional Abbott-Depakote Gabapentin PS SS Abbott Manufacturer Route Date:07/30/99ISR Number: 3315214-1Report Type:Expedited (15-DaCompany Report #049-0945-990017 Age:60 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Pneumonia Thrombocytopenia Foreign Health Neurontin (Gabapentin) PS White Blood Cell Count Professional Lopirin Pantozol Fortecortin Morphine Bifiteral C C C C C Route Duration 1400 MG (DAILY), PER Decreased ORAL Date:07/30/99ISR Number: 3315432-2Report Type:Expedited (15-DaCompany Report #USA010182 Age:60 YR Gender:Female I/FU:I ORAL Outcome Dose Death PT Report Source Product Role Bradycardia Cardiac Arrest Coma Completed Suicide Hypotension Intentional Misuse Pupil Fixed Therapeutic Agent Toxicity Ventricular Fibrillation Ventricular Tachycardia Other Vicodin Digoxin Percocet Co-Trim Ativan Valium Neuroxin Imipramine PS SS SS SS SS SS SS SS Date:07/30/99ISR Number: 3316074-5Report Type:Direct Age:70 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 257 Manufacturer Route Manufacturer Route Duration 10:40 AM PT Nausea Renal Failure Acute Syncope Company Report # Report Source Product Role Gabapentin Methocarbamol Cyclobenzaprine PS C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine Amitri Date:07/30/99ISR Number: 3316093-9Report Type:Direct Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT C C Company Report # Report Source Hypersensitivity Respiratory Distress Product Role Gabapentin PS Manufacturer Route Manufacturer Route Date:08/02/99ISR Number: 3316204-5Report Type:Expedited (15-DaCompany Report #10053825 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 40 MILLIGRAM, Initial or Prolonged ORAL PT Report Source Product Role Blood Creatinine Study Omapatrilat PS Increased Health Blood Urea Increased Cardiac Failure Condition Aggravated Renal Impairment Professional Neurontin (Gabapentin) SS ORAL Date:08/03/99ISR Number: 3317590-2Report Type:Expedited (15-DaCompany Report #001-0945-990442 Age:50 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 3200 MG (800 PT Report Source Product Role Accident Complex Partial Seizures Health Professional Neurontin (Gabapentin) PS Dilantin (Ucb) C C Drug Ineffective MG, QID) Thermal Burn Manufacturer Route Date:08/04/99ISR Number: 3319658-3Report Type:Expedited (15-DaCompany Report #001-0073-990304 Age:32 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Health Professional Dilantin (Phenytoin Sodium) PS Neurontin (Gabapentin) SS Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine) C Duration 600 MG (,DAILY) 600 MG(,DAILY) Date:08/05/99ISR Number: 3319851-XReport Type:Expedited (15-DaCompany Report #001-0945-990413 Age:79 YR Gender:Female I/FU:F Outcome Other 22-Aug-2005 Page: 258 PT Alopecia Deafness Decreased Appetite Depression Dermatitis Dizziness 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Eructation Flatulence Hypersensitivity Report Source Product Role Hypoaesthesia Muscular Weakness Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Spinal Epidural C Manufacturer Route Duration ORAL 1600 MG (400 Scab MG,QID),PER Skin Exfoliation ORAL Skin Ulcer Stomatitis Tremor Visual Disturbance Date:08/05/99ISR Number: 3319859-4Report Type:Expedited (15-DaCompany Report #044-0945-990080 Age: Gender:Male I/FU:F Outcome Dose Duration Congenital Anomaly TRANSPLACENTAL PT Abortion Induced Anal Atresia 2900 MG Complications Of Maternal Report Source Product Role Foreign Health Neurontin (Gabapentin) PS (Lamotrigine) (Clobazam) C C Professional (,DAILY), Exposure To Therapeutic PLACENTAL; IN Drugs UTERO Congenital Anomaly EXPOSURE Congenital Diaphragmatic Eventration Congenital Ectopic Bladder Exomphalos Limb Malformation Pulmonary Hypoplasia Spine Malformation Talipes Manufacturer Route Date:08/06/99ISR Number: 3320363-8Report Type:Expedited (15-DaCompany Report #001-0945-990684 Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 4800 MG (1200 Initial or Prolonged MG, QID), PER PT Report Source Product Role Manufacturer Route Anaemia Aplastic Anaemia Health Professional Neurontin (Gabapenin) PS ORAL Tegretol (Carbamazepine) SS ORAL Bone Marrow Depression Condition Aggravated ORAL Glossopharyngeal Neuralgia 1200 MG (300 Haematocrit Decreased MG, QID), PER Haemoglobin Decreased ORAL Neutropenia Pain Pancytopenia Pyrexia Thrombocytopenia Weight Decreased Date:08/06/99ISR Number: 3321578-5Report Type:Direct Age:63 YR Gender:Female I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Manufacturer Neurontin 300mg Parke Davis PS Parke Davis Duration Hypoaesthesia 2 TID Neurontin 400 Mg 22-Aug-2005 Page: 259 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parke Davis SS Atenolol Hydrocodone/Apap 5/500 C Parke Davis 2 TID Date:08/06/99ISR Number: 3321590-6Report Type:Direct Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Required 20MG DAILY 9 MON Intervention to Prevent Permanent Impairment/Damage 100MG/5CC PT C Company Report # Report Source Product Role Anxiety Prilosec PS Drug Interaction Eye Rolling Facial Palsy Neurontin Capsules Tegretol Susp 100mg/5cc SS Manufacturer Route SS Joint Stiffness Lip Disorder Medication Error Overdose Date:08/09/99ISR Number: 3321332-4Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other 300MG PO TID PT Report Source Product Role Manufacturer Route Neurontin 300mg /Parke Davis PS Parke Davis ORAL Prozac Xanax Synthroid Micronor Zretropbic-S Alphagan C C C C C C Manufacturer Route Duration Alopecia 2 WK Date:08/09/99ISR Number: 3321335-XReport Type:Direct Age: Gender:Female I/FU:I Outcome Dose Company Report # PT Duration Company Report # Report Source Product Role Other Alopecia Neurontin 300mg / Parke Davis PS Depakote Birth Control Pill C C Parke Davis ORAL Manufacturer Route 300GM 600 AS (PO) 2 WK Date:08/12/99ISR Number: 3325058-2Report Type:Expedited (15-DaCompany Report #001-0945-990356 Age: Gender:Female I/FU:I Outcome Dose Disability Other 600MG BID PT Report Source Product Role Blindness Macular Degeneration Health Professional Neurontin (Gabapentin) PS Visual Field Defect Company Representative Duration Date:08/17/99ISR Number: 3327673-9Report Type:Expedited (15-DaCompany Report #99USA10855 Age:39 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged 22-Aug-2005 Page: 260 10:40 AM PT Bone Marrow Depression Drug Interaction Leukopenia FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutropenia Pancytopenia Thrombocytopenia Dose Report Source Product Role Manufacturer Health Professional Tegretol Tablet (Carbamazepine) PS ORAL Neurontin Capsule (Gabapentin) SS ORAL Route Duration 300 MG, QID, ORAL 4800 MG, DAILY, ORAL Date:08/18/99ISR Number: 3328583-3Report Type:Expedited (15-DaCompany Report #033-0945-990051 Age:26 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Convulsion Hemiplegia Foreign Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 3600 MG (,DAILY), PER ORAL Date:08/18/99ISR Number: 3328584-5Report Type:Expedited (15-DaCompany Report #001-0945-990442 Age:50 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 3200 MG (800 PT Report Source Product Role Accident Complex Partial Seizures Health Professional Neurontin (Gabapentin) PS Dilantin (Ucb Lo59) C C Condition Aggravated MD, QID) Drug Ineffective Simple Partial Seizures Manufacturer Route Date:08/18/99ISR Number: 3328587-0Report Type:Expedited (15-DaCompany Report #001-0945-990735 Age: Gender:Female I/FU:I Outcome Dose Death Other PT Report Source Product Role Aplastic Anaemia Health Professional Neurontin (Gabapentin) PS Date:08/18/99ISR Number: 3329386-6Report Type:Direct Age:41 YR Gender:Female I/FU:I Outcome Dose Other 1 TID Route PT Manufacturer Route Company Report # Report Source Product Role Neurontin 300 Mg PS Duration Weight Increased Amitriptyline 75 Mg Qhs(Start 8/98) Premarin N0.625 Mg Qd(Long Term Use) Imitrex Tabs Prn (Long Term Use) Phrenilin Prn(Long Term Use) Date:08/18/99ISR Number: 3329515-4Report Type:Direct Age:43 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 261 Manufacturer Duration 10:40 AM PT Chest Pain Muscle Twitching Company Report # C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervousness Report Source Dose Product Role Neurontin Po PS Claritin D Desyrel Paxil Sulindac C C C C Manufacturer Route Duration ORAL 200 MG TID PO , WITH RECENT INCREASE IN DOSE Date:08/19/99ISR Number: 3329358-1Report Type:Expedited (15-DaCompany Report #10048908 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization 40 Initial or Prolonged MILLIGRAMS, PT Report Source Product Role Blood Creatinine Study Omapatrilat PS Increased Health Blood Urea Increased Professional 2/DAY ORAL Cardiac Failure Congestive Condition Aggravated Dialysis Renal Impairment Neurontin (Gabapentin) Vitamins + Minerals Lanoxin Furosemide Zaroxolyn Quinine Isosorbide Dinitrate Amlodipine Premarin Alprazolam Aspirin Nph Insulin Insulin Sliding Scale Sublingual Nitroglycerin SS C C C C C C C C C C C C C Manufacturer Route ORAL Tylenol Cimetidine Allopurinol Famotidine C C C C Date:08/26/99ISR Number: 3335019-5Report Type:Expedited (15-DaCompany Report #001-0945-990785 Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Blood Creatinine Increased Cardiac Arrest Cyanosis Renal Failure Acute Syncope Health Professional Neurontin Capsules 300 Mg (Gabapentin) Vasotec PS C Date:08/26/99ISR Number: 3335470-3Report Type:Expedited (15-DaCompany Report #001-0945-990792 Age:45 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 262 10:40 AM PT Cholecystectomy Gallbladder Disorder Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gingival Bleeding Gingivitis Oral Mucosal Blistering Dose Report Source Product Health Professional Neurontin (Gabapentin) Bactrim (Sulfamethoxazole, Trimethoprim) Role Manufacturer Route Manufacturer Route Duration Pyrexia Stomatitis Streptococcal Infection PS C Date:08/26/99ISR Number: 3335485-5Report Type:Expedited (15-DaCompany Report #033-0945-990044 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG; 1600 PT Report Source Product Role Clostridium Colitis Diarrhoea Foreign Health Neurontin (Gabapentin) PS Intestinal Functional Professional ORAL MG; 2400 MG; Disorder 3600 MG, Intestinal Obstruction DAILY PER ORAL Tegretol (Carbamazepine) Depakine (Valproate Sodium) Daflon (Diosmin) Hept-A-Myl (Heptaminol Hydrochloride) C C C C Date:08/27/99ISR Number: 3336220-7Report Type:Expedited (15-DaCompany Report #044-0945-990096 Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3600 MG, PT Report Source Product Role Dysphagia Oesophageal Carcinoma Foreign Health Neurontin (Gabapentin) PS Manufacturer Route ORAL Required DAILY, PER Intervention to ORAL Prevent Permanent Impairment/Damage Oesophagectomy Professional Tegretol Epanutin (Doxycycline) Date:09/01/99ISR Number: 3338636-1Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose C C C Company Report # PT Report Source Product Role Dermatitis Health Neurontin 300mg Po PS Dyspnoea Professional Manufacturer Route Duration ORAL 300MG PO Date:09/01/99ISR Number: 3338926-2Report Type:Expedited (15-DaCompany Report #001-0945-990799 Age: Gender:Unknown I/FU:I Outcome Dose Other 22-Aug-2005 Page: 263 PT Report Source Product Role Laryngeal Oedema Laryngitis Neoplasm Obstructive Airways Disorder Swelling Health Professional Neurontin (Gabapentin) PS Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/99ISR Number: 3339071-2Report Type:Expedited (15-DaCompany Report #002-0945-990009 Age:81 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Retinal Artery Thrombosis Visual Acuity Reduced Foreign Health Neurontin Capsules 100 Mg (Gabapentin) PS Diclofenac Acetaminophen Enalapril Humulin N Centrum Vitamin B12 Aspirin E.C. C C C C C C C Manufacturer Route Duration ORAL 200 MG (100 Professional MG, BID), PER ORAL (SEE IMAGE) Date:09/01/99ISR Number: 3339098-0Report Type:Expedited (15-DaCompany Report #001-0945-990786 Age:8 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (100 PT Report Source Product Role Anger Balance Disorder Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Convulsion Company Discomfort Representative MG, 6QD), PER ORAL Fall Fatigue Gingival Bleeding Gingivitis Haematuria Hypotonia Irritability Joint Swelling Muscular Weakness Oral Discomfort Personality Change Depakote (Valproate Semisodium) (Zinc) Vitamin E (Tocopherol) (Phenobarbital) C C C C Manufacturer Route ORAL Pyrexia Sedation Swelling Systemic Lupus Erythematosus Tooth Abscess Date:09/03/99ISR Number: 3341258-XReport Type:Expedited (15-DaCompany Report #001-0945-990798 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization 900 MG (300 Initial or Prolonged MG, TID), PER PT Report Source Product Role Cardio-Respiratory Arrest Encephalopathy Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Insulin Nph Amitriptyline Metoclopramide Lisinopril C C C C Hypertension Lethargy ORAL Myocardial Fibrosis Pneumonia Urinary Tract Infection 22-Aug-2005 Page: 264 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/99ISR Number: 3340968-8Report Type:Direct Age:71 YR Gender:Male I/FU:I Outcome Dose Other Company Report # PT Report Source Product Role Confusional State Nightmare Health Professional Gabapentin Fentanyl Transdermal System Patch Morphine Sulf Nortriptyline Casanthranol/Docusat e PS C Manufacturer Route Manufacturer Route Duration C C C C Date:09/07/99ISR Number: 3342223-9Report Type:Expedited (15-DaCompany Report #001-0945-990800 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG PER PT Report Source Product Role Cardiac Arrest Hyperkalaemia Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Elavil Risperidone Clonidine Zoloft Vitamin Percocet Hydroxyzine C C C C C C C ORAL Other ORAL (QHS) Date:09/07/99ISR Number: 3342225-2Report Type:Expedited (15-DaCompany Report #001-0945-990801 Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG DAILY PT Report Source Product Role Chest Pain Pain Consumer Neurontin (Gabapentin) PS Pulmonary Oedema Weight Increased Manufacturer Route Date:09/08/99ISR Number: 3342777-2Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Other 300MG 4 CAPS Company Report # PT Report Source Product Role Drug Ineffective Health Gabapentin PS Valproic Acid Phenytoin Loperamide Hcl Ascorbic Acid Vitamin B Complex Vitamin E C C C C C C Manufacturer Route ORAL Professional TID ORAL 209 DAY Date:09/08/99ISR Number: 3343403-9Report Type:Expedited (15-DaCompany Report #033-0945-990055 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 PT Report Source Product Role Hyponatraemia Foreign Health Neurontin Capsules 400 Mg (Gabapentin) PS Professional MG, TID), PER ORAL 22-Aug-2005 Page: 265 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Primidone(Primidone) SS ORAL 250 MG (250 MG, DAILY) PER ORAL Date:09/09/99ISR Number: 3344154-7Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG PO Initial or Prolonged TID 200MG Company Report # PT Report Source Product Role Manufacturer Route Confusional State Health Phenytoin PS ORAL Sedation Professional Gabapentin SS ORAL Doxazosin Lisinopril Albuterol Atrovent Zantac Isoniazid Pyridoxine C C C C C C C PO TID Date:09/16/99ISR Number: 3347966-9Report Type:Direct Age:57 YR Gender:Female I/FU:I Outcome Dose Other 300 MG TID PT Company Report # Report Source Product Role Gabapentin Neurotin 300 Mg PS Duration Hallucination 1 DAY Date:09/16/99ISR Number: 3349609-7Report Type:Expedited (15-DaCompany Report #002-0945-990026 Age:83 YR Gender:Female I/FU:I Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG Other (DAILY) PT Report Source Product Role Blood Creatine Phosphokinase Increased Foreign Health Neurontin(Gabapentin ) PS Fall Professional Neurontin(Gabapentin ) SS Hepatic Enzyme Increased Manufacturer Route Manufacturer Route 1200 MG (DAILY) Tylenol #3 Tylenol #3 Hydrochlorothiazide/ Triamterene Furosemide Allopurinol Indomethacin C C C C C C Date:09/16/99ISR Number: 3349611-5Report Type:Expedited (15-DaCompany Report #033-0945-990056 Age:79 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1600 MG Required (DAILY), PER Intervention to ORAL Prevent Permanent Impairment/Damage 1500 MG (DAILY), PER ORAL 22-Aug-2005 Page: 266 10:40 AM PT Report Source Product Role Cholangitis Hepatic Enzyme Increased Foreign Health Neurontin(Gabapentin ) PS ORAL Jaundice Professional Depakine(Valproate Sodium) SS ORAL Pyrexia Sepsis Stupor FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Caldine Acuitel Glucor C C C Date:09/16/99ISR Number: 3349614-0Report Type:Expedited (15-DaCompany Report #001-0073-990173 Age:45 YR Gender:Female I/FU:F Outcome Dose Disability PT Report Source Product Role Abdominal Distension Abdominal Pain Alopecia Consumer Dilantin Kapseals 100 Mg(Phenytoin Sodium) PS Blood Potassium Increased Confusional State Neurontin(Gabapentin ) SS Convulsion Disorientation Drug Level Below Therapeutic Fall Gingival Hyperplasia Myalgia Palpitations Parkinsonian Gait Tinnitus Visual Acuity Reduced Weight Increased Prempro C Manufacturer Route Duration ORAL 300 MG (100 Anxiety MG, TID), PER Arthralgia ORAL NDA #20-235 Date:09/17/99ISR Number: 3349410-4Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1500 MG/DAY 7 YR Initial or Prolonged 200 MG/DAY PT Company Report # Report Source Product Role Condition Aggravated Neurontin PS Grand Mal Convulsion Celebrex SS Manufacturer Route Date:09/20/99ISR Number: 3352296-5Report Type:Expedited (15-DaCompany Report #001-0945-990900 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Pulmonary Embolism Health Professional Neurontin (Gabapentin) Celexa Nortriptyline PS C C Date:09/21/99ISR Number: 3352979-7Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 400QID PO Initial or Prolonged 22-Aug-2005 Page: 267 10:40 AM PT Drug Effect Decreased Lower Limb Fracture Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Gabapentin PS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/99ISR Number: 3353364-4Report Type:Direct Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 300MG 2TT Q Initial or Prolonged HS PO Other Required Intervention to Prevent Permanent Impairment/Damage PT Product Role Neurontin 300mg 2 Qhs PS Oops C Manufacturer Route ORAL Platelet Count Decreased Thrombocytopenia PT Company Report # Report Source Candidiasis Dermatitis Date:09/21/99ISR Number: 3353373-5Report Type:Direct Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Report Source Idiopathic Thrombocytopenic Purpura Date:09/21/99ISR Number: 3353365-6Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Abdominal Pain Duodenitis Gastritis Nausea Vomiting Weight Decreased Product Role Neurontin Celebrex PS SS Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Gabapentin (Neurontin)/Unknown /Parke-Davis Coumadin Reglan Carafate Prilosec PS C C C C Date:09/22/99ISR Number: 3354867-9Report Type:Expedited (15-DaCompany Report #033-0945-990048 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG PT Report Source Product Role Aspartate Aminotransferase Foreign Health Neurontin (Gabapentin) PS Increased Professional Manufacturer Route ORAL (DAILY), PER Hepatitis B ORAL Date:09/22/99ISR Number: 3355464-1Report Type:Direct Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Product Role Manufacturer Route Abdominal Pain Duodenitis Gastritis Gabapentin (Neurontin) /Unknown /Parke-Davis PS Parke-Davis ORAL Nausea Vomiting Weight Decreased Coumadin Reglan Carafate Prilosec C C C C ORAL 22-Aug-2005 Page: 268 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/99ISR Number: 3359746-9Report Type:Periodic Age:78 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Company Report #001-0073-980587 PT Report Source Product Role Convulsion Dizziness Consumer Dilantin (Phenytoin Sodium) PS ORAL Neurontin (Gabapentin) SS ORAL Propranolol C Drug Level Above Therapeutic Manufacturer Route 300 MG Fatigue (DAILY), PER Sedation ORAL Date:09/23/99ISR Number: 3357467-XReport Type:Expedited (15-DaCompany Report #001-0945-990908 Age:54 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Grand Mal Convulsion Loss Of Consciousness Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG (600 Movement Disorder MG, QAM AND Tremor QHS), PER ORAL Doxepin (Doxepin) Prozac (Fluoxetine Hydrochloride) Ambien (Zolpidem Tartrate) Unspecified Hormones Date:09/24/99ISR Number: 3356788-4Report Type:Direct Age:53 YR Gender:Female I/FU:I Outcome Dose PT Duration C C C C Company Report # Report Source Product Role Manufacturer Route Other Required 2-300MG Intervention to 3X/DAY (1800 Prevent Permanent MG) 1 Impairment/Damage Blood Iron Decreased Coeliac Disease Health Professional Neurontin /300mg /Park/Davis PS Parke-Davis Product Role Manufacturer Dilantin Mysoline PS SS Neurontin Hydrochlodothiazide SS SS Malaise Oedema Peripheral YR Swelling Date:09/27/99ISR Number: 3358788-7Report Type:Direct Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Convulsion Thrombocytopenia Company Report # Report Source 250MG TID (A 2 YRS ON DIFFERENT SEIZURE MEDICATIONS) Date:09/28/99ISR Number: 3358820-0Report Type:Direct Age: Gender: I/FU:I Outcome Other Required Intervention to 22-Aug-2005 Page: 269 10:40 AM Company Report # Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage Dose PT Report Source Product Role Manufacturer Route Blood Iron Decreased Coeliac Disease Health Professional Neurontin 300mg Parke Davis PS Parke Davis Manufacturer Route Manufacturer Route Duration 2 300MG 3XDAY Dizziness 1800MG 1 YR Drug Effect Decreased Swelling Date:09/28/99ISR Number: 3360238-1Report Type:Expedited (15-DaCompany Report #001-0945-990356 Age: Gender: I/FU:F Outcome Dose Disability Other 600 MG BID PT Report Source Product Role Blindness Macular Degeneration Health Professional Neurontin (Gabapentin) PS Visual Field Defect Company Representative Pamelor (Nortriptyline Hydrochloride) (Methadone) C C Duration Date:09/28/99ISR Number: 3365123-7Report Type:Periodic Age:56 YR Gender:Male I/FU:I Outcome Dose Company Report #USA010666 PT Report Source Product Role Therapeutic Response Unexpected Consumer Other Meridia Depakote PS SS ORAL Neurontin SS ORAL Duration 1 TAB QID PO 2 CAP TID PO Date:09/28/99ISR Number: 3376280-0Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report #USA009300 Report Source Product Role Manufacturer Route Disturbance In Attention Fatigue Consumer Other Meridia Meridia PS SS ORAL Neurotin SS ORAL 10 MG OD PO Tremor 400 MG OD PO Date:09/29/99ISR Number: 3360703-7Report Type:Expedited (15-DaCompany Report #001-0945-990919 Age:34 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Convulsion Consumer Neurontin Capsules 300mg (Gabapentin) PS Manufacturer Route Duration ORAL 3600MG (1200MG TID) PER ORAL Date:09/29/99ISR Number: 3360705-0Report Type:Expedited (15-DaCompany Report #001-0945-990913 Age:31 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Health Professional Neurontin (Gabapentin) PS Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Triamine Hydrochloride, C Duration 1600MG 22-Aug-2005 Page: 270 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/99ISR Number: 3360707-4Report Type:Expedited (15-DaCompany Report #001-0073-990394 Age:1 DY Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Health Professional Dilantin (Phenytoin Sodium) PS Depakote (Valproate Semisodium) SS Neurontin (Gabapentin) SS Folic Acid (Folic Acid) C Manufacturer Route Manufacturer Route 550MG (DAILY) Drugs PLACENTAL Congenital Anomaly Pregnancy 750MG (DAILY) Skin Disorder PLACENAL 12 WK 2700MG (DAILY) PLACENTAL 12 WK Date:09/29/99ISR Number: 3360998-XReport Type:Expedited (15-DaCompany Report #B0071068A Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Death TWICE PER DAY PT Report Source Epilepsy Foreign Product Lamictal Role PS ORAL SS ORAL Sudden Death / ORAL Gabapentin (Formulation Unknown) (Gabapentin) 400 MG / THREE TIMES PER DAY / ORAL Calcium Glubionate Ferrous Sulfate C C Date:10/04/99ISR Number: 3363790-5Report Type:Expedited (15-DaCompany Report #9940757 Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent 5.00 MG Impairment/Damage TOTAL; DAILY; PT Report Source Product Role Manufacturer Route Convulsion Drug Interaction Health Professional Glucotrol Xl Extended Release Tablets PS ORAL Neurontin SS ORAL Lipitor C ORAL 100.00 MG TOTAL; DAILY; ORAL Date:10/08/99ISR Number: 3369321-8Report Type:Expedited (15-DaCompany Report #001-0073-990417 Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 PT Report Source Product Role Manufacturer Route Angioplasty Aspiration Health Professional Dilantin (Phenytoin Sodium) PS ORAL Gamma-Glutamyltransferase Increased Neurontin (Gabaentin) SS ORAL Grand Mal Convulsion Myocardial Infarction Lipitor (Atorvastatin) C Convulsion MG BID) Coronary Artery Disease PER ORAL PER ORAL 22-Aug-2005 Page: 271 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin (Acetylsalicylic Acid) Lescol (Fluvastatin Sodium) C C Date:10/08/99ISR Number: 3369324-3Report Type:Expedited (15-DaCompany Report #001-0945-990792 Age:45 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Gallbladder Disorder Gingival Bleeding Gingivitis Oral Mucosal Blistering Pyrexia Stomatitis Streptococcal Infection Health Professional Neurontin (Gabapentin) Bactrim (Sulfamethoxazole) Role Manufacturer Route Manufacturer Route PS C Date:10/12/99ISR Number: 3370404-7Report Type:Expedited (15-DaCompany Report #001-0991-991427 Age:38 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Biliary Cirrhosis Primary Chest Pain Consumer Other Rezulin (Troglitazone) PS ORAL Cholestasis Ear Pain Lipitor (Atorvastatin) SS ORAL Gallbladder Disorder Gastroenteritis Helicobacter Glycosylated Haemoglobin Increased Inflammation Neurontin (Gabapentin) Neurontin (Gabapentin) Rezulin (Troglitazone) Duration 200 MG Cholangitis Sclerosing (DAILY) 10 MG (DAILY) 400 MG Lacrimation Increased DAILY; ORAL Liver Function Test Prandin SS SS SS ORAL Abnormal (Repaglinide) SS Niacin Glucotrol Xl (Glipizide) Atrovent Inhaler (Ipratropium Bromide) Proventil Inhaler (Salbutamol) Flexeril (Cyclobenzaprine Hydrochloride) Citracal (Calcium Citrate) C 30 MG (10 MG, Muscle Spasms AC) Oedema Peripheral Pain Pharyngolaryngeal Pain Productive Cough Sinus Congestion Sputum Discoloured Tricuspid Valve Incompetence Vaginal Candidiasis Date:10/12/99ISR Number: 3371610-8Report Type:Expedited (15-DaCompany Report #001-0073-990458 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 272 10:40 AM PT Alanine Aminotransferase Increased Aspartate C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Condition Aggravated Hepatic Fibrosis Dose Report Source Product Role Manufacturer Route Health Professional Dilantin Kapseals 100 Mg (Phenytoin Sodium) PS ORAL Neurontin Capsules 300 Mg (Gabapentin) SS ORAL Duration 300 MG (HS), PER ORAL 300 MG (AM), PER ORAL Date:10/13/99ISR Number: 3370370-4Report Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Other 300MG PO Q 8 PT Company Report # Report Source Hypotension Product Role Neurotin PS Manufacturer Route ORAL HRS Date:10/13/99ISR Number: 3371607-8Report Type:Expedited (15-DaCompany Report #A0102566A Age:16 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Aggression Coma Grand Mal Convulsion Intentional Misuse Health Professional Company Representative Wellbutrin Tablet-Controlled Release (Bupropion Hydrochloride) PS ORAL Gabapentin (Formulation Unknown) (Gabapentin) SS ORAL 150 MG/SEE Lethargy TEXT/ORAL Suicide Attempt SEE TEXT/ORAL Date:10/13/99ISR Number: 3371688-1Report Type:Expedited (15-DaCompany Report #001-0945-990361 Age:52 YR Gender:Male I/FU:F Outcome Dose PT Report Source Product Role Cough Groin Pain Health Professional Neurontin Capules 300 Mg (Gabapentin) PS Daypro (Oxaprozin) C Manufacturer Route Duration ORAL 900 MG (300, Headache MG, TID), PER Myocardial Infarction ORAL Nausea Vomiting Date:10/13/99ISR Number: 3381528-2Report Type:Expedited (15-DaCompany Report #SP-9901025 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Confusional State Delusion Delusional Disorder, Persecutory Type Consumer Health Professional Remicade Remicade Remicade Prednisone PS SS SS SS Remicade SS Prozac SS Demerol Remicade Roxicodone SS SS SS Manufacturer Route LO-DOSE INTRAVENOUS Fatigue INTRAVENOUS Pain ORAL 30 MG Psychotic Disorder DAILY Vomiting ORAL UP TO 2 22-Aug-2005 Page: 273 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TABLETS DAILY Neurontin SS Pentasa Cipro Blephamide Tetracycline Tenex Furosemide Relafen B-12 Centrum Silver Ms Contin Prevacid Lotrel Ziac Phenobarbital K-Dur Locholest Powder Kerasal Folic Acid B/Complex-50 B/Complex-100 Magnesium Chloride Calcium Actigall Diphenoxylate Tridesilon Rowasa Proctofoam Cortifoam Claritin-D C C C C C C C C C C C C C C C C C C C C C C C C C C C C C ORAL ORAL 300 MG THREE TIMES DAILYS Date:10/15/99ISR Number: 3372051-XReport Type:Direct Age:38 YR Gender:Female I/FU:I Outcome Dose Other PO Company Report # PT Report Source Product Role Erythema Multiforme Health Gabipentin PS Manufacturer Route Duration Professional ORAL Date:10/15/99ISR Number: 3374004-4Report Type:Expedited (15-DaCompany Report #001-0945-990735 Age: Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Aplastic Anaemia Haemorrhagic Stroke Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 900 MG (300 Hypotension MG, Q8H) Leukopenia Staphylococcal Sepsis Thrombocytopenia Date:10/18/99ISR Number: 3374188-8Report Type:Expedited (15-DaCompany Report #991012-SK615 Age:60 YR Gender:Female I/FU:I Outcome Dose Duration Other 200.000 MG QD PT Report Source Product Role Convulsion Health Celebrex PS ORAL Drug Interaction Professional Gabapentin SS ORAL PO 2000.000 MG 22-Aug-2005 Page: 274 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report QD PO Carbamazepine SS ORAL 300.000 MG TID PO Date:10/18/99ISR Number: 3374895-7Report Type:Expedited (15-DaCompany Report #001-0945-991004 Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Anaemia Hypoglycaemia Jaundice Psychotic Disorder Health Professional Neurontin (Gabapentin) Unspecified Medications Role Manufacturer Route Manufacturer Route Manufacturer Route PS C Date:10/19/99ISR Number: 3375252-XReport Type:Expedited (15-DaCompany Report #033-0945-990065 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Hepatitis Foreign Health Professional Neurontin (Gabapentin) PS Duration Date:10/20/99ISR Number: 3376430-6Report Type:Expedited (15-DaCompany Report #001-0945-991001 Age:1 DY Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Health Professional Neurontin (Gabapentin) PS Duration 1200 MG DAILY Drugs PLACENTAL, Stillbirth CONCEPTIONWEEK 20 OF PREGNANCY-WEE Depakote (Valproate Semisodium) SS Prenatal Vitamins (Ergocalciferol, Ascorbic Acid, Pyridoxine Hydrochloride, (Folic Acid) C C 1500 MG DAILY PLACENTAL, CONCEPTION WEEK 20 OF PREGNANCY- Date:10/20/99ISR Number: 3376552-XReport Type:Expedited (15-DaCompany Report #001-0945-991040 Age: Gender:Female I/FU:I Outcome Dose Other 22-Aug-2005 Page: 275 PT Report Source Product Abortion Spontaneous Health Professional Neurontin (Gabapentin) Depakote (Valproate Semisodium) Role Duration 10:40 AM PS C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/99ISR Number: 3376554-3Report Type:Expedited (15-DaCompany Report #033-0945-990068 Age:54 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Dermatitis Rash Pustular Foreign Health Neurontin (Gabapentin) PS Professional Daonil (Glibenclamide) Glucophage (Metformin Hydrochloride) Creon (Pancreatin) Manufacturer Route Duration PER ORAL 6 ORAL MON C C C Date:10/21/99ISR Number: 3378259-1Report Type:Expedited (15-DaCompany Report #046-0945-990009 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG EVERY PT Report Source Product Role Blister Blood Creatinine Foreign Health Neurontin (Gabapentin) PS Increased Professional (Insulin) C Manufacturer Route ORAL SECOND DAY, Oedema Peripheral PER ORAL 6 WK Date:10/25/99ISR Number: 3381834-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001677 Age:46 YR Gender:Female I/FU:I Outcome Dose Death 1 MG PT Report Source Product Role Cardiac Disorder Cardio-Respiratory Arrest Coma Literature Health Professional Risperidone (Unspecified) (Risperidone) PS Manufacturer Route Duration 2 Coronary Artery Disease IN 1 DAY(S) Toxicologic Test Abnormal ORAL Gabapentin ORAL (Gabapentin) SS Clonazepam (Clonazepam) SS Paroxetine (Paroxetine) SS Remeron (Mirtazapine) SS 300 MG 2 IN 1 DAY(S) 10 MG 1 IN 1 DAY(S) 10 MG 1 IN 1 DAY(S) 15 MG ORAL 3 IN 1 DAY(S) ORAL Date:10/26/99ISR Number: 3382531-9Report Type:Expedited (15-DaCompany Report #001-0945-990908 Age:54 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Grand Mal Convulsion Loss Of Consciousness Health Professional Neurontin Gabapentin) PS 1200 MG (600 Movement Disorder MG, QAM AND Tremor QHS), PER ORAL Doxepin (Doxepin) Prozac (Fluoxetine Hydrochloride) Ambien (Zolpidem 22-Aug-2005 Page: 276 Manufacturer Route Duration 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) Unspecified Hormones C C Date:10/26/99ISR Number: 3382534-4Report Type:Expedited (15-DaCompany Report #033-0945-990069 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Balance Disorder Tremor Foreign Health Neurontin (Gabapentin) PS Manufacturer Route ORAL Professional MG, TID), PER ORAL Tegretol (Carbamazepine) Alepsal (Phenobarbital, Caffeine, Belladonna Extract) Date:10/26/99ISR Number: 3382855-5Report Type:Periodic Age:54 YR Gender:Male I/FU:I Outcome Dose Other 25.00 MG C C Company Report #9937604 PT Report Source Product Role Anorgasmia Consumer Viagra Tablets PS Neurontin Benadryl Lithium SS C C Manufacturer Route Duration ORAL TOTAL:PRN:ORA L Date:10/28/99ISR Number: 3383859-9Report Type:Expedited (15-DaCompany Report #001-0945-991048 Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other Abortion Spontaneous Benign Hydatidiform Mole Health Professional Neurontin Capsules 400 Mg(Gabapentin) PS 400 MG (DAILY), 1 MON Date:10/28/99ISR Number: 3383861-7Report Type:Expedited (15-DaCompany Report #001-0945-990900 Age:44 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 2100 PT Report Source Product Role Pulmonary Embolism Health Professional Neurontin(Gabapentin ) PS Celexa(Citalopram Hydrobromide) (Nortriptyline) C C MG(DAILY), PER ORAL Date:10/29/99ISR Number: 3383833-2Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 277 10:40 AM PT Dysarthria Hypotension Lethargy Loss Of Consciousness Company Report # Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Report Source Dose Date:10/29/99ISR Number: 3384938-2Report Type:Direct Age:64 YR Gender: I/FU:I Outcome Dose Role Inderal Nefazadone Neurontin Zantac Lisinipril PS SS SS C C Manufacturer Route PT Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Neurontin Ultram PS SS Duration Confusional State Lethargy Date:10/29/99ISR Number: 3393339-2Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Other 1 MG ONCE Product Duration Company Report #8-98345-067A PT Report Source Product Role Dizziness Consumer Ativan Tablets PS ORAL Elavil (Amitriptyline) Tablets SS ORAL Flomax (Tamsulosin) Capsules SS ORAL Neurontin (Gabapentin) Capsules SS ORAL Duration Gait Disturbance DAILY ORAL Paraesthesia Sedation Speech Disorder 100 MG DAILY ORAL 0.4 MG DAILY ORAL DOSE INCREASED UP TO 1200 MG DAILY ORAL Flomax (Tamsulosin) Capsules Elavil (Amitriptyline) Tablets Neurontin (Gabapentin) Capsules Date:11/01/99ISR Number: 3386804-5Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Disability C C C Company Report #M088774 PT Report Source Product Role Manufacturer Route Amnesia Emotional Disorder Health Professional Buspar Tabs (Buspirone Hcl) PS ORAL Neurontin (Gabapentin) SS ORAL Claritin Iodine Inderal Remeron C C C C Duration ORAL Hostility Psychotic Disorder ORAL 22-Aug-2005 Page: 278 1 WK 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3386879-3Report Type:Expedited (15-DaCompany Report #046-0945-990009 Age: Gender:Unknown I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG EVERY PT Report Source Product Role Blister Blood Creatine Increased Foreign Health Neurontin (Gabapentin) PS Infection Professional (Insuliin) C Manufacturer Route ORAL SECOND DAY Oedema Peripheral Renal Failure Acute Date:11/02/99ISR Number: 3388577-9Report Type:Expedited (15-DaCompany Report #001-0945-990735 Age:70 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Aplastic Anaemia Autoimmune Disorder Health Professional Neurontin (Gabapentin) PS Carbamazepine (Carbamazepine) SS Manufacturer Route Manufacturer Route Duration 900MG (300MG Drug Interaction Q8H) Haemorrhagic Stroke Platelet Count Decreased Staphylococcal Infection Thrombocytopenia White Blood Cell Count Decreased Date:11/03/99ISR Number: 3389013-9Report Type:Expedited (15-DaCompany Report #001-0945-990707 Age:71 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Blood Catecholamines Increased Health Professional Neurontin (Gabapentin) PS Epinephrine Increased Company Norepinephrine Increased Representative (DAILY), UNKNOWN Date:11/03/99ISR Number: 3392994-0Report Type:Periodic Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 TAB Q8H, PO DATA NA, Company Report #1999070012 PT Report Source Product Role Manufacturer Route Drug Toxicity Health Professional Carisoprodol + Aspirin PS ORAL Zyprexa (Olanzapine) SS ORAL Neurontin (Gabapentin) SS ORAL Paxil (Paroxetine) C ORAL Pepcid Armour Thyroid C C PO DATA NA, PO DATA NA, PO Date:11/04/99ISR Number: 3389255-2Report Type:Expedited (15-DaCompany Report #001-0945-990919 Age:34 YR Gender:Male I/FU:F Outcome Dose Death 3600 MG (1200 MG, TID), PER ORAL 22-Aug-2005 Page: 279 PT Report Source Product Role Epilepsy Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/99ISR Number: 3390033-9Report Type:Expedited (15-DaCompany Report #001-0945-990363 Age:43 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE TEXT, PER PT Report Source Product Role Bone Cyst Ecchymosis Health Professional Neurontin (Gabapentin) PS Manufacturer Route ORAL Increased Tendency To ORAL Bruise Platelet Count Decreased Platelet Function Test Abnormal Prozac (Fluoxetine Hydrochloride) Unspecified Tricyclic Antidepressant C C Date:11/05/99ISR Number: 3390036-4Report Type:Expedited (15-DaCompany Report #001-0945-990786 Age:8 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (100 PT Report Source Product Role Anger Asthenia Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Autoimmune Disorder Company Balance Disorder Representative MG, 6QD), PER ORAL Discomfort Epilepsy Fall Fatigue Gingival Bleeding Gingivitis Haematuria Hypotonia Irritability Joint Swelling Oedema Peripheral Personality Disorder Pyrexia Sedation Tooth Abscess Depakote (Valproate Semisodium) (Zinc) Vitamin E (Tocopherol) (Phenobarbital) C C C C Manufacturer Route ORAL Date:11/05/99ISR Number: 3390039-XReport Type:Expedited (15-DaCompany Report #033-0945-990065 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Hepatitis Foreign Health Neurontin (Gabapentin) PS Manufacturer Route ORAL Professional Date:11/05/99ISR Number: 3390073-XReport Type:Expedited (15-DaCompany Report #001-0073-990417 Age:48 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600MG (300MG PT Report Source Product Role Manufacturer Angioplasty Aspiration Health Professional Dilantin (Phenytoin Sodium) PS ORAL Coronary Artery Disease Coronary Artery Surgery Neurontin (Gabapentin) SS ORAL Gamma-Glutamyltransferase Increased Myocardial Infarction Lipitor (Atorvastatin) Aspirin (Acetylsalicylic Acid) Route Complex Partial Seizures BID) PER ORAL PER ORAL 22-Aug-2005 Page: 280 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lescol (Fluvastatin Sodium) C Date:11/09/99ISR Number: 3391927-0Report Type:Expedited (15-DaCompany Report #044-0945-990139 Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Abdominal Pain Hepatitis Foreign Health Professional Neurontin (Gabapentin) (Lactulose) Losec (Omeprazole) PS C C Date:11/10/99ISR Number: 3391573-9Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 800MG PO TID Initial or Prolonged Manufacturer Route ORAL Company Report # PT Report Source Product Role Feeling Jittery Health Gabapentin PS Intentional Misuse Medication Error Nausea Professional Manufacturer Route ORAL Date:11/10/99ISR Number: 3394036-XReport Type:Expedited (15-DaCompany Report #039-0945-990006 Age:44 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 160 MG PT Report Source Product Role Convulsion Foreign Health Gabapentin (Gabapentin) PS Professional (DAILY), PER ORAL Tavor (Lorazepam) Axoren (Buspirone Hydrochloride) C C Manufacturer Route ORAL Date:11/10/99ISR Number: 3394039-5Report Type:Expedited (15-DaCompany Report #039-0945-990004 Age:24 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG PT Report Source Product Role Manufacturer Route Arteriopathic Disease Coagulopathy Foreign Health Gabapentin (Gabapentin) PS ORAL Systemic Lupus Professional Maveral (Fluvoxamine Maleate) SS ORAL (DAILY), PER Erythematosus ORAL Thrombosis Vasospasm 300 MG (DAILY), PER ORAL Orap (Pimozide) Seroxat (Paroxetine Hydrochloride) Tegretol (Carbamazepine) Surmontil (Trimipramine) 22-Aug-2005 Page: 281 10:40 AM SS SS SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/99ISR Number: 3394044-9Report Type:Expedited (15-DaCompany Report #001-0945-991095 Age:53 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Hepatic Steatosis Hepatitis Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 3200 MG Hyperlipidaemia (DAILY), PER Liver Function Test ORAL Abnormal Weight Increased Prempro (Medroxyprogesterone , Acetate, Estrogens Conjugated) Prevacid (Lansoprazole) (Amitriptyline) Naprosyn (Naproxen) (Lorazepam) Thorazine (Chlorpromazine Hydrochloride) C C C C C C Date:11/10/99ISR Number: 3394049-8Report Type:Expedited (15-DaCompany Report #001-0945-990508 Age:81 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Activated Partial Thromboplastin Time Health Professional Neurontin (Gabapentin) PS Ratio Increased Prothrombin Time Coumadin (Warfarin Sodium) SS Prolonged (Erythropoietin) (Insulin) Cozaar (Losartan Potassium) (Glipizide) Duration 300 MG (AFTER Prolonged EACH DIALYSIS International Normalised TREATMENT) 6 MG (QHS) C C C C Manufacturer Route Date:11/10/99ISR Number: 3394054-1Report Type:Expedited (15-DaCompany Report #001-0945-990475 Age:9 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (QD), Other PER ORAL PT Report Source Product Role Abdominal Pain Gastric Ulcer Consumer Health Neurontin Capsules 400 Mg (Gabapentin) PS Gastritis Professional Glycosuria Haematochezia Malaise Nephritis Interstitial Nephrolithiasis Proteinuria Renal Disorder Vomiting Weight Decreased 22-Aug-2005 Page: 282 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/99ISR Number: 3396961-2Report Type:Expedited (15-DaCompany Report #001-0945-991109 Age:1 DY Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Depakote (Valproate Semisodium) SS Manufacturer Route Manufacturer Route 300 MG Drugs (DAILY), Polydactyly PLACENTAL; IN UTERO EXPOSURE 750 MG (DAILY), PLACENTAL; IN UTERO EXPOSURE Unspecified Antibiotics Ritalin (Methylphenidate Hydrochloride) "Clotadin" ... C C C C Date:11/12/99ISR Number: 3397340-4Report Type:Expedited (15-DaCompany Report #001-0945-990505 Age:31 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 3600 MG (2400 Other MG QAM, 1200 PT Report Source Product Role Hallucination Logorrhoea Health Professional Neurontin (Gabapentin) PS Multiple Sclerosis ORAL MG QPM), PER ORAL Many Unspecified Medications Date:11/17/99ISR Number: 3398677-5Report Type:Direct Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100MG BID PO PT C Company Report # Report Source Abdominal Pain Pancreatitis Product Role Gabapentin (Neurontin) PS Amlodipine (Norvasc) SS Manufacturer Route ORAL Date:11/17/99ISR Number: 3399557-1Report Type:Expedited (15-DaCompany Report #001-0945-991130 Age:62 YR Gender:Female I/FU:I Outcome Dose Other 22-Aug-2005 Page: 283 PT Report Source Product Role Blindness Diplopia Optic Nerve Disorder Retinal Disorder Vision Blurred Consumer Neurontin (Gabapentin) PS Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/99ISR Number: 3402695-8Report Type:Expedited (15-DaCompany Report #99USA11289 Age:60 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Convulsion Drug Interaction Health Professional Carbamazepine Tablet 300 Mg (Carbamazepine ) PS ORAL Gabapentin Tablet 2000 Mg (Gabapentin) SS ORAL Celebrex Tablet 200 Mg (Celecoxib) SS ORAL Duration 300 MG, TID, ORAL 2000 MG, TID, ORAL 200 MG, DAILY, ORAL Date:11/19/99ISR Number: 3403143-4Report Type:Expedited (15-DaCompany Report #033-0945-990064 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG PT Report Source Product Role Confusional State Depressed Level Of Foreign Study Gabapentin (Gabapentin) PS Consciousness Health Drug Level Below Professional (DAILY), PER ORAL Therapeutic Dry Mouth Electroencephalogram Abnormal Epilepsy Faecal Incontinence Grand Mal Convulsion Hyponatraemia Loss Of Consciousness Polydipsia Polyuria Piascledine (Soya Oil, Avocado Oil) Tegretol (Carbamazepine) Floxyfral (Fluvoxamine Maleate) C C C Manufacturer Route ORAL Status Epilepticus Stereotypy Thirst Urinary Incontinence Urine Sodium Decreased Date:11/22/99ISR Number: 3404156-9Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Required 300MG TID,PO Intervention to 10-20 MG HS, Prevent Permanent PO 8 WK Impairment/Damage 22-Aug-2005 Page: 284 10:40 AM Company Report # PT Report Source Product Role Body Temperature Health Gabapentin PS ORAL Increased Professional Amitriptylline SS ORAL Viokase Omeprazole Timolol Eye Drops Xalatan Eye Drops Vitamin E Vitamin C Dyazide Zostrix Cream C C C C C C C C Decreased Appetite Dermatitis Hepatitis Hepatocellular Damage Injury Jaundice Liver Function Test Abnormal Nausea Rash Maculo-Papular Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/99ISR Number: 3405277-7Report Type:Expedited (15-DaCompany Report #9940757 Age:76 YR Gender:Female I/FU:F Outcome Dose Duration Required Intervention to Prevent Permanent 5.00 MG Impairment/Damage TOTAL:DAILY:O PT Report Source Product Role Manufacturer Route Blood Glucose Increased Diabetes Mellitus Inadequate Control Health Professional Glucotrol Xl Extended Release Tablets PS ORAL Neurontin SS ORAL Topiramate SS ORAL Lipitor C Drug Interaction Epilepsy RAL 100.00 MG TOTAL:DAILY:O RAL 50.00 MG TOTAL DAILY ORAL Date:11/22/99ISR Number: 3405794-XReport Type:Periodic Age:27 YR Gender:Female I/FU:F Outcome Dose Other SEE IMAGE Company Report #8-99188-139A PT Report Source Product Role Manufacturer Route Grand Mal Convulsion Health Effexor Xr PS ORAL Professional Neurontin SS ORAL Duration 400 MG FOUR TIMES DAILY, ORAL Remeron (Mirtazapine) Neurontin (Gabapentin) Xanax (Alprazolam) C C C Date:11/24/99ISR Number: 3406789-2Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Disability 1800 MG DAILY PT Company Report # Report Source Ejaculation Failure Product Role Neurontin PS Manufacturer Route Manufacturer Route Erectile Dysfunction AS 600MG 3 X/DAY Date:11/30/99ISR Number: 3410392-8Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Disability 1,800MG /DAY PT Arthralgia Company Report # Report Source Product Role Neurontin PS Sexual Dysfunction Date:12/01/99ISR Number: 3412381-6Report Type:Expedited (15-DaCompany Report #001-0945-990799 Age:27 YR Gender:Male I/FU:F Outcome Death Other 22-Aug-2005 Page: 285 PT Drug Ineffective Dysphagia Dysphonia Facial Palsy Inflammation Laryngeal Disorder Laryngeal Oedema Neoplasm 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Obstructive Airways Disorder Vocal Cord Paralysis Dose Report Source Product Role Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG (400 MG, TID) PER ORAL Cyclosporine (Ciclosporin) Morphine (Morphine) Nystatin (Nystatin) Fentanyl Patch (Fentanyl) Lorazepam (Lorazepam) Scopolamine Patch (Hyoscine) Lansoprazole (Lansoprazole) Sulfamethoxazole-Tri methoprim (Sulfamethoxazole, Trimethoprim) C C C C C C C C Date:12/01/99ISR Number: 3412385-3Report Type:Expedited (15-DaCompany Report #045-0945-990004 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Toxic Epidermal Necrolysis Foreign Health Gabapentin (Gabapentin) PS Eltroxin (Levothyroxine Sodium) C Professional (DAILY) ORAL Manufacturer Route ORAL Pamol (Paracetamol) Losec (Omeprazole) Noritren (Nortriptyline Hydrochloride) C C C Date:12/02/99ISR Number: 3413007-8Report Type:Expedited (15-DaCompany Report #049-0945-980013 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Coma Drug Toxicity Foreign Health Neurontin Capsules 300 Mg (Gabapentin) PS Carboplatin (Carboplatin) SS M-Dolor C 600 MG Professional (DAILY), PER ORAL INTRAVENOUS 680 MG (IN THE EVENING), INTRAVENOUS 22-Aug-2005 Page: 286 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/99ISR Number: 3413575-6Report Type:Expedited (15-DaCompany Report #046-0945-990013 Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 300 MG (EVERY Initial or Prolonged OTHER DAY), PT Report Source Product Role Blister Dialysis Foreign Health Neurontin (Gabapentin) PS Leg Amputation Professional Renal Failure PER ORAL Achapid-Insulatard (Insulin Human Injection, Isophane) Levoxin (Levothyroxine Sodium) Rhinocort (Budesonide) (Acetylcysteine) Nitromex (Glyceryl Trinitrate) Glucophage (Metformin Hydrochloride) Zantac (Ranitidine Hydrochloride) Renitec (Enalapril Maleate) Trimgyl Lasix (Furosemide) Distalgesic (Paracetamol, Dextropropoxyphene Hydrochloride) Lopid (Gemfibrozil) Zocord (Simvastatin) Behepan (Cyanocobalamin) Seloken Zoc (Metoprolol Succinate) C C C C C C C C C C C C C C C Manufacturer Route ORAL Date:12/03/99ISR Number: 3413576-8Report Type:Expedited (15-DaCompany Report #001-0945-991185 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Blood Creatine Phosphokinase Increased Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 400 MG (200 Blood Creatine MG BID) PER Phosphokinase Mb ORAL Increased Date:12/03/99ISR Number: 3413577-XReport Type:Expedited (15-DaCompany Report #001-0945-991187 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 287 10:40 AM PT Report Source Product Alopecia Amnesia Convulsion Tremor Consumer Neurontin (Gabapentin) Micro K (Potassium Chloride) Lasix (Furosemide) Oxycontin (Oxycodone Role PS C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) Pamelor (Nortriptyline Hydrochloride) Lodine (Etodolac) Dilantin (Phenytoin Sodium) Ultram (Tramadol Hydrochloride) C C C C C Date:12/06/99ISR Number: 3414308-XReport Type:Expedited (15-DaCompany Report #044-0945-990166 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Convulsion Foreign Health Neurontin(Gabapentin ) PS Manufacturer Route Duration ORAL 1800 MG Professional (DAILY), PER ORAL Date:12/07/99ISR Number: 3415350-5Report Type:Expedited (15-DaCompany Report #001-0945-991179 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG PT Report Source Product Role Manufacturer Route Abdominal Pain Drug Interaction Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS ORAL Coumadin (Warfarin Sodium) SS ORAL Haemorrhage (DAILY), PER International Normalised ORAL/800 MG Ratio Increased (400 MG, Loss Of Consciousness BID), PER Platelet Count Decreased 3.75 MG (DAILY), PER ORAL (Insulin) C Date:12/07/99ISR Number: 3415388-8Report Type:Expedited (15-DaCompany Report #001-0945-991172 Age:73 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Blood Bilirubin Increased Decreased Appetite Health Professional Gabapentin (Gabapentin) PS ORAL (Amitriptyline) SS ORAL Duration 900 MG (300 Dermatitis MG, TID), PER Hepatitis ORAL Jaundice 10 - 20 MG Liver Function Test (HS), PER Abnormal ORAL 8 WK Nausea Pyrexia Rash Maculo-Papular 22-Aug-2005 Page: 288 10:40 AM Viokase (Pancrelipase) (Omeprazole) Timolol Eye Drops (Timolol) Xalatan Eye Drops (Latanoprost) Vitamin E (Tocopherol) Vitamin C (Ascorbic Acid) Dyazide (Hydrochlorothiazide C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report , Triamterene) Zostrix Cream (Capsaicin) Nerve Block Antiviral Therapy Steroid Nerve Root Therapy C C C C C Date:12/07/99ISR Number: 3415391-8Report Type:Expedited (15-DaCompany Report #001-0945-990707 Age:71 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Blood Catecholamines Increased Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Company (DAILY), Representative Date:12/08/99ISR Number: 3416552-4Report Type:Expedited (15-DaCompany Report #033-0945-990076 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 PT Report Source Product Role Deafness Foreign Health Neurontin (Gabapentin) PS ORAL Professional MG, TID), PER ORAL Date:12/08/99ISR Number: 3416555-XReport Type:Expedited (15-DaCompany Report #001-0945-991191 Age:36 YR Gender:Male I/FU:I Outcome Dose Other 500 MG (100 PT Report Source Product Role Convulsion Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Duration ORAL MG, AM, 200 MG NOON, 200 MG PM), PER ORAL Date:12/09/99ISR Number: 3417947-5Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome Dose Death ONE TID Company Report # PT Report Source Product Role Death Health Neurontin 300 Mg PS Professional Oxycontin C Manufacturer Route Manufacturer Route Duration 4 DAY Date:12/09/99ISR Number: 3417961-XReport Type:Expedited (15-DaCompany Report #001-0073-990417 Age:48 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 PT Report Source Product Role Aspiration Convulsion Health Professional Dilantin (Phenytoin Sodium) PS ORAL Increased Grand Mal Convulsion Neurontin (Gabapentin) SS ORAL Myocardial Infarction Lipitor Aspirin Lescol C C C Coronary Artery Disease MG BID), PER Gamma-Glutamyltransferase ORAL PER ORAL 22-Aug-2005 Page: 289 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/99ISR Number: 3417963-3Report Type:Expedited (15-DaCompany Report #033-0945-990069 Age:83 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Balance Disorder Tremor Foreign Health Neurontin (Gabapentin) PS Tegretol Alepsal Digoxin Lasilix C C C C Manufacturer Route ORAL Professional MG, TID), PER ORAL Date:12/10/99ISR Number: 3417908-6Report Type:Direct Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100MG QAM PT Company Report # Report Source Dermatitis Product Role Manufacturer Route Quetiapine 100mg Tablets PS ORAL Gabapentin 400mg Capsules SS ORAL Fluphenazine Fluvastatin C C 700MG HS ORAL 800MG TID ORAL Date:12/10/99ISR Number: 3417918-9Report Type:Direct Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Pancreatitis Acute Company Report # Report Source Product Role Neurontin PS Manufacturer Route Date:12/10/99ISR Number: 3418341-3Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Disability 1800 MG DAILY Company Report # PT Report Source Product Role Erectile Dysfunction Health Neurontin PS Manufacturer Route Manufacturer Route Professional AS 600MG 3X/DAY Date:12/13/99ISR Number: 3421603-7Report Type:Expedited (15-DaCompany Report #001-0945-991226 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (200 Required MG, TID), PER Intervention to ORAL Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 290 10:40 AM PT Report Source Product Role Back Pain Confusional State Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Premarin (Estrogens Conjugated) Vitamin B C C Coordination Abnormal Diplopia Diverticulitis Dry Throat Fatigue Peritonitis Skin Exfoliation Tremor Vision Blurred ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/99ISR Number: 3421213-1Report Type:Expedited (15-DaCompany Report #001-0945-991228 Age:21 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Ear Infection Health Professional Neurontin (Gabapentin) PS Topamax (Topiramate) SS Manufacturer Route Manufacturer Route Duration 1000 MG DAILY 75 MG DAILY Unspecified Antibiotic Prenatal Vitamins (Ergocalciferol, Ascorbic Acid, Pyridoxine Hydrochloride, Folic Acid C C C Date:12/14/99ISR Number: 3421380-XReport Type:Expedited (15-DaCompany Report #1999COU1453 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Cerebrovascular Accident Convulsion Drug Interaction Health Professional Coumadin (Crystalline Warfarin Sodium) PS 3.0-3.5 MG International Normalised DLY PO Ratio Decreased International Normalised Ratio Increased Liver Function Test Abnormal Neurontin (Gabapentin) Prempro (Conjugated Estrogen Medroxyprogesterone Acetate) Lanoxin (Digoxin) Zoloft (Sertraline Hydrochloride) Lipitor (Atorvastatin Calcium) Pen-Vee-K (Phenoxymethylpenici llin Potassium) SS C C C C C ORAL Darvocet-N (Di-Gesic) Ni (Centrum) C C Date:12/15/99ISR Number: 3422827-5Report Type:Expedited (15-DaCompany Report #032-0945-990023 Age:54 YR Gender:Male I/FU:I Outcome Dose Disability PT Report Source Product Role Arthropathy Difficulty In Walking Foreign Health Gabapentin (Gabapentin) PS Movement Disorder Professional (Flunitrazepam) (Codeine Phosphate, Paracetamol) Manufacturer Route Duration ORAL PER ORAL Date:12/16/99ISR Number: 3422780-4Report Type:Direct Age:63 YR Gender:Female I/FU:I Outcome Dose Other PT C Company Report # Report Source Product Role Neurontin 100mg Capsule PS Manufacturer Route Duration Rash Erythematous 100MG PO HS 22-Aug-2005 Page: 291 C 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal Zyprexa Docusate Benztropine Ibuprofen Date:12/16/99ISR Number: 3423915-XReport Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG C C C C C Company Report #001-0981-997129 PT Report Source Product Role Manufacturer Confusional State Jaundice Consumer Lipitor Tablets 20 Mg (Atorvastatin) PS ORAL Neurontin Capsules 300 Mg (Gabapentin) SS ORAL Route Liver Function Test (DAILY), PER Abnormal ORAL Nausea Urinary Tract Infection 300 MG QAM, Vomiting 600 MG QPM), Weight Decreased PER ORAL Lortab (Paracetamol, Hydrocodone Bitartrate) Clonidine Xanax (Alprazolam) Imitrex (Sumatriptan Succinate) Folic Acid Magnesium C C C C C C Date:12/21/99ISR Number: 3427109-3Report Type:Expedited (15-DaCompany Report #033-0945-990080 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNK, UNKNOWN PT Report Source Product Role Cardiac Disorder Foreign Study Gabapentin (Gabapentin) PS Manufacturer Route Health Professional Date:12/22/99ISR Number: 3428503-7Report Type:Expedited (15-DaCompany Report #001-0945-991232 Age:72 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Drug Interaction Drug Level Below Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Cyclosporin A (Ciclosporin) SS 200 MG Therapeutic (DAILY), PER ORAL Date:12/22/99ISR Number: 3428967-9Report Type:Expedited (15-DaCompany Report #001-0945-990986 Age:42 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 292 Manufacturer Route Duration 10:40 AM PT Akinesia Convulsion Crying Depression Difficulty In Walking ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Feeling Abnormal Mood Swings Dose Report Source Product Role Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration Nervousness Pain ORAL 600 MG (300 Palpitations MG, BID), PER Salivary Hypersecretion ORAL Screaming Suicidal Ideation Tremor Vision Blurred Date:12/23/99ISR Number: 3429041-8Report Type:Direct Age:21 YR Gender:Female I/FU:I Outcome Dose Other 300MG BID PT Company Report # Report Source Product Role Neurontin 300mg PS Synthroid C Manufacturer Route Manufacturer Route Duration Pruritus Date:12/23/99ISR Number: 3429829-3Report Type:Expedited (15-DaCompany Report #991217-SK111 Age:91 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization UNKNOWN PO Initial or Prolonged 300.000 MG OD Other PO / YEARS PT Report Source Product Role Bronchitis Health Celebrex PS ORAL Convulsion Professional Neurontin SS ORAL Drug Interaction Date:12/23/99ISR Number: 3430269-1Report Type:Expedited (15-DaCompany Report #033-0945-990082 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Genital Disorder Female Foreign Study Health Professional Gabapentin (Gabapentin) PS Manufacturer Route Manufacturer Route Date:12/23/99ISR Number: 3430270-8Report Type:Expedited (15-DaCompany Report #032-0945-990019 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Fall Psychotic Disorder Foreign Health Gabapentin (Gabapentin) PS Professional Company Representative (Vigabatrin) C ORAL Date:12/23/99ISR Number: 3430271-XReport Type:Expedited (15-DaCompany Report #001-0945-991048 Age: Gender:Female I/FU:F Outcome Dose Other 400 MG (DAILY) 22-Aug-2005 Page: 293 PT Report Source Product Role Abortion Spontaneous Benign Hydatidiform Mole Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Duration 1 MON 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/99ISR Number: 3431501-0Report Type:Expedited (15-DaCompany Report #001-0945-991087 Age:30 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Ventricular Fibrillation Health Professional Neurontin (Gabapentin) PS Betapace (Sotalol Hydrochloride) C Manufacturer Route Manufacturer Route Manufacturer Route Duration 300 MG (100 Company MG, TID), Representative UNKNOWN 2 DAY Date:12/29/99ISR Number: 3433678-XReport Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other 900MG DAILY PT Company Report # Report Source Product Role Neurontin PS Procardia Clonidine Nephrocaps Lipitor C C C C Duration Deafness Dialysis SEE ITEM B5 Date:12/29/99ISR Number: 3435167-5Report Type:Expedited (15-DaCompany Report #001-0945-991279 Age:16 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1)PER ORAL;2) Other 3000 MG (AS PT Report Source Product Role Grand Mal Convulsion Intentional Misuse Health Professional Neurontin (Gabapentin) PS Lethargy Loss Of Consciousness ONE DOSE), Suicide Attempt PER ORAL; 3) ORAL PER ORAL Wellbutrin (Amfebutamone Hydrochloride) SS ORAL 1) PER ORAL; 2) 4500 MG (AS ONE DOSE), PER ORAL; 3) PER Date:12/29/99ISR Number: 3435201-2Report Type:Expedited (15-DaCompany Report #001-0945-991179 Age:53 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1) 400 MG PT Report Source Product Role Manufacturer Abdominal Pain Drug Interaction Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS ORAL Coumadin (Warfarin Sodium) SS ORAL (Insulin) C Route Gastrointestinal (DAILY), PER Haemorrhage ORAL; 2) 800 International Normalised MG (400 MG, Ratio Increased BID), PER Loss Of Consciousness Platelet Count Decreased 3.75 MG (DAILY), PER ORAL 22-Aug-2005 Page: 294 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/99ISR Number: 3434744-5Report Type:Expedited (15-DaCompany Report #001-0945-990919 Age:34 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Convulsion Health Professional Neurontin Capsule 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 3600 (1200 MG, TID), PER ORAL Date:01/05/00ISR Number: 3436705-9Report Type:Direct Age:89 YR Gender:Female I/FU:I Outcome Dose Duration Other 600MGM BID PO PT Company Report # Report Source Product Role Posture Abnormal Neurontin 600mgm PS Tremor Fv Natural Tears Drops Synthroid Furosemide Zoloft Prinivil Multivitamins K-Dur Detrol Docusate Sod Pentoxifylline Metamucil Powder Baclofen Ranitidine Premarin Xylocaine Zoloft C C C C C C C C C C C C C C C C Manufacturer Route ORAL Date:01/05/00ISR Number: 3437848-6Report Type:Expedited (15-DaCompany Report #001-0945-990197 Age:63 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged 800 MG (200 Chest Pain Flushing Health Professional Neurontin (Gabapentin) PS Insomnia MG, QID), Oesophageal Spasm UNKNOWN Pain Peripheral Coldness Glyburide (Glibenclamide) Paxil (Paroxetine Hydrochloride) Zyprexa (Olanzapine) Levoxine (Levothyroxine Sodium) Trazodone Ambien (Zolpidem Tartrate) Date:01/06/00ISR Number: 3439277-8Report Type:Expedited (15-DaCompany Report #033-0945-990085 Age:67 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 295 10:40 AM PT Agranulocytosis Leukopenia Neutropenia Report Source Foreign Health Professional C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Dose Product Role Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG (DAILY), PER ORAL Phenytoin Depakine (Valproate Sodium) SS SS Date:01/07/00ISR Number: 3440278-4Report Type:Expedited (15-DaCompany Report #033-0945-990088 Age:87 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Respiratory Distress Initial or Prolonged Sedation SEE IMAGE 10 DAY Sleep Apnoea Syndrome Report Source Product Role Foreign Health Neurontin (Gabapentin) PS Professional Lovenox (Heparin-F-Raction, Sodium Salt) Bricanyl (Terbutal-Ine Sulfate) Lasilix (Furosemid) Atrovent (Ipratropium Bromide) Manufacturer Route ORAL C C C C Date:01/11/00ISR Number: 3442691-8Report Type:Expedited (15-DaCompany Report #001-0073-990417 Age:48 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 PT Report Source Product Role Aspiration Convulsion Health Professional Dilantin (Phenytoin Sodium) PS Manufacturer Route ORAL Coronary Artery Disease MG BID) Gamma-Glutamyltransferase Increased Grand Mal Convulsion Myocardial Infarction Quadruple Vessel Bypass Graft Neurontin (Gabapentin) Lipitor (Atorvastatin) Aspirin (Acetylsalicylic Acid) Lescol (Fluvastatin Sodium) SS ORAL C C C Date:01/11/00ISR Number: 3442693-1Report Type:Expedited (15-DaCompany Report #033-0945-990089 Age:80 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG PT Report Source Product Role Balance Disorder Electroencephalogram Foreign Health Neurontin Capsules 300 Mg (Gabapentin) PS Abnormal Professional (DAILY) Encephalopathy Memory Impairment Mental Disorder 22-Aug-2005 Page: 296 10:40 AM Hept-A-Myl(Heptamino l Hydrochloride) Seropram (Citalopram Hydrobromide) C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/00ISR Number: 3442696-7Report Type:Expedited (15-DaCompany Report #001-0945-M000001 Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Coma Depressed Level Of Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS ORAL Effexor (Venlafaxine Hydrochloride) SS ORAL Route Consciousness MG, TID) 75 MG (Q AM) Imdur (Isosorbide Mononitrate) Prilosec (Omeprazole) Pulmicort Inhaler (Budesonide) Permax (Pergolide Mesilate) Serzone (Nefazodone Hydrochloride) Oramorph (Morphine Sulfate) Estrace (Estradiol) Synthroid (Levothyroxine Sodium) Skelaxin (Metaxalone) Vicodin (Paracetamol, Hydrocodone Bitartrate) Date:01/12/00ISR Number: 3443156-XReport Type:Direct Age:44 YR Gender:Female I/FU:I Outcome PT Dose Duration Other Depression 600 MG PO TID 3 MON Libido Decreased Sedation C C C C C C C C C C Company Report # Report Source Product Role Neurontin PS Compazine Imipramine C C Manufacturer Route ORAL Tremor Weight Increased Levoxyl Date:01/12/00ISR Number: 3443414-9Report Type:Expedited (15-DaCompany Report #001-0945-990475 Age:8 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 297 10:40 AM PT Abdominal Pain Gastric Ulcer Gastritis Glycosuria Haematochezia Malaise Nephritis Interstitial Nephrolithiasis Proteinuria Red Blood Cell Sedimentation Rate Increased Uveitis Vomiting C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Dose Report Source Product Role Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:01/12/00ISR Number: 3443416-2Report Type:Expedited (15-DaCompany Report #044-0945-M000001 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 80 CAPSULE PT Report Source Product Role Hyperglycaemia Intentional Misuse Foreign Health Neurontin (Gabapentin) PS Loss Of Consciousness Suicidal Ideation Professional Carbamazepine (Carbamazepine) SS Date:01/13/00ISR Number: 3443614-8Report Type:Expedited (15-DaCompany Report #001-0945-991308 Age:31 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged DAILY (AT Other BEDTIME) PT Report Source Product Role Condition Aggravated Dysmenorrhoea Health Professional Neurontin (Gabapentin) PS Endometriosis Menorrhagia UNKNOWN Date:01/18/00ISR Number: 3444902-1Report Type:Expedited (15-DaCompany Report #033-0945-990085 Age:67 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (DAILY), PER PT Report Source Product Role Agranulocytosis Leukopenia Foreign Health Neurontin (Gabapentin) PS Neutropenia Professional ORAL ORAL (Phenytoin) Depakine (Valproate Sodium) SS SS Date:01/18/00ISR Number: 3445011-8Report Type:Expedited (15-DaCompany Report #001-0945-M000009 Age:91 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG PT Report Source Product Role Bronchitis Convulsion Study Health Neurontin Capsules 300 Mg(Gabapentin) PS ORAL Celebrex (Celecoxib) SS ORAL Manufacturer Route Professional (DAILY), PER ORAL/ YEARS YR PER ORAL Date:01/19/00ISR Number: 3446467-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000032 Age:46 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Myocardial Infarction Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS 1500 MG (300 Company MG, FIVE Representative TIMES A DAY), PER ORAL Rocephin (Lidocaine 22-Aug-2005 Page: 298 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride, Ceftriaxone Sodium) INTRAMUSCULAR SS (ONE DOSE), INTRAMUSCULAR Biaxin (Clarithromycin) Soma (Carisoprodol) Ultram (Tramadol Hydrochloride) SS C C Date:01/20/00ISR Number: 3445368-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000022 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Convulsion Suicidal Ideation Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:01/21/00ISR Number: 3445655-3Report Type:Expedited (15-DaCompany Report #A000496 Age:43 YR Gender:Female I/FU:I Outcome Dose Duration Disability 150.00 MG Required TOTAL:DAILY:O Intervention to RAL Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Alopecia Health Diflucan PS ORAL Asthenia Professional Fatigue Neurontin SS ORAL Feeling Cold Formication Hyperinsulinism Paraesthesia Sedation Lipitor-"Started Several Years Ago" Insulin C C Dry Skin Date:01/21/00ISR Number: 3446297-6Report Type:Expedited (15-DaCompany Report #032-0945-990023 Age:54 YR Gender:Male I/FU:F Outcome Dose Disability Other 300 MG PT Report Source Product Role Arthropathy Difficulty In Walking Foreign Health Gabapentin (Gabapentin) PS Haematoma Professional Manufacturer Route Duration ORAL (DAILY), PER Insomnia ORAL Movement Disorder (Flunitrazepam) (Codeine Phosphate, Paracetamol) C C Date:01/24/00ISR Number: 3446735-9Report Type:Expedited (15-DaCompany Report #001-0945-970529 Age:10 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG Other (DAILY), PER PT Report Source Product Role Aggression Convulsion Consumer Neurontin (Gabapentin) PS Irritability Mania ORAL Panic Attack Psychomotor Hyperactivity Suicide Attempt 22-Aug-2005 Page: 299 10:40 AM Depakote (Valproate Semisodium) Wellbutrin (Amfebutamone Hydrochloride) Zinc Multivatimn (Ergocalciferol, C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C Date:01/24/00ISR Number: 3446771-2Report Type:Expedited (15-DaCompany Report #001-0945-990846 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Drug Abuser Health Professional Company Representative Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:01/24/00ISR Number: 3446901-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000038 Age:72 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Corneal Oedema Visual Acuity Reduced Consumer Health Neurontin Capsules 100 Mg (Gabapentin) PS Duration ORAL 900 MG (300 Professional MG TID) PER ORAL Date:01/24/00ISR Number: 3528453-1Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose Company Report #990924010015 PT Report Source Product Role Manufacturer Asthenia Consumer Tobi PS Pathogenesis Corp Peripheral Vascular Disorder Gabapentin (Gabapentin) SS Vasodilatation Nelfinavir C Duration RESPIRATORY (INHALATION) Diarrhoea 300 MG, BID, Hyperhidrosis Health Professional INH MG Route Alprazolam (Alprazolam) Doxepin (Doxepin) Oxycontin (Oxycodone Hydrochloride) C C C Date:01/27/00ISR Number: 3447340-0Report Type:Expedited (15-DaCompany Report #001-0945-991232 Age:71 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Drug Interaction Drug Level Below Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Cyclosporin A (Ciclosporin) SS Manufacturer Route Duration ORAL 200 MG (100 Therapeutic MG, BID), PER Fluid Overload ORAL Renal Impairment Date:01/27/00ISR Number: 3447378-3Report Type:Expedited (15-DaCompany Report #033-0945-990065 Age:51 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG DAILY PT Report Source Product Role Blood Bilirubin Increased Hepatitis Foreign Health Neurontin (Gabapentin) PS Liver Function Test Professional PER ORAL Abnormal 22-Aug-2005 Page: 300 10:40 AM Rivotril Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Date:01/27/00ISR Number: 3447391-6Report Type:Expedited (15-DaCompany Report #225690 Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Confusional State Hallucination, Visual Foreign Other Rivotril (Clonazepam) PS ORAL Tardyferon (Ferrous Sulfate) SS ORAL Tranxene (Clorazepate Dipotassium) SS ORAL Leponex (Clozapine) SS ORAL Mopral (Omeprazole) SS ORAL Neurontin (Gabapentin) SS ORAL Medication Error Manufacturer Route ORAL 100 MG 1 PER 1 DAY ORAL 600 MG 1 PER 1 DAY ORAL ORAL 200 MG 1 PER 1 DAY ORAL Date:01/27/00ISR Number: 3447413-2Report Type:Expedited (15-DaCompany Report #033-0945-990080 Age:70 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Cardiac Disorder Foreign Study Gabapentin (Gabapentin) PS Health (DAILY), Professional Vasten (Pravastatin Sodium) Aspegic C Manufacturer Route (Acetylsalicylate Lysine) Mopral (Omeprazole) Atarax ( Hydroxyzine Hydrochloride) Temesta (Lorazepam) Lescol (Fluvastatin Sodium) C C C C C Date:01/28/00ISR Number: 3448298-0Report Type:Expedited (15-DaCompany Report #001-0945-990219 Age:46 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Optic Neuropathy Visual Acuity Reduced Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 900 MG (300 MG, TID), PER ORAL Date:01/31/00ISR Number: 3448775-2Report Type:Expedited (15-DaCompany Report #991217-SK111 Age:91 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization PO Initial or Prolonged 300.000 MG QD Other PO YR 22-Aug-2005 Page: 301 10:40 AM PT Report Source Product Role Bronchitis Health Celebrex PS ORAL Convulsion Professional Neurontin SS ORAL Drug Interaction Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/00ISR Number: 3451302-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000094 Age:35 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNK, PER ORAL PT Report Source Product Role Arterial Occlusive Disease Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Drug Interaction Mechanical Complication Of Implant Prothrombin Time Coumadin (Warfarin Sodium) Zithromax (Azithromycin) Shortened Glucophage (Metformin Hydrochloride) Elavil (Amitriptyline Hydrochloride) Manufacturer Route ORAL SS SS ORAL UNK, PER ORAL C C Date:02/03/00ISR Number: 3451420-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000067 Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Death Hospitalization 1600 MG (400 Initial or Prolonged MG, QID) PER Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Intestinal Perforation Pain Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Neurontin Capsules 400 Mg(Gabapentin) Synthroid (Levothyroxine Sodium) Manufacturer Route ORAL SS C Date:02/04/00ISR Number: 3453020-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000072 Age:50 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other Cognitive Disorder Cystitis Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Unspecified Medication C ORAL 1200 MG (300 Pain In Extremity MG, QID), PER Renal Failure ORAL Rhabdomyolysis Date:02/07/00ISR Number: 3454025-3Report Type:Expedited (15-DaCompany Report #032-0945-M0000002 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Mental Disorder Foreign Study Gabapentin (Gabapentin) PS Manufacturer Route ORAL Health Professional Date:02/07/00ISR Number: 3454086-1Report Type:Expedited (15-DaCompany Report #001-0945-991025 Age:70 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Dizziness Dysarthria Consumer Neurontin (Gabapentin) PS Urinary Incontinence (DAILY) 22-Aug-2005 Page: 302 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Percocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone Xanax (Alprazolam) C C Date:02/07/00ISR Number: 3454386-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000074 Age:74 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (QHS), Other PER ORAL PT Report Source Product Role Blood Creatine Increased Blood Urea Increased Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route ORAL Coma Lethargy Toxic Epidermal Necrolysis Synthroid (Levothyroxine Sodium) Ecotrin (Acetylsalicyclic Acid) Trental (Pentoxifylline) Diovan (Valsartan) Trandate (Labetalol Hydrochloride) C C C C C Date:02/07/00ISR Number: 3454396-8Report Type:Expedited (15-DaCompany Report #001-0945-991063 Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Cerebrovascular Accident Chills Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Costochondritis MG, TID), PER Dysarthria ORAL Eye Pain Lotrel (Benazepril, Manufacturer Route ORAL Face Oedema Amlodipine) SS ORAL 1 TABLET (S) Headache (DAILY), PER Hyperhidrosis ORAL Hypersensitivity Hypertension Palpitations Vision Blurred Date:02/08/00ISR Number: 3454305-1Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly 22-Aug-2005 Page: 303 10:40 AM PT Calcinosis Congenital Anomaly Nervous System Disorder Glyburide(Glibenclam ide) Asa (Acetylsalicylic Acid) C C Company Report # Report Source Product Role Klonopin Paxil Depakote Gabapentin Wellbutrin PS SS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/00ISR Number: 3454394-4Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Death PT Company Report # Report Source Product Role Manufacturer Route Gabapentin 300mg (Parke-Davis) PS Parke-Davis ORAL Bactrim Ds SS ORAL Zantac SS ORAL Megace Roxicodene Pogy C C C Duration Leukopenia Neutropenia 300MG 1T PO TID 1T PO PO TID Date:02/09/00ISR Number: 3455426-XReport Type:Expedited (15-DaCompany Report #032-0945-990023 Age:54 YR Gender:Male I/FU:F Outcome Dose Disability Other 300MG PT Report Source Product Role Arthralgia Arthropathy Foreign Health Gabapentin (Gabapentin) PS Depression Professional Manufacturer Route Duration ORAL (DAILY), PER Difficulty In Walking ORAL Haematoma Insomnia Muscle Injury Oedema Peripheral Flunitrazepam Codeine Phosphate, Paracetamol C C Date:02/10/00ISR Number: 3456148-1Report Type:Expedited (15-DaCompany Report #00P-056-0086712-00(0) Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Confusional State Hallucination, Visual Foreign Health Tranxene (Tranxene) (Clorazepate Role Manufacturer Route Professional Dipotassium) PS ORAL Clonazepam (Clonazepam) SS ORAL Ferrous Sulfate (Ferrous Sulfate) SS ORAL Clozapine (Clozapine) SS ORAL Omeprazole (Omeprazole) SS ORAL Gabapentin (Gabapentin) SS ORAL 100 MG, 1 IN 1 D, PER ORAL PER ORAL PER ORAL 600 MG, 1 IN 1 D, PER ORAL PER ORAL 200 MG, 1 IN 1 D, PER ORAL Date:02/11/00ISR Number: 3457020-3Report Type:Expedited (15-DaCompany Report #033-0945-M0000015 Age:34 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Route Agranulocytosis Pyrexia Foreign Health Neurontin (Gabapentin) PS ORAL Professional Tegretol (Carbamazepine) SS ORAL Zocor (Simvasstatin) SS ORAL Bi-Profenid (Ketoprofen) SS ORAL Lexomil (Bromazepam) SS ORAL PER ORAL PER ORAL PER ORAL PER ORAL 22-Aug-2005 Page: 304 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoltum (Omeprazole) SS Chemotherapy SS ORAL PER ORAL Date:02/14/00ISR Number: 3457402-XReport Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Death 15MG/DAY Company Report # PT Report Source Product Role Coma Health Zyprexa 15 Mg/Day PS Muscle Rigidity Professional Lithobid 600 Mg Bid SS Pyrexia Neurontil 600mg Tid SS Tremor Symmetrel 900mg/Day SS Manufacturer Route Manufacturer Route Duration 600 MG BID 600MG TID 900MG/DAY Date:02/14/00ISR Number: 3459086-3Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Disability Other 1200 MG (QHS) Company Report #001-0945-990364 PT Report Source Product Role Deafness Tinnitus Health Professional Neurontin (Gabapentin) PS Vertigo Company ORAL , PER ORAL Representative Date:02/14/00ISR Number: 3459088-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Bronchospasm Dyspnoea Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration 1800 MG Pulmonary Embolism (DAILY), PER Company Report #001-0945-990384 ORAL Pulmonary Oedema ORAL Pulmonary Thrombosis Snoring Date:02/14/00ISR Number: 3459089-9Report Type:Periodic Age:72 YR Gender:Male I/FU:I Outcome Dose Disability Company Report #001-0945-990404 PT Report Source Product Role Blindness Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS 400 MG (200 MG, BID) , PER ORAL Lotensin (Benazepril Hydrochloride) (Digoxin) Nph Insulin (Insulin Injection, Isophane) (Acetylsalicylic Acid) Vitamin B12 (Cyanocobalamin) Date:02/14/00ISR Number: 3459090-5Report Type:Periodic Age:40 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 305 Manufacturer Route Duration 10:40 AM PT Blood Thyroid Stimulating Hormone Increased Company Report #001-0945-990405 C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Failure Congestive Dose Report Source Product Role Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 400 MG (DAILY), PER ORAL (Lithium) Depakote (Valproate Semisodium) Zyprexa (Olanzapine) Luvox (Fluvoxamine Maleate) Date:02/14/00ISR Number: 3459091-7Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1500 MG SS C C C Company Report #001-0945-990411 PT Report Source Product Role Confusional State Depression Health Professional Neurontin (Gabapentin) PS Haldol (Haloperidol) SS Manufacturer Route Manufacturer Route Drug Interaction (DAILY) , / Hallucination MONTHS AGO Mood Swings 5 MG ((DAILY) Date:02/14/00ISR Number: 3459092-9Report Type:Periodic Age:67 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Insomnia Pollakiuria Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Duration 100 MG (QHS), Weight Decreased PER ORAL Company Report #001-0945-990441 ORAL (Amitriptyline) Date:02/14/00ISR Number: 3459093-0Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1600 MG (400 C Company Report #001-0945-990472 PT Report Source Product Role Confusional State Drug Toxicity Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS (Baclofen) (Atenolol) (Cimetidine) (Ranitidine) Oxybutynin) (Ferrous Sulfate) C C C C C C Manufacturer Route ORAL Encephalopathy MG, QID), PER Sedation ORAL Date:02/14/00ISR Number: 3459094-2Report Type:Periodic Age:66 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-990511 PT Report Source Product Role Breast Cancer Female Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS 600 MG (300 MG, BID) , PER ORAL Premarin (Estrogens 22-Aug-2005 Page: 306 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Conjugated) Advil (Ibuprofen) Date:02/14/00ISR Number: 3459095-4Report Type:Periodic Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 C C Company Report #001-0945-990591 PT Report Source Product Role Thrombocytopenia Health Professional Neurontin Capsules 300 Mg(Gabapentin) PS Manufacturer Route ORAL MG, TID), PER ORAL Cardizem (Diltiazem Hydrochloride) Prevacid (Lansoprazole) Toprol Xl (Metoprolol Succinate) Senokot (Senna Fruit) Accupril (Quinapril Hydrochloride) Date:02/14/00ISR Number: 3459096-6Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose Other C C C C C Company Report #001-0945-990641 PT Report Source Product Role Cerebral Atrophy Health Professional Neurontin Capsules 300 Mg(Gabapentin) PS Manufacturer Route Duration 1200 MG (300 MG, 2 QAM, 10PMHS), PER ORAL Celebrex (Celecoxib) Xanax (Alprazolam) Premarin (Estrogens C C ORAL Conjugated) Parafon Forte (Chlorzoxazone, Paracetamol) Armour Thyroid (Thyroid) Date:02/14/00ISR Number: 3459099-1Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG (800 C C C Company Report #001-0945-990679 PT Report Source Product Role Acute Respiratory Distress Syndrome Health Professional Neurontin (Gabapentin) PS Antibiotic C MG, QID) , PER ORAL Date:02/14/00ISR Number: 3459101-7Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 307 10:40 AM Company Report #001-0945-990744 Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose PT Report Source Product Role Abdominal Pain Accidental Overdose Health Professional Neurontin Capsules 400 Mg(Gabapentin) PS Manufacturer Route Duration ORAL 4800 MG (1200 Overdose MG, QID), PER Palpitations ORAL / 3200 Road Traffic Accident MG (400 MG, Syncope QID), PER Vision Blurred Vomiting Date:02/14/00ISR Number: 3459108-XReport Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 Company Report #001-0945-990762 PT Report Source Product Role Pancreatitis Urinary Tract Infection Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS MG, BID) Coumadin (Warfarin Sodium) Ativan (Lorazepam) Levoxyl (Levothyroxine Sodium) (Propranolol) Cortef (Hydrocortisone Acetate) Azmacort Inhaler (Triamcinolone Acetonide) Albuterol Inhaler (Salbutamol) Premarin (Estrogens Conjugated) C C C C C C C C Manufacturer Route Colace (Docusate Sodium) Tenormin (Atenolol) Date:02/14/00ISR Number: 3459110-8Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Disability C C Company Report #001-0945-990770 PT Report Source Product Role Accidental Overdose Amnesia Consumer Neurontin Capsules 300 Mg (Gabapentin) PS SEE IMAGE , Constipation PER ORAL Disturbance In Attention Oedema Skin Exfoliation 22-Aug-2005 Page: 308 Manufacturer Route Duration 10:40 AM (Trazodone) Valium (Diazepam) Percocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3459111-XReport Type:Periodic Age:32 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-990771 PT Report Source Product Role Cataract Condition Aggravated Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 1600 MG (800 Sedation MG BID) (800 MG), PER ORAL (Lithium) (Clozapine) Colace (Docusate Sodium) Date:02/14/00ISR Number: 3459112-1Report Type:Periodic Age:84 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (QHS) C C C Company Report #001-0945-990794 PT Report Source Product Role Amnesia Confusional State Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route ORAL Pneumonia , PER ORAL Zocor (Simvastatin) Synthroid (Levothyroxine Sodium) (Trazodone) Colace (Docusate Sodium) Paxil (Paroxetine Hydrochloride) Date:02/14/00ISR Number: 3459113-3Report Type:Periodic Age:75 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - C C C C C Company Report #001-0945-990839 PT Report Source Product Confusional State Consumer Neurontin Capsules Role Manufacturer Route Initial or Prolonged 2700 MG (900 Mental Retardation 300 Mg (Gabapentin) PS ORAL Severity Unspecified MG, TID), PER Pneumonia ORAL Sedation Tegretol (Carbamazepine) Unspecified Blood Pressure Medication Vicodin (Paracetamol, Hydrocodone Bitartrate) Date:02/14/00ISR Number: 3459115-7Report Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL 10:40 AM C C Company Report #001-0945-990888 PT Report Source Product Role Abdominal Pain Blood Bilirubin Increased Health Professional Neurontin (Gabapentin) PS Hepatic Enzyme Increased 22-Aug-2005 Page: 309 C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3459117-0Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-990903 PT Report Source Product Role Eye Pain Vision Blurred Health Professional Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL SEE IMAGE Visual Acuity Reduced PER ORAL Premarin (Estrogens Conjugated) Tylenol (Paracetamol) Date:02/14/00ISR Number: 3459119-4Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged C Company Report #001-0945-990909 PT Report Source Product Role Convulsion Hypersensitivity Health Professional Company Representative Neurontin (Gabapentin) PS Date:02/14/00ISR Number: 3459500-3Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged TITRATED UP C Route Manufacturer Route Company Report #001-0945-991218 PT Report Source Product Role Asthenia Back Pain Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Cardiac Failure TO A DAILY Coordination Abnormal (DOSE OF Dizziness 2700MG), PER Fall ORAL; SEE Headache Nausea Manufacturer Lasix (Furosemide) Oxycontin (Oxycodone C ORAL Hydrochloride) Wellbutrin (Amfebutamone) Soma (Carisoprodol) Pamelor (Nortriptylne Hydrochloride) Micro-K (Potassium Chloride) Date:02/14/00ISR Number: 3459504-0Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Other C C C C C Company Report #001-0945-991219 PT Report Source Product Role Deafness Health Professional Neurontin (Gabapentin) PS 300 MG (100 MG, TID), PER ORAL Darvocet (Paracetamol, Dextropropoxyphene) Prilosec (Omeprazole) Promethazine Lactulose Levothyroid 22-Aug-2005 Page: 310 Manufacturer Route Duration 10:40 AM C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine) Temazepam Prevacid (Lansoprazole) K-Dur (Potassium Chloride) Neomycin Date:02/14/00ISR Number: 3459507-6Report Type:Periodic Age:20 YR Gender:Female I/FU:I Outcome Dose Death C C C C C Company Report #001-0945-991268 PT Report Source Product Role Death Health Professional Neurontin (Gabapentin) PS Depakote (Valproate Semisodium) C Manufacturer Route Duration ORAL 2400-2700 MG (DAILY), PER ORAL Date:02/14/00ISR Number: 3459511-8Report Type:Periodic Age:32 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-991308 PT Report Source Product Role Dysmenorrhoea Menorrhagia Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 3800 MG Overdose (DAILY) Date:02/14/00ISR Number: 3459514-3Report Type:Periodic Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG Company Report #001-0945-991310 PT Report Source Product Role Hallucination Insomnia Consumer Neurontin (Gabapentin) PS ORAL Logorrhoea (DAILY), PER Restlessness ORAL Vitamins Unspecified Water Pill Date:02/14/00ISR Number: 3459516-7Report Type:Periodic Age:50 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE TEXT, PER C C Company Report #001-0945-980487 PT Report Source Product Role Manufacturer Route Arthralgia Convulsion Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS ORAL Peganone (Ehtotoin) SS ORAL Dermatitis ORAL Dyspnoea 250 MG Mental Disorder (DAILY), PER Overdose ORAL Stupor Syncope 22-Aug-2005 Page: 311 10:40 AM Zoloft (Sertraline Hydrochloride) Tranxene (Clorazepam Dipotassium) Haldol (Haloperidol) Felbatol (Felbamate) Depakote (Valproate Sodium) Gabitril (Tiagabine) C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topamax (Topiramate) Lamictal (Lamotrigine) Date:02/14/00ISR Number: 3459524-6Report Type:Periodic Age:28 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 C C Company Report #001-0945-980710 PT Report Source Product Role Manufacturer Route Convulsion Drug Withdrawal Consumer Neurontin (Gabapentin) PS ORAL Depakote (Valproate Sodium) SS ORAL Convulsions MG, TID), PER ORAL 250 MG (TOOK ONE MG, TID) PER ORAL Buspar (Buspirone Hydrochloride) Zoloft (Sertraline Hydrochloride) Dilantin (Phenytoin Sodium) Advil (Ibuprofen) Date:02/14/00ISR Number: 3459550-7Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 ORAL C C C Company Report #001-0945-980831 PT Report Source Product Role Pancreatitis Post Procedural Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Complication MG, TID), PER C Manufacturer Route ORAL Vicodin (Paracetamol, Hydrocodone Bitartrate) Prilosec (Omeprazole) Date:02/14/00ISR Number: 3459553-2Report Type:Periodic Age:40 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (150 MG,BID), PER ORAL 22-Aug-2005 Page: 312 10:40 AM C Company Report #001-0945-980872 PT Report Source Product Role Suicidal Ideation Health Professional Neurontin (Gabapentin) PS Date:02/14/00ISR Number: 3459567-2Report Type:Periodic Age:24 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL C Manufacturer Route Manufacturer Route Company Report #001-0945-980906 PT Report Source Product Role Stevens-Johnson Syndrome Health Professional Neurontin (Gabapentin) PS ORAL Zyban (Amfebutamone) SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3459570-2Report Type:Periodic Age:35 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 Company Report #001-0945-990003 PT Report Source Product Role Epistaxis Haemoglobin Decreased Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Headache Company Hypersensitivity Representative Manufacturer Route ORAL MG, BID), PER ORAL Photophobia Thrombocytopenia Aciclovir Prilosec (Omeprazole) Tylenol (Paracetamol) Imitrex (Sumatriptan Succinate) St. John'S Wort (Hypericum Extract) Vitamin C (Ascorbic Acid) Papain Date:02/14/00ISR Number: 3459580-5Report Type:Periodic Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG C C C C C C C Company Report #001-0945-990011 PT Report Source Product Role Dyspnoea Liver Function Test Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Abnormal (DAILY), PER ORAL Coumadin (Warfarin Sodium) (Insulin) Zoloft (Sertraline Hydrochloride) K-Dur (Potassium Chloride) Lanoxin (Digoxin) C C C C C Manufacturer Route ORAL Lotrel (Benazepril, Amlodipine) Demadex (Torasemide) Date:02/14/00ISR Number: 3459583-0Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #001-0945-990059 PT Report Source Product Role Lipids Abnormal Nephrotic Syndrome Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS 3200 MG (DAILY), PER ORAL Synthroid (Levothyroxine Sodium) Norvasc (Amlodipine Besilate) Tegretol (Carbamazepine) Wellbutrin (Amfebutamone Hydrochloride) Motrin (Ibuprofen) 22-Aug-2005 Page: 313 Manufacturer Route Duration 10:40 AM C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3459587-8Report Type:Periodic Age:23 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Company Report #001-0945-990063 PT Report Source Product Role Bipolar Disorder Condition Aggravated Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route ORAL MG, TID), PER ORAL (Lithium) Depakote (Valproate Semisodium) Vistaril (Hydroxyzine Embonate) Trazodone) Synthroid (Levothyroxine Sodium) Clonidine Date:02/14/00ISR Number: 3459588-XReport Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG SS SS SS SS C C Company Report #001-0945-990067 PT Report Source Product Role Asthenia Coordination Abnormal Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Dizziness (DAILY), PER Hypersensitivity ORAL Tremor Vomiting Synthroid (Levothyroxine Sodium) Voltaren (Diclofen-Ac Sodium) Nortriptyline (Echinacea Extract) L-Lysine (Lysine) Vitamin E C C C C C Manufacturer Route ORAL (Tocopherol) (Calcium) Date:02/14/00ISR Number: 3459594-5Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG (100 C C Company Report #001-0945-990068 PT Report Source Product Role White Blood Cell Count Decreased Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Motrin (Ibuprofen) C Manufacturer Route ORAL MG, BID), PER ORAL Date:02/14/00ISR Number: 3459609-4Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (100 Company Report #001-0945-990073 PT Report Source Product Role Convulsion Drug Interaction Health Professional Neurontin (Gabapentin) PS MG, TID), Ginkgo Biloba Serzone (Nefazodone 22-Aug-2005 Page: 314 10:40 AM SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) Date:02/14/00ISR Number: 3459611-2Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL C Company Report #001-0945-990106 PT Report Source Product Role Agitation Drug Level Above Consumer Neurontin (Gabapentin) PS ORAL Lithobid (Lithium Carbonate) SS ORAL Zyprexa (Olanzapine) SS ORAL Wellbutrin (Amfebutamone Hydrochloride) SS ORAL Ambien (Zolpidem Tartrate) SS ORAL Zoloft (Sertraline Hydrochloride) SS ORAL Klonopin (Clonazepam) SS ORAL Benzotropine (Benzatropine Mesilate) SS ORAL Inderal (Propranolol Hydrochloride) C Therapeutic Feeling Drunk Manufacturer Route 600 MG Nausea (DAILY), PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL Date:02/14/00ISR Number: 3459615-XReport Type:Periodic Age:18 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report #001-0945-990118 Report Source Product Role Manufacturer Route Other Convulsion Delusion Consumer Health Depression Professional Neurontin (Gabapentin) PS ORAL 900-1100 MG (DAILY), PER Suicide Attempt ORAL Marijuana (Cannabis) Unspecified Birth Control Pills Prozac (Fluoxetine Hydrochloride) Date:02/14/00ISR Number: 3459618-5Report Type:Periodic Age:86 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG (600 SS C C Company Report #001-0945-990129 PT Report Source Product Role Hallucination Consumer Neurontin Capsules 300 Mg (Gabapentin) PS MG, QID), PER ORAL Cardizem (Diltiazem Hydrochloride) Lanoxin (Digoxin) (Acetylsalicylic Acid) 22-Aug-2005 Page: 315 10:40 AM C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3459620-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Pancreatitis Health Professional Neurontin (Gabapentin) PS Route Manufacturer Route Manufacturer Route Manufacturer Route Company Report #001-0945-990166 PT Report Source Product Role Pericardial Effusion Health Professional Neurontin (Gabapentin) PS Duration Date:02/14/00ISR Number: 3459627-6Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Other Manufacturer Duration Date:02/14/00ISR Number: 3459624-0Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other Company Report #001-0945-990159 Company Report #001-0945-990215 PT Report Source Product Role Feeling Hot Hypersensitivity Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Duration 300 MG Sinus Headache Methocarbamol Naprelan (Naproxen Sodium) Date:02/14/00ISR Number: 3459631-8Report Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (100 MG, TID), PER ORAL C C Company Report #001-0945-990265 PT Report Source Product Role Dysphagia Pneumonia Aspiration Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS ORAL Date:02/14/00ISR Number: 3459634-3Report Type:Periodic Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 Company Report #001-0945-990267 PT Report Source Product Role Convulsion Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Topamax (Topiramate) SS Manufacturer Route ORAL MG,TID), PER ORAL Date:02/14/00ISR Number: 3459638-0Report Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged YR PT Report Source Product Role Cerebrovascular Accident Consumer Neurontin (Gabapentin) PS Date:02/14/00ISR Number: 3459641-0Report Type:Periodic Age:3 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 22-Aug-2005 Page: 316 10:40 AM Company Report #001-0945-990268 Manufacturer Route Manufacturer Route Company Report #001-0945-990269 PT Report Source Product Role Stevens-Johnson Syndrome Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG, BID) PER ORAL Date:02/14/00ISR Number: 3459646-XReport Type:Periodic Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG Company Report #001-0945-990271 PT Report Source Product Role Mental Disorder Oedema Peripheral Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route Manufacturer Route (DAILY) Date:02/14/00ISR Number: 3459648-3Report Type:Periodic Age:75 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-990284 PT Report Source Product Role Visual Disturbance Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Depakote(Valproate Semisodium) (Ibuprofen) C C Duration ORAL 600 MG (300 MG,BID), PER ORAL Date:02/14/00ISR Number: 3459650-1Report Type:Periodic Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL Company Report #001-0945-990319 PT Report Source Product Role Bronchitis Gingival Bleeding Consumer Health Neurontin (Gabapentin) PS Influenza Like Illness Professional Sporanox Manufacturer Route ORAL Leukopenia (Itraconazole) SS Ibuprofen Skelaxin (Metaxalone) C ORAL ONE WEEK ON, Thrombocytopenia THREE WEEKS OFF (200 MG,BID) PER ORAL Date:02/14/00ISR Number: 3459653-7Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged MON C Company Report #001-0945-990325 PT Report Source Product Role Anaemia Consumer Health Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Professional Date:02/14/00ISR Number: 3459738-5Report Type:Periodic Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1600 MG (400 Company Report #001-0945-990914 PT Report Source Product Role Convulsion Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS MG, QID), PER ORAL Effexor Xr (Venlafaxin 22-Aug-2005 Page: 317 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS Remeron (Mirtazapine) Xanax (Alprazolam) C C ORAL 37.5 MG (DAILY), PER ORAL; 75 MG (DAILY), PER ORAL; 150 MG Date:02/14/00ISR Number: 3459740-3Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Other Required 4100 MG Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Convulsion Facial Pain Consumer Neurontin (Gabapentin) PS Headache Neck Pain Overdose Effexor (Venlafaxine Hydrochloride) Motrin (Ibuprofen) Tylenol (Paracetamol) Date:02/14/00ISR Number: 3459742-7Report Type:Periodic Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 Company Report #001-0945-990945 TID), PER Manufacturer Route C C C PT Report Source Product Role Drug Toxicity Mental Impairment Health Professional Neurontin (Gabapentin) PS Respiratory Distress Company Representative (100 MG, Route Company Report #001-0945-990967 MG, TID), PER ORAL; 300 MG Manufacturer ORAL Date:02/14/00ISR Number: 3459745-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Renal Failure Acute Health Professional Neurontin (Gabapentin) PS Date:02/14/00ISR Number: 3459748-8Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 318 10:40 AM Manufacturer Route Manufacturer Route Manufacturer Route Company Report #001-0945-991016 PT Report Source Product Role Pneumonia Pyrexia Urinary Tract Infection Health Professional Neurontin (Gabapentin) PS Date:02/14/00ISR Number: 3459777-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #001-0945-991015 Company Report #001-0945-991017 PT Report Source Product Role Stevens-Johnson Syndrome Health Professional Neurontin (Gabapentin) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3459781-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Stevens-Johnson Syndrome Health Professional Neurontin (Gabapentin) PS Date:02/14/00ISR Number: 3459784-1Report Type:Periodic Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (QHS) Company Report #001-0945-991019 Report Source Product Role Dermatitis Health Professional Neurontin (Gabapentin) PS Asa (Acetylsalicylic Acid) (Citalopram) Cardizem Cd (Diltiazem Hydrochloride) (Metoprolol) (Valproic Acid) Outcome Dose Duration Hospitalization Initial or Prolonged 1500 MG PT Manufacturer Route Manufacturer Route C C C C C Company Report #001-0945-991037 Report Source Product Role Disorientation Drug Interaction Neurontin Capsules 100 Mg (Gabapentin) PS Drug Level Above Therapeutic Depakote (Valproate Semisodium) SS 1750 MG Pyrexia Date:02/14/00ISR Number: 3459793-2Report Type:Periodic Age:52 YR Gender:Female I/FU:I Route Company Report #001-0945-991034 PT Date:02/14/00ISR Number: 3459786-5Report Type:Periodic Age: Gender:Male I/FU:I Manufacturer Company Report #001-0945-991041 Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (SEE PT Report Source Product Role Manufacturer Route Back Injury Drug Interaction Health Professional Neurontin (Gabapentin) PS ORAL Ziac (Hydrochlorothiazide , Bisoprolol Fumarate) SS ORAL Paxil (Paroxetine Hydrochloride) SS ORAL Lasix (Furosemide) SS ORAL Syncope TEXT), PER ORAL; 300 MG (DAILY), PER ORAL ONE (DAILY), PER ORAL 20 MG (DAILY), PER ORAL ONE (DAILY), PER ORAL Estratab (Estrogens Esterified) Indomethacin (Indometacin) 22-Aug-2005 Page: 319 10:40 AM SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3459797-XReport Type:Periodic Age:18 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Intentional Misuse Suicide Attempt Health Professional Neurontin (Gabapentin) Luvox (Fluvoxamine Maleate) Zyprexa (Olanzapine) Tylenol (Paracetamol) Date:02/14/00ISR Number: 3459801-9Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-991042 Role Manufacturer Route Manufacturer Route PS SS C C Company Report #001-0945-991067 PT Report Source Product Role Drug Withdrawal Syndrome Feeling Abnormal Consumer Neurontin Capsules 400 Mg (Gabapentin) PS (Baclofen) (Nortriptyline) C C Duration ORAL 1600 MG (400 Tachycardia MG, QID), PER ORAL Date:02/14/00ISR Number: 3459807-XReport Type:Periodic Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2700 MG (300 MG, TID), PER ORAL Company Report #001-0945-991088 PT Report Source Product Role Urinary Retention Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route ORAL Date:02/14/00ISR Number: 3459812-3Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Other Company Report #011-0945-991099 PT Report Source Product Role Blindness Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Flexeril (Cyclobenzaprine Hydrochloride) C Manufacturer Route Manufacturer Route Duration 1200 MG (300 MG, QID) Date:02/14/00ISR Number: 3459815-9Report Type:Periodic Age:78 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 Company Report #001-0945-991113 PT Report Source Product Role Agitation Dermatitis Health Professional Neurontin Capsules 400 Mg (Gabapentin) PS Difficulty In Walking MG, TID), PER Fall ORAL; 400 MG Hypotension (DAILY), PER ORAL Celexa (Citalopram Hydrobromide) Aerocef (Cefixime Trihydrate) 22-Aug-2005 Page: 320 10:40 AM SS C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/00ISR Number: 3459820-2Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Death Company Report #001-0945-991161 PT Report Source Product Role Death Other Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:02/14/00ISR Number: 3459825-1Report Type:Periodic Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG (100 Company Report #001-0945-991164 PT Report Source Product Role Pancreatitis Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Norvasc (Amlodipine Besilate) C ORAL MG, BID), PER ORAL Date:02/14/00ISR Number: 3459829-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Death Company Report #001-0945-991171 PT Report Source Product Role Death Health Professional Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 900 MG TO Company 3600 MG Representative (DAILY) Date:02/14/00ISR Number: 3459832-9Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report #011-0945-991173 Report Source Product Role Other Hepatic Enzyme Increased Weight Increased Consumer Neurontin Capsules 300 Mg (Gabapentin) PS ORAL 300 MG (DAILY), PER ORAL (Morphine) Zestril (Lisinopril) Prilosec (Omeprazole) Synthroid (Levothyroxine Sodium) Date:02/14/00ISR Number: 3459838-XReport Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1600 MG (400 C C C C Company Report #011-0945-991197 PT Report Source Product Role Drug Interaction Eating Disorder Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Fatigue MG, QID), PER Hypotension ORAL Mental Impairment Sedation 22-Aug-2005 Page: 321 10:40 AM Tylenol Pm (Diphenhydramine, Paracetamol) Propulsid (Cisapride) Prevacid (Lansoprazole) SS C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Calcium) Estratest (Methyltestosterone, Estrogens Esterified) (Baclofen) Celebrex (Celecoxib) Multivitamins Date:02/16/00ISR Number: 3536823-0Report Type:Periodic Age:82 YR Gender:Male I/FU:I Outcome Dose C C C C C Company Report #1999-003129 PT Report Source Product Role Manufacturer Route Gynaecomastia Health Professional Flomax PS Boehringer Ingelheim Pharmaceuticals Inc ORAL Manufacturer Route Duration 0.4 MG/QD/PO Neurontin Lorazepam Vitamins SS C C Date:02/17/00ISR Number: 3459377-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000148 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 2700 MG (900 Prevent Permanent MG, TID), PER Impairment/Damage ORAL PT Report Source Product Role Fracture Impaired Healing Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Zoloft Motrin C C ORAL Injury Date:02/18/00ISR Number: 3459733-6Report Type:Expedited (15-DaCompany Report #033-0945-M0000012 Age:89 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Death Cardiac Disorder Foreign Study Gabapentin (Gabapentin) PS 1200 MG Health (DAILY), PER Professional ORAL Adancor (Nicorandil) Tildiem (Diltiazem Hydrochloride) Renitec (Enalapril Maleate) Kardegic (Acetylsalicylate Lysine) Digoxine Nativelle (Digoxin) Lasilix (Furosemide) Date:02/22/00ISR Number: 3460749-4Report Type:Expedited (15-DaCompany Report #032-0945-M0000002 Age:32 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 322 10:40 AM PT Depression Mental Disorder Report Source Foreign Study Health C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Dose Product Role Gabapentin (Gabapentin) PS Manufacturer Route Duration ORAL 1200 MG (DAILY), PER ORAL Valproate (Valproate Bismuth) Clonazepam Venlafaxine Dicalium Chlorazepate C C C C Date:02/22/00ISR Number: 3460889-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000141 Age:38 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Convulsion Health Professional Neurontin (Gabapentin) PS Tegretol (Carbamzepine) SS Lamictal (Lamotrigine) SS Topamax (Topiramate) SS Allegra (Fexofenadine Hydrochloride) C Duration 1200 MG (DAILY) 1200 MG (DAILY) 600 MG (DAILY) 25 MG (DAILY) Manufacturer Route Date:02/22/00ISR Number: 3460892-XReport Type:Expedited (15-DaCompany Report #046-0945-990013 Age:75 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization 300 MG Initial or Prolonged (DAILY) PER PT Report Source Product Role Blister Dermatitis Bullous Foreign Health Neurontin (Gabapentin) PS Dialysis Professional Gangrene ORAL Leg Amputation Oedema Peripheral Renal Failure Skin Infection 22-Aug-2005 Page: 323 10:40 AM Actrapid (Insulin Human) Levoxin (Levothyroxine Sodium) Rhinocort (Budesone) (Acetylcysteine) Nitromex (Glyceryl Trinitrate) Glucophage (Metformin Hydrochloride) Zantac (Ranitidine Hydrochloride) Renitec (Enalapril Maleate) Trombyl (Acetylsalicylic Acid) C C C C C C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix (Furosemide) Distalgesic (Paracetamol, Dextroppropoxyphene) Lopid (Gemfibrozil) Zocord (Simvastatin) Behepan (Cyanocobalamin) Seloken Zoc (Metoprolol Succinate) C C C C C C Date:02/22/00ISR Number: 3461092-XReport Type:Expedited (15-DaCompany Report #WAES 00021101 Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PO Hospitalization Initial or Prolonged PT Report Source Product Role Biopsy Liver Abnormal Health Tab Vioxx Unk PS Blood Bilirubin Increased Hepatic Cirrhosis Hepatic Failure Hepatitis Cholestatic Jaundice Liver Function Test Abnormal Prothrombin Time Prolonged Professional Neurontin Celebrex Ambien Cozaar Norvasc Reglan SS SS C C C C Date:02/22/00ISR Number: 3462547-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Route ORAL Company Report #S99-USA-02204-01 PT Report Source Product Role Bradycardia Hypotension Sedation Health Professional Company Representative Celexa Neurontin PS SS Date:02/23/00ISR Number: 3462050-1Report Type:Periodic Age:22 YR Gender:Male I/FU:I Manufacturer Company Report #9941953 Manufacturer Route Outcome Dose Other PT Report Source Product Role Hallucination Hostility Nervousness Neurosis Pain Suicidal Ideation Health Professional Zoloft Tablets Effexor Unspecified Medication Neurontin PS SS Date:02/23/00ISR Number: 3462475-4Report Type:Periodic Age:38 YR Gender:Male I/FU:I Outcome Dose Other ORAL Route Manufacturer Route SS SS Company Report #9937754 PT Report Source Product Role Anorgasmia Health Zoloft Tablets PS ORAL Libido Increased Professional Neurontin SS ORAL Levoxyl Zantac C C Duration 1500.00 MG TOTAL: TID : ORAL 22-Aug-2005 Page: 324 Manufacturer Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3468455-7Report Type:Periodic Age:33 YR Gender:Female I/FU:I Outcome Dose Other 50.00 MG Company Report #9948357 PT Report Source Product Role Anxiety Consumer Zoloft Tablets PS Neurontin Amitriptyline SS SS Manufacturer Route Duration ORAL Insomnia TOTAL:DAILY:O RAL Date:02/23/00ISR Number: 3469143-3Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Other ORAL Company Report #9828199 PT Report Source Product Role Diarrhoea Health Zoloft Tablets PS Drug Interaction Professional Neurontin Ambiem Hydrocodone/ Acetaminophen Unknown Estrogen SS C Manufacturer Route Duration ORAL C C Date:02/24/00ISR Number: 3462590-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000139 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Coombs Direct Test Positive Haematocrit Decreased Haemoglobin Decreased Health Professional Neurontin (Gabapentin) Seroquel (Quentiapine) 600 MG Haemolytic Anaemia Psychotic Disorder Role PS SS Manufacturer Route Date:02/25/00ISR Number: 3464185-6Report Type:Expedited (15-DaCompany Report #033-0945-990080 Age:70 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Atrioventricular Block Cardiac Disorder Foreign Study Gabapentin (Gabapentin) PS Dyspnoea Health (DAILY) Professional Vasten (Pravastatin Sodium) Aspegic (Acetylsalicylate Lysine) Mopral (Omeprazole) Atarax (Hydroxyzine Hydrochloride) Temesta (Lorazepam) Lescol (Fluvastatin Sodium) Date:02/25/00ISR Number: 3464390-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000074 Age:74 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 325 10:40 AM PT Blood Creatinine Increased Blood Urea Increased C C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Coma Headache Lethargy Report Source Product Role Nasal Congestion Sneezing Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route Duration ORAL 300 MG (QHS), Toxic Epidermal PER ORAL Necrolysis Vomiting Avandia (Rosiglitazone) Synthroid (Levothyroxine Sodium) Ecotrin (Acetylsalicylic Acid) Trental (Pentoxifylline) Diovan (Valsartan) Trandate (Labetalol Hydrochloride) Insulin N Normodyne (Labetalol Hydrochloride) C C C C C C C C Date:02/28/00ISR Number: 3464506-4Report Type:Expedited (15-DaCompany Report #032-0945-M0000005 Age:39 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Agitation Delirium Foreign Health Gabapentin (Gabapentin) PS Hallucination Professional Mental Impairment Company (Valporate Sodium) SS Phenytoin (Pheytoin) C 1200 MG (DAILY), PER ORAL Representative INTRAVENOUS Manufacturer Route Duration 1600 MG (DAILY), INTRAVENOUS ORAL (Vigabatrin) (Carbamazepine) C C Date:02/28/00ISR Number: 3464509-XReport Type:Expedited (15-DaCompany Report #055-0945-M0000003 Age:75 YR Gender:Female I/FU:I Outcome Dose Other 800 MG PT Report Source Product Role Lymphopenia Foreign Gabapentin PS Captopril Nifedipine Hydrochlorothiazide Glibenclamide C C C C Manufacturer Route Duration ORAL Health (DAILY), PER Professional ORAL Date:02/28/00ISR Number: 3464512-XReport Type:Expedited (15-DaCompany Report #033-0945-990068 Age:54 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Dermatitis Rash Pustular Foreign Health Neurontin (Gabapentin) PS 6 TABLET(S) Professional (DAILY), PER ORAL 22-Aug-2005 Page: 326 Manufacturer Route Duration 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Daonil (Glibenclamide) Glucophage (Metformin Hydrochloride) Creon (Pancreatin) Atarax (Hydroxyzine Hydrochloride) C C C C Date:02/28/00ISR Number: 3464660-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000167 Age:34 YR Gender:Female I/FU:I Outcome Dose Other 1500 MG PT Report Source Product Role Astrocytoma Consumer Neurontin PS Tegretol (Carbamazepine) C Manufacturer Route Duration ORAL Feeling Drunk (DAILY), PER ORAL Date:02/29/00ISR Number: 3465569-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000175 Age:44 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Deafness Neurosensory Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route Duration 1200 MG 400 MG TID PER ORAL (Trazodone) Tricor (Fenofibrate) Vicodin (Paracetamol, Hydrocodone Bitartrate) Oxycontin (Oxycodone Hydrochloride) C C C C ORAL Date:03/02/00ISR Number: 3468824-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000168 Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG BID, PT Report Source Product Role Abnormal Dreams Confusional State Health Professional Neurontin Capsules 300 Mg (Gapapentin) PS Coumadin (Warfarin Sodium) C Coordination Abnormal 600 MG QHS, Dehydration PER ORAL Disturbance In Attention Dysphemia International Normalised Ratio Increased Parkinsonian Gait Tremor Date:03/02/00ISR Number: 3468827-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000174 Age:79 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 327 10:40 AM PT Bronchitis Fall Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Vision Blurred Dose Report Source Product Role Consumer Neurontin (Gabapentin) PS Unspecified Anti-Hypertensive C Manufacturer Route Duration ORAL 200 MG (DAILY), PER ORAL Date:03/02/00ISR Number: 3468836-1Report Type:Expedited (15-DaCompany Report #039-0945-M0000001 Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Route Purpura Rash Erythematous Foreign Health Neurontin (Gabapentin) PS ORAL Professional Laroxyl (Amitriptyline Hydrochloride) SS ORAL 15 DROPS (DAILY) , PER ORAL Date:03/02/00ISR Number: 3469856-3Report Type:Expedited (15-DaCompany Report #USA/00/00481/MES Age:65 YR Gender:Male I/FU:I Outcome Dose Death 100 MG, THREE TIMES A DAY, ORAL PT Report Source Product Role Aspiration Convulsion Health Professional Mesantoin (Mephenytoin) PS Manufacturer Route Duration ORAL Dilantin (Phenytoin Sodium) Neurontin (Gabapentin) SS SS Date:03/06/00ISR Number: 3471053-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000172 Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Asthenia Burning Sensation Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route ORAL Condition Aggravated MG, TID), PER Micturition Urgency ORAL Oliguria Restless Legs Syndrome Spinal Column Stenosis Date:03/06/00ISR Number: 3552811-2Report Type:Periodic Age:31 YR Gender:Female I/FU:I Outcome Dose Company Report #1999UW04406 PT Report Source Product Role Manufacturer Route Movement Disorder Consumer Seroquel PS Astrazeneca Uk Ltd ORAL Neuropathy Neurontin SS Speech Disorder Ambien Lamictal C C Duration 400 MG HS PO; Muscle Rigidity 50 MG QAM PO; Peripheral Sensory 400 MG HS PO 1500 MG DAILY 22-Aug-2005 Page: 328 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor Zoloft Date:03/09/00ISR Number: 3472211-3Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Sexual Dysfunction Product Role Gabapentin Oxycodone Hcl Docusate Na Fosinopril Na PS C C C Manufacturer Route PT Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Gabapentin Warfarin (Coumadin) Na Isosorbide Dinitrate Captopril Metoprolol Tartrate Pravastatin Ranitidine Hcl Bepridil Hcl Nitroglycerin Gabapentin PS Duration Sexual Dysfunction Date:03/09/00ISR Number: 3472319-2Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Other Company Report # Duration Date:03/09/00ISR Number: 3472317-9Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Other C C PT C C C C C C C C C Company Report # Report Source Product Role Gabapentin Fentanyl Beclomethasone Morphine S04 PS C C C Duration Sexual Dysfunction Date:03/09/00ISR Number: 3472320-9Report Type:Direct Age:32 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Gabapentin Venlafaxine Hcl Lansoprazole Sa Tolmetin Sodium Fentanyl PS C C C C Manufacturer Route Manufacturer Route Duration Sexual Dysfunction Date:03/09/00ISR Number: 3472445-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000188 Age: Gender:Unknown I/FU:I Outcome Dose Duration Life-Threatening 22-Aug-2005 Page: 329 10:40 AM PT Report Source Product Role Respiratory Arrest Health Professional Company Representative Neurontin (Gabapentin) (Methadone) PS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/00ISR Number: 3472446-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000196 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged TWO (TID), PT Report Source Product Role Ovarian Cyst Vomiting Consumer Neurontin (Gabapentin) PS Manufacturer Route ORAL PER ORAL (Baclofen) Synthroid (Levothyroxine Sodium) Ms Contin (Morphine Sulfate) Date:03/10/00ISR Number: 3473306-0Report Type:Direct Age:86 YR Gender:Female I/FU:I Outcome Dose C C C Company Report # PT Report Source Product Role Movement Disorder Health Neurontin PS Professional Asa Calcium Cardizem Premarin Fe-So4 Lasix Prevacid Synthroid Mag Ox Peri-Colace K-Dur Prednisone Vit E C C C C C C C C C C C C C Manufacturer Route Duration ORAL 100MG PO TID Date:03/10/00ISR Number: 3473911-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000200 Age:78 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged 1200 MG (300 Drug Interaction Respiratory Arrest Health Professional Neutrontin (Gabapentin) PS MG,DAILY) Ms Contin (Morphine Sulfate) Synthroid (Levothy-Roxine Sodium) Norvasc (Amlodipine Besilate) Enteric Coated Aspirin (Acetylsalicylic Acid) Plavix (Clopidogrel) Diovan (Valsartan) Duragesic (Fentanyl) 22-Aug-2005 Page: 330 10:40 AM SS C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/00ISR Number: 3475095-2Report Type:Expedited (15-DaCompany Report #002-0945-990030 Age:10 YR Gender:Female I/FU:I Outcome Dose Death Other 1400 MG PT Report Source Product Role Manufacturer Route Cardiac Disorder Cardio-Respiratory Arrest Foreign Health Neurontin (Gabapentin) PS Drug Interaction Professional Morphine (Morphine) SS Carbamazepine (Carbamazepine) SS ORAL Amitriptyline (Amitriptyline) SS ORAL Duration ORAL (DAILY), PER Liver Disorder ORAL Viral Infection INTRAVENOUS INTRAVENOUS PER ORAL PER ORAL Date:03/14/00ISR Number: 3475239-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000022 Age: Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Convulsion Suicidal Ideation Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:03/14/00ISR Number: 3475240-9Report Type:Expedited (15-DaCompany Report #001-0945-991191 Age:36 YR Gender:Male I/FU:F Outcome Dose Other 400 MG (200MG AT 7AM, 200MG AT 12 NOON), PER ORAL PT Report Source Product Role Convulsion Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Duration ORAL Date:03/16/00ISR Number: 3476700-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000202 Age:31 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Blood Pressure Decreased Confusional State Disturbance In Attention Dizziness Drug Level Above Consumer Neurontin (Gabapentin) Thorazine (Chlorpromazine Hydrochloride) Role Route PS SS 200 MG (AT Therapeutic BEDTIME), PER Dry Mouth ORAL Dysarthria Dysphagia Dyspnoea Hyperhidrosis Hypoaesthesia Hypotension Hypotonia Muscle Disorder Muscle Rigidity Muscular Weakness Nausea Pharyngeal Oedema Tremor Urinary Incontinence Vertigo 22-Aug-2005 Page: 331 Manufacturer Duration 10:40 AM Valium (Diazepam) Xanax (Alprazolam) Prozac (Fluoxetine Hydrochloride) Buspar (Buspirone Hydrochloride) Adipex (Phentermine Hydrochloride) Topamax (Topiramate) Vioxx Skelatin (Metaxalone) Ultram (Tramadol Hydrochloride) Maxalt Risperdal (Risperidone) C C C C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ceroquel C Date:03/16/00ISR Number: 3477633-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000022 Age: Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Convulsion Suicidal Ideation Consumer Neurontin (Gabapentin) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:03/17/00ISR Number: 3478331-1Report Type:Expedited (15-DaCompany Report #001-0945-991153 Age:72 YR Gender:Male I/FU:F Outcome Dose Death 3600 MG PT Report Source Product Role Amyotrophic Lateral Health Neurontin PS Sclerosis Professional ... ... Aspirin (Acetylsalicylic Acid) Multivitamins (Ergocalcirerol, Ascorbid Acid, Folic Acid, Thiamine Hydrochloride, C C Duration (DAILY), Condition Aggravated (1200MG TID) Decreased Appetite Drug Withdrawal Syndrome Flatulence Influenza Like Illness Insomnia Malaise Sedation Weight Decreased C C Date:03/20/00ISR Number: 3477886-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000232 Age:1 DY Gender:Male I/FU:I Outcome Dose Death SEE TEXT, PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Health Professional Neurontin (Gabapentin) PS Duration Drugs PLACENTAL Stillbirth (IN UTERO Umbilical Cord Around EXPOSURE) Neck Levoxyl (Levothyroxine Sodium) Antibiotics Nos Haldol (Haloperidol) Celexa (Citalopram Hydrobromide) Benadryl (Diphenhydramine Hydrochloride) C C C C C Date:03/20/00ISR Number: 3477887-2Report Type:Expedited (15-DaCompany Report #034-0945-M0000027 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Microcytic Anaemia Pulmonary Embolism Foreign Study Gabapentin Or Placebo PS Placebo Levodopa SS C Health (DAILY), PER Professional ORAL 22-Aug-2005 Page: 332 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report L-Dopa Retard Donperidona Bromazepam Amantadine Entacapone Pramipexole C C C C C C Date:03/20/00ISR Number: 3477889-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000229 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Inflammation Oedema Peripheral Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Manufacturer Route ORAL MG, DAILY) PER ORAL Xanax (Alprazolam) Zoloft (Sertraline Hydrochloride) Trazodone) C C C Date:03/20/00ISR Number: 3477970-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000224 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Convulsion Drug Interaction Health Professional Company Representative Neurontin (Gabapentin) Ultram (Tramadol Hydrochloride) Role Manufacturer Route Manufacturer Route Duration PS SS Date:03/21/00ISR Number: 3478591-7Report Type:Expedited (15-DaCompany Report #225690 Age:35 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization - PT Report Source Product Confusional State Foreign Rivotril Role Initial or Prolonged ORAL Hallucination Other (Clonazepam) PS ORAL Tardyferon (Ferrous Sulfate) SS ORAL Tranxene (Clorazepate Dipotassium) SS ORAL Leponex (Clozapine) SS ORAL Mopral (Omeprazole) SS ORAL Neurontin (Gabapentin) SS ORAL ORAL 100 MG 1 PER 1 DAY ORAL 600 MG 1 PER 1 DAY ORAL ORAL 200 MG 1 PER 1 DAY ORAL Date:03/22/00ISR Number: 3478695-9Report Type:Expedited (15-DaCompany Report #033-0945-M0000021 Age:87 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 333 10:40 AM PT Alanine Aminotransferase Increased Diarrhoea Hepatitis Cholestatic Pyrexia FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Dose Report Source Product Role Foreign Health Gabapentin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration 100 MG Professional INCREASE TO 600 MG DAILY Renitec (Enalapril Maleate) Lasilix (Furosemide) Nitriderm(Glyceryl Trinitrate) Loxen (Nicardipine) Digoxine (Digoxin) Asasantine (Acetylsalicylic Acid, Dipyridamole) C C C C C C Date:03/22/00ISR Number: 3478699-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000168 Age:79 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG BID, PT Report Source Product Role Abnormal Dreams Confusional State Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Coumadin (Warfarin Sodium) C Coordination Abnormal 600 MG QHS, Dehydration PER ORAL Disturbance In Attention Dysphemia International Normalised Ratio Increased Parkinsonian Gait Tremor Date:03/22/00ISR Number: 3478702-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000250 Age:47 YR Gender:Male I/FU:I ORAL Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG (100 PT Report Source Product Role Ascites Pyrexia Consumer Neurontin Capsules 100 Mg (Gabapentin) PS Sepsis MG, QID) PER Urine Analysis Abnormal ORAL Lasix (Furosemide) Aldactone (Spironolactone) Lactulose Noroxin (Norfloxacin Magnesium Tylenol Pm (Diphenhydramine, Paracetamol) Date:03/22/00ISR Number: 3479004-1Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome Death Life-Threatening 22-Aug-2005 Page: 334 10:40 AM PT Culture Urine Positive Depressed Level Of Consciousness Company Report # C C C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Discomfort Escherichia Infection Escherichia Sepsis Dose Report Source Product Role Neurontin Capsules 300 Mg PS Sandimmune Capsules 25,50 Mg SS Morphine Vancomycin Mag Ox Imuran Bumex Prednisone Coumadin C C C C C C C Manufacturer Route Duration Fluid Overload Leg Amputation ORAL NEURONTIN 300 Multi-Organ Failure MG PO TID Nausea Oedema 25-50 MG Oesophageal Disorder QD-BID Polyuria Renal Failure Acute Sepsis Vomiting Date:03/23/00ISR Number: 3479097-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000260 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Arrhythmia Chest Pain Consumer Neurontin (Gabapentin) PS Pain In Extremity Synthroid (Levothyroxine Sodium) Estrace (Estradiol) Sinequan (Doxepin Hydrochloride) Manufacturer Route ORAL C C C Date:03/23/00ISR Number: 3479098-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000264 Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Confusional State Consumer Neurontin Tablets Role Manufacturer Route Initial or Prolonged 1800 MG (600 Disorientation Health Renal Cell Carcinoma Professional 600 Mg (Gabapentin) PS Zestril (Lisinopril) Levoxyl (Levothyroxine Sodium) Celebrex (Celecoxib) Baby Aspirin (Acetylsalicylic Acid) C MG, TID), PER Stage Unspecified ORAL Date:03/23/00ISR Number: 3479103-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000243 Age:86 YR Gender:Female I/FU:I Outcome Disability Other 22-Aug-2005 Page: 335 PT Aphasia Cerebrovascular Accident Confusional State Decreased Activity Depressed Level Of Consciousness Fall 10:40 AM C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Dose Report Source Product Role Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Zyprexa (Olanzapine) C Manufacturer Route Duration AT LEAST 600 MG, DAILY, Date:03/24/00ISR Number: 3540755-1Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Company Report #USA012640 PT Report Source Product Role Manufacturer Route Medication Error Therapeutic Response Consumer Other Meridia PS Knoll Pharmaceutical Co Sub Basf Corp ORAL Manufacturer Route Duration 15 MG BID PO Unexpected Neurontin SS Date:03/27/00ISR Number: 3480819-4Report Type:Expedited (15-DaCompany Report #034-0945-M0000027 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Dyspnoea Epistaxis Foreign Study Gabapentin Or Palcebo PS Fatigue Health Influenza Professional (Levodopa) L-Dopa Retard Donperidona (Bromazepam) (Amantadine) Entacapone (Pramipexole) C C C C C C C (DAILY), PER ORAL Iron Deficiency Anaemia Microcytic Anaemia Parkinson'S Disease Pulmonary Embolism ORAL Date:03/28/00ISR Number: 3480968-0Report Type:Expedited (15-DaCompany Report #001-0073-M0000120 Age:2 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 336 10:40 AM PT Abnormal Behaviour Aphasia Balance Disorder Clonic Convulsion Convulsion Coordination Abnormal Decreased Appetite Drooling Drug Level Above Therapeutic Drug Level Below Therapeutic Ear Disorder Eye Rolling Gingival Bleeding Gingival Pain Grand Mal Convulsion Insomnia Intentional Self-Injury Nervous System Disorder Neurosis Nystagmus FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Petit Mal Epilepsy Psychotic Disorder Pyrexia Dose Report Source Product Role Manufacturer Route Consumer Dilantin Kapseals 100 Mg (Phenytoin Sodium) PS Dilantin (Phenytoin Sodium) SS Dilantin Suspension 125 Mg/5 Ml (Phenytoin Sodium) SS ORAL Dilantin Infatabs 50 Mg (Phenytoin Sodium) SS ORAL Neurontin (Gabapentin) SS ORAL Duration Status Epilepticus Tremor Vomiting ORAL 200 MG(100 MG, BID), PER ORAL INTRAVENOUS (ONE DOSE), INTRAVENOUS 2 MILLILITERS (BID), PER ORAL 200 MG (100 MG, BID), PER ORAL 300 MG (DAILY), PER ORAL (Phenobarbital) Lamictal (Lamotrigine) Tegretol (Carbamazepine) SS SS C Date:03/28/00ISR Number: 3480981-3Report Type:Expedited (15-DaCompany Report #034-0945-M0000027 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Dyspnoea Epistaxis Foreign Study Gabapentin Or Placebo PS Fatigue Health Influenza Professional (Levodopa) L-Dopa Retard Donperidona (Bromazepam) (Amantadine) Entacapone (Pramipexole) C C C C C C C Manufacturer Route ORAL (DAILY), PER ORAL Microcytic Anaemia Parkinson'S Disease Pulmonary Embolism Date:03/29/00ISR Number: 3481645-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000270 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Amnesia Anxiety Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Delusion Hallucination Road Traffic Accident Upper Limb Fracture 22-Aug-2005 Page: 337 10:40 AM Konopin (Clonazepam) Seroquel (Quentiapine) Artane (Trihexyphenidyl Hydrochloride) C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/00ISR Number: 3482018-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000257 Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Back Pain Blood Pressure Health Professional Neurontin (Gabapentin) PS Fluctuation Company Blood Pressure Systolic Representative Manufacturer Route ORAL MG, TID), PER ORAL Increased Condition Aggravated Cyst Drug Withdrawal Syndrome Spinal Disorder Tachycardia Percocet Unspecified Anti Depressant C C Date:03/30/00ISR Number: 3482026-8Report Type:Expedited (15-DaCompany Report #034-0945-M0000027 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG Required (DAILY), PER Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Dyspnoea Epistaxis Foreign Study Gabapentin Or Placebo PS Fatigue Health Influenza Professional (Levodopa) L-Dopa Retard Donperidona (Bromazepam) (Amantadine) Entacapon E Pramipexole C C C C C C C Iron Deficiency Anaemia Microcytic Anaemia Parkinson'S Disease Pulmonary Embolism Date:03/31/00ISR Number: 3482626-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000288 Age:36 YR Gender:Female I/FU:I Manufacturer Route ORAL Outcome Dose Other PT Report Source Product Role Abortion Spontaneous Health Professional Neurontin (Gabapentin) PS Prenatal Vitamins C Manufacturer Route Manufacturer Route Duration 1200 MG (DAILY) 7 WK Date:03/31/00ISR Number: 3482703-9Report Type:Periodic Age:74 YR Gender:Male I/FU:I Outcome Dose Duration Disability 4.00 MG TOTAL Company Report #9940167 PT Report Source Product Role Confusional State Consumer Cardura PS ORAL Neurontin SS ORAL Stool Softner Risperidone C C Diarrhoea DAILY ORAL Headache 100.00 MG Nervousness TOTAL DAILY Oedema Peripheral ORAL Sedation Date:04/03/00ISR Number: 3483336-0Report Type:Expedited (15-DaCompany Report #032-0945-M0000010 Age: Gender:Unknown I/FU:I Outcome Death 22-Aug-2005 Page: 338 PT Completed Suicide Intentional Misuse 10:40 AM Report Source Foreign Study FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Dose Product Role Gabapentin (Gabapentin) PS (Carbamazepine) (Loprazolam) SS SS Manufacturer Route Duration ORAL PER ORAL Date:04/06/00ISR Number: 3484701-8Report Type:Direct Age:31 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 2 DAY Initial or Prolonged Company Report # PT Report Source Product Role Asthenia Health Neurontin PS Dizziness Nausea Professional Manufacturer Route Manufacturer Route Date:04/07/00ISR Number: 3486543-6Report Type:Expedited (15-DaCompany Report #034-0945-M0000028 Age:48 YR Gender:Male I/FU:I Outcome Dose Death 600 MG PT Report Source Product Role Drug Interaction Foreign Gabapentin PS Hepatic Function Abnormal Study Sedation Health (Morphine Sulfate) (Prednisone) (Metamizole) (Clebopride Hydrogen Maleate) (Dimeticone) (Ranitidine) (Megestrol Acetate) (Alprazolam) (Bisacodyl) (Furosemide) (Lormetazepam) C C C Duration (DAILY), PER ORAL Professional C C C C C C C C ORAL (Midazolam) C Date:04/11/00ISR Number: 3487404-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000314 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Lung Infiltration Pneumonia Respiratory Failure Health Professional Company Representative Neurontin (Gabapentin) PS Date:04/12/00ISR Number: 3487347-0Report Type:Direct Age:35 YR Gender:Female I/FU:I Outcome Dose PT Route Manufacturer Route Company Report # Report Source Product Role Neurontin 300mg PS Duration Urinary Incontinence 300MG PO QNS 22-Aug-2005 Page: 339 Manufacturer 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/00ISR Number: 3487365-2Report Type:Expedited (15-DaCompany Report #033-0945-990082 Age: Gender:Female I/FU:F Outcome Dose PT Report Source Product Role Genital Disorder Female Vaginal Laceration Foreign Study Health Professional Gabapentin (Gabapentin) PS Manufacturer Route Manufacturer Route Duration Date:04/12/00ISR Number: 3487585-7Report Type:Expedited (15-DaCompany Report #001-0945-990641 Age:56 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Atrophy Nervous System Disorder Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Duration ORAL 1200 MG (300 MG, 2QAM, 1QPMHS), PER ORAL Celebrex (Celecoxib) Xanax (Alprazolam) Premarin (Estrogens Conjugated) Parafon Forte (Chlorzoxazone, Paracetamol) Armour Thyroid (Thyroid) C C C C C Date:04/13/00ISR Number: 3487954-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000329 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blister Dermatitis Joint Swelling Neuralgia Consumer Neurontin (Gabapentin) PS Manufacturer Route Oedema Peripheral Date:04/17/00ISR Number: 3488983-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000328 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG (600 Initial or Prolonged MG QAM, 600 PT Report Source Product Role Amnesia Consumer Neurontin PS Manufacturer Route ORAL Convulsion MG QPM) PER ORAL Date:04/18/00ISR Number: 3490109-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000347 Age:10 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL; 900 PT Report Source Product Role Convulsion Status Epilepticus Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Methylphenidate (Methylphenidate) Gabitril (Tiagabine) C C MG (300 MG, TID) 22-Aug-2005 Page: 340 10:40 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/00ISR Number: 3490454-XReport Type:Expedited (15-DaCompany Report #001-0945-990404 Age:72 YR Gender:Male I/FU:F Outcome Dose Duration Death Disability 400 MG (200 PT Report Source Product Role Blindness Cerebrovascular Accident Health Professional Neurontin Capsules 100 Mg (Gabapentin) PS Manufacturer Route ORAL MG, BID), PER ORAL Lotensin (Benazepril Hydrochloride) (Digoxin) Nph Insulin (Insulin Injection, Isophane) (Acetylsalicylic Acid) Vitamin B12 (Cyanocobalamin) C C C C C Date:04/19/00ISR Number: 3490455-1Report Type:Expedited (15-DaCompany Report #032-0945-M0000011 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Dyskinesia Middle Insomnia Foreign Health Gabapentin (Gabapentin) PS Professional (Sertraline) C Manufacturer Route Duration SEE IMAGE Date:04/20/00ISR Number: 3490311-9Report Type:Direct Age:46 YR Gender:Male I/FU:I Outcome Dose PT Company Report #U-026700 Report Source Product Role Manufacturer Route Neurontin Capsules Generic Garbapentin PS Parke Davis Div Warner Lambert Co ORAL Duration Burning Sensation Mucosal Medication Error Skin Lesion Date:04/21/00ISR Number: 3491093-7Report Type:Expedited (15-DaCompany Report #2000-04-0197 Age:33 YR Gender:Male I/FU:F Outcome Dose Duration Other Required 10MG ONCE Intervention to ORAL Prevent Permanent 1500 MG DAILY Impairment/Damage ORAL PT Report Source Product Role Manufacturer Route Convulsion Drug Interaction Foreign Health Claritin (Loratadine) Tablets PS ORAL Epival Tablets SS ORAL Lamotrigine Tablets SS ORAL Gabapentin Capsules SS ORAL Professional 150 MG BID ORAL 2000 MG DAILY ORAL Date:04/24/00ISR Number: 3491511-4Report Type:Expedited (15-DaCompany Report #A013075 Age: Gender:Male I/FU:I Outcome Dose Disability 22-Aug-2005 Page: 341 PT Report Source Product Role Amputation Consumer Glucotrol Tablets Nifedipine Glucophage Neurontin Imdur Lasix PS SS SS SS C C Duration 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Plavix Prevacid Hydralazine Multi Vitamin Iron Lopid Date:04/24/00ISR Number: 3492908-9Report Type:Periodic Age:62 YR Gender:Male I/FU:I Outcome Dose Other 100.00 MG C C C C C C Company Report #A007326 PT Report Source Product Role Manufacturer Route Chromatopsia Consumer Viagra Tablets PS ORAL Neurontin SS ORAL Duration Drug Ineffective TOTAL PRN ORAL ORAL Date:04/26/00ISR Number: 3493066-7Report Type:Expedited (15-DaCompany Report #001-0073-M0000173 Age:22 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required 200 MG QAM, Intervention to 100 MG QPM, Prevent Permanent PER ORAL; 200 Impairment/Damage MG QAM, 200 PT Report Source Product Role Manufacturer Route Chills Colonic Polyp Constipation Consumer Dilantin Kapseals 100 Mg (Phenytoin Sodium) PS ORAL Neurontin (Gabapentin) SS ORAL Dizziness Electroencephalogram Abnormal Gastrooesophageal Reflux MG QPM, PER Disease Hiatus Hernia SEE TEXT, PER Nausea ORAL Nervousness Paranoia Centrum (Vitamins Nos, Minerals Nos) C Date:04/26/00ISR Number: 3493518-XReport Type:Expedited (15-DaCompany Report #000418-SK917 Age: Gender: I/FU:I Outcome Dose Duration Other 100.000 MG QD PT Report Source Product Role Manufacturer Route Convulsion Health Celebrex PS ORAL Drug Interaction Professional Neurontin SS ORAL Tegretol SS ORAL PO 400.000 MG TID PO 500.000 MG QD PO Date:04/26/00ISR Number: 3493555-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000022 Age:43 YR Gender:Male I/FU:F Outcome Dose PT Report Source Product Role Agitation Anger Health Professional Neurontin (Gabapentin) PS 1800 MG (600 Convulsion MG, TID), PER Suicidal Ideation ORAL Propulsid (Cisapride) Nasalcrom (Cromoglicate Sodium) 22-Aug-2005 Page: 342 Manufacturer Route Duration 10:40 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Celebrex (Celecoxib) Copaxone (Glatiramer Acetate) Alphagan (Brimonidine Tartrate) Maxair (Pirbuterol Acetate) C C C C Date:04/26/00ISR Number: 3493556-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000375 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 PT Report Source Product Role Bronchitis Eye Disorder Consumer Neurontin Capsules 400 Mg (Gabapentin) PS Manufacturer Route ORAL Pruritus MG, TID), PER Scab ORAL (SEVERAL YEARS) Insulin (Insulin) Glucophage (Metformin Hydrochloride) Actos (Pioglitazone) C C C Date:04/26/00ISR Number: 3493557-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000022 Age:43 YR Gender:Male I/FU:F Outcome Dose PT Report Source Product Role Agitation Anger Health Professional Neurontin (Gabapentin) PS Propulsid (Cisapride) C Manufacturer Route Duration 1800 MG (600 Condition Aggravated MG, TID), PER Convulsion ORAL Suicidal Ideation ORAL Nasalcrom (Cromoglicate Sodium) Celebrex (Celecoxib) Copaxone (Glatirame Acetate) Alphagan (Brimonidine Tartrate) Maxair (Pirbuterol Acetate) Date:04/26/00ISR Number: 3559476-4Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose C C C C C Company Report #HQ1012110FEB2000 PT Report Source Product Role Manufacturer Route Drug Interaction Neuropathy Peripheral Consumer Alesse PS Wyeth Ayerst Laboratories Inc ORAL Duration 1 TABLET 1 X PER 1 DAY, ORAL Celecoxib Neurontin Pamelor Synthroid 22-Aug-2005 Page: 343 10:40 AM SS SS SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/00ISR Number: 3493649-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000301 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Abnormal Dreams Amblyopia Consumer Neurontin Tablets 600 Mg (Gabapentin) PS Pain Medication Unspecified Celexa C C Manufacturer Route ORAL Amnesia MG, TID), PER Back Pain ORAL; 2400 MG Confusional State (600 MG BID, Coordination Abnormal 1200 MG QHS), Cyst Delusional Disorder, Persecutory Type Depression Dizziness Drug Withdrawal Syndrome Dry Mouth Dry Throat Dysarthria Euphoric Mood Fatigue Feeling Abnormal Headache Hostility Meningeal Disorder Muscle Twitching Oedema Thinking Abnormal Tremor Vomiting Weight Decreased Date:04/27/00ISR Number: 3493651-2Report Type:Expedited (15-DaCompany Report #033-0945-M0000036 Age:11.5 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Drug Effect Decreased Foreign Neurontin Duration Role Manufacturer Route Mydriasis Study (Gabapentin) PS ORAL 1200 MG Health (DAILY), PER Professional ORAL; 2000 MG (DAILY), PER ORAL Date:04/28/00ISR Number: 3494391-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000387 Age:1 DY Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Health Professional Neurontin (Gabapentin) PS Tegretol (Carbamazepine) SS Trazodone Prenatal Vitamins Folic Acid C C C Duration TRANSPLACENTAL Complications Of Maternal Exposure To Therapeutic SEE TEXT , Drugs PLACENTAL TRANSPLACENTAL Growth Retardation Premature Baby SEE TEXT, PLACENTAL 22-Aug-2005 Page: 344 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/00ISR Number: 3494392-8Report Type:Expedited (15-DaCompany Report #032-0945-M0000017 Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG PT Report Source Product Role Manufacturer Route Convulsion Lung Disorder Foreign Study Gabapentin (Gabapentin) PS ORAL Gabapentin (Gabapentin) SS ORAL (Valproate Sodium) (Phenytoin) (Vigabatrin) C C C Health (DAILY), PER Professional ORAL 800 MG (DAILY) PER ORAL; 1200MG,1600MG ; 2000MG; Date:05/03/00ISR Number: 3496584-0Report Type:Expedited (15-DaCompany Report #WAES 00021101 Age:66 YR Gender:Female I/FU:F Outcome Dose Duration Death PO Life-Threatening Hospitalization PO Initial or Prolonged Other PT Report Source Product Role Cholestasis Health Tab Vioxx PS ORAL Condition Aggravated Hepatic Cirrhosis Professional Neurontin Celebrex SS SS ORAL Ambien Cozaar Klonopin Norvasc Percocet Reglan C C C C C C Hepatic Failure Hepatic Neoplasm Malignant Hepatitis Cholestatic Hyperbilirubinaemia Jaundice Liver Function Test Abnormal Manufacturer Route Prothrombin Time Prolonged Date:05/03/00ISR Number: 3496676-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000397 Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Abdominal Pain Blepharospasm Consumer Neurontin Capsules 300 Mg (Gabapentin) PS Oxycontin (Oxycodone Hydrochloride) C Diarrhoea Eye Rolling Hyperhidrosis Intervertebral Disc Protrusion Mood Swings Muscle Twitching Pyrexia Tongue Disorder Manufacturer Route ORAL Date:05/03/00ISR Number: 3496680-8Report Type:Expedited (15-DaCompany Report #033-0945-M0000037 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL 22-Aug-2005 Page: 345 10:40 AM PT Report Source Product Role Abdominal Pain Upper Liver Function Test Foreign Health Neurontin (Gabapentin) PS Abnormal Professional Unspecified Hormonal Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Replacement C Date:05/03/00ISR Number: 3496913-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000403 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 4000 MG (800 PT Report Source Product Role Pulmonary Fibrosis Respiratory Distress Health Professional Neurontin Tablets 800 Mg (Gabapentin) PS Manufacturer Route ORAL MG TID, 1600 MG QHS), PER ORAL Zoloft (Sertraline Hydrochloride) Depakote (Valproate Semisodium) C C Date:05/08/00ISR Number: 3498035-9Report Type:Expedited (15-DaCompany Report #A014180 Age: Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Pain Road Traffic Accident Consumer Zoloft Tablets Neurontin Xanax Lorcet Acetaminophen/Propox yphene Napsylate Hctz/Triamterene Omeprazole Gemfibrozil Famotidine Other Medication PS SS SS SS Date:05/09/00ISR Number: 3498444-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000421 Age:72 YR Gender:Female I/FU:I C C C C C C Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE, Other PER ORAL PT Report Source Product Role Manufacturer Route Arterial Occlusive Disease Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Cerebrovascular Accident Dermatitis Drug Interaction Headache Aspirin (Acetylsalicylic Acid) SS 325 MG Loss Of Consciousness (DAILY), PER Rosacea ORAL Premarin (Estrogens Conjugated) Aldactone (Spironolactone) Prilosec (Omeprazole) (Allopurinol) Wellbutrin (Amfebutamone Hydrochloride) Diamox (Acetazolamide) (Oxybutynin) Synthroid (Levothyroxine 22-Aug-2005 Page: 346 10:40 AM C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) Kaon Cl 10 (Potassium Chloride) Date:05/10/00ISR Number: 3497915-8Report Type:Direct Age:30 YR Gender:Female I/FU:I Outcome Dose PT C C Company Report # Report Source Product Role Manufacturer PS Parke-Davis SS Parke Davis Route Duration Medication Error Neurontin (Gabapeptin) Rezulin (Troglitazine) Date:05/11/00ISR Number: 3499450-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000434 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Convulsion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Topamax (Topiramate) Valium (Diazepam) Prozac (Fluoxetine Hydrochloride) Desyrel (Trazodone Hydrochloride) Zanaflex (Tizanidine) Lasix (Furosemide) (Potassium) (Glucosamine) (Calcium) Multi Vitamin (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C C Duration 2400 MG (DAILY) C C C C C C C C Route Date:05/12/00ISR Number: 3500049-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000424 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Blood Bilirubin Increased Cholelithiasis Jaundice Liver Function Test Abnormal Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd (Prednisone) Antivert (Nicotinic Acid, Meclozine Hydrochloride) C Route Duration C Date:05/12/00ISR Number: 3500051-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000192 Age:8 YR Gender:Female I/FU:I Outcome Dose Other 1200 MG (400 MG, TID), PER ORAL 22-Aug-2005 Page: 347 PT Report Source Product Role Manufacturer Route Deafness Otitis Media Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/00ISR Number: 3500052-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000074 Age:74 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (QHS), Other PER ORAL PT Report Source Product Role Manufacturer Route Atrial Flutter Coma Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Depressed Level Of Consciousness Dermatitis Diabetes Mellitus Inadequate Control Headache Hyperglycaemia Laceration Lethargy Nasal Congestion Pyrexia Renal Failure Acute Skin Exfoliation Sneezing Toxic Epidermal Necrolysis Vasculitis Vomiting Avandia (Rosiglitazone) Synthroid (Levothyroxine Sodium) Ecotrin (Acetylsalicylic Acid) Trental (Pentoxifylline) Diovan (Valsartan) Trandate (Labetalol Hydrochloride) Insulin N (Insulin) Normodyne (Labetalol Hydrochloride) C C C C C C C C Date:05/12/00ISR Number: 3500082-5Report Type:Expedited (15-DaCompany Report #009-056-0089670-00 (0) Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Ileus Paralytic Mesenteric Occlusion Foreign Health Professional Depakene PS Abbott Laboratories Pharmaceutical Products Div ORAL PER ORAL Gabapentin (Gabapentin) 3600 MG, 1 IN 1D, PER ORAL SS ORAL Date:05/15/00ISR Number: 3499784-9Report Type:Direct Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization TID Initial or Prolonged PT Company Report # Report Source Product Role Manufacturer Route Fall Neurontin 300mg Tid PS ORAL Lethargy Loss Of Consciousness Depakote 500 In Am & 1000mg At Night SS ORAL Oxybutynin Celexa Lorazepam Clozapine ... C C C C C 500 MG PO IN Syncope AM; 1000 MG PO AT NIGHT Date:05/17/00ISR Number: 3501974-3Report Type:Periodic Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 348 10:40 AM Company Report #S99-USA-02204-01 PT Report Source Product Role Manufacturer Bradycardia Hypotension Sedation Health Professional Company Representative Celexa PS Forest Laboratories Inc Neurontin SS Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/00ISR Number: 3501821-XReport Type:Expedited (15-DaCompany Report #044-0945-M0000073 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG PT Report Source Product Role Manufacturer Route Hepatitis Hypoglycaemia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Liver Function Test Professional (DAILY), PER Abnormal ORAL (Amitriptyline) Thyroxine (Levothyroxine Sodium) (Traamadol) (Dihydrocodeine) (Paracetamol) (Insulin) C C C C C C Date:05/22/00ISR Number: 3502357-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000461 Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE Other PT Report Source Product Role Manufacturer Route Arthralgia Back Pain Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Constipation Depression Dysuria Groin Pain Nephrolithiasis Pain Pyrexia Date:05/22/00ISR Number: 3503320-8Report Type:Direct Age:52 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Other 300 MG HS Dermatitis Health Pruritus Professional Date:05/22/00ISR Number: 3504442-8Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Other Neurontin PS Company Report #99USA11129 PT Report Source Product Role Manufacturer Route Photosensitivity Reaction Systemic Lupus Consumer Tegretol-Xr PS Novartis Pharmaceuticals Corp ORAL Duration 400 MG, BID, Erythematosus ORAL White Blood Cell Count Decreased Neurontin Tablet 300 Mg (Gabapentin) SS Imitrex Inderal Prednisone C C C ORAL 600 MG, DAILY,ORAL Date:05/24/00ISR Number: 3504448-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000347 Age:10 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 22-Aug-2005 Page: 349 10:40 AM PT Report Source Product Role Manufacturer Route Convulsion Status Epilepticus Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG, BID), PER ORAL Gabitril (Tiagabine) SS ORAL SEE IMAGE Methylphenidate (Methylphenidate) Risperdal (Risperidone) C C Date:05/24/00ISR Number: 3504450-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000260 Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG PT Report Source Product Role Manufacturer Route Arrhythmia Bipolar Disorder Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Chest Pain (QHS), PER Condition Aggravated ORAL Faecaloma Memory Impairment Pain In Extremity Sedation Weight Increased Synthroid (Levothyroxine Sodium) Estrace (Estradiol) Sinequan (Doxepin Hydrochloride) Depakote (Valproate Semisodium) Zestril (Lisinopril) C C C C C Date:05/24/00ISR Number: 3504470-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000446 Age:36 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Colour Blindness Ear Pain Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 600 MG (300 Eye Movement Disorder MG, BID), PER Eye Pain ORAL Headache Hyperaesthesia Hyperthyroidism Muscle Disorder Photosensitivity Reaction Visual Acuity Reduced Visual Disturbance Mestinon (Pyridostigmine Bromide) Paxil (Paroxetine Hydrochloride) Tapazole (Thiamazole) (Trazodone) (Prednisone) C C C C C Date:05/25/00ISR Number: 3504988-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000488 Age: Gender:Male I/FU:I Outcome Dose Death 22-Aug-2005 Page: 350 PT Report Source Product Role Manufacturer Pulmonary Oedema Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Unspecified Medications C Duration 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/00ISR Number: 3565099-3Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #JRFUSA2000002822 PT Report Source Product Role Manufacturer Route Chest Pain Chills Depersonalisation Health Professional Propulsid PS Janssen Research Fdn Div Johnson And Johnson ORAL Duration 20 MG, 3 IN 1 Headache DAY (S), ORAL Myalgia Nausea Neurontin (Gabapentin) SS Visual Disturbance Vomiting Lasix Trilisate Hydrocodone Imodium Cystospaz Trimpex Miacalcin Vasotec Hytrin Evista Zantac C C C C C C C C C C C ORAL ORAL Date:05/31/00ISR Number: 3506570-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000496 Age:1 DY Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Manufacturer Cardiac Aneurysm Complications Of Maternal Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Unspecified Anti-Nausea Medication Prenatal Vitamins C C PLACENTAL Exposure To Therapeutic Drugs Congenital Anomaly Date:05/31/00ISR Number: 3506574-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000493 Age:1 DY Gender:Female I/FU:I Route Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Manufacturer Complications Of Maternal Exposure To Therapeutic Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Prenatal Vitamins C Route SEE TEXT, Drugs PLACENTAL Congenital Anomaly Microcephaly Date:05/31/00ISR Number: 3506578-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000504 Age:18 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Bone Disorder Bone Infection Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1800 MG (300 Infection MG , EVERY 4 Jaw Disorder HOURS), PER Oral Soft Tissue Disorder ORAL Hytrin Catapres (Baclofen) Prevacid Effexor Remeron Septra 22-Aug-2005 Page: 351 10:40 AM C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Nifedipine) Ms Contin Dalmane Percocet (Prednisone) (Nortriptyline) Cipro (Ciprofloxacin Hydrochloride) Date:06/02/00ISR Number: 3507300-8Report Type:Direct Age:70 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Hypoglycaemia Required 1/2 OF 8MG Intervention to TAB QD PO Prevent Permanent Impairment/Damage OPHTHALMIC 1T CAP PO QD C C C C C C C Company Report # Report Source Product Role Avandia 8 Mg Tab -1/2 Tab Qd PS Neurontin 300mg Cap Qd SS ... C Manufacturer Route ORAL Date:06/02/00ISR Number: 3507547-0Report Type:Expedited (15-DaCompany Report #A014180 Age: Gender:Male I/FU:F Outcome PT Dose Duration Required Decreased Activity Intervention to Pain UNKNOWN UNKNOWN Prevent Permanent Road Traffic Accident UNKNOWN UNKNOWN Impairment/Damage UNKNOWN UNKNOWN UNKNOWN Report Source Product Role Manufacturer Consumer Health Zoloft PS Pfizer Pharmaceuticals Inc Professional Neurontin SS Xanax SS Lorcet SS Acetaminophen/Propox yphene Napsylate Hctz/Triamterene Omeprazole Gemfibrozil C C C C UNKNOWN Route Famotidine Other Medication C C Date:06/05/00ISR Number: 3508848-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000487 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Ecchymosis Retinal Haemorrhage Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Product Role Manufacturer Amnesia Neurotin PS Cognitive Disorder Klonapin SS Road Traffic Accident Lamictal SS Speech Disorder Lithium SS Date:06/06/00ISR Number: 3508774-9Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening SEE IMAGE PT Company Report # Report Source SEE IMAGE SEE IMAGE SEE IMAGE Visual Acuity Reduced 22-Aug-2005 Page: 352 Route Duration 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/00ISR Number: 3509324-3Report Type:Expedited (15-DaCompany Report #033-0945-M0000022 Age:74 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization 1200 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Manufacturer Route Aphasia Electroencephalogram Foreign Study Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Abnormal Health Epilepsy Professional ORAL Fall Haemorrhagic Stroke Head Injury Hemiplegia Gardenal (Phenobarbital) Lioresal (Baclofen) Tildiem (Diltiazem Hydrochloride) Nitriderm (Glyceryl Trinitrate) Ecazide (Hydrochlorothiazide , Captopril) C C C C C Date:06/06/00ISR Number: 3509327-9Report Type:Expedited (15-DaCompany Report #033-0945-M0000012 Age:89 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Atrial Fibrillation Cardiac Disorder Foreign Study Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Cardiac Enzymes Increased Health Electrocardiogram Professional Duration 1200 MG (DAILY), PER ORAL Abnormal Myocardial Infarction Pulmonary Oedema Ventricular Fibrillation Adancor (Nicorandil) Renitec (Enalapril Maleate) Kardegic (Acetylsalicylate Lysine) Digoxine Nativelle (Digoxin) Lasilix (Furosemide) C C C C C Date:06/07/00ISR Number: 3508630-6Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT Company Report #UPC 081291 Report Source Product Role Manufacturer Noroxin 400mg Neurontin (Gabapentin) PS Roberts Pharm SS Parke-Davis Duration Medication Error Date:06/07/00ISR Number: 3509637-5Report Type:Expedited (15-DaCompany Report #049-0945-M0000012 Age:56 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 353 10:40 AM PT Acetabulum Fracture Blood Iron Abnormal Colitis Difficulty In Walking Escherichia Infection Fall Gastric Ulcer Haematocrit Decreased Haemoglobin Decreased Haemorrhoids Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Steatosis Microcytic Anaemia Oesophageal Ulcer Dose Report Source Product Role Manufacturer Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Nonsteroidal Antiinrheumatic Medication SS Route Duration Pain Renal Cyst Rib Fracture Spondylolisthesis Acquired Urinary Tract Infection Date:06/07/00ISR Number: 3509913-6Report Type:Expedited (15-DaCompany Report #033-0945-M0000045 Age:56 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Optic Neuritis Retrobulbar Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Visual Disturbance Professional Dafalgan Route Duration PER ORAL C Date:06/08/00ISR Number: 3510771-4Report Type:Expedited (15-DaCompany Report #044-0945-M0000083 Age:6 YR Gender:Female I/FU:I Outcome Dose Death 8 PT Report Source Product Role Manufacturer Rhinorrhoea Sarcoma Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Professional (Carbamazepine) C Duration MON Date:06/14/00ISR Number: 3514932-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000421 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Other MG, TID), PER PT Report Source Product Role Manufacturer Route Cerebral Artery Occlusion Cerebrovascular Accident Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dermatitis Drug Interaction ORAL (SEE Headache IMAGE)/ YEARS Loss Of Consciousness Aspirin SS Premarin Aldactone Prilosec Allopurinol Wellbutrin Diamox Oxybutynin Synthroid Kaon Cl 10 Aspirin C C C C C C C C C C ORAL 325 MG Malaise (DAILY), PER Rosacea ORAL Date:06/15/00ISR Number: 3514232-8Report Type:Expedited (15-DaCompany Report #033-0945-M0000037 Age:50 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged UNK, PER ORAL 22-Aug-2005 Page: 354 10:40 AM PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Cholelithiasis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Liver Function Test Abnormal Professional Utrogestan (Progesterone) C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/00ISR Number: 3514245-6Report Type:Expedited (15-DaCompany Report #033-0945-M0000022 Age:74 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization 1200 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Manufacturer Route Aphasia Brain Contusion Foreign Study Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Electroencephalogram Health Abnormal Professional Manufacturer Route ORAL Epilepsy Fall Haemorrhagic Stroke Hemiplegia Date:06/16/00ISR Number: 3514712-5Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG TID Initial or Prolonged PT Syncope Date:06/16/00ISR Number: 3514718-6Report Type:Direct Age:50 YR Gender:Male I/FU:I Gardenal (Phenobarbital) Lioresal (Baclofen) Tildiem (Diltazem Hydrochloride) Nitriderm (Glyceryl Trinitrate) Ecazide (Hydrochlorothiazide , Captopril) C C C C C Company Report # Report Source Product Role Gabapentin PS Percocet Ca Acetate Diltiazem Prevacid Combivent Flexeril Flezeril Zoloft Cipro C C C C C C C C C Company Report # Outcome Dose Duration Hospitalization 900MG TID Initial or Prolonged PT Report Source Syncope Product Role Gabapentin PS Furosemide Elavil Baclofen C C C Manufacturer Route Route Date:06/16/00ISR Number: 3515102-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000556 Age:39 YR Gender:Male I/FU:I Outcome Dose Disability Other SEE IMAGE PT Report Source Product Role Manufacturer Blindness Unilateral Blood Pressure Increased Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Lamictal (Lamotrigine) SS Duration Convulsion Dizziness SEE IMAGE Dysarthria Dysgraphia Ecchymosis Haemorrhage Hepatic Function Abnormal Hepatitis C Retinal Vein Thrombosis Speech Disorder 22-Aug-2005 Page: 355 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/00ISR Number: 3515159-8Report Type:Direct Age:64 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report #USP 51901 Report Source Medication Error Date:06/19/00ISR Number: 3516052-7Report Type:Periodic Age:56 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Role Manufacturer Neurontin Noroxin (Norfloxacin) PS Parke-Davis SS Roberts Pharmaceutical Route Outcome Dose Duration Required Intervention to 3 PO QD Prevent Permanent 1 PO TID Impairment/Damage Report Source Product Role Manufacturer Colitis Fall Femur Fracture Gastric Ulcer Haemorrhoids Iron Deficiency Anaemia Obesity Urinary Tract Infection Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Nonsteroidal Antiinrheumatic Medication Unspecified SS Route Company Report # PT Report Source Product Role Dermatitis Health Professional Dilantin 300mg Capseal PS ORAL Neurontin 100mg SS ORAL Date:06/20/00ISR Number: 3515928-4Report Type:Direct Age: Gender:Male I/FU:I PT Duration Company Report #049-0945-M0000012 PT Date:06/20/00ISR Number: 3515844-8Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Product Duration Manufacturer Route Company Report # Report Source Product Role Manufacturer Route Hospitalization Hepatitis 400 MGM QID 3 MON Initial or Prolonged Liver Function Test Abnormal Health Gabapentin PS Professional Date:06/20/00ISR Number: 3516398-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000461 Age:63 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG Other (DAILY), PER PT Report Source Product Role Manufacturer Route Back Pain Dysuria Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Nephrolithiasis Pain ORAL Pyrexia Date:06/20/00ISR Number: 3516404-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000446 Age:36 YR Gender:Female I/FU:F Outcome Other 22-Aug-2005 Page: 356 PT Colour Blindness Ear Pain Eye Movement Disorder Eye Pain 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Headache Hyperthyroidism Myopathy Report Source Product Role Manufacturer Route Optic Neuropathy Photophobia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 600 MG (300 Tenderness MG, BID), PER Vision Blurred ORAL Visual Acuity Reduced Mestinon (Pyridostigmine Bromide) Paxil (Paroxetine Hydrochloride) Tapazole (Thiamazole) (Trazodone) (Prednisone) C C C C C Date:06/20/00ISR Number: 3516800-6Report Type:Expedited (15-DaCompany Report #049-0945-M0000012 Age:56 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Acetabulum Fracture Arthropathy Bladder Disorder Blood Iron Decreased Bone Disorder Colitis Cystitis Escherichia Difficulty In Walking Fall Haematocrit Decreased Haemoglobin Decreased Haemorrhoids Hepatic Steatosis Microcytic Anaemia Renal Cyst Rib Fracture Spondylolisthesis Acquired Ulcer Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Nonsteroidal Antiinrheumatic Medication SS Urinary Tract Infection Date:06/21/00ISR Number: 3517187-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000585 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Gastrointestinal Carcinoma Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Duration 200 MG DAILY Glyburide (Glibenclamide) (Glibenclamide) Procardia (Nifedipine) Calcium 22-Aug-2005 Page: 357 10:40 AM C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/00ISR Number: 3517277-7Report Type:Expedited (15-DaCompany Report #A013075 Age: Gender:Male I/FU:F Outcome Dose Disability PT Report Source Product Role Manufacturer Amputation Consumer Health Professional Glucotrol Nifedipine Glucophage Neurontin Imdur Lasix Plavix Prevacid Hydralazine Multi Vitamin Iron Lopid PS SS SS SS C C C C C C C C Pfizer Inc Route Duration Date:06/23/00ISR Number: 3518913-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000564 Age:45 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Anxiety Asthenia Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Duration 1500 MG Chronic Fatigue Syndrome (DAILY), PER Condition Aggravated ORAL 1300 Dizziness MG (DAILY), O Drug Dependence Euphoric Mood Viral Infection Date:06/26/00ISR Number: 3519080-0Report Type:Direct Age:53 YR Gender:Female I/FU:I Outcome Dose PT Duration Duragesic Patch (Fentanyl) Robaxin (Methocarbamol) C C Company Report # Report Source Product Role Other 100MG PO QD Nightmare Health Vomiting Professional Neurontin 100mg PS ORAL Date:06/26/00ISR Number: 3519483-4Report Type:Expedited (15-DaCompany Report #200166 Age:59 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 40 MG BID PO Initial or Prolonged PT Report Source Product Role Manufacturer Route Dehydration Health Oxycontin PS Purdue Pharma Lp ORAL Pneumonia Renal Failure Professional Company Neurontin (Gabapentin) SS Representative Medrol (Methylprednisolone) Naprosyn (Naproxen) Inderal (Propranolol) Prilosec (Omeprazole) Lotensin (Benazepril) Indocin (Indomethacin) Ambien (Zolpidem Tartrate) PO 22-Aug-2005 Page: 358 10:40 AM C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/00ISR Number: 3520577-8Report Type:Expedited (15-DaCompany Report #001-0945-990475 Age:9 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG (200 Other MG, BID), PER PT Report Source Product Role Manufacturer Route Abdominal Pain Gastric Ulcer Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Gastritis Glycosuria ORAL Haematochezia Malaise Nephritis Interstitial Nephrolithiasis Proteinuria Red Blood Cell Sedimentation Rate Increased Uveitis Vomiting Weight Decreased Date:06/28/00ISR Number: 3521445-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000456 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1500 MG PT Report Source Product Role Manufacturer Mental Disorder White Blood Cell Count Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Depakote (Valproate Semisodium) SS Ambien (Zolpidem Tartrate) C Decreased (DAILY); 2400 MG (800 MG, TID) 1000 MG (AT BEDTIME) Wellbutrin (Amfebutamone Hydrochloride) Lorazepam C C Date:06/30/00ISR Number: 3522928-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000384 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG (100 PT Report Source Product Role Manufacturer Paraesthesia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Neurontin Capsules 100 Mg (Gabapentin) SS Route Other MG BID AND 200 MG 400 MG (100 MG BID AND 200 MG HS), PER ORAL Diphenhydramine Divalproex (Valproate Semisodium) Hydroxyzine Citalopram Clonazepam 22-Aug-2005 Page: 359 10:40 AM C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/00ISR Number: 3522929-9Report Type:Expedited (15-DaCompany Report #044-0945-M0000100 Age: Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Cardiac Failure Congestive Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Coronary Artery Occlusion Professional Gabapentin (Gabapentin) SS Route Duration 300 MG (100 MG, TID) SEE IMAGE 600 MG (200, TID), 900 MG (300MG TID)600 MG (200 MG, TID) Date:06/30/00ISR Number: 3522931-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000616 Age:2 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Speech Disorder Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300 MG (100 MG, TID), PER ORAL Hydroxyzine Hydrochloride) Date:06/30/00ISR Number: 3522932-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000612 Age:76 YR Gender:Male I/FU:I C Outcome Dose Other PT Report Source Product Role Manufacturer Coordination Abnormal Prostate Cancer Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Neurontin Capsules 300 Mg (Gabapentin) SS Route Duration 600 MG (300 MG, TWO TIMES ORAL 600 MG (300 MG, TWO TIMES DAILY), PER ORAL Glucophage (Metformin Hydrochloride) Glucotrol (Glipizide) Lopid (Gemfibrozil) Vitamin E (Tocopherol) Flomax (Morniflumate) C C C C C Date:06/30/00ISR Number: 3523184-6Report Type:Expedited (15-DaCompany Report #034-0945-M0000032 Age:73 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG DAILY PT Report Source Product Role Manufacturer Route Dizziness Mouth Ulceration Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Vomiting Professional PER ORAL (Hydrochlorothiazide , Amiloride) 22-Aug-2005 Page: 360 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/00ISR Number: 3583462-1Report Type:Periodic Age:15 YR Gender:Female I/FU:I Outcome Dose Company Report #2000032 PT Report Source Product Role Manufacturer Route Anorexia Consumer Keppra PS Ucb Pharma Inc ORAL Depression Keppra SS ORAL Hallucination Neurontin SS ORAL Duration 500 MG 1/D PO 250 MG 2/D PO 300 MG DAILY Insomnia PO Nausea Sedation Vertigo Date:07/03/00ISR Number: 3523547-9Report Type:Expedited (15-DaCompany Report #M0456-2000 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 225 MG PO Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Coma Intentional Misuse Health Professional Remeron PS Organon Inc Sub Akzona Inc ORAL Route Suicide Attempt Benadryl Neurontin Prozac Unisom Lipitor Tricor SS SS SS SS C C Date:07/03/00ISR Number: 3524069-1Report Type:Expedited (15-DaCompany Report #049-0945-M0000012 Age:56 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Acetabulum Fracture Bladder Disorder Blood Iron Decreased Colitis Congenital Spondylolysis Escherichia Infection Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Nonsteroidal Antiinrheumatic Medication SS Fall Gastric Ulcer Haematocrit Decreased Haemorrhoids Hepatic Steatosis Microcytic Anaemia Musculoskeletal Disorder Oesophageal Ulcer Pain Renal Cyst Urinary Tract Infection Urine Analysis Abnormal Date:07/03/00ISR Number: 3524082-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000421 Age:72 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 361 10:40 AM PT Cerebral Artery Occlusion Drug Interaction Fatigue Headache Loss Of Consciousness Malaise Rosacea FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Transient Ischaemic Attack Vertigo Dose Report Source Product Role Manufacturer Route Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Weight Decreased 900 MG (300 MG, TID), PER ORAL Aspirin SS Premarin Aldactone Prilosec Allopurinol Wellbutrin Diamox Oxybutynin Synthroid Kaon Cl 10 Aspirin Mylosine C C C C C C C C C C C ORAL 325 MG (DAILY), PER ORAL Date:07/03/00ISR Number: 3524605-5Report Type:Expedited (15-DaCompany Report #A020973 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 100.00 MG Prevent Permanent TOTAL:DAILY Impairment/Damage 200.00 MG PT Report Source Product Role Manufacturer Anxiety Chest X-Ray Abnormal Consumer Zoloft PS Pfizer Pharmaceuticals Inc Celebrex SS Neurontin SS Confusional State Fear Influenza Like Illness TOTAL:BID Insomnia 900.00 MG Route Interstitial Lung Disease TOTAL:DAILY Lung Disorder Trazodone Pain Photophobia Scar Nicoderm (Subject Drug) Tylenol (Subject Drug) SS PRN Date:07/05/00ISR Number: 3524156-8Report Type:Direct Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 100MG 3 X DAY PT Agitation Convulsion ORAL Drug Interaction Dysarthria Injury Jaw Disorder Loss Of Employment Therapeutic Agent Toxicity Tremor 22-Aug-2005 Page: 362 10:40 AM C C Company Report # Report Source Product Role Neurontin 100mg PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525714-7Report Type:Expedited (15-DaCompany Report #001-0945-0000638 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization (X ONE DOSE), Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Route Circulatory Collapse Respiratory Arrest Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL (Baclofen) Vasotec (Enalapril Maleate) Elavil (Amitriptyline Hydrochloride) Fosamax (Alendronate Sodium) Dilaudid (Hydromorphone Hydrochloride) Prilosec (Omeprazole) Triamterene/Hctz (Hydrochlorothiazide , Triamterene) (Atenolol) Tegretol (Carbamazepine) Senekot (Senna Fruit) Date:07/06/00ISR Number: 3582416-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C C C C C C C C C Company Report #2000016289US PT Report Source Product Role Manufacturer Route Drug Interaction Feeling Hot Consumer Detrol PS Pharmacia And Upjohn Co ORAL Duration UNK, UNK, Flushing ORAL Pruritus Neurontin (Gabapentin) Estrace (Estradiol) SS SS Date:07/07/00ISR Number: 3526376-5Report Type:Expedited (15-DaCompany Report #001-0073-M0000261 Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300-600 MG Other DAILY, PER Required ORAL Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 363 10:40 AM PT Report Source Product Role Manufacturer Route Brain Neoplasm Brain Oedema Consumer Dilantin PS Parke Davis Div Warner Lambert Co ORAL Convulsion Drug Level Above Therapeutic Haematemesis Meningioma Nervous System Disorder Sedation Weight Decreased Neurontin (Gabapentin Slow Mag Magnesium Detropan SS C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/00ISR Number: 3526414-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000603 Age:54 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Amnesia Concussion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 200 MG (100 Confusional State MG, BID), PER Convulsion ORAL Dental Caries Ecchymosis Neurontin Tablets 600 Mg (Gabapentin) SS ORAL 3600 MG (1200 Enamel Anomaly MG TID), PER Fall ORAL Haemorrhage Head Injury Laceration Migraine Tooth Disorder Tooth Resorption Klonopin (Clonazepam) Paxil (Paroxetine Hydrochloride) C C Date:07/07/00ISR Number: 3526415-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000653 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Anaphylactoid Reaction Health Professional Other Neurontin PS Parke Davis Pharmaceuticals Ltd Vibramycin (Doxycycline Hyclate) SS Route Duration Date:07/07/00ISR Number: 3526416-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000652 Age:65 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Haematocrit Decreased Health Neurontin PS Parke Davis Duration Route Haemoglobin Decreased Professional Pharmaceuticals Ltd 1200 MG (400 MG, TID), PER ORAL Paxil (Paroxetine Hydrochloride) Glucophage (Metformin Hydrochloride0 Klonopin (Clonazepam) Prilosec (Omeprazole) Diovan (Valsartan) Cardura (Doxazosin Mesilate) Ditropan (Oxybutynin) Vioxx (Rofecoxib) Furosemide 22-Aug-2005 Page: 364 10:40 AM C C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/00ISR Number: 3526417-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000639 Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Acute Respiratory Distress Syndrome Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Dermatitis MG, TID), PER Eosinophilia ORAL Pneumonia Pyrexia Respiratory Failure Dulcolax (Bisacodyl) Colace (Docusate Sodium) Senna (Senna) Zantac (Ranitidine Hydrochloride) Reglan (Metoclopramide) Cacl Heparin Atrovent (Ipratropium Bromide) Albuterol (Salbutamol) Diazepam) Fentanyl Klonopin (Clonazepam) Methadone Decadron (Dexamethasone) C C C C C C C C C C C C C C Date:07/11/00ISR Number: 3527371-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000662 Age:28 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Abortion Spontaneous Complications Of Maternal Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration 1200 MG Exposure To Therapeutic (DAILY) Drugs Depakote (Valproate Semisodium) SS 1500 MG (DAILY) Folic Acid Prenatal Viamins (Ergocalciferol, Ascoric Acid, Pyridoxine Hydrochloride, Baby Aspirin (Acetylsalicylic Acid) C C C Date:07/11/00ISR Number: 3527372-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000661 Age: Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Complications Of Maternal Exposure To Therapeutic Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration PLACENTAL; IN Drugs UTERO Intra-Uterine Death EXPOSURE Depakote (Valoproate 22-Aug-2005 Page: 365 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) SS PLACENTAL IN UTERO EXPOSURE Date:07/11/00ISR Number: 3527375-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000659 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Abortion Spontaneous Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Depakote (Valproate Semisodium) ... ... SS C C Route Duration Date:07/11/00ISR Number: 3527788-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000004632 Age:54 YR Gender:Female I/FU:I Outcome Dose Death TRANSDERMAL PT Report Source Product Role Manufacturer Health Duragesic PS Alza Corp Professional Paroxetine (Paroxetine) Carisoprodol (Carisoprodol) Methadone (Methadone) Alprazolam (Alprazolam) Propoxyphene (Dextropropoxyphene) Gabapentin (Gabapentin) Meperidine Hydrochloride (Pethidine Hydrochloride) Duration Death 75, TRANSD Overdose SS SS SS SS SS SS SS Route Date:07/12/00ISR Number: 3527368-2Report Type:Expedited (15-DaCompany Report #033-0945-M0000036 Age:11 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Drug Ineffective Mydriasis Foreign Study Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Health Professional Magne-Be (Pyridoxine Hydrchloride, Magnesium Lactate) Duration SEE IMAGE Date:07/14/00ISR Number: 3529931-1Report Type:Expedited (15-DaCompany Report #033-0945-M0000060 Age:32 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 366 PT Abortion Spontaneous Complications Of Maternal Exposure To Therapeutic Drugs Condition Aggravated Intra-Uterine Death Mediastinum Neoplasm 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Tract Neoplasm Teratoma Dose Report Source Product Role Manufacturer Route Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1600 MG Professional (DAILY), PER ORAL Carbamazepine SS ORAL 600 MG (DAILY), PER ORAL Date:07/14/00ISR Number: 3529933-5Report Type:Expedited (15-DaCompany Report #033-0945-M0000061 Age: Gender:Unknown I/FU:I Outcome PT Dose Duration Death Abortion Spontaneous Life-Threatening Complications Of Maternal TRANSPLACENTAL SEE TEXT, Congenital Anomaly Exposure To Therapeutic PLACENTAL IN Other Drugs UTERO Multiple Congenital EXPOSURE Abnormalities TRANSPLACENTAL SEE TEXT, Neuroblastoma PLACENTAL IN Teratoma UTERO Report Source Product Role Manufacturer Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Carbapazepine SS Professional EXPOSURE Date:07/17/00ISR Number: 3530654-3Report Type:Expedited (15-DaCompany Report #048-0945-M0000001 Age: Gender:Unknown I/FU:I Route Outcome Dose Death PT Report Source Product Role Manufacturer Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd (Carbamazeppine( C Route Duration TRANSPLACENTAL Complications Of Maternal Exposure To Therapeutic SEE TEXT, Drugs Professional PLACENTAL Stillbirth Date:07/17/00ISR Number: 3530655-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000684 Age:31 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Clonic Convulsion Grand Mal Convulsion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1200 MG (400 Loss Of Consciousness MG, TID); Salivary Hypersecretion ORAL Urinary Incontinence (Oxycodone) (Ibuprofen) Remeron (Mirtazapine) Date:07/17/00ISR Number: 3530680-4Report Type:Expedited (15-DaCompany Report #00F--10588 Age:32 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 367 10:40 AM PT Abortion Spontaneous Complications Of Maternal Exposure To Therapeutic Drugs Intra-Uterine Death Neoplasm C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Teratoma Dose Report Source Product Role Manufacturer Route Foreign Health Tegretol-Xr PS Novartis Pharmaceuticals Corp ORAL Duration 800 MG DAILY Professional ORAL Other Neurontin Capsule (Gabapentin) SS ORAL 1600 MG DAILY ORAL Date:07/20/00ISR Number: 3532098-7Report Type:Direct Age:20 YR Gender:Female I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Manufacturer Route Neurontin 300mg (Parke-Davis) PS Parke Davis ORAL Product Role Manufacturer Route Gingival Bleeding Neurontin 300mg PS Medication Error Retinal Haemorrhage Meclomen Premarin Claritin C C C Duration Dyspnoea Feeling Jittery TID PO Hyperventilation (300MG) Date:07/20/00ISR Number: 3532361-XReport Type:Direct Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Required 300 4 ORAL Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Date:07/20/00ISR Number: 3532568-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000603 Age:54 YR Gender:Female I/FU:F ORAL Outcome Dose Disability Other 300-3000 MG PT Report Source Product Role Manufacturer Route Amnesia Bronchitis Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Concussion (DAILY), PER Confusional State ORAL;3600 MG Convulsion 9DAILY), PER Dental Caries ORAL Ecchymosis Fall Haemorrhage Head Injury Injury Laceration Loss Of Consciousness Migraine Oedema Respiratory Disorder Tooth Disorder Tooth Extraction Tooth Injury Weight Increased 22-Aug-2005 Page: 368 10:40 AM Klonopin (Clonazepam) Paxil (Paroxetine Hydrochloride) Premarin (Estrogens Conjugated) C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/00ISR Number: 3533344-6Report Type:Direct Age:58 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report # Report Source Sexual Dysfunction Date:07/25/00ISR Number: 3534544-1Report Type:Direct Age:45 YR Gender:Female I/FU:I Outcome Dose Disability Other TID 300MG Product Role Gabapentin PS Manufacturer Route Manufacturer Route Duration PT Company Report # Report Source Product Role Neurontin 300mg Tid X 7 PS Duration Arthralgia Depression 7 DAY Joint Stiffness Joint Swelling Listless Date:07/25/00ISR Number: 3535251-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000704 Age:68 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Joint Dislocation Urinary Incontinence Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 Company MG, TID), PER Representative ORAL Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, Advil (Ibuprofen) Date:07/27/00ISR Number: 3536358-5Report Type:Expedited (15-DaCompany Report #055-0945-M0000003 Age:75 YR Gender:Female I/FU:F C C Outcome Dose Other PT Report Source Product Role Manufacturer Route Lymphopenia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional Captopril Nifedipine Hydrochlorothiazide Glibenclamide Duration 800 MG, PO C C C C Date:07/27/00ISR Number: 3536593-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000652 Age:65 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Haematocrit Decreased Haemoglobin Decreased Health Professional Neurontin PS Boston Life Sciences Inc ORAL Duration 1200 MG (400 MG, TID), PER ORAL Paxil (Paroxetine Hydrochloride) Glucophage (Metformin Hydrochloride) Klonopin (Clonazepam) Prilosec 22-Aug-2005 Page: 369 10:40 AM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Omeprazole) Diovan (Valsartan) Cardura (Doxazosin Mesilate) Ditropan (Oxybutynin) Vioxx (Rofecoxib) Furosemide Date:07/28/00ISR Number: 3537248-4Report Type:Direct Age:70 YR Gender:Male I/FU:I Outcome Dose PT C C C C C C Company Report # Report Source Product Role Neurontin PS Trental Elavil Vasotec Lipitor Glucophage Glipizide Tylenol With Codeine Arthrotec Plavix C C C C C C C C C Manufacturer Route Duration Faecal Incontinence ORAL PO 2700MG Date:07/28/00ISR Number: 3540354-1Report Type:Periodic Age:54 YR Gender:Male I/FU:I Outcome Dose Other 20 MG THREE Company Report #8-99104-073A PT Report Source Product Role Manufacturer Route Confusional State Consumer Ponderex PS Ah Robins Co ORAL Neurontin SS Duration Convulsion TIMES DAILY, Lethargy ORAL Syncope 2 TABLETS EVERY 4 HOURS AS NEEDED Prozac SS Ultram SS Amitriptyline SS Propulsid Tagamet C C 40 MG DAILY 2 TABLETS EVERY 4 HOURS AS NEEDED 50MG AT BEDTIME Date:07/31/00ISR Number: 3537477-XReport Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other 300MG PT Company Report # Report Source Product Role Manufacturer Route Neurontin 300mg Parke Davis PS Parke Davis ORAL Plaquenil C Duration Chest Discomfort Dyspnoea 1 DOSE Dystonia ORAL Myalgia Sedation Suffocation Feeling Swelling 22-Aug-2005 Page: 370 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/00ISR Number: 3538330-8Report Type:Expedited (15-DaCompany Report #2000UW02610 Age:89 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 50 MG DAILY PT Report Source Product Role Manufacturer Route Hypoventilation Respiratory Depression Foreign Health Elavil PS Astrazeneca Pharmaceuticals Lp ORAL Professional PO Other Gabapentin SS Fentanyl SS ORAL 2700 MG DAILY PO 2400 UG TP Date:08/01/00ISR Number: 3539513-3Report Type:Expedited (15-DaCompany Report #044-0945-M0000114 Age:1 DY Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly TRANSPLACENTAL PT Complications Of Maternal Exposure To Therapeutic PLACENTAL Drugs Report Source Product Role Manufacturer Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd (Valproate Sodium) SS Route Professional (IN UTERO Congenital Anomaly EXPOSURE) TRANSPLACENTAL PLACENTAL (IN UTERO EXPOSURE) Date:08/02/00ISR Number: 3540047-0Report Type:Expedited (15-DaCompany Report #032-0945-M0000002 Age:32 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Depression Foreign Neurontin PS Parke Davis Route Initial or Prolonged 1200 MG Study Pharmaceuticals Ltd ORAL Health (DAILY), PER Professional ORAL Valproate (Valproate Bismuth) Clonazepam Venlafaxine Dicalium Chlorazepate C C C C Date:08/02/00ISR Number: 3540480-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000603 Age:54 YR Gender:Female I/FU:F Outcome Dose Disability Other 300-3000 MG PT Report Source Product Role Manufacturer Route Amnesia Bronchitis Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Bronchospasm (DAILY), PER Concussion ORAL; DOSE Confusional State INCREASE TO Convulsion 3600 MG Dental Caries Dyspnoea Ecchymosis Fall Haemorrhage Loss Of Consciousness Migraine Oedema Tooth Disorder Weight Increased 22-Aug-2005 Page: 371 10:40 AM Klonopin Paxil Premarin C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/00ISR Number: 3542522-1Report Type:Direct Age:5 MON Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 50 MG TID Company Report # PT Report Source Product Role Choreoathetosis Hypotonia Health Professional Neurontin 100mg Capsules PS Manufacturer Route Manufacturer Route Sedation Date:08/08/00ISR Number: 3548549-8Report Type:Direct Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Cataract Product Role Neurontin 300mg Caps 3 X Daily PS Date:08/09/00ISR Number: 3546749-4Report Type:Expedited (15-DaCompany Report #044-0945-M0000121 Age:81 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100 MG (QHS), PT Report Source Product Role Manufacturer Route Leukocytoclastic Vasculitis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Purpura Professional PER ORAL (Bumetanide) (Penicillamine) Imdur (Isosorbide Mononitrate) Iron Sulfate (Ferrous Sulfate) (Macrogol) Aspirin (Acetylsalicylic Acid) (Salbutamol) Atrovent (Ipratropium C C C C C C C Bromide) C Date:08/09/00ISR Number: 3546777-9Report Type:Expedited (15-DaCompany Report #033-0945-M0000066 Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Coma Dyspnoea Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Laryngeal Disorder Professional 200 MG DAILY PER ORAL Lung Disorder Respiratory Depression Laroxyl (Amitriptyline Hydrochloride) SS ORAL Lioresal (Baclofen) SS ORAL Lexomil (Bromazepam) SS ORAL Levothyrox (Levothyroxine Sodium) Diffu-K (Potassium Chloride) C 25 MG DAILY PER ORAL 15 MG DAILY PER ORAL 9 MG DAILY PER ORAL 22-Aug-2005 Page: 372 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/00ISR Number: 3546781-0Report Type:Expedited (15-DaCompany Report #032-0945-M0000023 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Myocardial Infarction Vasospasm Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration Date:08/09/00ISR Number: 3546783-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000721 Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Chest Pain Hallucinations, Mixed Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Nausea MG, TID) PER ORAL Vasotec (Enalapril Maleate) Prilosec (Omeprazole) Inderal (Propranolol Hydrochloride) Buspar (Buspirone Hydrochloride) Wellbutrin (Amfebutamone Hydrochloride) Depakote (Valproate Semisodium) C C C C C C Date:08/09/00ISR Number: 3546786-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000653 Age:55 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (ONE PT Report Source Product Role Manufacturer Route Anaphylactic Reaction Dyspnoea Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Throat Tightness Other DOSE ONLY) Urticaria PER ORAL Vibramycin (Doxycycline Hyclate) SS 100 MG (ONE DOSE ONLY) (Guaifenesin) Bupropion (Amfebutamone) (Simvastatin) (Atenolol) (Liothyronine) Enteric Coated Aspirin (Acetylsalicylic Acid) Date:08/09/00ISR Number: 3546788-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000220 Age:84 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 373 PT Deafness Hearing Impaired 10:40 AM C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Macular Degeneration Vision Blurred Dose Report Source Product Role Manufacturer Route Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 100 MG DAILY PER ORAL; 1200 MG (400 MG TID) PER ORAL; 900 MG (Choline Magnesium Trisalicylate) C Date:08/10/00ISR Number: 3548299-8Report Type:Expedited (15-DaCompany Report #00F--10677 Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 15 MG DAILY Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Coma Depressed Level Of Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Consciousness Professional Drug Interaction Dyspnoea Other Lexomil Tablet (Bromazepam) SS ORAL Laroxyl Tablet (Amitriptyline Hydrochloride) SS ORAL Neurontin Capsule (Gabapentin) SS ORAL Diffu-K Capsule C 9 MG DAILY Laryngeal Disorder ORAL Lung Disorder Overdose Respiratory Depression 25 MG Respiratory Disorder DAILYORAL 200 MG DAILY ORAL Levothyrox Tablet C Date:08/14/00ISR Number: 3550651-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000684 Age:31 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Clonic Convulsion Grand Mal Convulsion Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 1200 MG (400 Loss Of Consciousness MG TID) PER Urinary Incontinence ORAL (Oxycodone) (Ibuprofen) Remeron (Mirtazapine) C C C Date:08/14/00ISR Number: 3550652-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000742 Age:73 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Pain Sensory Loss Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Ultram (Tramadol Hydrochloride) SS Transient Ischaemic MG TID) : Attack 2400 MG (600 Vomiting MG QID) Vulval Disorder 600 MG (100 MG PRN EVERY 4 HOURS) 22-Aug-2005 Page: 374 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/00ISR Number: 3550701-2Report Type:Expedited (15-DaCompany Report #032-0945-M0000017 Age:33 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1) 400 MG, 2) PT Report Source Product Role Manufacturer Route Convulsion Lung Disorder Foreign Study Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Health 800 MG, 3) Professional 1200 MG, 4) 1600 MG, 5) 2000 MG, 6) (Valproate Sodium) (Phenytoin) (Vigabatrin) C C C Date:08/14/00ISR Number: 3550704-8Report Type:Expedited (15-DaCompany Report #044-0945-M0000094 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1)300 MG PT Report Source Product Role Manufacturer Route Bronchospasm Oedema Peripheral Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional (DAILY), PER ORAL; 2) 600 MG (DAILY), PER ORAL; 3) Mst (Morphine Sulfate) (Diazepam) Voltarol (Diclofenac Sodium) Prothiaden (Dosulepin) C C C C Date:08/15/00ISR Number: 3550788-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000748 Age:65 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Cardiac Failure Congestive Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Condition Aggravated Company Route Duration 900 MG (DAILY) 1 WK Representative Date:08/15/00ISR Number: 3550789-9Report Type:Expedited (15-DaCompany Report #033-0945-M0000021 Age:87 YR Gender:Female I/FU:F Outcome Dose Duration Death Hospitalization 100 MG Initial or Prolonged INCREASED TO PT Report Source Product Role Manufacturer Blood Bilirubin Increased Cholestasis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Diarrhoea Professional Hepatitis 600 MG Liver Function Test Abnormal Pyrexia Vomiting 22-Aug-2005 Page: 375 10:40 AM Renitec (Enlapril Maleate) Lasilix (Fursemide) Nitriderm (Glyceryl Trinitrate) Loxen (Nicardipine) Digoxine (Digoxin) Asasantine (Acetylsalicylic Acid, Dipyridamole) C C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/00ISR Number: 3551074-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000534 Age:84 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Condition Aggravated Confusional State Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1100 MG Decreased Appetite (DAILY), PER Delusion ORAL Difficulty In Walking Drug Level Above Neurontin (Gabapentin) SS ORAL 600 MG Therapeutic (DAILY), PER Feeding Disorder ORAL Hallucination, Visual Psychotic Disorder Vascular Dementia Visual Disturbance Zoloft (Sertraline Hydrochloride) Synthroid (Levothyroxine Sodium) Prinivil (Lisinopril) Lipitor (Atorvastatin) Os-Cal (Ergocalciferol, Calcium) Risperdal (Risperidone) C C C C C C Date:08/15/00ISR Number: 3551075-3Report Type:Expedited (15-DaCompany Report #033-0945-M0000065 Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (DAILY), PER PT Report Source Product Role Manufacturer Route Infection Leukopenia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Lung Disorder Professional Neutropenia ORAL Nootropyl (Piracetam) C Date:08/15/00ISR Number: 3551076-5Report Type:Expedited (15-DaCompany Report #032-0945-M0000010 Age:38 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Completed Suicide Intentional Misuse Foreign Study Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Health Professional (Carbamazepine) (Loprazolam) Sertralin (Sertraline) (Periciazin (Periciazine) (Prothipendyl) (Prothipendyl) Duration ORAL Date:08/16/00ISR Number: 3551317-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000488 Age: Gender:Male I/FU:I Outcome Death 22-Aug-2005 Page: 376 PT Medication Error Pulmonary Hypertension 10:40 AM SS SS C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Oedema Dose Report Source Product Role Manufacturer Route Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Duration 5600 MG (1800 MG, TID), PER ORAL Oxycontin (Oxycodone Hydrochloride) Unspecified Medications Date:08/16/00ISR Number: 3551899-2Report Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose Other PT C C Company Report # Report Source Product Role Neurontin (Gabapentin) PS Baclofen C Duration Hepatic Enzyme Increased VARIOUS Date:08/17/00ISR Number: 3552349-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000616 Age:2 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Speech Disorder Vomiting Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300 MG (100 MG, TID) PER ORAL Depakote (Valproate Semisodium) Hydroxyzine Hydrochloride SS C Phenobarbital Lactulose Senokot (Senna Fruit) Date:08/18/00ISR Number: 3589082-7Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose INTRAVENOUS PT C C C Company Report #2000025335US Report Source Product Role Manufacturer Health Professional Zyvox PS Pharmacia And Upjohn Co Gabapentin (Gabapentin) SS Duration Blood Creatinine Increased 600 MG, BID; IV 2 DAY Prozac (Fluoxetine Hydrochloride) Buspar (Buspirone Hydrochloride) Ambien (Zilpidem Tartrate) Benadryl (Diphenhydramine Hydrochloride) Ferrous Sulfate (Ferous Sulfate) 22-Aug-2005 Page: 377 10:40 AM C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/00ISR Number: 3554563-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000782 Age:31 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Sudden Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 7200 MG (2400 MG, TID), PER ORAL Nortriptyline (Nortriptyline) Duragesic (Fentanyl) Oxycontin (Oxycodone Hydrochloride) Paxil (Paroxetine Hydrochloride) Allopurinal (Allopurinol) Sudafed (Pseudoephedrine Hydrochloride) Clonapin (Clonazepam) Benadryl (Diphenhydramine Hydrochloride) Lomotil (Atropine Sulfate, Diphenoxylate Hydrochloride) Vioxx (Rofecoxib) SS SS C C C C C C C C Date:08/21/00ISR Number: 3554633-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000775 Age:90 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Gastrointestinal Haemorrhage Prothrombin Time Prolonged Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Coumadin (Warfarin Sodium) Lasix (Furosemide) C C Glucotrol (Glipizide) Insulin Benadryl (Diphenhydramine Hydrochloride) Lanoxin (Digoxin) C C C C Date:08/21/00ISR Number: 3554634-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000781 Age:36 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Sudden Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration SEE IMAGE Nortriptyyline (Nortriptyline) Methadone (Methadone) Topamax (Topiramate) Xanax (Alprazolam) 22-Aug-2005 Page: 378 10:40 AM SS C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor (Venlafaxine Hydrochloride) C Date:08/23/00ISR Number: 3556467-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000488 Age: Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Pulmonary Hypertension Pulmonary Oedema Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 5600 MG (1800 MG, TID), PER ORAL Oxycontin (Oxycodone Hydrochloride) Unspecified Medications Date:08/24/00ISR Number: 3557189-6Report Type:Direct Age:37 YR Gender:Female I/FU:I Outcome Dose Other PT C C Company Report # Report Source Product Role Manufacturer Route Neurontin 600mg Tablets/Parke-Davis PS Parke-Davis ORAL Oxycontin Nortriptyline Vioxx C C C Duration Sedation 1T PO TID Date:08/24/00ISR Number: 3557541-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000684 Age:31 YR Gender:Male I/FU:F Outcome Dose Other 1200 MG (400 PT Report Source Product Role Manufacturer Route Grand Mal Convulsion Loss Of Consciousness Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Movement Disorder MG, TID), PER Salivary Hypersecretion ORAL Urinary Incontinence (Oxycodone) (Ibuprofen) Remeron (Mirtazapine) C C C Date:08/24/00ISR Number: 3557542-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000802 Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3 PT Report Source Product Role Manufacturer Dehydration Drug Interaction Drug Toxicity Vomiting Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Dilantin (Phenytoin Sodium) SS Route YR Date:08/24/00ISR Number: 3557543-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000812 Age:72 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Blood Creatine Phosphokinase Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd (Promethazine) C Duration 200 MG (100 MG, BID) 22-Aug-2005 Page: 379 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tylenol (Paracetamol) Asa (Acetylsalicylic Acid) (Clonidine) Synthroid (Levothyroxine Sodium) Betoptic (Betaxolol Hydrochloride) Xalatan (Latanoprost) Flonase (Fluticasone Propionate) Lanoxin (Digoxin) Nitro-Dur (Glyceryl Trinitrate) Tiazac (Diltiazem Hydrochloride) Coumadin (Warfarin Sodium) Darvocet (Paracetamol, Dextropropoxyphene) Albuterol (Salbutamol) Ultram (Tramadol Hydrochloride) Hyzaar (Hydrochlorothiazide , Losartan Potassium) C C C C C C C C C C C C C C C Date:08/24/00ISR Number: 3557597-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000818 Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Dyspnoea Heart Rate Irregular Consumer Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional MG, TID), PER ORAL Flomax (Morniflumate) Prilosec (Omeprazole) Unspecified Pain Medications C C C Date:08/24/00ISR Number: 3557600-0Report Type:Expedited (15-DaCompany Report #033-0945-M0000069 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Death Hospitalization 1) 800 MG Initial or Prolonged (DAILY, PER ORAL; PT Report Source Product Role Manufacturer Route Cardio-Respiratory Arrest Convulsion Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Mydriasis Professional 2) 2000 MG (DAILY), PER Diovenor (Diosmin) PER ORAL 22-Aug-2005 Page: 380 10:40 AM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Naramig (Naratriptan Hydrochloride) SS ORAL Zocor (Simvastatin) SS ORAL PER ORAL 20 MG (DAILY), PER ORAL Date:08/24/00ISR Number: 3557604-8Report Type:Expedited (15-DaCompany Report #047-0945-M0000003 Age: Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly TRANSPLACENTAL PT Cleft Lip And Palate Complications Of Maternal SEE TEXT, Exposure To Therapeutic Report Source Product Role Manufacturer Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Frisium (Clobazam) SS (Folic Acid) Vitamin D (Ergocalciferol) C Route Professional PLACENTAL (IN Drugs UTERO Congenital Anomaly EXPOSURE) TRANSPLACENTAL SEE TEXT, PLACENTAL (IN UTERO EXPOSURE) C Date:08/24/00ISR Number: 3557620-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000816 Age:55 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Convulsion Health Neurontin PS Parke Davis Duration Route Drug Withdrawal Syndrome Professional Pharmaceuticals Ltd ORAL 900 MG (300 Grand Mal Convulsion MG, TID), PER Loss Of Consciousness ORAL Medication Error Ativan (Lorazepam) Wellbutrin (Amfebutamone Hydrochloride) SS C Date:08/24/00ISR Number: 3557675-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000196 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Biliary Colic Hypothyroidism Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Liver Function Test MG, TID), PER Abnormal ORAL;2400 MG Ovarian Cyst (800 MG, Vomiting TID);2100 MG (Baclofen) Ms Contin (Morphine Sulfate) Date:08/25/00ISR Number: 3559072-9Report Type:Expedited (15-DaCompany Report #2000-06-0135 Age:39 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 381 10:40 AM PT Amnesia Dermatitis Drug Toxicity C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Epilepsy Grand Mal Convulsion Hypoaesthesia Report Source Product Role Manufacturer Route Malaise Petit Mal Epilepsy Health Professional Rebetol PS Schering Plough Research Institute ORAL Route Duration 800 MG QD Pyrexia ORAL Weight Decreased SUBCUTANEOUS Inton A (Interferon Alfa-2b Recombinant) Injectable Solution SS Dilantin SS Neurontin SS Tylenol W/Codeine C 3 MU TIW SUBCUTANEOUS TID TID Date:08/30/00ISR Number: 3562156-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000815 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Convulsion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Mellaril (Thioridazine Hydrochloride) C Duration Date:08/30/00ISR Number: 3562157-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000843 Age:83 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 PT Report Source Product Role Manufacturer Route Chest Pain Dyspnoea Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Muscle Spasms MG, TID), PER Panic Attack ORAL (Furosemide) Kdur (Potassium Chloride) Pravachol (Pravastatin Sodium) Tylenol #3 (Codeine Phosphate, Paracetamol) C C C C Date:08/30/00ISR Number: 3562158-6Report Type:Expedited (15-DaCompany Report #044-0945-M0000114 Age:1 DY Gender:Male I/FU:F Outcome Dose Duration Congenital Anomaly TRANSPLACENTAL PT Complications Of Maternal Exposure To Therapeutic PLACENTAL Drugs Foetal Valproate Syndrome Report Source Product Role Manufacturer Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Professional Other Date:08/30/00ISR Number: 3562165-3Report Type:Expedited (15-DaCompany Report #046-0945-980003 Age:58 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 382 10:40 AM PT Epilepsy Grand Mal Convulsion Report Source Foreign Health Professional Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose Product Role Manufacturer Route Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1200 MG (400 MG, TID); 2400 MG (800 MG, TID), PER ORAL Renitec (Enalapril Maleate) Seloken (Metoprolol Tartrate) Trombyl (Acetylsalicylic Acid) Cipramil (Citalopram Hydrobromide) Lamictal (Lamotrigine) Date:08/31/00ISR Number: 3562881-3Report Type:Direct Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100 @HS PO PT Blood Creatine Phosphokinase Increased C C C C C Company Report # Report Source Product Role Manufacturer Route Neurontin 100 Mg (Parke-Davis) PS Parke-Davis ORAL Tylenol Albuterol Coumadin Transderm Nitro Digoxin Flonase C C C C C C Pain In Extremity THEN 100MG @ 0800 Betoptic Xalatan Synthroid Ec Aspirin Ultram Darvocet N-100 Ocean Nasal Spray Clonidine Apap Phenergan Date:09/01/00ISR Number: 3562866-7Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Required 60MG PO Q HS Intervention to 150MG PO TID Prevent Permanent 600MG 1 PO Impairment/Damage QAM AMD 2 PO PT C C C C C C C C C C Company Report # Report Source Product Role Manufacturer Route Circulatory Collapse Remeron PS ORAL Pulse Absent Wellbutrin Sr SS ORAL Neurontin SS ORAL Lamictal SS ORAL Cytomel SS Q HS 200MG PO BID 25MCG PO QD 22-Aug-2005 Page: 383 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/00ISR Number: 3571451-2Report Type:Expedited (15-DaCompany Report #00070414 Age:70 YR Gender:Female I/FU:F Outcome PT Dose Duration Other Abnormal Dreams SUBCUTANEOUS 25 MG, BIW, Clavicle Fracture SUBCUTANEOUS Coma Dizziness Fall Hallucination Headache Injection Site Pain Loss Of Consciousness Meniere'S Disease Nausea Precerebral Artery Occlusion Report Source Product Role Consumer Enbrel 25 Mg PS Oxybutynin Atenolol/ Chlorthalidone Gabapentin Estrogen Prednisone Buffered Aspirin Potassium Chloride SS Manufacturer Route Health Professional SS SS C C C C Date:09/05/00ISR Number: 3565734-XReport Type:Expedited (15-DaCompany Report #B0086640A Age:45 YR Gender:Male I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Cardio-Respiratory Arrest Foreign Amerge PS Glaxo Wellcome Inc ORAL Diosmin (Diosmin) SS Duration Mydriasis ORAL ORAL Simvastatin Tablet-Controlled Release (Simvastatin) Gabapentin Capsule (Gabapentin) SS SS ORAL 400 MG / ORAL Date:09/07/00ISR Number: 3567398-8Report Type:Expedited (15-DaCompany Report #044-0945-M0000138 Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged 300 MG Dizziness Fall Foreign Health Femur Fracture Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route (DAILY), PER Hyponatraemia ORAL Nausea (Amlodipine) (Atenolol) (Enalapril) C C C Date:09/07/00ISR Number: 3567399-XReport Type:Expedited (15-DaCompany Report #039-0945-M0000004 Age:38 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 384 10:40 AM PT Report Source Product Role Manufacturer Hepatitis Non-A Non-B Non-C Foreign Neurontin PS Parke Davis Pharmaceuticals Ltd En (Delorazepam) Fevarin (Fluvoxamine Maleate) Rivotril (Clonazepam) Sereupin (Paroxetine Hydrochloride) SS SS SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/00ISR Number: 3567609-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000881 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Colitis Ischaemic Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Dyazide (Hydrochlorothiazide , Triamterene) Avapro (Irbesartan) Provera (Medroxyprogeterone Acetate) Prilosec (Omeprazole) Estrace (Estradiol) Amitriptyline Route C C C C C C Date:09/07/00ISR Number: 3567612-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000639 Age:46 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Acute Respiratory Distress Syndrome Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dermatitis MG, TID), PER Eosinophilia ORAL Pneumonia Pyrexia Respiratory Failure Dulcolax (Bisacodyl) Colace (Docusate Sodium) Senna (Senna) Zantac (Ranitidine Hydrochloride) Reglan (Metoclopramide) Cacl Heparin Atrovent (Irratropium Bromide) Albuterol C C C C C C C C (Salbutamol) Diazepam Fentanyl Klonopin (Clonazepam) Methadone Decadron (Dexamethasone) Date:09/08/00ISR Number: 3568199-7Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT C C C Company Report #USP 53257 Report Source Product Role Manufacturer Valproic Acid PS Banner Pharmacaps/Udl Labs Neurontin (Gabapentin) Parke-Davis SS Parke-Davis Duration Medication Error 22-Aug-2005 Page: 385 C C C 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/00ISR Number: 3568485-0Report Type:Expedited (15-DaCompany Report #033-0945-M0000020 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening 1200 MG Hospitalization (DAILY), PER Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Cardio-Respiratory Arrest Convulsion Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Limb Discomfort Professional Mydriasis Sudden Death Zocor (Simvastatin) SS ORAL Diovenor (Diosmin) SS ORAL Naratriptan SS ORAL Tegretol (Carbamazepine) C 20 MG (DAILY), PER ORAL 1200 MG (DAILY), PER ORAL PER ORAL Date:09/08/00ISR Number: 3568968-3Report Type:Expedited (15-DaCompany Report #001-0184-M0000026 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 225 MG , PER ORAL PT Report Source Product Role Manufacturer Coma Intentional Misuse Suicide Attempt Toxicologic Test Abnormal Health Professional Benadryl (Diphenhydramine Hydrochloride) PS Parke Davis Div Warner Lambert Co Neurontin (Gabapentin) Remeron (Mirtazapine) Route SS SS ORAL Prozac (Fluoxetine Hydrochloride) Unisom (Doxylamine Succinate) Tricor (Fenofibrate) Lipitor (Atorvastatin) SS SS C C Date:09/11/00ISR Number: 3568218-8Report Type:Expedited (15-DaCompany Report #243804 Age:38 YR Gender:Male I/FU:I Outcome Dose Other TAKEN FOR PT Report Source Product Role En PS Fevarin SS Gabapentin SS Paroxetin SS Rivotril SS Manufacturer Duration Hepatitis YEARS. TAKEN FOR YEARS. TAKEN FOR YEARS. TAKEN FOR YEARS. TAKEN FOR YEARS. 22-Aug-2005 Page: 386 10:40 AM Roche Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/00ISR Number: 3569156-7Report Type:Expedited (15-DaCompany Report #061-0945-M0000007 Age:40 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Apathy Confusional State Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional Unspecified Medication Duration PER ORAL C Date:09/11/00ISR Number: 3569221-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000885 Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Other MG TID) PER PT Report Source Product Role Manufacturer Route Electroencephalogram Abnormal Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Epilepsy Fall ORAL Mental Impairment Temporal Lobe Epilepsy Altram (Cimetidine) Stadol (Butorphanol Tartrate) Plavix (Clopidogrel Carafate (Sucralfate) Lopid (Gemfibrozil) Zyrtec (Cetirizine Hydrochloride) Elavil (Amitriptyline Hydrochloride) Triavil (Perphenazine, Amitriptyline Hydrochloride) Inderal La (Propranolol Hydrochloride) Folic Acid Prevacid (Lansoprazole) C C C C C C C C C C C Propulsid (Cisapride) C Date:09/11/00ISR Number: 3569222-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000895 Age:76 YR Gender:Male I/FU:I Outcome Dose Death Other UNKNOWN 22-Aug-2005 Page: 387 PT Report Source Product Role Manufacturer Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Respiratory Disorder Snoring UNKNOWN Ventricular Fibrillation 10:40 AM Lipitor (Atorvastatin) Vasotec (Enalapril Maleate) Insulin (Insulin) Ultram (Tramadol Hydrochloride) Sleeping Pill (Unspecified) Vitamin B Complex (Pyridoxine Hydrochloride, C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thiamine Hydrochloride, Date:09/12/00ISR Number: 3570455-3Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL C Company Report #001-0945-M0000314 PT Report Source Product Role Manufacturer Route Pneumonia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Company Representative Date:09/12/00ISR Number: 3570619-9Report Type:Expedited (15-DaCompany Report #20000900037 Age:81 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 20 MG QD Initial or Prolonged PT Report Source Product Role Manufacturer Condition Aggravated Foreign Prilosec PS Astrazeneca Lp Epilepsy Loss Of Consciousness Malaise Health Professional Neurontin Idarac Praxilene SS SS SS Date:09/13/00ISR Number: 3571290-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000748 Age:64 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG (400 Other MG, BID), PER PT Report Source Product Role Manufacturer Route Cardiac Failure Congestive Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Condition Aggravated Company Weight Increased Representative ORAL Neurontin (Gabapentin) 1600 MG (800 MG, BID), PER SS ORAL ORAL Lasix (Furosemide) Lanoxin (Digoxin) Capotin (Captopril) Glynase (Glibenclamide) Zaroxolyn (Metolazone) SS C C C C Date:09/15/00ISR Number: 3571515-3Report Type:Expedited (15-DaCompany Report #243804 Age:38 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Hepatitis Foreign Other Clonopin PS Hoffmann La Roche Inc ORAL Duration 2 MG 3 PER DAY ORAL En (Delorazepam) 0.5 Mg SS ORAL Fevarin (Fluvoxamine) 100 Mg SS ORAL 0.5 MG 1 PER DAY ORAL 150 MG 1 PER DAY ORAL Gabapentin (Gabapentin) Paroxetine (Paroxetine) 22-Aug-2005 Page: 388 10:40 AM SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/00ISR Number: 3572552-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000818 Age:73 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Bradycardia Dyspnoea Consumer Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Heart Rate Irregular Professional MG, TID), PER Tachycardia ORAL Flomax Prilosec Unspecified Pain Medications C C C Date:09/15/00ISR Number: 3572553-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000257 Age:49 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Back Pain Blood Pressure Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Fluctuation Company Condition Aggravated Representative MG, TID), PER ORAL Cyst Drug Withdrawal Syndrome Tachycardia Lsinopril (Lisinopril) Cyclobenzaprine (Cyclobenzaprine) SS SS 30 MG (10 MG, PRN) Percocet Unspecified Anti Depressant Date:09/18/00ISR Number: 3573121-3Report Type:Direct Age:79 YR Gender:Male I/FU:I Company Report # C C Outcome Dose Other PT Report Source Product Role Gabapentin PS Manufacturer Route Route Duration Lethargy Date:09/18/00ISR Number: 3575012-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000329 Age: Gender:Female I/FU:F Outcome Dose PT Report Source Product Role Manufacturer Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Blister Dermatitis UNKNOWN Joint Swelling Neuralgia Oedema Peripheral Staphylococcal Infection UNKNOWN Date:09/19/00ISR Number: 3575155-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000742 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged UNK; 1800MG PT Report Source Product Role Manufacturer Fall Hypoaesthesia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Ultram (Tramadol Hydrochloride) SS Transient Ischaemic (600MG,TID); Attack 900MG (300MG, Vertigo TID) Vomiting 600MG 22-Aug-2005 Page: 389 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (100MG;PRN/ EVERY 4 HOURS) Date:09/19/00ISR Number: 3575156-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000250 Age:47 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG (100 PT Report Source Product Role Manufacturer Route Ascites Pyrexia Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Sepsis MG, QID), PER Urine Analysis Abnormal ORAL Neurontin Capsules 100 Mg (Gabapentin) SS ORAL 400 MG (100 MG, QID), PER ORAL Lasix (Furosemide) Aldactone (Spironolactone) (Lactulose) Noroxin (Norfloxacin) Magnesium (Magnesium) Tylenol Pm (Diphenhydramine, Paracetamol) C C C C C C Date:09/20/00ISR Number: 3576782-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000937 Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Impaired Gastric Emptying Health Neurontin PS Parke Davis Route Initial or Prolonged Professional Pharmaceuticals Ltd Date:09/22/00ISR Number: 3578483-9Report Type:Expedited (15-DaCompany Report #A0127729A Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Asthma Consumer Imitrex PS Glaxo Wellcome Inc ORAL Imitrex Aqueous Spray (Sumatriptan Succinate) SS Imitrex Injection (Sumatriptan Succinate) SS Carpal Tunnel Syndrome Cerebrospinal Fluid Leakage INTRANASAL SUBCUTANEOUS 22-Aug-2005 Page: 390 Chronic Fatigue Syndrome Convulsion Dizziness SUBCUTANEOUS 6 MON Drug Ineffective Fibromyalgia Loss Of Consciousness Nausea Pain Tremor Visual Acuity Reduced 10:40 AM Gabapentin (Gabapentin) Semisodium Valproate (Divalproex Sodium) Acetazolamide (Acetazolamide) Loratadine Fluticasone Propionate Montelukast Sodium SS SS SS C C C NASAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/00ISR Number: 3578806-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000942 Age:43 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Chills Convulsion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 300MG (DAILY) Cystitis PER ORAL Sedation White Blood Cells Urine Positive Nph Insulin Humalong (Insulin Lispro) Glucopahage (Metformin Hydrochloride) Prinivil (Lisinopril) Aciphex (Rabeprazole Sodium) Lipitor (Atorvastatin) Soy Isoflavones (Calcium) Flaxseed Oil C C C C C C C C C Date:09/22/00ISR Number: 3578808-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000946 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Ecchymosis Hepatocellular Damage Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Date:09/26/00ISR Number: 3580558-5Report Type:Expedited (15-DaCompany Report #A0127864A Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 150 MG / PT Report Source Product Role Manufacturer Route Amnesia Consumer Zyban PS Glaxo Wellcome Inc ORAL Initial or Prolonged TWICE DAY / Hypotension Pneumonia ORAL Sedation Speech Disorder Urine Analysis Abnormal 2 Nifedipine (Formulation Unknown) (Nifedipine) Atenolol (Formulation Unknown) (Atenolol) Gabapentin (Formulation Unknown) (Gabapentin) SS SS SS YR Date:09/26/00ISR Number: 3580593-7Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Drug Withdrawal Convulsions Consumer Dilantin PS Parke Davis Div Warner Lambert Co ORAL Duration 400 MG (200 Drug Withdrawal Syndrome MG QAM AND QPM) PER ORAL 22-Aug-2005 Page: 391 Company Report #001-0073-M0000285 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin Capsules 300 Mg(Gabapentin) SS .. .. C C ORAL 600 MG (300 MG, QAM AND QPM),PER ORAL Date:09/26/00ISR Number: 3580611-6Report Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (100 Company Report #001-0073-990364 PT Report Source Product Role Manufacturer Route Hypersensitivity Consumer Dilantin PS Parke Davis Div Warner Lambert Co ORAL MG, 3QD), PER ORAL Neurontin Capsules 300 Mg (Gabapentin) SS Norvasc Azmacort Proventil Prilosec Tenormin Celebrex C C C C C C ORAL 900 MG (300 MG, TID), PER ORAL Date:09/26/00ISR Number: 3580645-1Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - Company Report #001-0073-M0000022 PT Report Source Product Role Manufacturer Condition Aggravated Consumer Dilantin PS Parke Davis Div Route Initial or Prolonged SEE TEXT, PER Confusional State Warner Lambert Co ORAL Convulsion ORAL Nasal Congestion Dilantin Infatabs 50mg (Phenytoin Sodium) SS ORAL Neurontin Capsules 100 Mg (Gabapentin) SS ORAL Donnatal Verapamil Prempro SS C C 50 MG (QOD), PER ORAL 300 MG (100 MG, TID), PER ORAL Date:09/27/00ISR Number: 3581564-7Report Type:Expedited (15-DaCompany Report #001-0184-M0000026 Age:57 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent 225 MG (UNK), Impairment/Damage PER ORAL PT Report Source Product Role Manufacturer Coma Laboratory Test Abnormal Suicide Attempt Health Professional Benadryl Hcl PS Parke Davis Div Warner Lambert Co Neurontin (Gabapentin) Remeron (Mirtazapine) Prozac (Fluoxetine Hydrochloride) 22-Aug-2005 Page: 392 10:40 AM Route SS SS SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unisom (Doxylamine Succinate) Tricor (Fenofibrate) Lipitor (Atorvastatin) SS C C Date:09/27/00ISR Number: 3581715-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000949 Age:1 DY Gender:Female I/FU:I Outcome PT Dose Duration Congenital Anomaly Arrhythmia Neonatal Required Cardiac Disorder TRANSPLACENTAL SEE TEXT, Intervention to Complications Of Maternal PLACENTAL, IN Prevent Permanent Exposure To Therapeutic UTERO Impairment/Damage Drugs EXPOSURE Heart Block Congenital Neonatal Disorder TRANSPLACENTAL SEE TEXT, Report Source Product Role Manufacturer Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Keppra (Levetiracetam) SS Route PLACENTAL, IN UTERO EXPOSURE Date:09/28/00ISR Number: 3582746-0Report Type:Direct Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 400MG PO Initial or Prolonged PT Company Report # Report Source Product Role Asthenia Gabapentin Cap Oral PS Mental Impairment Tremor Acetaminophen Supp,Rtl Human Nph Insulin Inj Sulfamethox 400/Trimethop 80mg C C C Manufacturer Route ORAL Metoprolol Lansoprazole Digoxin Piperacillin/Tazobac tam Human Regular Insulin U-100 C C C C C Date:09/28/00ISR Number: 3582912-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000885 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Other MG,TID); ORAL PT Report Source Product Role Manufacturer Route Clonic Convulsion Complex Partial Seizures Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Electroencephalogram Abnormal Epilepsy Ultram (Tramadol Hydrochloride) SS Elavil(Amitriptyline Hydrochloride) SS Triavil(Perphenazine , Amitriptyline Hydrochloride) SS Lopid (Gemfibrozil) C 200 MG (50 Fall MG, QID); Mental Impairment ORAL Simple Partial Seizures 50 MG (QHS) 1700 MG (425 MG,QID) 22-Aug-2005 Page: 393 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Plavix (Clopidogrel) Carafate (Sucralfate) Stadol (Butorphanol Tartrate) Zyrtec (Cetirizine Hydrochloride) Inderal La (Propranolol Hydrochloride) (Folic Acid) Prevacid (Lansoprazole) Propulsid (Cisapride) C C C C C C C C Date:09/28/00ISR Number: 3582950-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000038 Age:72 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Corneal Oedema Visual Acuity Reduced Consumer Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 Professional MG, TID), PER ORAL Contact Lens Alphagan (Brimonidine Tartrate) Timoptic Xe (Timolol Maleate) Prinivil (Lisinopril) Calan (Verapamil Hydrochloride) Excedrin (Acetylsalicylic Acid, Cafeine, Salicylamide, Paracetamol) Vancenase (Beclometasone SS C C C C C Dipropionate) Prilosec (Omeprazole) C C Date:09/28/00ISR Number: 3583024-6Report Type:Expedited (15-DaCompany Report #033-0945-M0000020 Age:45 YR Gender:Male I/FU:F Outcome Dose Duration Death Life-Threatening SEE IMAGE Hospitalization 20 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Manufacturer Route Asthenia Cardio-Respiratory Arrest Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Convulsion Professional Zocor (Simvastatin) SS ORAL Diovenor (Diosmin) SS ORAL Naratriptan SS ORAL Tegretol C Mydriasis Sudden Death ORAL 1200 MG (DAILY), PER ORAL PER ORAL 22-Aug-2005 Page: 394 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/00ISR Number: 3584736-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000188 Age: Gender: I/FU:F Outcome Dose Duration Life-Threatening Other PT Report Source Product Role Manufacturer Drug Interaction Respiratory Arrest Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd (Methadone) SS Route Date:09/29/00ISR Number: 3584739-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000998 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged (DAILY) PER PT Report Source Product Role Manufacturer Route Convulsion Fall Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Loss Of Consciousness ORAL Cognex (Tacrine Hydrochloride) Detrol (Tolterodine Tartrate) Selenium Vitamin E (Tocopherol) C C C C Date:09/29/00ISR Number: 3584741-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000966 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG PT Report Source Product Role Manufacturer Blindness Medication Error Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Optic Neuritis (DAILY), 1600 Retinal Haemorrhage MG (DAILY), Vision Blurred 3600 MG Visual Disturbance (DAILY), 4800 Date:10/02/00ISR Number: 3585871-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000942 Age:43 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Chills Convulsion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300 MG Cystitis (DAILY), PER Sedation ORAL White Blood Cells Urine Positive 22-Aug-2005 Page: 395 10:40 AM Nph Insulin (Insulin Injection Isophane) Humalog Insulin (Insulin Lispro) Glucophage (Metformin Hydrochloride) Prinivil (Lisinopril) Aciphex (Rabeprazole Sodium) Lipitor (Atorvastatin) Soy Isoflavones Calcium Flaxseed Oil C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/00ISR Number: 3585877-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000616 Age:2 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Autism Communication Disorder Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Duration 300 MG (100 Encephalopathy MG, TID), PER Mental Impairment ORAL Psychomotor Hyperactivity Speech Disorder Vomiting Date:10/03/00ISR Number: 3586510-8Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose PT Depakote (Valproate Semisodium) Hydroxyzine Hydrchloride Phenobarbital Lactulose Senokot (Senna Fruit) SS C C C C Company Report # Report Source Product Role Gabapentin PS Duration Hyperglycaemia ORAL PO Neuralgia Date:10/04/00ISR Number: 3587595-5Report Type:Expedited (15-DaCompany Report #001-0073-M0000261 Age:68 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300-600 MG Other DAILY, PER Required ORAL Intervention to PT Report Source Product Role Manufacturer Route Brain Neoplasm Brain Oedema Health Professional Dilantin PS Parke Davis Div Warner Lambert Co ORAL Convulsion Haematemesis Meningioma Neurontin Prevent Permanent Impairment/Damage Oligodendroglioma Sedation Weight Decreased (Gabapentin) Slow Mag (Magnesium Chloride Anhydrous) Detropan Date:10/04/00ISR Number: 3587597-9Report Type:Expedited (15-DaCompany Report #001-0073-M0000120 Age:2 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 396 10:40 AM PT Abnormal Behaviour Aphasia Balance Disorder Brain Scan Abnormal Clonic Convulsion Constipation Convulsion Coordination Abnormal Decreased Appetite Drooling Drug Toxicity Dystonia Ear Infection Electroencephalogram Abnormal Eye Rolling Fall SS C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Gait Disturbance Gastrointestinal Disorder Dose Report Source Product Role Manufacturer Route Consumer Dilantin PS Parke Davis Div Warner Lambert Co ORAL Duration Gingival Bleeding Gingival Pain SEE IMAGE Grand Mal Convulsion Insomnia Joint Stiffness SEE IMAGE Lethargy Motor Dysfunction INTRAVENOUS Dilantin Injection Ampoules Ml (Phenytoin Sodium) SS Dilantin Suspension (Phenytoin Sodium) SS ORAL Nystagmus Otorrhoea Dilantin Infatabs (Phenytoin Sodium) SS ORAL Petit Mal Epilepsy Pruritus Neurontin (Gabapentin) SS ORAL Phenobarbital SS 2 MILLILITERS Nervous System Disorder (BID), PER Neurosis ORAL SEE IMAGE 300 MG Psychomotor Hyperactivity (DAILY), PER Psychotic Disorder ORAL Pyrexia 80 MG (40 MG, Respiratory Arrest BID) Status Epilepticus Tremor Vomiting Date:10/05/00ISR Number: 3588846-3Report Type:Direct Age:76 YR Gender:Female I/FU:I Outcome Dose Other 300MG PO PT Lamictal (Lamotrigine) Tegretol (Carbamazepine) SS C Company Report # Report Source Product Role Neurontin 300g PS Manufacturer Route Duration Mental Impairment ORAL Celebrex 100mg Qd SS ORAL 100MG PO Date:10/06/00ISR Number: 3590629-5Report Type:Expedited (15-DaCompany Report #001-0945-M0001009 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Alcohol (Ethanol) SS Route Duration UNKNOWN Alcohol Interaction Hepatic Enzyme Increased UNKNOWN UNKNOWN UNKNOWN Serzone (Nefazodone Hydrochloride) Celexa (Citalopram Hydrobromide) Seroquel (Quentiapine) Unspecified Medications C C C C Date:10/06/00ISR Number: 3590665-9Report Type:Expedited (15-DaCompany Report #001-0945-M0001003 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 397 10:40 AM PT Report Source Product Role Manufacturer Drug Interaction Mental Impairment Renal Impairment Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Celebrex (Celecoxib) SS Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/00ISR Number: 3590674-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000970 Age:42 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Diabetes Mellitus Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL MG TID) PER ORAL : 300 MG (100 MG TID) PER ORAL Date:10/06/00ISR Number: 3590675-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000937 Age:45 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG PT Report Source Product Role Manufacturer Route Impaired Gastric Emptying Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL (DAILY) PER ORAL Oxycontin (Oxycodone Hydrochloride) (Amitriptyline) Reglan (Metoclopramide) Klonopin (Clonazepam) Prilosec (Omeprazole) (Iron) Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C C C C C C C Date:10/06/00ISR Number: 3590677-5Report Type:Expedited (15-DaCompany Report #001-0945-M0001021 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Drug Interaction Mental Impairment Renal Impairment Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Celebrex (Celecoxib) SS Route Date:10/06/00ISR Number: 3590679-9Report Type:Expedited (15-DaCompany Report #001-0945-M0001020 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Drug Interaction Mental Impairment Renal Impairment Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Celebrex (Celecoxib) SS Route Date:10/06/00ISR Number: 3590680-5Report Type:Expedited (15-DaCompany Report #001-0945-M0001019 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 398 10:40 AM PT Report Source Product Role Manufacturer Drug Interaction Mental Impairment Renal Impairment Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Celebrex (Celecoxib) SS Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/00ISR Number: 3590681-7Report Type:Expedited (15-DaCompany Report #001-0945-M0001018 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Drug Interaction Mental Impairment Renal Impairment Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Celebrex (Celecoxib) SS Route Date:10/06/00ISR Number: 3590682-9Report Type:Expedited (15-DaCompany Report #001-0945-M0001016 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Drug Interaction Mental Impairment Renal Impairment Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Celebrex (Celecoxib) SS Date:10/06/00ISR Number: 3601896-3Report Type:Periodic Age:29 YR Gender:Female I/FU:I Outcome Dose Route Company Report #USA015094 PT Report Source Product Role Manufacturer Route Nonspecific Reaction Consumer Other Meridia PS Knoll Pharmaceutical Co Sub Basf Corp ORAL Duration 10 MG OD PO Neurontin SS ORAL Motrin SS ORAL Darvocet SS ORAL Percodan SS ORAL Ambien SS ORAL 400 MG TID PO MG OD PO 2 TAB PRN PO 1 TAB Q2HR PO 15 MG PRN PO Date:10/11/00ISR Number: 3592825-XReport Type:Direct Age:73 YR Gender:Male I/FU:I Company Report # Outcome Dose Other 2TT PO TID PT Report Source Product Role Gabapentin 100mg PS Manufacturer Route Duration Gingival Hyperplasia ORAL Gingivitis Date:10/11/00ISR Number: 3593414-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000942 Age:43 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Arthralgia Asthenia Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300 MG Chills (DAILY), PER Convulsion ORAL Cystitis Hyperglycaemia Joint Stiffness Sedation Tremor White Blood Cells Urine Positive 22-Aug-2005 Page: 399 10:40 AM Nph Insulin (Insulin Injection, Isophane) Humalog Insulin (Insulin Lispro) Glucophage (Metformin Hydrochloride) Prinivil (Lisinopril) Aciphex (Rabeprazole Sodium) Lipitor (Atorvastatin) Soy Isoflavones Calcium C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flaxseed Oil Date:10/11/00ISR Number: 3597496-4Report Type:Periodic Age: Gender: I/FU:I Outcome Dose C Company Report #000928-SK358 PT Report Source Product Role Manufacturer Route Confusional State Health Celebrex PS Gd Searle And Co ORAL Drug Interaction Professional Neurontin SS Duration UNKNOWN PO ORAL UNKNOWN PO Date:10/11/00ISR Number: 3597497-6Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #000928-SK359 PT Report Source Product Role Manufacturer Route Confusional State Health Celebrex PS Gd Searle And Co ORAL Drug Interaction Professional Neurontin SS Duration UNKNOWN PO ORAL UNKNOWN PO Date:10/11/00ISR Number: 3597498-8Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #000928-SK360 PT Report Source Product Role Manufacturer Route Confusional State Health Celebrex PS Gd Searle And Co ORAL Drug Interaction Professional Neurontin SS Duration UNKNOWN PO ORAL UNKNOWN PO Date:10/11/00ISR Number: 3597499-XReport Type:Periodic Age: Gender: I/FU:I Outcome Dose UNKNOWN PO Company Report #000928-SK361 PT Report Source Product Role Manufacturer Route Confusional State Health Celebrex PS Gd Searle And Co ORAL Duration Drug Interaction Professional Neurontin SS ORAL UNKNOWN PO Date:10/11/00ISR Number: 3597500-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #000928-SK362 PT Report Source Product Role Manufacturer Route Confusional State Health Celebrex PS Gd Searle And Co ORAL Drug Interaction Professional Neurontin SS Duration UNKNOWN PO ORAL UNKNOWN PO Date:10/11/00ISR Number: 3597501-5Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #000928-SK363 PT Report Source Product Role Manufacturer Route Confusional State Health Celebrex PS Gd Searle And Co ORAL Professional Neurontin SS Duration UNKNOWN PO OPHTHALMIC Drug Interaction UNKNOWN PO Date:10/11/00ISR Number: 3597869-XReport Type:Periodic Age: Gender:Not SpecifiI/FU:I Outcome Dose Company Report #000707-SK453 PT Report Source Product Role Manufacturer Route Mouth Ulceration Health Celebrex PS Gd Searle And Co ORAL Professional Neurontin SS Duration PO PO 22-Aug-2005 Page: 400 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/00ISR Number: 3598630-2Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Company Report #000821-SK376 PT Report Source Product Role Manufacturer Route Neuropathy Peripheral Health Celebrex PS Gd Searle And Co ORAL Neurontin SS Atorvastatin Triamterene Hydrochlorothiazide Potassium Zolpidem Conjugated Estrogens Diltiazem Hydrochloride Omeprazole Methocarbamol Hydrocodone C C C C C C Duration 200.000 MG Professional BID PO ORAL 200.000 MG TID PO C C C C Date:10/12/00ISR Number: 3595695-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000990 Age:40 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Anuria Blood Creatinine Literature Health Neurontin PS Parke Davis Pharmaceuticals Ltd Increased Professional Salsalate(Salsalate) Furosemide (Furosemide) Asathioprine (Azathioprine) Macrodantin SS Duration 400 MG (200 MG, BID), 600 Blood Urea Increased MG (200 MG, Drug Interaction BID) Failure Of Implant Renal Impairment SS C Route (Nitrofurantoin) Isosorbide Dinitrate (Isosorbide Dinitrate) Nph Insulin (Insulin Injection, Isophane) Metoprolol (Metoprolol) Lovastatin (Lovastatin) L-Thyroxine (Levothyroxine) C C C C C C Date:10/13/00ISR Number: 3594860-4Report Type:Expedited (15-DaCompany Report #044-0945-M0000100 Age:73 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Cardiac Failure Congestive Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Condition Aggravated Professional Duration 300 MG (100 MG TID) PER Coronary Artery Disease ORAL; 600 MG Coronary Artery Occlusion (200 MG TID); Medication Error 900 MG (300 Trypitzol (Amitriptyline 22-Aug-2005 Page: 401 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:10/13/00ISR Number: 3594937-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000972 Age:84 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Hepatic Neoplasm Malignant Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 400 MG (100 Metastases To Liver MG, QID) PER ORAL Zocor (Simvastatin) Synthroid (Levothyroxine Sodium) (Iron) Vitamins Date:10/16/00ISR Number: 3595964-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000006335 Age:48 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged Disability Other Required Intervention to Prevent Permanent Impairment/Damage PT Abdominal Pain Abnormal Behaviour Aggression Angina Pectoris Anhedonia Anxiety Arachnoiditis Asthenia Back Pain Bronchitis Acute Cardiac Disorder Cardiomegaly Cervical Spinal Stenosis Chest Pain Condition Aggravated Constipation Coronary Artery Disease Cough Decreased Appetite C C C C Depression Diarrhoea Dizziness Dry Mouth Dyspnoea Echocardiogram Abnormal Ejection Fraction Abnormal Electrocardiogram Abnormal Electrocardiogram Qt Prolonged Emotional Disorder Fall Fibrosis Gastric Ulcer Gastrooesophageal Reflux Disease Haematochezia Hallucination 22-Aug-2005 Page: 402 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Hyperhidrosis Hypoaesthesia Dose Report Source Product Role Manufacturer Route Health Professional Propulsid PS Janssen Research Fdn Div Johnson And Johnson ORAL Duration Hypotension Influenza Like Illness Injury 20 MG, 4 IN 1 Insomnia DAY(S), ORAL Joint Swelling Malaise Mental Disorder Pamelor (Nortriptyline Hydrochloride) SS ORAL Promethazine SS ORAL 75 MG, 1 IN 1 Mitral Valve Incompetence DAY (S), ORAL Mononeuropathy 50 MG, 4 IN 1 Muscle Spasms DAILY, ORAL Myalgia Myocardial Infarction Nasal Congestion Nausea Neck Pain Nervous System Disorder Nervousness Nuclear Magnetic Mellaril (Thioridazine Hydrochloride) Compazine (Prochlorperazine Edisylate) Neurontin (Gabapentin) SS SS SS 600 MG, 2 IN Resonance Imaging 1 DAILY Abnormal Pain Biaxin (Clarithromycin) SS 500 MG, 2 IN Pain In Extremity 1 DAILY Palpitations Pancreatic Disorder Pancreatitis Pharyngitis Pharyngolaryngeal Pain Polydipsia Polyp Polyuria Pruritus Pyrexia Rash Erythematous Elavil (Amitriptyline Hydrochloride) Prilosec (Omeprazole) Paxil (Paroxetine Hydrochloride) Prozac (Fluoxetine Hydrochloride) Nitroglycerin (Nitroglycerin Comp. SS C C C Rash Papular Rectal Haemorrhage Renal Colic Rhinitis Road Traffic Accident Sinus Tachycardia Spinal Osteoarthritis Suicidal Ideation Swelling Syncope Tachycardia Tricuspid Valve Incompetence Ultrasound Scan Abnormal Urinary Retention Urinary Tract Infection Ventricular Extrasystoles Ventricular Fibrillation Vision Blurred Vomiting Weight Decreased 22-Aug-2005 Page: 403 10:40 AM /Net/) Vicodin Procardia (Nifedipine) Valium (Diazepam) Prevacid (Lansoprazole) Reglan (Metoclopramide) Baclofen Vistaril (Hydroxyzine Embonate) Vitamins Darvocet Parafon (Parafon Forte) Flexeril (Cyclobenzaprine Hydrochloride) Isocet (Axotal (Old Form)) Trazodone Amoxil (Amoxicillin) Metoprolol C C C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbamazepine Talacen (Fortagesic) Nifrex-150 Forte Celexa (Citalopram Hydrobromide) Medrol Dose Pack (Methylprednisolone) Lactulose Atarax (Hydroxyzine Hydrochloride) Limbitrol Baclofen Remeron (Mirtazapine) Ms Contin (Morphine Sulfate) Oxycontin (Oxycodone Hydrochloride) Hemorrhoidal Suppository (Unspecified) Midrin (Midrid) Zithromax (Azithromycin) Viokase (Pancrelipase) Lorazepam C C C C C C C C C C C C C C C C C Date:10/17/00ISR Number: 3597073-5Report Type:Expedited (15-DaCompany Report #001-0945-M0001041 Age:14 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Anxiety Apraxia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Lamictal (Lamotrigine) SS Duration 2400 MG (800 Condition Aggravated MG TID) Convulsion Dizziness Memory Impairment Mental Impairment Psychomotor Retardation Sedation Tearfulness Route Date:10/17/00ISR Number: 3597076-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000603 Age:54 YR Gender:Female I/FU:F Outcome Disability Other 22-Aug-2005 Page: 404 PT Accidental Overdose Amnesia Bronchitis Bronchospasm Confusional State Convulsion Dental Caries Dyspnoea Ecchymosis Enamel Anomaly Fall Haemorrhage 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Laceration Migraine Oedema Report Source Product Role Manufacturer Route Tooth Injury Toxic Epidermal Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300-3000 MG Necrolysis (DAILY) PER Weight Increased ORAL Klonopin (Clonazepam) Paxil (Paroxetine Hydrochloride) Premarin (Estrogens Conjugated) C C C Date:10/17/00ISR Number: 3597083-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000887 Age:36 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Clonic Convulsion Epilepsy Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 2700 MG (900 Insomnia MG TID) PER ORAL Neurontin (Gabapentin) SS 3600 MG (1200 MG TID ) PER ORAL Paxil (Paroxetine Hydrochloride) Ultram (Tramadol Hydrochloride) Aspirin (Acetylsalicylic Acid) Baclofen (Baclofen) C C C C ORAL (Potassium) Lasix (Furosemide) Prilosec (Omeprazole) Medrin (Paracetamol , Dichloralphenazone, Isometheptene) C C C C Date:10/17/00ISR Number: 3597587-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000895 Age:76 YR Gender:Male I/FU:F Outcome Dose Death Other 600 MG (300 PT Report Source Product Role Manufacturer Route Coronary Artery Disease Medication Error Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Sedation MG QPM QAM Snoring PRN) PER ORAL Ventricular Fibrillation 22-Aug-2005 Page: 405 10:40 AM Lipitor (Atorvastatin) Vasotec (Enalapril Maleate) Insulin (Insulin) Ultram (Tramadol Hydrochloride) Sleeping Pill C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin B Complex (Pyridoxine Hydrochloride, Thiamine Hydrochloride, C Date:10/18/00ISR Number: 3597552-0Report Type:Expedited (15-DaCompany Report #001-0945-M0001039 Age:60 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Manufacturer Route Chest Pain Convulsion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dizziness Neurontin Tablets SS Bromocriptine C ORAL 2400 MG (600 Feeling Jittery MG, QID), PER ORAL Date:10/20/00ISR Number: 3599374-3Report Type:Expedited (15-DaCompany Report #A030358 Age:57 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization ORAL Initial or Prolonged 225.00 MG Required TOTAL:ORAL Intervention to ORAL Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Coma Intentional Misuse Consumer Health Unisom PS Pfizer Laboratories Div Pfizer Inc ORAL Suicide Attempt Professional Remeron SS ORAL Benadryl SS ORAL Neurontin SS ORAL Lipitor Tricor Prozac C C C Date:10/23/00ISR Number: 3599981-8Report Type:Expedited (15-DaCompany Report #001-0945-M0001090 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 Required MG, TID), PER Intervention to ORAL Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 406 10:40 AM PT Report Source Product Role Manufacturer Route Condition Aggravated Fistula Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Haemorrhage Hypercholesterolaemia Weight Decreased Premarin (Estrogens Conjugated) Claritin-D (Pseudoephedrine Sulfate, Loratadine) Robaxin (Methocarbamol) Darvocet (Paracetamol, Dextropropoxyphene) Lortab (Paracetamol, Hydrocodone Bitartrate) C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/00ISR Number: 3599982-XReport Type:Expedited (15-DaCompany Report #001-0945-M0001092 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1) 300 MG PT Report Source Product Role Manufacturer Route Bradycardia Chest Pain Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dyspnoea (QHS), PER Electrolyte Imbalance ORAL; 2) 100 Feeling Hot MG (DAILY), PO; 3) 200 MG Humulin N (Insulin Human Injection, Isophane) Humulin R (Insulin Human) Cardizem (Diltiazem Hydrochloride) Lanoxin (Digoxin) Zocor (Simvastatin) Bufferin (Acetylsalicylic Acid, Magnesium Carbonate, Aluminium Glycinate) Ntg Slow Cap (Glyceryl Trinitrate) C C C C C C C Date:10/23/00ISR Number: 3599983-1Report Type:Expedited (15-DaCompany Report #001-0945-M0001064 Age:48 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Colour Blindness Retinal Oedema Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 Visual Disturbance MG, TID), PER ORAL Demadex (Torasemide) Zoloft (Sertraline Hydrochloride) Remeron (Mirtazapine) Premarin (Estrogens Conjugated) Prevacid (Lansoprazole) Imitrex (Sumatriptan Succinate) C C C C C C Date:10/23/00ISR Number: 3600259-4Report Type:Expedited (15-DaCompany Report #001-0073-M0000385 Age:1 DY Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Complications Of Maternal Exposure To Therapeutic Health Professional Dilantin PS Parke Davis Div Warner Lambert Co Neurontin (Gabapentin) SS Proventil Theo-Dur C C Duration SEE TEXT, Drugs PLACENTAL SEE TEXT, PLACENTAL 22-Aug-2005 Page: 407 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/00ISR Number: 3600264-8Report Type:Expedited (15-DaCompany Report #001-0945-M0001065 Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG (100 PT Report Source Product Role Manufacturer Route Balance Disorder Blood Pressure Increased Consumer Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dyspnoea Professional MG BID) PER Haematuria ORAL; 100 MG Headache (DAILY) PER Hypoaesthesia ORAL Muscle Rigidity Pain Paraesthesia Urinary Tract Infection Glucotrol (Glipizide) Actos (Pioglitazone) Zestril (Lisinopril) Celebrex (Celecoxib) Lipitor (Atorvastatin) C C C C C Date:10/23/00ISR Number: 3600485-4Report Type:Expedited (15-DaCompany Report #002-0945-M0000031 Age:50 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Myopia Presbyopia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 1600 MG Professional (DAILY), PER ORAL Date:10/23/00ISR Number: 3600690-7Report Type:Expedited (15-DaCompany Report #PHRM2000FR01473 Age:25 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Convulsion Foreign Tegretol-Xr PS Novartis Initial or Prolonged 1200 MG/DAY, Drug Interaction Health Pharmaceuticals Corp ORAL Professional ORAL Other Neurontin(Gabapentin ) Capsule SS ORAL Nutrition Supplements(Nutritio n Supplements) SS ORAL Urbanyl C 2400 MG/DAY, ORAL ORAL Date:10/24/00ISR Number: 3600703-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000004632 Age:54 YR Gender:Female I/FU:F Outcome Dose Death TRANSDERMAL PT Report Source Product Role Manufacturer Literature Duragesic PS Alza Corp Paroxetine (Paroxetine) SS Duration Completed Suicide 11 PATCH, 1 Drug Toxicity Health IN 1 TIME Medication Error Professional (S), TRANSD TRANSDERMAL 11 PATCH, 1 IN 1 TIME (S), TRANSD Carisoprodol (Carisoprodol) Methadone (Methadone) Alprazolam (Alprazolam) 22-Aug-2005 Page: 408 10:40 AM SS SS SS Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propoxyphene (Dextropropoxyphene) Gabapentin (Gabapentin) Meperidine Hydrochloride (Pethidine Hydrochloride) Date:10/25/00ISR Number: 3608771-9Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Other SS SS SS Company Report #A030491 PT Report Source Product Role Manufacturer Diabetes Mellitus Consumer Viagra PS Pfizer Agricultural Div Gabapentin SS Atenolol Diazepam Trandolapril Diltiazem Indapamide Gamolenic Acid Potassium Bicarbonate Amiloride Allopurinol Frusemide Hydroxocobalamin Naprosyn Metformin Gliclazide C C C C C C Route Duration ORAL 300.00 MG TOTAL:ORAL Date:10/26/00ISR Number: 3602007-0Report Type:Direct Age:27 YR Gender:Female I/FU:I Outcome Dose Other 200 MG TID PT C C C C C C C C Company Report # Report Source Product Role Neurontin 200 Mg Tid PS Manufacturer Route Duration Hepatomegaly ORAL Lung Disorder ORAL Nortriptyline C Date:10/27/00ISR Number: 3603072-7Report Type:Expedited (15-DaCompany Report #001-0945-M0001107 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Abnormal Behaviour Drug Dependence Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration 600 MG (300 MG, BID) Date:10/27/00ISR Number: 3603073-9Report Type:Expedited (15-DaCompany Report #001-0945-M0001057 Age: Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 409 PT Accidental Overdose Blood Creatinine Increased Creatinine Renal 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clearance Decreased Renal Impairment Dose Report Source Product Role Manufacturer Other Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration 2700 MG (DAILY) Date:10/27/00ISR Number: 3603074-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000639 Age:46 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Acute Respiratory Distress Syndrome Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dermatitis MG,TID), PER Eosinophilia ORAL Infection Pneumonia Pyrexia Respiratory Failure Dulcolax (Bisacodyl) Colace (Docusate Sodium) Senna(Senna) Zantac (Ranitidine Hydrochloride) Reglan (Metoclopramide) Cacl (Heparin) Atrovent (Ipratropium Bromide) Albuterol (Salbutamol) (Diazepam) (Fentanyl) Klonopin (Clonazepam) (Methadone) Decadron (Dexamethasone) C C C C C C C C C C C C C C Date:10/31/00ISR Number: 3604437-XReport Type:Direct Age:66 YR Gender:Female I/FU:I Outcome Dose Other 300MG TID PT Company Report # Report Source Product Role Gabapentin PS Etanercept Hydrochlorothiazide Estrogens Conjugated Ferrous Sulfate Salsalate Sulfasalazine Hydroxychloroquine Sulfate C C C C C C Amnesia Disturbance In Attention ORAL Myalgia 22-Aug-2005 Page: 410 Manufacturer Route Duration 10:40 AM C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/00ISR Number: 3605449-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000887 Age:36 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Clonic Convulsion Epilepsy Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration SEE IMAGE Insomnia Paxil (Paroxetine Hydrochloride) Ultram (Tramadol Hydrochloride) Aspirin (Acetylsalicylic Acid) Baclofen (Baclofen) (Potassium) Lasix (Furosemide) Prilosec (Omeprazole) Midrin (Paracetamol, Dichloralphenazone, Isometheptene) Lotanax (Terfenadine) C C C C C C C C C Date:11/01/00ISR Number: 3605452-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000878 Age:64 YR Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Manufacturer Depression Disturbance In Attention Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Facial Nerve Disorder MG, TID) Facial Pain Fatigue Neuralgia Oedema Peripheral Trigeminal Neuralgia Oxycontin (Oxycodone Hydrochloride) Clonopin (Clonazepam) Celebrex (Celecoxib) Lorcet (Paracetamol, Hydrocodone Bitartrate) C C C C Date:11/01/00ISR Number: 3605777-0Report Type:Expedited (15-DaCompany Report #044-0945-M0000161 Age:34 YR Gender:Male I/FU:I Outcome Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 411 10:40 AM PT Arthropathy Atrial Fibrillation Brain Hypoxia Cerebellar Ataxia Choreoathetosis Coma Cyanosis Dementia Electroencephalogram Abnormal Epilepsy Joint Dislocation Loss Of Consciousness Metabolic Acidosis Pupil Fixed Respiratory Arrest FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Skin Disorder Dose Report Source Product Role Manufacturer Route Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 100 MG (ONE Professional DOSE), PER ORAL (Phenytoin) (Clobazam) (Valproic Acid) (Insulin Porcine) C C C C Date:11/01/00ISR Number: 3605778-2Report Type:Expedited (15-DaCompany Report #033-0945-M0000089 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL Required Intervention to Prevent Permanent PER ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Anaemia Megaloblastic Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional Asasantin (Acetylsalicylic Acid, Dipyridamole) SS ORAL Ventoline (Salbutamol) SS ORAL Mopral (Omeprazole) SS ORAL PER ORAL PER ORAL Date:11/01/00ISR Number: 3605833-7Report Type:Expedited (15-DaCompany Report #001-0945-M0001134 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Disorientation Drug Interaction Feeling Abnormal Mania Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Biaxin (Clarithromycin) SS Route Pharyngitis Streptococcal Stress Vision Blurred Unspecified Antibiotic SS Date:11/02/00ISR Number: 3606194-XReport Type:Expedited (15-DaCompany Report #044-0945-M0000078 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG, PT Report Source Product Role Manufacturer Route Dehydration Dizziness Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Hypotension Professional (DAILY), PER Nephrotic Syndrome ORAL Oedema Peripheral Polyuria Proteinuria 22-Aug-2005 Page: 412 10:40 AM (Amitriptyline) Tegretol Retard (Carbamazepine) Frusemide (Furosemide) (Simvastatin) C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/00ISR Number: 3606706-6Report Type:Direct Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Constipation Product Role Gabapentin PS Manufacturer Route Date:11/03/00ISR Number: 3607276-9Report Type:Expedited (15-DaCompany Report #20001100032 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 10 MG QD PO Initial or Prolonged 2 DOSE QD PO PT Report Source Product Role Manufacturer Route Anaemia Megaloblastic Foreign Prilosec PS Astrazeneca Lp ORAL Blood Folate Decreased Health Asasantin SS ORAL Crepitations Professional Neurontin SS ORAL Ventoline Inhalator SS Bronchokod Vitamin B 1 And B6 Doliprane Lasilix Sodium Chloride C C C C C 400 MG TID PO Dyspnoea RESPIRATORY Haemoglobin Decreased (INHALATION) Mean Cell Volume Increased Pallor Red Blood Cell Count Decreased Tachycardia Date:11/07/00ISR Number: 3608452-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000257 Age:49 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 MG, TID), PER PT Report Source Product Role Manufacturer Route Back Pain Blood Pressure Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Fluctuation Company Bone Cyst Representative ORAL Condition Aggravated Drug Withdrawal Syndrome Tachycardia Lisinopril (Lisinopril) Percocet (Paracetamol, Oxycodone Hydrochloride, Oxycodone Unspecified Anti Depressant SS C C Date:11/07/00ISR Number: 3608453-3Report Type:Expedited (15-DaCompany Report #001-0945-M0000966 Age:47 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 413 10:40 AM PT Report Source Product Role Manufacturer Blindness Colour Blindness Optic Disc Haemorrhage Optic Neuritis Photopsia Retinal Haemorrhage Vision Blurred Visual Field Defect Consumer Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/00ISR Number: 3609052-XReport Type:Expedited (15-DaCompany Report #2000-FF-S0618 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG/200 MG PT Report Source Product Role Manufacturer Route Anaemia Anaemia Megaloblastic Foreign Other Aggrenox PS Boehringer Ingelheim Pharmaceuticals Inc ORAL Blood Folate Decreased X2/DAY/PO Dyspnoea Ventoline SS Pallor Neurontin SS ORAL Mopral C ORAL Bronchokod Doliprane Lasilix Chlorure De Sodium Vitamine B1- B6 C C C C C BU 1.2 G/PO 10 MG/PO Date:11/08/00ISR Number: 3609094-4Report Type:Expedited (15-DaCompany Report #033-0945-M0000081 Age:76 YR Gender:Male I/FU:I Outcome Dose Death Other 300 MG PT Report Source Product Role Manufacturer Brain Oedema Sepsis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Thrombocytopenia Professional Unspecified Corticoids Medrol Mopral Cordarone SS C C C Duration (DAILY) Date:11/09/00ISR Number: 3610385-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000006335 Age:48 YR Gender:Male I/FU:F Outcome Hospitalization - PT Abdominal Pain Route Initial or Prolonged Disability Other Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 414 10:40 AM Abnormal Behaviour Abnormal Dreams Angina Pectoris Anhedonia Anxiety Arachnoiditis Asthenia Back Pain Bladder Disorder Bronchitis Bronchitis Acute Cardiac Disorder Cardiomegaly Cervical Spinal Stenosis Chest Pain Colonic Polyp Condition Aggravated Constipation Coronary Artery Disease Cough Decreased Appetite Depression Diarrhoea Dizziness Dry Mouth Dyspnoea FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Echocardiogram Abnormal Ejection Fraction Abnormal Electrocardiogram Abnormal Electrocardiogram Qt Prolonged Emotional Disorder Fall Fibrosis Gait Disturbance Gastric Ulcer Gastrooesophageal Reflux Disease Haematochezia Hallucination Hyperhidrosis Hypoaesthesia Hypotension Influenza Like Illness Injury Insomnia Joint Swelling Malaise Mental Disorder Migraine Mitral Valve Incompetence Mononeuropathy Muscle Spasms Myalgia Myocardial Infarction Nasal Congestion Nausea Neck Pain Nervous System Disorder Nervousness Nuclear Magnetic Resonance Imaging Abnormal Pain Pain In Extremity Palpitations Pancreatitis Pharyngitis Pharyngolaryngeal Pain Polydipsia Polyuria Pruritus Pyrexia Rash Erythematous Rectal Haemorrhage Renal Colic Rhinitis Road Traffic Accident Sinus Tachycardia Spinal Osteoarthritis Suicidal Ideation Swelling Syncope Tricuspid Valve Incompetence 22-Aug-2005 Page: 415 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Ventricular Extrasystoles Ventricular Fibrillation Dose Report Source Product Role Manufacturer Route Health Professional Propulsid PS Janssen Research Fdn Div Johnson And Johnson ORAL Duration Vision Blurred Vomiting Weight Decreased SEE IMAGE Pamelor (Nortriptyline Hydrochloride) SS ORAL Promethazine (Promethazine) SS ORAL 75 MG, 1 IN 1 DAY(S), ORAL 50 MG, 4 IN 1 DAILY, ORAL Mellaril (Thioridazine Hydrochloride) Compazine (Prochlorperazine Edisylate) Neurontin (Gabapentin) SS SS SS 600 MG, 2 IN 1 DAILY Biaxin (Clarithromycin) SS 500 MG, 2 IN 1 DAILY Elavil (Amitriptyline Hydrochloride) Prilosec (Omeprazole) Paxil (Paroxetine Hydrochloride) Prozac (Fluoxetine Hydrochloride) Nitroglycerin (Nitroglycerin Comp. /Net/) SS C C C C Vicodin (Vicodin) Procardia (Nifedipine) Valium (Diazepam) Prevacid (Lansoprazole) Reglan (Metoclopramide) Baclofen (Baclofen) Vistaril (Hydroxyzine Embonate) Vitamins (Vitamins) Darvocet (Darvocet) Parafon (Parafon Forte) Flexeril (Cyclobenzaprine Hydrochloride) Isocet (Axotal (Old Form)) Trazodone (Trazodone) Amoxil (Amoxicillin) 22-Aug-2005 Page: 416 10:40 AM C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metoprolol (Metoprolol) Carbamazepine (Carbamazepine) Talacen (Fortagesic) Nifrex-150 Forte (Unspecified) Celexa (Citalopram Hydrobromide) Lorazepam (Lorazepam) Medrol Dose Pack (Methylprednisolone) Lactulose (Lactulose) Atarax (Hydroxyzine Hydrochloride) Limbitrol (Limbitrol) Baclofen (Baclofen) Remeron (Mirtazapine) Ms Contin (Morphine Sulfate) Oxycontin (Oxycodone Hydrochloride) Hemorrhoidal Suppository (Unspecified) Midrin (Midrid) Zithromax (Azithromycin) Viokase (Pancrelipase) C C C C C C C C C C C C C C C C C C Date:11/13/00ISR Number: 3610818-0Report Type:Expedited (15-DaCompany Report #001-0945-M0001170 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Asthma Blindness Transient Cerebrovascular Accident Convulsion Loss Of Consciousness Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Diamox (Acetazolamide) Depakote (Valproate SS Route Tremor Visual Disturbance Semisodium) (Loratadine) (Fluticasone Propionate) (Montelukast) Date:11/13/00ISR Number: 3610819-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000977 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 417 10:40 AM PT Amnesia Balance Disorder Disturbance In Attention Dizziness Fall SS C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervousness Dose Report Source Product Role Manufacturer Route Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 1) 4800 MG (1200 MG, QID), PER ORAL; 2) UNK, UNKNOWN (Prednisone) (Calcium) C C Date:11/13/00ISR Number: 3610826-XReport Type:Expedited (15-DaCompany Report #2000UW04157 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Amnesia Confusional State Hypotension Consumer Tenormin PS Astrazeneca Pharmaceuticals Lp Zyban SS Nifedipine Gabapentin SS SS ORAL 150 MG BID PO Pneumonia Sedation Speech Disorder Toxicologic Test Abnormal Date:11/13/00ISR Number: 3610971-9Report Type:Expedited (15-DaCompany Report #002-0945-M0000035 Age:71 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Convulsion Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Duration 1200 MG (400 Professional MG, TID) Dilantin (Phenytoin Route Sodium) SS ORAL 100 MG EVERY SECOND DAY PER ORAL Date:11/13/00ISR Number: 3610972-0Report Type:Expedited (15-DaCompany Report #033-0945-M0000088 Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Route Bundle Branch Block Drug Interaction Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dyspnoea Fatigue Professional Flecaine (Flecainide Acetate) SS Depakine (Valproate Sodium) C ORAL PER ORAL Sinus Bradycardia Date:11/13/00ISR Number: 3610973-2Report Type:Expedited (15-DaCompany Report #002-0945-M0000035 Age:71 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Convulsion Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Dilantin (Phenytoin Sodium) SS Route Duration 1200 MG (400 Professional MG, TID) 100 MG EVERY SECOND DAY, 22-Aug-2005 Page: 418 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PER ORAL Date:11/13/00ISR Number: 3611141-0Report Type:Expedited (15-DaCompany Report #001-0945-M0001165 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (300 PT Report Source Product Role Manufacturer Cardiac Arrest Dysentery Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Route Pneumonia MG, QID) Klonopin (Clonazepam) Desyrel Trazodone Hydrochloride) Lithium Prochlorperazine Folic Acid Inderal (Propranolol Hydrochloride) Methadone Duragesic Patch (Fentanyl) C C C C C C C C Date:11/13/00ISR Number: 3611143-4Report Type:Expedited (15-DaCompany Report #001-0945-M0001145 Age:16 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 12000 MG (3000 MG, QID), PER ORAL PT Report Source Product Role Manufacturer Route Status Epilepticus Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Date:11/13/00ISR Number: 3611145-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000998 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other (DAILY), PER PT Report Source Product Role Manufacturer Route Cerebrovascular Accident Coma Convulsion Consumer Neurontin (Gabapentin) PS Parke Davis Pharmaceuticals Ltd ORAL Difficulty In Walking ORAL Dizziness Fall Loss Of Consciousness Paralysis Speech Disorder Cognex (Tacrine Hydrochloride0 Detrol (Tolterodine Tartrate) Selenium Vitamin E ... ... Date:11/13/00ISR Number: 3614257-8Report Type:Periodic Age:18 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO C C C C C C Company Report #FLUV00299001382 PT Report Source Product Role Manufacturer Route Intentional Misuse Health Professional Luvox PS Solvay Pharmaceuticals ORAL Neurontin SS Zyprexa Tylenol C C DAILY PO 22-Aug-2005 Page: 419 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/00ISR Number: 3611688-7Report Type:Expedited (15-DaCompany Report #033-0945-M000088 Age:76 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged UNK, PER ORAL PT Report Source Product Role Manufacturer Route Bundle Branch Block Left Drug Interaction Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dyspnoea Fatigue Professional Flecaine (Flecainide Acetate) SS Depakine (Valproate Sodium) C ORAL UNK, PER ORAL Sinus Bradycardia Date:11/14/00ISR Number: 3611783-2Report Type:Expedited (15-DaCompany Report #044-0945-M0000136 Age:70 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Aphasia Hypertonia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Masked Facies Professional Duration 200 MG (DAILY), PER Paralysis ORAL (SEE Parkinson'S Disease IMAGE) Tremor Thyroxine C Date:11/14/00ISR Number: 3612066-7Report Type:Expedited (15-DaCompany Report #A036504 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Required 300.00 MG Intervention to TOTAL TID PT Report Source Product Role Manufacturer Route Confusional State Dissociative Disorder Health Professional Zoloft PS Pfizer Pharmaceuticals Inc ORAL Dysarthria Headache Gabapentin SS ORAL Prevent Permanent ORAL Impairment/Damage Insomnia Memory Impairment Mental Disorder Paranoia Speech Disorder Lithium Hydrocodone + Acetaminophen Estrogen Ergotamine + Caffeine C C C C Date:11/14/00ISR Number: 3612196-XReport Type:Expedited (15-DaCompany Report #001-0945-M0001210 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Blood Electrolytes Abnormal Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Route Date:11/15/00ISR Number: 3612105-3Report Type:Expedited (15-DaCompany Report #001-0902-M0000076 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Blood Pressure Decreased Hiv Infection Cdc Group I Consumer Nardil PS Parke Davis Div Warner Lambert Co ORAL Duration 90-120 MG Insomnia (DAILY), PER Nephrolithiasis ORAL Sexual Dysfunction Visual Disturbance 22-Aug-2005 Page: 420 10:40 AM Neurontin (Gabapentin) Viracept (Nelfinavir Mesilate) Epivir (Lamivudine) SS C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zerit (Stavudine) Lipitor (Atrovastatin) C C Date:11/15/00ISR Number: 3612446-XReport Type:Expedited (15-DaCompany Report #044-0945-M0000078 Age:66 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Manufacturer Route Blood Albumin Increased Dehydration Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dizziness Professional (DAILY), PER Nephrotic Syndrome ORAL Oedema Peripheral Orthostatic Hypotension Proteinuria (Amitriptyline) Tegretol Retard (Carbamazepine) Frusemide (Furosemide) (Simvastatin) C C C C Date:11/15/00ISR Number: 3612748-7Report Type:Expedited (15-DaCompany Report #001-0945-M0001107 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Drug Dependence Feeling Abnormal Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Duration 900 MG (300 MG, TID), PER ORAL Date:11/15/00ISR Number: 3612749-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000966 Age:47 YR Gender:Female I/FU:F Outcome Dose PT Duration Report Source Product Role Hospitalization Initial or Prolonged 800 MG Blindness Colour Blindness Consumer Health Optic Disc Haemorrhage Professional Neurontin PS Parke Davis Pharmaceuticals Ltd (DAILY); 1600 Optic Neuritis MG (DAILY); Photopsia 3600 MG Vision Blurred (DAILY); 4800 Visual Field Defect Date:11/15/00ISR Number: 3612842-0Report Type:Expedited (15-DaCompany Report #001-0945-M0001191 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Drug Abuser Euphoric Mood Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration 4800 MG Intentional Misuse (DAILY) Date:11/16/00ISR Number: 3611875-8Report Type:Expedited (15-DaCompany Report #A0122366A Age:70 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 421 10:40 AM PT Abdominal Pain Abdominal Pain Upper Concussion Erythema Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Feeling Abnormal Gastric Mucosal Lesion Dose Report Source Product Role Manufacturer Route Dilantin Neurontin Depakote Lamictal PS SS SS SS Glaxo Wellcome ORAL Lamictal SS Glaxo Wellcome ORAL Duration Hand Fracture Head Injury Overdose Spinal Fracture 200MG SEE TEXT 100MG SEE TEXT Date:11/16/00ISR Number: 3612811-0Report Type:Expedited (15-DaCompany Report #001-0981-992632 Age:49 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other 10 MG PT Report Source Product Role Manufacturer Route Amnesia Brain Damage Cerebrovascular Accident Consumer Health Professional Lipitor PS Pfizer Ireland Pharmaceuticals, Tablet Plant ORAL Route Condition Aggravated (DAILY), PER Diabetic Neuropathy ORAL Hypertension Pain In Extremity Peripheral Vascular Disorder Neurontin (Gabapentin) Glucophage Rezulin Insulin SS C C C Date:11/16/00ISR Number: 3613034-1Report Type:Expedited (15-DaCompany Report #049-0945-M0000019 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Hepatitis Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Date:11/17/00ISR Number: 3613404-1Report Type:Expedited (15-DaCompany Report #00P-163-0099888-00 (0) Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 250 MG, 3 IN Initial or Prolonged 1 D, PER ORAL PT Report Source Product Role Manufacturer Route Asthma Consumer Depakote PS Abbott Laboratories ORAL Tremor Other Gabapentin (Gabapentin) SS Visual Disturbance 300 MG, 1 IN 1 D, PER ORAL Oxycodone Sonata Tizanidine Tylox Singulair Nometasone Furoate Fluticasone Propionate Salbutamol 22-Aug-2005 Page: 422 10:40 AM C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/00ISR Number: 3615207-0Report Type:Expedited (15-DaCompany Report #001-0945-M0001218 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Other MG, DAILY), PT Report Source Product Role Manufacturer Route Chills Dizziness Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Fall Feeling Abnormal PER ORAL Foot Fracture (Hydrocodone) SS Fosamax Norvasc Calcium C C C ORAL 7.5 MG/750 MG Influenza Like Illness (UNK), PER Lower Limb Fracture ORAL Nausea Vomiting Date:11/20/00ISR Number: 3615275-6Report Type:Expedited (15-DaCompany Report #A0122366A Age:70 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 100 MG/SEE Initial or Prolonged TEXT/ORAL PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Consumer Lamictal PS Glaxo Wellcome Inc ORAL Convulsion Phenytoin SS Endoscopy Gabapentin SS Endoscopy Abnormal Fall Semisodium Valproate Lamictal SS SS Back Injury 100 MG 100 MG 200 MG/SEE Feeling Abnormal TEXT/ORAL Hand Fracture Nervous System Disorder ORAL Date:11/20/00ISR Number: 3615311-7Report Type:Expedited (15-DaCompany Report #358-0945-M0000005 Age:2 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRAVENOUS PT Report Source Product Role Manufacturer Convulsion Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Meronem (Meropenem) SS Levolac (Lactulose) Zantac (Ranitidine Hydrochloride) Pulmicort (Budenonide) Deprakine (Valproate Sodium) Sabrilex (Vigabatrin) Propulsin (Cisapride Monohydrate) Orfiril (Valproate Sodium) Salbuvent (Salbutamol Sulfate) Oradexon (Dexamethasone) Rifampicin Topimax (Topiramate) Hydantin (Phenytoin) C 1500 MG (DAILY) INTRAVENOUS 22-Aug-2005 Page: 423 10:40 AM C C C C C C C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/00ISR Number: 3631160-8Report Type:Periodic Age:73 YR Gender:Male I/FU:I Outcome Dose Company Report #2000026966US PT Report Source Product Role Manufacturer Tremor Health Professional Zyvox PS Pharmacia And Upjohn Co Neurontin SS Route Duration Date:11/21/00ISR Number: 3615603-1Report Type:Expedited (15-DaCompany Report #001-0945-M0001057 Age: Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Accidental Overdose Creatinine Renal Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Clearance Decreased Other Route Duration 2700 MG (DAILY) Renal Impairment Date:11/21/00ISR Number: 3615604-3Report Type:Expedited (15-DaCompany Report #001-0945-M0001206 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Blood Electrolytes Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Decreased MG TID ) PER Disorientation ORAL Drug Interaction (Methadone) SS ORAL Drug Level Above Morphine SS ORAL Therapeutic Baclofen SS ORAL Hypertension Memory Impairment Migraine Muscle Contractions Zoloft (Sertraline Hydrochloride) Clonidine Cardizem (Diltiazem C C PER ORAL PER ORAL PER ORAL Involuntary Tachycardia Tremor 22-Aug-2005 Page: 424 10:40 AM Hydrochloride) (Potassium) Theophylline Hydrochlorothiazide Flovent (Fluticasone Propionate) (Fluocinonide) Combivent (Ipratropium Bromide, Salbutamol Sulfate) Teargen (Benzalkonium Chloride) Vitamin B12 (Cyancobalamin) Vasocon (Phenylmercuric Acetate, Sodium Carbonate Anhydrous, Naphazoline Docusate Compazine (Prochlorperazine Edisylate) (Capsaicin) Herbal Natural Estrogen C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin E (Tocopherol) Coenzyme Q10 (Ubidecarenone) Stresstab(Vitamins Nos) (Garlic) Very Green Supplement Echinacea Extract Vicodin (Paracetamol, Hydrocodone Bitartrate) Bacitracin /Polymixin Ointment) Benadryl (Diphenhydramine Hydrochloride) Ibuprofen Nystatin Cream C C C C C C C C C C C Date:11/21/00ISR Number: 3615857-1Report Type:Expedited (15-DaCompany Report #00P-056-0099941-00 (0) Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Bradycardia Bundle Branch Block Left Drug Interaction Foreign Health Professional Depakene PS Abbott Laboratories Pharmaceutical Products Div ORAL 500 MG, 1 IN Dyspnoea 1 D, PER ORAL Fatigue Flecainide Acetate (Flecainide Acetate) SS ORAL Gabapentin (Gabapentin) SS ORAL PER ORAL PER ORAL Date:11/21/00ISR Number: 3615920-5Report Type:Expedited (15-DaCompany Report #033-0945-M0000081 Age:76 YR Gender:Male I/FU:F Outcome Dose Death Other 300 MG PT Report Source Product Role Manufacturer Brain Oedema Sepsis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Thrombocytopenia Professional Unspecified Corticoids Medrol Mopral Cordarone SS C C C Route Duration (DAILY), Date:11/21/00ISR Number: 3615921-7Report Type:Expedited (15-DaCompany Report #044-0945-M0000168 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Raynaud'S Phenomenon Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 Professional MG, TID), PER ORAL Warfarin Digoxin 22-Aug-2005 Page: 425 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paracetamol C Date:11/21/00ISR Number: 3616938-9Report Type:Expedited (15-DaCompany Report #001-0945-M001206 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Blood Electrolytes Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Decreased MG, TID) PER Disorientation ORAL Drug Level Above Methadone SS ORAL Therapeutic Morphine SS ORAL Dysgraphia Baclofen SS ORAL Hypertension Migraine Movement Disorder Pain Tachycardia Tremor Zoloft Clonidine Cardizem Potassium Theophylline Hydrochlorothiazide Flovent Fluocinonide Combivent Teargen Vitamin B12 Vasocon Docusate Compazine Capsaicin Herbal Natural Estrogen Vitamin E Coenzyme Q10 Stresstab Garlic Very Green Supplement Echinacea Extract Vicodin C C C C C C C C C C C C C C C PER ORAL PER ORAL PER ORAL C C C C C C C C Bacitracin/Polymixin Ointment Benadryl Ibuprofen Nystatin Cream Date:11/22/00ISR Number: 3616186-2Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Other C C C C Company Report #98811.01 PT Report Source Product Role Manufacturer Route Drug Ineffective Drug Interaction Consumer Lorazepam PS Mylan Pharmaceuticals Inc ORAL Parke-Davis ORAL Duration 1 MG, BID, ORAL Neurontin Capsules 300 Mg Parke-Davis SS Rochephin C 600 MG QAM & QHS, 400 MG TID, ORAL 22-Aug-2005 Page: 426 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/00ISR Number: 3616394-0Report Type:Expedited (15-DaCompany Report #044-0945-M0000168 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Raynaud'S Phenomenon Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 900 MG (300 Professional MG, TID), PER Other ORAL (Warfarin) (Digoxin) (Paracetamol) C C C Date:11/22/00ISR Number: 3616395-2Report Type:Expedited (15-DaCompany Report #033-0945-M0000081 Age:76 YR Gender:Male I/FU:F Outcome Dose Death Other 300 MG PT Report Source Product Role Manufacturer Brain Oedema Sepsis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Thrombocytopenia Professional Corticoids SS Duration (DAILY) Other CEREBRAL EDEMA Medrol (Methylprednisolone) Mopral (Omeprazole) Cordarone (Amiodarone Hydrochloride) C C C Date:11/22/00ISR Number: 3617771-4Report Type:Expedited (15-DaCompany Report #A036897 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Amnesia Health Procardia Xl PS Pfizer Laboratories Route Initial or Prolonged ORAL Confusional State Professional Hypotension Div Pfizer Inc Bupropion SS Gabapentin Atenolol SS SS ORAL ORAL 300.00 MG Pneumonia TOTAL:BID:ORA Sedation L Speech Disorder Toxicologic Test Abnormal Date:11/24/00ISR Number: 3616346-0Report Type:Expedited (15-DaCompany Report #249263 Age:55 YR Gender:Female I/FU:I Outcome Dose Other 20 MG DAILY PT Report Source Product Role Manufacturer Route Breast Cancer Female Health Accutane PS Hlr Technology ORAL Neurontin (Gabapentin) SS Duration Professional ORAL 100 MG DAILY ORAL Date:11/24/00ISR Number: 3617228-0Report Type:Expedited (15-DaCompany Report #033-0945-M0000093 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 427 10:40 AM PT Anaemia Leukopenia Pancytopenia Pulmonary Oedema ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocytopenia Dose Report Source Product Role Manufacturer Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Triatec (Ramipril) Kardegic (Acetylsalicylate Lysine) Trivastal (Piribedil) Sermion (Nicergoline) C Route Duration 400 MG (200 Professional MG, BID), C C C Date:11/24/00ISR Number: 3617229-2Report Type:Expedited (15-DaCompany Report #358-0945-M0000006 Age:83 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Blood Disorder Clonic Convulsion Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Condition Aggravated Professional Muscle Twitching Company Duration 600 MG (DAILY), PER ORAL Representative Marevan (Warfarin Sodium) Tramal Retard (Tramodol Hydrochloride) Panodil (Paracetamol) Lanzo (Lansoprazole) Spesicor (Metoprolol Tartrate) Cozaar (Losartan Potassium) Hydrex Semi(Hydrochlorothiz ide) C C C C C C C Furesis Special (Furosemide) Laxoberon (Sodium Picosulfate) Oxepam (Oxazepam) Insulin Mixtard (Insulin Injection, Isophane) Zomax (Zomepirac Sodium) C C C C C Date:11/24/00ISR Number: 3617402-3Report Type:Expedited (15-DaCompany Report #047-0945-M0000004 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG Other (DAILY), PER PT Report Source Product Role Manufacturer Route Blindness Unilateral Optic Neuritis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional ORAL Rivotril (Clonazepam) 22-Aug-2005 Page: 428 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Several Unspecified Medications C Date:11/27/00ISR Number: 3616029-7Report Type:Expedited (15-DaCompany Report #249263 Age:55 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Neurontin Accutane Capsules PS SS Roche Route Duration Breast Cancer Female Date:11/29/00ISR Number: 3619050-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000009351 Age:21 YR Gender:Male I/FU:I Outcome Dose Death TRANSDERMAL PT Report Source Product Role Manufacturer Route Health Duragesic PS Alza Corp Percocet (Oxycodone) SS ORAL Seroquel (Seroquel) SS ORAL Revia (Naltrexone) SS ORAL Neurontin (Gabapentin) SS ORAL Trazodone (Trazodone) SS ORAL Depakote (Valproate Semisodium) SS ORAL Amitriptyline (Amitriptyline0 SS ORAL Celexa (Citalopram Hydrobromie) SS ORAL Duration Aspiration 75 MCG/H, 1 Medication Error Professional IN 1 TIME(S), TRANSD ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL Anti-Depressants (Nos) Antideppressants) Fentanyl (0,05 Mg/Ml Injection) (Fentanyl) INTRAVENOUS 1 IN 1 TIME(S), IV Date:11/29/00ISR Number: 3619079-XReport Type:Expedited (15-DaCompany Report #001-0945-M0001245 Age:48 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Other 22-Aug-2005 Page: 429 10:40 AM PT Abdominal Pain Abnormal Dreams Aggression Angina Pectoris Anxiety Arachnoiditis Arrhythmia Asthenia Back Pain Bronchitis Cardiac Disorder Cardiomegaly Cervical Spinal Stenosis Chest Pain Condition Aggravated Constipation SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Appetite Depression Diarrhoea Dose Report Source Product Role Manufacturer Route Neurontin PS Parke Davis Pharmaceuticals Ltd Propulsid (Cisapride) SS ORAL Pamelor (Nortriptyline Hydrochloride) SS ORAL (Promethazine) SS ORAL Duration Dizziness Drug Abuser 1200 MG Dry Mouth (DAILY), Dyspnoea UNKNOWN Electrocardiogram Qt Prolonged 30 MG Gastric Ulcer (DAILY), PER Hallucination ORAL,40 MG Hyperhidrosis (DAILY), PER Hypotension ORAL Influenza Like Illness Insomnia Mental Disorder 75 MG Mitral Valve Incompetence (DAILY), PER Muscle Spasms ORAL Myalgia 200 MG Myocardial Ischaemia (DAILY), PER Neck Pain ORAL Neuropathy Peripheral Pancreatic Carcinoma Pancreatitis Pharyngitis Polydipsia Polyp Polyuria Pruritus 1000 MG Rash Papular (DAILY) Mellaril (Thioridazine Hydrochloride) Compazine (Prochlorperazine Edisylate) Biaxin (Clarithromycin) SS SS SS Rectal Haemorrhage Renal Colic Rhinitis Road Traffic Accident Suicidal Ideation Suicide Attempt Syncope Tachycardia Tricuspid Valve Incompetence Ultrasound Scan Abnormal Urinary Retention Urinary Tract Infection Ventricular Extrasystoles Ventricular Fibrillation Vision Blurred Vomiting Weight Decreased 22-Aug-2005 Page: 430 10:40 AM Elavil (Amitriptyline Hydrochloride) Prilosec (Omeprazole) Paxil (Paroxetine Hydrochloride) Prozac (Fluoxetine Hydrochloride Vicodin (Paracetamol, Hydrocodone Bitartrate) Procardia (Nifedipine) Valium (Diazepam) Prevacid (Lansoprazole) Reglan (Metoclopramide) (Baclofen) Vistaril (Hydroxyzine Embonate) Vitamins (Vitamins Nos) Nitroglycerin (Phenobarbital, Atropine Methonitrate, Glyceyl Trinitrate, SS C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Darvocet (Paracetamol, Dextropropoxyphene) Parafon Forte (Chlorzoxazone, Paracetamol) Flexeril (Cyclobenzaprine Hydrochloride) Isocet (Caffeine, Butalbital, Paracetamol) (Trazodone) Amoxil (Amoxicillin) (Metoprolol) (Carbamazepine) Talacen (Paracetamol, Pentazocine Hydrochloride) Niferex-150 Forte (Vitamins Nos, Minerals Nos) Celexa (Citalopram Hydrobromide) (Lorazepam) Medrol Dose Pak (Methylprednisolone) (Lactulose) Atarax (Hydroxyzine Hydrochloride) Limibitrol (Chlordiazepoxide, Amitriptyline Hydrochloride) Remeron (Mirtazapine) Ms Contin (Morphine Sulfate) Oxycontin (Oxycodone Hydrochloride) Hemorrhoidal Suppository Unspecified Midrin (Paracetamol, Dichoralphenazone, Isometheptene) C C C C C C C C C C C C C C C C C C C C C Zithromax (Azithromycin) Viokase (Pancrelipase) C C Date:11/30/00ISR Number: 3618967-8Report Type:Expedited (15-DaCompany Report #B0092629A Age:65 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization RESPIRATORY Initial or Prolonged (INHALATION) PT Anaemia Report Source Product Role Manufacturer Route Ventoline PS Glaxo Wellcome Asasantine SS ORAL Mopral SS ORAL Dyspnoea Exertional Pallor 2UNIT per day 10MG Per day 22-Aug-2005 Page: 431 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin SS Bronchokod Doliprane Lasilix Sodium Chlorure B-Vitamins C C C C C ORAL 1200MG per day Date:11/30/00ISR Number: 3619921-2Report Type:Expedited (15-DaCompany Report #358-0945-M000005 Age:2 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged INTRAVENOUS PT Report Source Product Role Manufacturer Convulsion Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Meronem (Meropenem) SS Levolac (Lactulose) Zantac (Ranitidine Hydrochloride) Pulmicort (Budesonide) Deprakine (Valproate Sodium) Sabrilex (Vigabatrin) Propulsin (Cisapride Monohydrate) Orfiril (Valproate Sodium) Salbuvent (Salbutamol Sulfate) Oradexon (Dexamethasone) (Rifampicin) Topimax (Topiramate) Hydantin (Phenytoin) C 1500 MG DAILY INTRAVENOUS C C C C C C C C C C C Route Date:11/30/00ISR Number: 3620127-1Report Type:Expedited (15-DaCompany Report #001-0945-M0001264 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 432 10:40 AM PT Report Source Product Role Manufacturer Fall Muscle Twitching Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd (Oxcarbazepine) Zoloft (Sertraline Hydrochloride) Ultram (Tramadol Hydrochloride) Elavil (Amitriptyline Hydrochloride) Clonidine (Clonidine) Lotrim (Clotrimazole) Vitamins (Vitamins Nos) SS C C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/00ISR Number: 3620128-3Report Type:Expedited (15-DaCompany Report #001-0945-M0001254 Age:30 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1) 200 MG PT Report Source Product Role Manufacturer Back Injury Condition Aggravated Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Route Coordination Abnormal (100 MG, Dizziness BID); 2) Dysarthria 1500 MG Fall (500MG, TID) Syncope Prozac (Fluoxetine Hydrochloride) Vioxx (Rofecoxib) (Diazepam) (Hydrochlorothiazide , Triamterene) Demerol (Pethidine Hydrochloride) C C C C C Date:11/30/00ISR Number: 3620130-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000462 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Blood Glucose Increased Cellulitis Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Disturbance In Attention MG, TID), PER Dizziness ORAL Headache Nausea Speech Disorder Tremor Vision Blurred (Insulin) Aleve (Naproxen Sodium) C C Date:12/01/00ISR Number: 3621120-5Report Type:Expedited (15-DaCompany Report #B0092629A Age:65 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Anaemia RESPIRATORY Initial or Prolonged Dyspnoea Exertional (INHALATION) 100 MCG Pallor INHALED Report Source Product Role Manufacturer Route Foreign Ventolin PS Glaxo Wellcome Inc Asasantin Capsule (Asasantin) SS ORAL Omeprazole Capsule (Omeprazole) SS ORAL Gabapentin Capsule (Gabapentin) SS ORAL Carbocisteine Paracetamol Frusemide Sodium Chloride Compound Vitamin B C C C C C ORAL 10 MG PER DAY ORAL 400 MG ORAL Date:12/01/00ISR Number: 3621320-4Report Type:Expedited (15-DaCompany Report #001-0945-M0001245 Age:48 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 433 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Disability Other PT Anhedonia Anxiety Arrhythmia Asthenia Back Pain Bronchitis Cardiac Disorder Cardiomegaly Chest Pain Condition Aggravated Cough Dizziness Drug Abuser Dyspnoea Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Prolonged Emotional Disorder Emotional Distress Fall Fear Of Disease Fibrosis Headache Heart Rate Irregular Hyperhidrosis Hypoaesthesia Injury Joint Swelling Left Ventricular Failure Malaise Mental Disorder Mitral Valve Incompetence Myalgia Nasal Congestion Nausea Neck Pain Nuclear Magnetic Resonance Imaging Abnormal Pain Pancreatic Carcinoma Pancreatitis Pharyngitis Pharyngolaryngeal Pain Polydipsia Polyuria Pyrexia Rash Erythematous Renal Colic Rhinitis Road Traffic Accident Sinus Tachycardia Spinal Osteoarthritis Suicide Attempt Syncope Tricuspid Valve 22-Aug-2005 Page: 434 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Incompetence Urinary Retention Urinary Tract Infection Ventricular Fibrillation Dose Report Source Product Role Manufacturer Neurontin PS Parke Davis Pharmaceuticals Ltd Propulsid SS ORAL Promethazine SS ORAL Pamelor SS ORAL Mellaril Biaxin SS SS Elavil Compazine Prilosec Trazodone Isocet Flexeril Parafon Forte Darvocet Nitroglycerin Vitamins Vistaril Baclofen Zithromax SS SS C C C C C C C C C C C Route Duration Vomiting 1200 MG (DAILY) 30 MG (DAILY), PER ORAL (SEE IMAGE) 200 MG (DAILY), PER ORAL 75 MG (DAILY), PER ORAL 1000 MG (DAILY) Midrin Hemorrhoidal Suppository Unspecified Oxycontin Ms Contin Remeron Limbitrol Atarax Lactulose Viokase Medrol Dose Pak Lorazepam Celexa Niferex-150 Forte Talacen Carbamazepine Metoprolol Amoxil Vicodin Procardia Valium Reglan Prevacid Paxil Prozac 22-Aug-2005 Page: 435 10:40 AM C C C C C C C C C C C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/00ISR Number: 3622411-4Report Type:Direct Age:83 YR Gender:Male I/FU:I Outcome Dose Other 200MG PO PT Company Report # Report Source Product Role Gabapentin PS Amiodarone Calcium Carbonate Docusate Erythropoietin Folic Acid Metoprolol Tamsulosin Lactulose Promethazine Carbamazepine C C C C C C C C C C Manufacturer Route Duration Coma ORAL Dialysis AFTER Mental Impairment DIALYSIS Date:12/05/00ISR Number: 3622509-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000301 Age:57 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Abnormal Dreams Amblyopia Amnesia Back Pain Consumer Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL 1800 MG (600 Confusional State MG,TID), PER Coordination Abnormal ORAL / 2400 Depression MG (600 MG Dizziness BID, 1200 MG Drug Withdrawal Syndrome Dry Mouth Dry Throat Dysarthria Euphoric Mood Pain Medication Unspecified Celexa(Citalopram Hydrobromide) C C Fatigue Headache Hostility Muscle Twitching Oedema Thinking Abnormal Tremor Vomiting Weight Decreased Date:12/05/00ISR Number: 3622510-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000403 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Pulmonary Fibrosis Respiratory Distress Health Professional Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL 4000 MG (800 MG TID, 1600 MG QHS), PER ORAL Zoloft(Sertraline Hydrochloride) Depakote(Valproate Semisodium) 22-Aug-2005 Page: 436 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/00ISR Number: 3622666-6Report Type:Expedited (15-DaCompany Report #001-0945-M0000264 Age:71 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Confusional State Disorientation Renal Cell Carcinoma Stage Unspecified Consumer Health Professional Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL 1800 MG (600 MG, TID), PER ORAL Zestril (Lisinopril) Levoxyl (Levothyroxine Sodium) Celebrex (Celecoxib) Baby Aspirin (Acetylsalicylic Acid) C C C C Date:12/06/00ISR Number: 3623444-4Report Type:Expedited (15-DaCompany Report #042-0945-M0000001 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG PT Report Source Product Role Manufacturer Route Coordination Abnormal Headache Foreign Company Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Nystagmus Representative (DAILY), PER Vertigo ORAL Sanepil (Phenobarbital, Phenytoin) Date:12/06/00ISR Number: 3623667-4Report Type:Expedited (15-DaCompany Report #055-0945-M0000020 Age:50 YR Gender:Male I/FU:I SS Outcome Dose Other PT Report Source Product Role Manufacturer Route Visual Acuity Reduced Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1200 MG (600 Professional MG, BID), PER ORAL Date:12/07/00ISR Number: 3623654-6Report Type:Direct Age:29 YR Gender:Female I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Manufacturer Route Neurontin 300mg Parke-Davis PS Parke-Davis ORAL Fioricet Generic Geneva Labs SS Geneva Labs ORAL Rizotriptan C Duration Coordination Abnormal Disorientation NEURONTIN TID Dizziness ORAL Lethargy Medication Error FIORICET Q 4-6 HRS ORAL Date:12/07/00ISR Number: 3638462-XReport Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome 22-Aug-2005 Page: 437 PT Alanine Aminotransferase Increased 10:40 AM Company Report #2000-09-0259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Blood Lactate Dehydrogenase Increased Haptoglobin Decreased Report Source Product Role Manufacturer Route Hyperbilirubinaemia Health Temodar PS Schering Corp ORAL Reticulocytosis Professional Neurontin Tablets SS Duration 570 MGQDX5D, ORAL ORAL 900 MG ORAL Date:12/11/00ISR Number: 3626585-0Report Type:Expedited (15-DaCompany Report #001-0945-M0001297 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (100 PT Report Source Product Role Manufacturer Route Abdominal Pain Cholelithiasis Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Loss Of Consciousness MG, TID), PER Malaise ORAL; Nausea 600MG(200MG,T ID), PER Date:12/11/00ISR Number: 3626586-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000937 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Impaired Gastric Emptying Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL MG, TID), PER ORAL Oxycontin (Oxycodone Hydrochloride) 240 MG (80 SS MG, TID) YR (Amitriptyline) Reglan (Metoclopramide) Klonopin (Clonazepam) Prilosec (Omeprazolle) (Ferous Sulfate) Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochliride, C C C C C C Date:12/11/00ISR Number: 3626929-XReport Type:Expedited (15-DaCompany Report #044-0945-M0000180 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Vasculitis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 100 MG Professional (DAILY), PER ORAL (Amlodipine) (Zomitriptan) 22-Aug-2005 Page: 438 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/00ISR Number: 3626930-6Report Type:Expedited (15-DaCompany Report #033-0945-M0000101 Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1600 MG PT Report Source Product Role Manufacturer Route Dyskinesia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional (DAILY), PER Other ORAL Date:12/11/00ISR Number: 3626931-8Report Type:Expedited (15-DaCompany Report #032-0945-M0000027 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL Other PT Report Source Product Role Manufacturer Route Agranulocytosis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional Other (Valproate Sodium) Route SS Date:12/14/00ISR Number: 3630113-3Report Type:Expedited (15-DaCompany Report #001-0945-M0001324 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Bradycardia Hypothermia Pneumonia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Olanzapine Quazepam C C Date:12/14/00ISR Number: 3630345-4Report Type:Expedited (15-DaCompany Report #002-0945-M0000043 Age:43 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Tunnel Vision Foreign Neurontin PS Parke Davis Duration Route Visual Field Defect Health Pharmaceuticals Ltd ORAL 1200 MG Professional (DAILY), PER ORAL Date:12/18/00ISR Number: 3632818-7Report Type:Expedited (15-DaCompany Report #001-0945-M0001218 Age:68 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Chills Dizziness Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 Fall MG, DAILY), Feeling Abnormal PER ORAL Influenza Like Illness Hydrocodone SS 7.5 MG/750 Lower Limb Fracture MG, PER ORAL Nausea Vomiting 22-Aug-2005 Page: 439 10:40 AM Fosamax (Alendronate Sodium) Norvasc (Amlodipine Besilate) Calcium C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/00ISR Number: 3633147-8Report Type:Expedited (15-DaCompany Report #000928-SK359 Age: Gender:Not SpecifiI/FU:F Outcome Dose Duration Hospitalization PO Initial or Prolonged 300.00 MG BID PT Report Source Product Role Manufacturer Route Drug Interaction Health Celebrex PS Gd Searle And Co ORAL Mental Impairment Professional Neurontin SS ORAL PO Date:12/18/00ISR Number: 3633149-1Report Type:Expedited (15-DaCompany Report #000928-SK360 Age: Gender:Not SpecifiI/FU:F Outcome Dose Duration Hospitalization PO Initial or Prolonged 300.000 MG PT Report Source Product Role Manufacturer Route Drug Interaction Health Celebrex PS Gd Searle And Co ORAL Mental Impairment Professional Neurontin SS ORAL BID PO Date:12/18/00ISR Number: 3633153-3Report Type:Expedited (15-DaCompany Report #000928-SK361 Age: Gender:Not SpecifiI/FU:F Outcome Dose Duration Hospitalization PO Initial or Prolonged 300.00 MG BID PT Report Source Product Role Manufacturer Route Drug Interaction Health Celebrex PS Gd Searle And Co ORAL Mental Impairment Professional Neurontin SS ORAL Renal Impairment PO Date:12/18/00ISR Number: 3633172-7Report Type:Expedited (15-DaCompany Report #000928-SK358 Age: Gender: I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization UNKNOWN PO Initial or Prolonged 300.000 MG Drug Interaction Health Celebrex PS Mental Impairment Professional Neurontin SS Gd Searle And Co ORAL ORAL Renal Impairment BID PO Date:12/18/00ISR Number: 3633301-5Report Type:Expedited (15-DaCompany Report #002-0945-M0000044 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Cerebrovascular Accident Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration PER ORAL Professional Date:12/18/00ISR Number: 3633302-7Report Type:Expedited (15-DaCompany Report #002-0945-M0000031 Age:50 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Diplopia Myopia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Presbyopia Professional Duration 1600 MG (400 MG, QID), PER ORAL Date:12/18/00ISR Number: 3633381-7Report Type:Expedited (15-DaCompany Report #001-0945-M0001322 Age: Gender: I/FU:I Outcome Congenital Anomaly 22-Aug-2005 Page: 440 10:40 AM PT Complications Of Maternal Exposure To Therapeutic Drugs FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cyst Foetal Disorder Dose Report Source Product Role Manufacturer Route Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd OTHER Duration SEE TEXT, PLACENTAL Tegretol (Carbamazepine) SS Folic Acid C OTHER SEE TEXT, PLACENTAL Date:12/18/00ISR Number: 3633384-2Report Type:Expedited (15-DaCompany Report #001-0945-M0001064 Age:48 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Colour Blindness Macular Oedema Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 MG, TID), PER ORAL Demadex Zoloft Remeron Premarin Prevacid Imitrex C C C C C C Date:12/19/00ISR Number: 3632885-0Report Type:Expedited (15-DaCompany Report #A0133661A Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 50MG Per day PT Convulsion Report Source Product Role Manufacturer Route Lamictal PS Glaxo Wellcome ORAL Initial or Prolonged YR Disability Coordination Abnormal Neurontin ORAL Drug Interaction Date:12/19/00ISR Number: 3633682-2Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 400 MG PO Initial or Prolonged 1 MG PO SS Company Report # PT Report Source Product Role Coordination Abnormal Health Neurontin PS ORAL Tremor Professional Lamotrigine SS ORAL Folate C Manufacturer Route Date:12/19/00ISR Number: 3633778-5Report Type:Expedited (15-DaCompany Report #001-0945-M0001323 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to 300 MG Prevent Permanent (DAILY) PER Impairment/Damage ORAL 22-Aug-2005 Page: 441 10:40 AM PT Report Source Product Role Manufacturer Route Chest Pain Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/00ISR Number: 3633823-7Report Type:Expedited (15-DaCompany Report #A0122366A Age:70 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 100MG See Initial or Prolonged text PT Report Source Abdominal Pain Upper Product Role Manufacturer Route Lamictal PS Glaxo Wellcome ORAL Dilantin Neurontin Depakote Lamictal SS SS SS SS Glaxo Wellcome ORAL Concussion Constipation Decreased Appetite Drug Ineffective Facial Bones Fracture 200MG See Fall text Hand Fracture Insomnia Nausea Overdose Spinal Fracture Date:12/20/00ISR Number: 3635081-6Report Type:Expedited (15-DaCompany Report #2000TRE0088 Age:21 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Aspiration Health Professional Revia PS Dupont Merck Pharmaceutical Co ORAL Duration PO Percocet (Oxycodone /Acetaminophen) SS Duragesic(Fentanyl) SS (Seroquel) SS ORAL Neurontin (Gabapentin) SS ORAL (Trazodone) SS ORAL ORAL PO TRANSDERMAL 75 MCG/H ONCE TD PO PO PO (Antidepressant-Unsp ecified) Depakote (Valproate Semisodium) SS SS ORAL Amitriptyline (Amitriptyline) SS ORAL Celexa (Citalopram Hydrobromide) SS ORAL (Fentanyl) SS PO PO PO INTRAVENOUS 0.05 MG/ML INJECTION ONCE IV Date:12/20/00ISR Number: 3635094-4Report Type:Expedited (15-DaCompany Report #A0133661A Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 50 MG PER DAY Initial or Prolonged ORAL Disability ORAL 22-Aug-2005 Page: 442 YR 10:40 AM PT Report Source Product Role Manufacturer Route Coordination Abnormal Health Lamictal PS Glaxo Wellcome Inc ORAL Drug Interaction Professional Gabapentin (Formulation Unknown) (Gabapentin) SS Epilepsy ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/00ISR Number: 3635529-7Report Type:Expedited (15-DaCompany Report #2000031428US Age:77 YR Gender:Female I/FU:I Outcome Dose Disability EPIDURAL PT Report Source Product Role Manufacturer Consumer Depo-Medrol PS Pharmacia And Upjohn Co Route Duration Alopecia Deafness EPIDURAL Madarosis Visual Acuity Reduced Neurontin (Gabapentin) Cardura (Doxazosin Mesilate) SS C Date:12/20/00ISR Number: 3635742-9Report Type:Expedited (15-DaCompany Report #001-0945-M0001228 Age:75 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 900 MG (300 Prevent Permanent MG, TID) Impairment/Damage PT Report Source Product Role Manufacturer Diarrhoea Lymphoma Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Fosamax Unspecified Vitamins Lipitor C C C Route Oesophageal Pain Osteoporosis Date:12/21/00ISR Number: 3635867-8Report Type:Expedited (15-DaCompany Report #A039777 Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Difficulty In Walking Fall Pain Consumer Norvasc PS Pfizer Agricultural Div Neurontin Lipitor Coumadin Pain Medication SS SS SS C Date:12/22/00ISR Number: 3635929-5Report Type:Expedited (15-DaCompany Report #001-0945-M0000616 Age:4 YR Gender:Female I/FU:F Route Outcome Dose Other PT Report Source Product Role Manufacturer Route Autism Developmental Delay Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300 MG (100 Encephalopathy MG, TID), PER Psychomotor Hyperactivity ORAL Speech Disorder Vomiting 22-Aug-2005 Page: 443 10:40 AM Depakote (Valproate Semisodium) (Hydroxyzine Hydrochloride) (Phenobarbital) (Lactulose) Senokot (Senna Fruit) Ryna-12s (Chlorpheniramine, Pseudoephedrine Hydrochloride) SS C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/00ISR Number: 3637300-9Report Type:Expedited (15-DaCompany Report #033-0945-M0000104 Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG DAILY PT Report Source Product Role Manufacturer Route Delirium Mania Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Professional PER ORAL Laroxyl (Amitriptyline Hydorchloride) Eucalcic (Calcium Carbonate) Plavix (Clopidogrel) Lasilix (Furosemide) Tahor (Atorvastatin) Tadenan (Pygeum Africanum) Speciafoldine (Folic Acid) Josir (Tamsulosin Hydrochloride) C C C C C C C C Date:12/26/00ISR Number: 3638427-8Report Type:Expedited (15-DaCompany Report #001-0945-M0001357 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Epistaxis Pulmonary Haemorrhage Respiratory Tract Haemorrhage Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Date:12/26/00ISR Number: 3638430-8Report Type:Expedited (15-DaCompany Report #001-0073-M0000496 Age:1 DY Gender:Female I/FU:I Outcome Dose Other SEE TEXT, PT Report Source Product Role Manufacturer Complications Of Maternal Exposure To Therapeutic Health Professional Dilantin PS Parke Davis Div Warner Lambert Co Duration Route Drugs PLACENTAL Small For Dates Baby Neurontin (Gabapentin) SS Unspecified Nasal Spray Unspecified Inhaler Folic Acid Ampicillin Terbutaline C C C C C SEE TEXT, PLACENTAL Date:12/26/00ISR Number: 3638773-8Report Type:Expedited (15-DaCompany Report #A0122366A Age:70 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 444 10:40 AM PT Concussion Drug Effect Decreased Eating Disorder Fall Feeling Abnormal Gastric Mucosal Lesion Hand Fracture FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Sleep Disorder Spinal Fracture Dose Report Source Product Role Manufacturer Route Consumer Lamictal PS Glaxo Wellcome Inc ORAL Phenytoin (Formulation Unknown) SS Gabapentin (Gabapentin_) SS Duration 100 MG SEE TEXT ORAL 100 MG 100 MG Semisodium Valproate (Divalproex Sodium) Lamictal Tablet (Lamotrigine) SS SS ORAL 200 MG SEE TEXT ORAL Date:12/26/00ISR Number: 3640195-0Report Type:Expedited (15-DaCompany Report #358-0945-M0000007 Age:50 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Amnesia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 1200 MG Professional (DAILY), PER ORAL Date:12/26/00ISR Number: 3640196-2Report Type:Expedited (15-DaCompany Report #044-0945-M0000195 Age:1 DY Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Complications Of Maternal Foreign Neurontin PS Parke Davis Duration Exposure To Therapeutic Health Drugs Developmental Delay Professional Pharmaceuticals Ltd PLACENTAL Phenytoin (Phenytoin) SS (Carbamazepine) SS SEE TEXT, Visual Disturbance PLACENTAL SEE TEXT, PLACENTAL Date:12/26/00ISR Number: 3640197-4Report Type:Expedited (15-DaCompany Report #044-0945-M0000193 Age:90 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG PT Report Source Product Role Manufacturer Route Dizziness Fatigue Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Sleep Attacks Professional (DAILY), PER ORAL (Fluoxetine) Aspirin (Acetylsalicylic Acid) Date:12/26/00ISR Number: 3640361-4Report Type:Expedited (15-DaCompany Report #001-0945-M0000595 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 445 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent Dose Duration Impairment/Damage PT Report Source Product Role Manufacturer Route Angina Pectoris Chest Pain Coordination Abnormal Coronary Artery Embolism Consumer Health Professional Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL 1600 MG (800 Coronary Artery Occlusion MG, BID), PER Deep Vein Thrombosis ORAL Difficulty In Walking Drug Level Above Depakote (Valproate Semisodium) SS Coumadin (Warfarin Sodium) SS Remeron (Mirtazapine) SS ORAL 750 MG (250 Therapeutic MG, TID), PER Memory Impairment ORAL Myocardial Infarction Pneumonia YEARS 30 MG (DAILY), Lipitor (Atorvastatin) Lasix (Furosemide) K-Dur (Potassium Chloride) Synthroid (Levothyroxine Sodium) Ambien (Zolpidem Tartrate) Plavix (Clopidogrel) C C C C C C Date:01/02/01ISR Number: 3640315-8Report Type:Expedited (15-DaCompany Report #049-0945-M0000031 Age:65 YR Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Life-Threatening Other 1600 MG Required (DAILY) PER Intervention to ORAL Prevent Permanent Impairment/Damage Arterial Disorder Hepatic Failure Foreign Health Hepatocellular Damage Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Pancreatitis Necrotising Pulmonary Oedema Date:01/02/01ISR Number: 3640317-1Report Type:Expedited (15-DaCompany Report #046-0945-M0000059 Age:24 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG DAILY PT Report Source Product Role Manufacturer Route Abdominal Abscess Hypersensitivity Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Health PER ORAL;3200 Professional MG (DAILY), PER ORAL Trileptal (Oxcarbazepine) Topimax (Topiramate) Ergenyl (Valproate Sodium) Pentasa (Mesasalazine) 22-Aug-2005 Page: 446 10:40 AM SS SS SS C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/01ISR Number: 3640912-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB02178 Age:2 YR Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly TRANSPLACENTAL PT Complications Of Maternal Exposure To Therapeutic 4 TABS DAILY, Drugs Report Source Product Role Manufacturer Foreign Health Tegretol PS Novartis Pharmaceuticals Corp Phenytoin SS Gabapentin SS Route Professional TRANSPLACENTA Developmental Delay Other L TRANSPLACENTAL Vision Abnormal Neonatal 2 TABS DAILY, TRANSPLACENTA L TRANSPLACENTAL TRANSPLACENTA L Date:01/02/01ISR Number: 3640986-6Report Type:Expedited (15-DaCompany Report #001-0945-M0001170 Age:52 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Cerebrovascular Accident Convulsion Loss Of Consciousness Tremor Visual Disturbance Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Diamox Depakote Loratadine Fluticasone Propionate Montelukast SS SS C Date:01/03/01ISR Number: 3641648-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000196 Age:40 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged PT Arthralgia Asthenia C C Route Other 22-Aug-2005 Page: 447 Blood Potassium Decreased Carpal Tunnel Syndrome Cholelithiasis Cholestasis Decreased Activity Dental Caries Depression Difficulty In Walking Dry Mouth Fall Fatigue Gallbladder Disorder Gallbladder Pain Headache Hypoaesthesia Hypothyroidism Joint Dislocation Lethargy Liver Function Test Abnormal Lymphadenopathy Malnutrition Movement Disorder Nervous System Disorder Oedema Peripheral Osteoporosis Ovarian Cyst 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain In Extremity Pruritus Skin Discolouration Dose Report Source Product Role Manufacturer Route Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Skin Ulcer Tendon Disorder 900 MG(300 MG Vomiting TID):2400MG(8 Weight Decreased 00MG Weight Increased TID):2100MG(7 00MG Baclofen SS ORAL Ms Contin SS Propulsid Methadone SS SS Percocet SS Valium SS Zanaflex SS ORAL Zoloft SS ORAL Hydrochlorothiazide SS ORAL Veetids SS ORAL Synthroid Oxy Ir (Oxycodone SS 80 MG PER ORAL 1600 MG 2500 MG 1 OR 2 (Q 4 H PRN) 80 MG 8 MG PER ORAL 200 MG PER ORAL 100 MG PER ORAL 2000 MG PER ORAL 1 WK Hydrochloride) SS Lasix SS Ritalin SS K-Dur SS Seroquel Ketamine Klonopin Corgard Relafen Celebrex SS SS SS SS SS SS Carafate SS Dextromethorphan SS Nadolol Tegaderm SS SS 8-10 DAILY 80 MG 80 MG 20 MCG 800 MG 4 MG 200 MG Date:01/04/01ISR Number: 3641829-7Report Type:Expedited (15-DaCompany Report #001-0945-M0001204 Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Chloasma Ecchymosis Neuroma Skin Discolouration Consumer Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL 400 MG (100 MG, QID) PER ORAL Celebrex (Celecoxib) Tetracycline Fastin (Phentermine Hydrochloride) Limbitrol (Chlordiazepoxide, Amitriptyline Hydrochloride) 22-Aug-2005 Page: 448 10:40 AM C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/01ISR Number: 3642095-9Report Type:Periodic Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #001-0945-M0000363 PT Report Source Product Role Manufacturer Route Convulsion Headache Increased Appetite Consumer Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL Route 1200 MG (600 MG, BID) PER ORAL Premarin (Estrogens Conjugated) Depakote (Valproate Semisodium) Prinivil (Lisinopril) Centrum Silver (Ascorbic Acid)Tocoperyl Acetate, Retinol, Zinc, Calcium, Calcium C C C C C Date:01/04/01ISR Number: 3649424-0Report Type:Expedited (15-DaCompany Report #001-0945-M0001074 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Angioneurotic Oedema Drug Interaction Company Representative Other Neurontin PS Parke Davis Pharmaceuticals Ltd Celebrex (Celecoxib) SS Duration ORAL UNK, PER ORAL Date:01/05/01ISR Number: 3642314-9Report Type:Expedited (15-DaCompany Report #A0135985A Age:39 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other 1MG Twice per Abdominal Pain Lotronex PS Neurontin Trazodone Phenergan Celebrex Vicodin Soma Epidural SS C C C C C C Glaxo Wellcome ORAL Route Condition Aggravated day 10 MON Diarrhoea Epilepsy Migraine Nightmare Weight Decreased Date:01/05/01ISR Number: 3642723-8Report Type:Expedited (15-DaCompany Report #001-0945-M0001381 Age:57 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Postmenopausal Haemorrhage Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Vioxx C Duration SEE IMAGE 22-Aug-2005 Page: 449 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/01ISR Number: 3642728-7Report Type:Expedited (15-DaCompany Report #358-0945-M0000007 Age:55 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Visual Pathway Disorder Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 600 MG Professional (DAILY), PER ORAL Seroxat (Paroxetine Hydrochloride) Triptyl (Amitripty-Line Hydrochloride) C C Date:01/08/01ISR Number: 3643521-1Report Type:Expedited (15-DaCompany Report #A0135985A Age:39 YR Gender:Female I/FU:I Outcome Dose Other 1 MG/TWICE PT Report Source Product Role Manufacturer Route Abdominal Distension Consumer Lotronex PS Glaxo Wellcome Inc ORAL Gabapentin Trazodone Promethazine Hcl Celecoxib Vicodin Carisoprolol Local Anesthetic SS C C C C C C Manufacturer Route Duration Abdominal Pain PER DAY, ORAL Condition Aggravated Constipation Diarrhoea Fear Grand Mal Convulsion Irritable Bowel Syndrome Migraine Nightmare Weight Decreased Date:01/09/01ISR Number: 3643569-7Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization - PT Depressed Mood Company Report # Report Source Product Gabapentin (400 Mg Role Initial or Prolonged 400 MG PO BID Suicidal Ideation Caps, Parke-Davis) Date:01/09/01ISR Number: 3643578-8Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other PT Parke-Davis ORAL Product Role Manufacturer Route Neurontin Zyprexa PS SS Company Report # Report Source Duration Oedema Peripheral Date:01/10/01ISR Number: 3650510-XReport Type:Periodic Age:84 YR Gender:Female I/FU:I Outcome Dose PS Company Report #001102-SK642 PT Report Source Product Role Manufacturer Route Anorexia Consumer Celebrex PS Gd Searle And Co ORAL Neurontin SS Duration UNKNOWN PO Back Pain 200.000 MG Dysgeusia QHS PO 22-Aug-2005 Page: 450 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/10/01ISR Number: 3652472-8Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Company Report #001026-SK879 PT Report Source Product Role Manufacturer Route Constipation Consumer Celebrex PS Gd Searle And Co ORAL Dry Skin Neurontin SS Dyspepsia Cosmetics SS Paraesthesia Cardiac Therapy SS Vitamins Omeprazole C C Duration 100 MG QD PO ORAL 1800 MG PO TOPICAL TOP MORB/MORT NEC Date:01/10/01ISR Number: 3652476-5Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #001026-SK896 PT Report Source Product Role Manufacturer Route Dyspepsia Health Celebrex PS Gd Searle And Co ORAL Hypertension Professional Neurontin SS Duration 200 MG BID PO ORAL 100 MG PO Tramadol Hydrochloride Hydrocodone Bitartrate Acetaminophen Quinapril Hydrochloride Hydroclorothiazide Alendronate C C C C C C Date:01/11/01ISR Number: 3646470-8Report Type:Expedited (15-DaCompany Report #001-0945-M0001385 Age:50 YR Gender:Female I/FU:I Outcome Dose Other 900 MG (300 PT Report Source Product Role Manufacturer Route Balance Disorder Disturbance In Attention Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Dizziness MG TID) PER Grand Mal Convulsion ORAL; 1200 Nervousness (400 TID) PER Speech Disorder ORAL Tremor Premarin (Estrogens Conjugated) Provera (Medroxyprogesterone Acetate) C C Date:01/11/01ISR Number: 3646508-8Report Type:Expedited (15-DaCompany Report #033-0945-M0100001 Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG (100 PT Report Source Product Role Manufacturer Route Condition Aggravated Hepatic Enzyme Increased Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Hepatitis B Professional MG, QID), PER Hepatitis C ORAL Hiv Infection Norvir (Ritonavir) SS ORAL Prothrombin Time Zerit (Stavudine) SS ORAL Prolonged Depamide (Valpromide) SS ORAL Hivid (Zalcitabine) SS ORAL PER ORAL PER ORAL PER ORAL 0.75 MG (DAILY), PER ORAL Zoloft (Sertraline 22-Aug-2005 Page: 451 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL 300 MG (DAILY), PER ORAL Date:01/11/01ISR Number: 3646509-XReport Type:Expedited (15-DaCompany Report #033-0945-M0100002 Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1500 MG Other (DAILY), PER PT Report Source Product Role Manufacturer Route Agranulocytosis Multiple Myeloma Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Pyrexia Professional ORAL INTRAVENOUS Axepim (Cefepime Hydrochloride) SS Oflocet (Ofloxacin) SS ORAL Moprol (Omeprazole) SS ORAL Laroxyl (Amitriptyline Hydrochloride) SS ORAL Aldactone (Spironolactone) SS ORAL INTRAVENOUS 400 MG (DAILY), PER ORAL 20 MG (DAILY), PER ORAL 50 MG (DAILY), PER ORAL 100 MG (DAILY), PER ORAL Date:01/12/01ISR Number: 3647192-XReport Type:Expedited (15-DaCompany Report #2001COU0016 Age:81 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Convulsion Drug Effect Decreased Consumer Coumadin PS Dupont Merck Pharmaceutical Co ORAL Duration 2.5-5 MG DLY PO Neurontin (Gabapentin) SS ORAL PO Date:01/12/01ISR Number: 3647234-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100033 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 4200 MG (1400 PT Report Source Product Role Manufacturer Sickle Cell Anaemia With Crisis Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Augmentin (Clavulanate Potassium, Amoxicillin Trihydrate) Flovent (Fluticasone Propionate) Proventil (Salbutamol Sulfate) C MG, TID) 22-Aug-2005 Page: 452 10:40 AM C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/01ISR Number: 3648660-7Report Type:Expedited (15-DaCompany Report #EMADSS2001000052 Age:68 YR Gender:Female I/FU:I Outcome Dose Other TRANSDERMAL PT Report Source Product Role Manufacturer Foreign Duragesic PS Alza Corp Gabapentin (Gabapentin) SS ORAL Carbamazepine (Carbamazepine) SS ORAL Route Duration Face Oedema 50 MCG/H 1 Urticaria Papular Health IN 72 HOUR(S) Professional TRANSD 300 MG 3 IN 1 DAY(S) ORAL 200 MG 3 IN 1 DAY(S) ORAL Date:01/16/01ISR Number: 3649660-3Report Type:Periodic Age:14 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Drug Ineffective Drug Interaction Consumer Zomig PS Astrazeneca Pharmaceuticals Lp Sertraline Gabapentin Cyproheptadine SS SS C Route Duration Date:01/17/01ISR Number: 3648107-0Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Dose Company Report #2000UW01295 PT Company Report # Report Source Product Role Gabapentin PS Manufacturer Route Duration Anxiety 1200 MG TID Insomnia ORAL Sense Of Oppression ORAL Date:01/17/01ISR Number: 3649282-4Report Type:Expedited (15-DaCompany Report #001-0073-M0100016 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Visual Acuity Reduced Consumer Dilantin PS Parke Davis Div Warner Lambert Co Neurontin (Gabapentin) SS Route Duration Date:01/17/01ISR Number: 3649325-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100045 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Monoparesis Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration 3200 MG (DAILY) 2000 MG (DAILY) Date:01/17/01ISR Number: 3649697-4Report Type:Expedited (15-DaCompany Report #031-0945-M0100003 Age:70 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Post-Traumatic Stress Disorder Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG Professional (DAILY), PER 22-Aug-2005 Page: 453 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Amitriptyline C Date:01/17/01ISR Number: 3649895-XReport Type:Expedited (15-DaCompany Report #A100542 Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent 900.00 MG Impairment/Damage TOTAL: BID: PT Report Source Product Role Manufacturer Convulsion Health Professional Zoloft PS Pfizer Pharmaceuticals Inc Neurontin SS Tylenol #3 Xanax Dilantin C C C Route ORAL ORAL Date:01/17/01ISR Number: 3649942-5Report Type:Expedited (15-DaCompany Report #A0135986A Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Other 1 MG / TWICE PT Report Source Product Role Manufacturer Route Abdominal Pain Consumer Lotronex PS Glaxo Wellcome Inc ORAL Gabapentin Paroxetine Hydrochloride Aspirin+Butalbital+C affn. Sumatriptan Succinate SS Colitis PER DAY / Colonic Polyp ORAL Constipation Dysgeusia Dyspepsia Nausea Oral Candidiasis Rectal Haemorrhage Date:01/18/01ISR Number: 3651104-2Report Type:Expedited (15-DaCompany Report #055-0945-M0000020 Age:50 YR Gender:Male I/FU:F C C C Outcome Dose Disability PT Report Source Product Role Manufacturer Route Visual Acuity Reduced Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 1200 MG (600 Professional MG, BID), PER ORAL Date:01/19/01ISR Number: 3652097-4Report Type:Expedited (15-DaCompany Report #033-0945-M0100009 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Complications Of Maternal Exposure To Therapeutic Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Drugs Foetal Growth Retardation Professional Duration PLACENTAL Date:01/22/01ISR Number: 3652942-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100059 Age:93 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 454 10:40 AM PT Confusional State Dyspnoea Gastrointestinal Disorder Mental Disorder FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myocardial Infarction Pain Dose Report Source Product Role Manufacturer Route Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 MG, TID), PER ORAL Fosamax (Alendronate Sodium) Demerol (Pethidine Hydrochloride) Lotrel (Amlodipine Besylate, Benazepril Hydrochloride) Norvasc (Amlodipine Besilate) (Levothyroxine) Beta Blocker Eye Drop Unspecified Eye Drop SS SS C C C C C Date:01/23/01ISR Number: 3654063-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100050 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL; PT Report Source Product Role Manufacturer Route Fibromyalgia Muscular Weakness Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Musculoskeletal Disorder 2400 MG (DAILY), PER ORAL Norvasc(Amlodipine Besilate) Synthroid(Levothyrox ine Sodium) Trazodone Trilafon(Perphenazin C C C e) Depakote(Valproate Semisodium) Klonopin(Clonazepam) Efflexor(Venlafaxine Hydrochloride) C C C C Date:01/24/01ISR Number: 3654153-3Report Type:Expedited (15-DaCompany Report #001-0945-M0001380 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG PT Report Source Product Role Manufacturer Route Chest Pain Circadian Rhythm Sleep Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Disorder (DAILY) PER Dizziness ORAL Feeling Drunk Halo Vision Neurontin Capsules 300 Mg (Gabapentin) SS ORAL Neurontin Capsules, 300 Mg (Gabapentin) SS ORAL 600 MG DAILY Oxygen Saturation PER ORAL Decreased Sedation 300 MG Tinnitus (DAILY) PER ORAL Ziac 22-Aug-2005 Page: 455 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Hydrochlorothiazide , Bisoprolol Fumarate) Xanax (Alprazolam) C C Date:01/25/01ISR Number: 3655720-3Report Type:Expedited (15-DaCompany Report #A036897 Age:58 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Amnesia Blood Pressure Decreased Consumer Health Procardia Xl PS Pfizer Laboratories Div Pfizer Inc ORAL Pneumonia Professional Bupropion SS Gabapentin Atenolol SS SS ORAL 300.00 MG Sedation TOTAL:BID:ORA Speech Disorder L Toxicologic Test Abnormal Date:01/25/01ISR Number: 3655725-2Report Type:Direct Age:70 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 CAPSULE 1 PT Company Report # Report Source Abdominal Pain Upper Dyspepsia Product Role Manufacturer Route Neurontin 300 Mg Parke-Davis PS Parke-Davis ORAL Nausea PER DAY ORAL Vomiting Date:01/25/01ISR Number: 3656817-4Report Type:Expedited (15-DaCompany Report #044-0073-M0000028 Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Manufacturer Route Urticaria Foreign Health Dilantin PS Parke Davis Div Warner Lambert Co ORAL Professional Gabapentin SS Carbamazepine C ORAL 900 MG (DAILY), PER ORAL Date:01/26/01ISR Number: 3655965-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100066 Age:83 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Condition Aggravated Confusional State Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 1200 MG (400 Dizziness MG, TID), PER Grand Mal Convulsion ORAL Hallucination Oedema Date:01/26/01ISR Number: 3655975-5Report Type:Expedited (15-DaCompany Report #001-0981-M0100322 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Coeliac Disease Health Professional Lipitor PS Pfizer Ireland Pharmaceuticals, Tablet Plant Neurontin (Gabapentin) SS Duration 20 MG (DAILY) 900 MG (TID) 22-Aug-2005 Page: 456 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyrtec (Cetirizine Hydrochloride) Oxycodone Hydrochloride Tramadol Hydrochlorde Metoclopramide Pantoprazole Carisoprodol Venlafaxine Hydrochloride Sucralfate Metoprolol Succinate Carbamazepine SS C C C C C C C C C Date:01/26/01ISR Number: 3656004-XReport Type:Expedited (15-DaCompany Report #001-0945-M0000616 Age:4 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Autism Dementia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration SEE IMAGE Psychomotor Hyperactivity Speech Disorder Vomiting Depakote (Valproate Semisodium) Hydroxyzine Hydrochloride Phenobarbital Lactulose Senokot Ryna-12s Date:01/29/01ISR Number: 3656958-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other SS C C C C C Company Report #A037518 PT Report Source Product Role Manufacturer Route Neuralgia Consumer Health Professional Tikosyn PS Pfizer Pharmaceuticals Production Corp Ltd ORAL Duration 1000.00 MCG TOTAL:BID:ORA L Neurontin SS Lanoxin Aspirin Diltiazem Naproxen Lidopatch Ultram Restoril Paxil C C C C C C C C 2400.00 MG TOTAL:TID Date:01/30/01ISR Number: 3656653-9Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged Disability 22-Aug-2005 Page: 457 10:40 AM Company Report # FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congenital Anomaly PT Dose Report Source Product Role Manufacturer Neurontin 300mg Parke-Davis PS Parke-Davis Route Duration Diabetes Mellitus Inadequate Control 2TID Dysgeusia Escherichia Infection Medication Error Myocardial Infarction Skin Discolouration Urinary Tract Infection Date:01/30/01ISR Number: 3657634-1Report Type:Expedited (15-DaCompany Report #081-0945-M0100001 Age: Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Death Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1800 MG Professional (DAILY), PER ORAL Date:01/30/01ISR Number: 3657801-7Report Type:Expedited (15-DaCompany Report #001-0945-M0100072 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Colon Cancer Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Duration UNK, PER ORAL Date:01/30/01ISR Number: 3657802-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000878 Age:64 YR Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Hospitalization Initial or Prolonged "SEE IMAGE Depression Disturbance In Attention Health Professional Fatigue Insomnia Oedema Peripheral Trigeminal Neuralgia Neurontin PS Celebrex (Celecoxib) Oxycontin (Oxycodone Hydrochloride) Clonopin (Clonazepam) Lorcet (Paracetamol, Hydrocodone Bitartrate) SS Parke Davis Pharmaceuticals Ltd C C C Date:01/30/01ISR Number: 3657930-8Report Type:Expedited (15-DaCompany Report #033-0945-M0100011 Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1600 MG Other (DAILY), PER PT Report Source Product Role Manufacturer Route Blood Creatine Phosphokinase Increased Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Diabetic Ketoacidosis Professional Hyperglycaemia ORAL Myocardial Infarction Pancreatic Pseudocyst Pancreatitis Necrotising Depakine Chrono (Valproic Acid, Valproate Sodium) 2000 MG (DAILY), PER ORAL Gardenal 22-Aug-2005 Page: 458 10:40 AM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Phenobarbital) SS ORAL 150 MG (DAILY), PER ORAL Glucophage (Metformin Hydrochloride) Humulin Nph (Insulin Human Injection, Isophane) Mopral (Omeprazole) Fungizone (Amphotericin B) C C C C Date:01/30/01ISR Number: 3658310-1Report Type:Expedited (15-DaCompany Report #032-0945-M000026 Age:43 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE TEXT, PER PT Report Source Product Role Manufacturer Route Condition Aggravated Drug Ineffective Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Drug Interaction Professional ORAL Fall Neuropathy Peripheral Pain Sedation Vertigo Rifampicin Isoniazid Ethambutol Pyrazinamide Morphine Sulfate Fentanyl SS SS SS SS SS C Date:01/30/01ISR Number: 3659137-7Report Type:Expedited (15-DaCompany Report #001-0945-M0000950 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (100 PT Report Source Product Role Manufacturer Route Condition Aggravated Depression Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Disorientation MG X3 QPM) Dizziness PER ORAL Fall Hypotension Serzone (Nefazodone Hydrochloride) SS ORAL Neurontin (Gabapentin) SS ORAL Serzone (Nefazodone Hydrochloride) SS ORAL Klonopin (Clonazepam) C 400 MG (200 Post-Traumatic Stress MG BID) PER Disorder ORAL Syncope 400 MG (100 MG X1 QAM & X3 QPM) PER ORAL 375 MG (DAILY) PER ORAL Date:01/30/01ISR Number: 3659920-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100130 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNKNOWN Disability 50 MG DAILY 22-Aug-2005 Page: 459 10:40 AM PT Report Source Product Role Manufacturer Convulsion Coordination Abnormal Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Lamictal (Lamotrigine) SS Drug Interaction Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PER ORAL Lamictal (Lamotrigine) SS ORAL 200 MG (400 MG, BID) PER ORAL Date:01/31/01ISR Number: 3657867-4Report Type:Expedited (15-DaCompany Report #001-0073-M0100040 Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL, 400 Other MG (DAILY), PT Report Source Product Role Manufacturer Route Arthritis Convulsion Consumer Dilantin PS Parke Davis Div Warner Lambert Co ORAL Dysgraphia Grand Mal Convulsion PER ORAL Reading Disorder Neurontin (Gabapentin) SS Unspecified Arthritis Medication C ORAL SEE IMAGE Date:02/01/01ISR Number: 3659970-1Report Type:Expedited (15-DaCompany Report #A101069 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 150.00 MG Required TOTAL:DAILY Intervention to 400.00 MG Prevent Permanent TOTAL:BID Impairment/Damage 375.00 MG PT Report Source Product Role Manufacturer Blood Pressure Decreased Disorientation Health Professional Zoloft PS Pfizer Pharmaceuticals Inc Neurontin SS Serzone SS Dizziness Fall Insomnia Oral Intake Reduced Route Syncope TOTAL:BID Proamatine Ambien Unspecified Blood Pressure Medication Klonopin SS C C C Date:02/01/01ISR Number: 3660088-2Report Type:Expedited (15-DaCompany Report #001-0945-M0001381 Age:57 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Postmenopausal Haemorrhage Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 900 MG (300 MG,TID),PER ORAL ; 1800 MG (600 MG, TID) Vioxx (Rofecoxib) C Date:02/01/01ISR Number: 3660544-7Report Type:Expedited (15-DaCompany Report #044-0945-M0100024 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 460 10:40 AM PT Report Source Product Role Manufacturer Abdominal Tenderness Tenderness Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/01ISR Number: 3660545-9Report Type:Expedited (15-DaCompany Report #055-0945-M0100001 Age:71 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 PT Report Source Product Role Manufacturer Route Arrhythmia Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Route MG, TID), PER ORAL (Diltiazem Hydrochloride) Date:02/02/01ISR Number: 3660343-6Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization . Initial or Prolonged Company Report # PT Report Source Product Role Hypotonia Health Clozaril PS Loss Of Consciousness Sedation Professional Depakote Neurontin Ativan SS SS SS Date:02/05/01ISR Number: 3660381-3Report Type:Periodic Age:52 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #A038643 PT Report Source Product Role Manufacturer Penis Disorder Consumer Zyrtec Neurontin PS SS Pfizer Inc Synthorid C Duration 600.00 MG TOTAL:BID:ORA L ORAL Date:02/05/01ISR Number: 3660479-XReport Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Hospitalization 400MG PO @HS Initial or Prolonged PT Company Report # Report Source Dizziness Product Role Neurontin PS Manufacturer Route ORAL Dysarthria Gait Disturbance Medication Error Vision Blurred Date:02/05/01ISR Number: 3661087-7Report Type:Expedited (15-DaCompany Report #A101296 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Depression Post-Traumatic Stress Disorder Health Professional Zoloft PS Pfizer Pharmaceuticals Inc Neurontin SS Vicodin Colace Seroquel C C C 1600.00 MG TOTAL: QID: ORAL 22-Aug-2005 Page: 461 10:40 AM Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/01ISR Number: 3661327-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100100 Age: Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Completed Suicide Consumer Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Unspecified Medications SS Route Duration Date:02/05/01ISR Number: 3661537-6Report Type:Expedited (15-DaCompany Report #001-0991-M0001451 Age:44 YR Gender:Female I/FU:F Outcome Dose Disability Other PT Report Source Product Role Manufacturer Abdominal Pain Ammonia Increased Anhedonia Anxiety Blood Urea Increased Cholelithiasis Cough Depression Dermatitis Emotional Distress Consumer Rezulin PS Parke Davis Pharmaceuticals Ltd Duration Vasotec (Enalapril Maleate) Hyoscyamine (Hyoscyamine) Amitryptyline (Amitriptyline) Neurontin (Gabapentin) SS SS SS SS 300 MG Fatigue (DAILY), Fungal Rash UNKNOWN Gallbladder Disorder Hepatic Cirrhosis Hepatic Steatosis Hepatocellular Damage Hypergammaglobulinaemia Hypertension Ill-Defined Disorder Irritable Bowel Syndrome Metrorrhagia Nausea Neuralgia Oedema Peripheral Oligomenorrhoea Osteoarthritis Pain Diabeta (Glibenclamide) Glucophage (Metformin Hydrochloride) Spironolactone (Spironolactone) Zyrtec (Cetirizine Hydrochloride) Demulen (Mestranol, Etynodiol Diacetate) Trazodone (Trazodone) Vancenase (Beclometasone C C C C C C Route Platelet Count Decreased Pollakiuria Polyp Purpura Red Blood Cell Count Decreased Scar Sedation Serum Ferritin Increased Skin Ulcer Thermal Burn Date:02/06/01ISR Number: 3660931-7Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Other 300MG PO TID 22-Aug-2005 Page: 462 10:40 AM PT Dipropionate) C Company Report # Report Source Product Role Glossodynia Neurontin PS Vulvovaginal Discomfort Premarin Lysine Dhea C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium Thyrolar Levoxyl Triazolam Temazepam Estrogen/Testosteron e/Progesterone Vit E Docusate Date:02/06/01ISR Number: 3660950-0Report Type:Direct Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Disability 100MG TID PO PT C C C C C C C C Company Report # Report Source Complex Regional Pain Product Role Neurontin 100mg PS Manufacturer Route ORAL Syndrome Condition Aggravated Date:02/06/01ISR Number: 3661566-2Report Type:Expedited (15-DaCompany Report #002-0945-M0100008 Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization PER ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Myocardial Infarction Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Professional Company Representative Date:02/08/01ISR Number: 3662303-8Report Type:Direct Age:42 YR Gender:Male I/FU:I Outcome Dose Death 400 MG QID PT Report Source Product Role Neurontin PS Duration Abnormal Behaviour Aggression ORAL Company Report # ORAL Anxiety Aspiration Brain Damage Delusional Disorder, Persecutory Type Hostility Thinking Abnormal Vomiting Fentanyl Patch Prozac Inderal Zyprexa Klonopin Phenergan Date:02/09/01ISR Number: 3663421-0Report Type:Expedited (15-DaCompany Report #001-0945-M0001385 Age:50 YR Gender:Female I/FU:F Outcome Other 22-Aug-2005 Page: 463 PT Balance Disorder Convulsion Decreased Appetite Disturbance In Attention Dizziness Dysarthria Epileptic Aura Head Injury Memory Impairment Nausea 10:40 AM C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervousness Speech Disorder Tremor Dose Report Source Product Role Manufacturer Route Consumer Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Weight Decreased 900 MG (300 Professional MG, TID), PER ORAL Neurontin (Gabapentin) SS Neurontin(Gabapentin ) SS ORAL 1200 MG (400 MG, TID), PER ORAL 3600 MG (900 MG, QID) Premarin (Estrogens Conjugated) Provera (Medroxyprogesterone Acetate) Zyprexa (Olanzapine) Depakote (Valproate Semisodium) C C C C Date:02/09/01ISR Number: 3663763-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100133 Age:38 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Convulsion Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Cyclobenzaprine Vicodin (Paracetamol, SS Duration 1800 MG (600 MG, TID) Route Hydrocodone Bitartrate) Ultram (Tramadol Hydrochloride Paracetamol, Dextropropoxyphene Naprosyn (Naproxen) C C C C Date:02/09/01ISR Number: 3663766-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100134 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Nephritis Interstitial Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Unspecified Antibiotic C Route Duration Date:02/09/01ISR Number: 3663787-1Report Type:Expedited (15-DaCompany Report #047-0945-M0100001 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Route Folate Deficiency Polyneuropathy Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Transient Ischaemic Attack 22-Aug-2005 Page: 464 10:40 AM Analgesics C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/01ISR Number: 3663987-0Report Type:Expedited (15-DaCompany Report #A102512 Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 20.00 MG Prevent Permanent TOTAL:DAILY Impairment/Damage 900.00 MG PT Report Source Product Role Manufacturer Coeliac Disease Health Professional Zyrtec Lipitor PS SS Pfizer Inc Neurontin SS Oxycontin Ultram Reglan Protonix Soma Effexor Xr Carafate Toprol Xl Tegretol C C C C C C C C C Route TOTAL:TID Date:02/12/01ISR Number: 3664294-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100153 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Clonic Convulsion Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration Date:02/12/01ISR Number: 3664402-3Report Type:Expedited (15-DaCompany Report #2001SE01042 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Cardiac Failure Coma Overdose Foreign Health Professional Pulmicort PS Astrazeneca Pharmaceuticals Lp Allopurinol Choay SS Route Respiratory Disorder Other Hemi-Daonil SS Fonzylane SS Lasilix Neurontin SS SS Acuitel Burinex Monicor Aspirine C C C C 2.5 MG BID 300 MG DAILY 100 MG TID Date:02/13/01ISR Number: 3665130-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE00577 Age:54 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Asthenia Convulsion Foreign Health Trileptal PS Novartis Pharmaceuticals Corp ORAL Headache Professional Overdose Vertigo Company Representative Neurontin (Gabapentin) Regimen SS Vomiting Other Orfiril "Desitin" C Duration 600 MG, BID, ORAL 400 MG, QID 22-Aug-2005 Page: 465 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/01ISR Number: 3665203-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000488 Age: Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Pain Pulmonary Hypertension Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Manufacturer Route Manufacturer Route Duration 4800 MG (1200 Pulmonary Oedema MG, TID), PER Sleep Apnoea Syndrome ORAL Oxycontin (Oxycodone Hydrochloride) Unspecified Medication Date:02/13/01ISR Number: 3665430-4Report Type:Direct Age:57 YR Gender:Male I/FU:I Outcome Dose Disability PT SS C Company Report # Report Source Product Role Gabapentin Olanzapine PS SS Duration Diplopia Eye Pain Date:02/13/01ISR Number: 3666436-1Report Type:Expedited (15-DaCompany Report #358-0945-M0100001 Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Confusional State Foreign Neurontin PS Dizziness Health Drug Interaction Professional ORAL Dysstasia Movement Disorder Pneumonia Panacod (Codeine Phosphate, Paracetamol) Diltiazem Hydrochloride Nizax (Nizatidine) Amitriptyline SS C C ORAL Hydrochloride Levofloxacin Tazocin (Tazobactam Sodium) Klexane (Heparin-Fraction, Sodium Salt) Levoac C C C C C Date:02/14/01ISR Number: 3666754-7Report Type:Expedited (15-DaCompany Report #HQ7038409FEB2001 Age:31 YR Gender:Female I/FU:I Outcome Dose Other 0.5 MG AS PT Report Source Product Role Convulsion Consumer Lorazepam PS NEEDED, ORAL Dilantin (Phenytoin Sodium) Neurontin (Gabapentin) 22-Aug-2005 Page: 466 Manufacturer Route Duration 10:40 AM SS SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/01ISR Number: 3666772-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000998 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (300 Other MG BID), PER PT Report Source Product Role Cerebrovascular Accident Coma Consumer Neurontin (Gabapentin ) PS Manufacturer Route ORAL Complex Partial Seizures Convulsion ORAL Dizziness Postural Date:02/15/01ISR Number: 3665971-XReport Type:Direct Age:76 YR Gender:Male I/FU:I Outcome Dose Other PT Cognex (Tacrine Hydrochloride) Detrol (Tolterodine Tartrate) (Selenium) Vitamin E (Tocopherol) Estrogen Lorazepam Zantac (Ranitidine Hydrochloride) C C C C C C C Company Report # Report Source Product Role Gabapentin PS Manufacturer Route Manufacturer Route Duration Necrosis Ischaemic Pulmonary Oedema Date:02/15/01ISR Number: 3665997-6Report Type:Direct Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Fatigue Liver Function Test Abnormal Company Report # Report Source Product Role Pioglitazone Furosemide 40 Mg Tab Glyburide 5mg Tab Spironolactone 25mg Tab Gabapentin 600mg Tab PS SS SS SS SS Fluoxetine Hcl 20mg Cap Lisinopril 40mg Tab SS SS Date:02/15/01ISR Number: 3666590-1Report Type:Expedited (15-DaCompany Report #033-0945-M0100017 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (100 PT Report Source Product Role Manufacturer Route Accidental Overdose Coma Foreign Health Neurotin (Gabapentin) PS ORAL Lasilix (Furosemide) SS ORAL Allopurinol SS ORAL Pulmicort (Budesonide) SS Hemi-Daonil (Glibenclamide) SS ORAL Fonzylane (Buflomedil Hydrochloride) SS ORAL Professional MG TID) PER ORAL ORAL ORAL ORAL 2.5 MG DAILY PER ORAL 600 MG DAILY 22-Aug-2005 Page: 467 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PER ORAL Date:02/15/01ISR Number: 3666595-0Report Type:Expedited (15-DaCompany Report #2001SE01042 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Cardiac Failure Coma Overdose Foreign Health Professional Pulmicort Allopurinol Choay Hemi-Daonil PS SS SS Respiratory Disorder Other Fonzylane SS Lasilix Neurontin SS SS Acuitel Burinex Monicor Aspirine C C C C Manufacturer Route Manufacturer Route 2.5 MG BID 300 MG DIALY 100 MG TID Date:02/15/01ISR Number: 3666979-0Report Type:Expedited (15-DaCompany Report #001-0981-M0100322 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Coeliac Disease Health Professional Atorvastatin (Atorvastatin) PS Neurontin (Gabapentin) SS Duration 20 MG (DAILY) 900 MG (TID) Zyrtec (Cetirizine Hydrochloride) (Oxycodone Hydrochloride) (Tramadol Hydrochloride) (Metoclopramide) (Pantoprazole) (Carisoprodol) (Venlafaxine Hydrochloride) SS C C C C C C (Sucralfate) (Metoprolol Succinate) (Carbamazepine) C C C Date:02/15/01ISR Number: 3667107-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100148 Age:46 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Burning Sensation Complex Regional Pain Consumer Health Neutrotin (Gabapentin) PS ORAL Syndrome Professional Electromyogram Abnormal Hypoaesthesia Neurontin (Gabapentin) SS ORAL Pain Paraesthesia Thermogram Abnormal (Oxycodone Hydrochloride) C Duration 100 MG (DAILY), PER Condition Aggravated ORAL 300 MG QD 22-Aug-2005 Page: 468 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/01ISR Number: 3667759-2Report Type:Expedited (15-DaCompany Report #001-0945-M0000781 Age:36 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Sudden Death Health Professional Neurontin (Gabapentin) PS Parke Davis Pharmaceuticals Ltd ORAL Duration SEE IMAGE Propoxyphene (Dextropropoxyphene) Nortriptyline(Nortri ptyline) Methadone (Methadone) Topamax (Topiramate) Xanax (Alprazolam) Effexor (Venlafaxine Hydrochloride) (Diphenhydramine) Norpropoxyphene SS SS C C C C C C Date:02/16/01ISR Number: 3667760-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000782 Age:31 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Drug Toxicity Overdose Sudden Death Health Professional Neurontin (Gabapentin) PS Parke Davis Pharmaceuticals Ltd ORAL Duration 7200 MG (2400 MG, TID), PER ORAL Duragesic (Fentanyl) SS Nortriptyline Oxycontin (Oxycodone Hydrochloride) Paxil (Paroxetine Hydrochloride) Allopurinal C 150 MCG (Q 3 DAYS) C C (Allopurinol) Sudafed (Pseudoephedrine Hydrochloride) Clonapin (Clonazepam) Benadryl (Diphenhydramine Hydrochloride) Lomotil (Atropine Sulfate, Diphenoxylate Hydrochloride) Vioxx (Rofecoxib) Date:02/20/01ISR Number: 3667183-2Report Type:Direct Age:51 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Disability 22-Aug-2005 Page: 469 10:40 AM PT Atrial Fibrillation Cardiac Failure Oedema Pneumonia Company Report # C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Respiratory Failure Sinusitis Dose Report Source Product Role Neurontin PS Tilgade Accolate Serevent Allergy Shots C C C C Manufacturer Route Duration ORAL 300 MGM TID Date:02/20/01ISR Number: 3668598-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100158 Age:35 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Anuria Consumer Health Professional Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL Duration "SEE IMAGE" Prevacid (Lansoprazole) Muscle Relaxant C C Date:02/21/01ISR Number: 3668636-3Report Type:Expedited (15-DaCompany Report #055-0945-M0100002 Age:21 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 PT Report Source Product Role Manufacturer Route Convulsion Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL MG, TID), PER ORAL Valproic Acid Valproate Sodium C C Date:02/21/01ISR Number: 3669398-6Report Type:Expedited (15-DaCompany Report #NSADSS2001002487 Age: Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Drug Level Above Therapeutic Health Professional Topamax (Unspecified) (Topiramate) Alprazolam (Alprazolam) Gabapentin (Gabapentin) Carbamazepine (Carbamazepine) Role Manufacturer Route Duration PS SS SS SS Date:02/22/01ISR Number: 3669600-0Report Type:Expedited (15-DaCompany Report #001-0073-M0100040 Age:48 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL, 40 Other MG (DAILY), PT Report Source Product Role Manufacturer Route Arthritis Convulsion Consumer Dilantin PS Parke Davis Div Warner Lambert Co ORAL Dysgraphia Grand Mal Convulsion PER ORAL Reading Disorder Neurontin (Gabapentin) 100MG TID Unspecified 22-Aug-2005 Page: 470 10:40 AM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Arthritis Medication C Date:02/22/01ISR Number: 3669601-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100197 Age:43 YR Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Drug Dependence Medication Error Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 900 MG (300 MG, TID), PER ORAL Date:02/22/01ISR Number: 3669602-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100169 Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged HIGH DOSE PT Report Source Product Role Manufacturer Drug Ineffective Drug Withdrawal Syndrome Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Malaise Tremor Date:02/22/01ISR Number: 3669972-7Report Type:Expedited (15-DaCompany Report #002-0945-M0100015 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Clumsiness Confusional State Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300 MG DAILY Diabetes Mellitus PER ORAL; 1500 MG DAILY PER ORAL Iron Clonidine C C Glyburide (Glibenclamide) Date:02/23/01ISR Number: 3670105-1Report Type:Expedited (15-DaCompany Report #001-0991-M0001451 Age:44 YR Gender:Female I/FU:F Outcome Disability Other 22-Aug-2005 Page: 471 PT Abdominal Mass Anhedonia Anxiety Back Pain Benign Laryngeal Neoplasm Cholelithiasis Cough Depression Emotional Disorder Fungal Rash Hepatic Cirrhosis Hepatic Steatosis Hepatocellular Damage Hepatomegaly Hypertension Ill-Defined Disorder Injury Irritable Bowel Syndrome Liver Function Test Abnormal 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Oedema Peripheral Oligomenorrhoea Dose Report Source Product Role Manufacturer Consumer Rezulin PS Parke Davis Pharmaceuticals Ltd Route Duration Pain Pharyngolaryngeal Pain SEE IMAGE Pollakiuria Psoriasis Purpura Thermal Burn Vasotec (Enalapril Maleate) Hyoscyamine (Hyoscyamine) Amitryptyline (Amitriltyline) Neurontin (Gabapentin) SS SS SS SS SEE IMAGE Diabeta (Glibenclamide) Glucophage (Metformin Hydrochloride) Spironolactone (Spironolactone) Zyrtec (Cetirizine Hydrochloride) Demulen (Mestranol, Etynodiol Diacetate) Trazodone (Trazodone) Vancenase (Beclometasone Dipropionate) Axid (Nizatidine) Glyburide (Glibenclamide) C C C C C C C C C Date:02/26/01ISR Number: 3671118-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100190 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG (100 PT Report Source Product Role Manufacturer Route Delusion Dyspnoea Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Euphoric Mood MG, BID), PER Feeling Abnormal ORAL Hallucination Heart Rate Increased Neurontin (Gabapentum) SS ORAL Neurontin (Gabapentin) SS ORAL Neurontin (Gabapentin) SS ORAL Neurontin (Gabapentin) SS ORAL Neurontin (Gabapentin) SS ORAL 400 MG (200 Hyperreflexia MG, BID), PER Insomnia ORAL Oral Intake Reduced Paranoia 800 MG (400 MG, BID), PER ORAL 1800 MG (400 MG, BID), PER ORAL 900 MG (DAILY), PER ORAL 500 MG, PER ORAL 22-Aug-2005 Page: 472 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin (Gabapentin) SS ORAL Neurontin (Gabapentin) SS ORAL 400 MG, PER ORAL 200 MG, PER ORAL Date:02/26/01ISR Number: 3671137-XReport Type:Expedited (15-DaCompany Report #044-0945-M0100024 Age:49 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 6.4 GM PT Report Source Product Role Manufacturer Route Abdominal Tenderness Accidental Overdose Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional (DAILY), PER ORAL Neurontin (Gabapentin) SS (Amitriptyline) C ORAL 2.4 GM (DAILY), PER ORAL Date:02/27/01ISR Number: 3671673-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100214 Age:31 YR Gender:Female I/FU:I Outcome Dose Other 900 MG (300 MG TID) PER PT Report Source Product Role Manufacturer Route Diabetes Mellitus Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration ORAL Prozac (Fluoxetine Hydrochloride) Diovan (Valsartan) Imitrex (Sumatriptan Succinate) Unspecified Birth Control Pills C C C C Date:02/27/01ISR Number: 3671675-XReport Type:Expedited (15-DaCompany Report #001-0945-M0001385 Age:50 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Balance Disorder Decreased Appetite Consumer Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Disturbance In Attention Professional Duration 900 MG 300 MG TID PER ORAL; Dysarthria 2400 MG DAILY Epileptic Aura ORAL; 3600 MG Grand Mal Convulsion (900 MG QID) Head Injury Memory Impairment Nausea Nervousness Photopsia Thinking Abnormal Tremor Weight Decreased 22-Aug-2005 Page: 473 10:40 AM Premarin (Estrogens Conjugated) Provera (Medroxyprogesterone Acetate) Zyprexa (Olanzapine) Depakote (Valproate Semisodium) Heroin (Diamorphine) Methadone (Methadone) C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Librium (Chlordiazepoxide Hydrochloride) C Date:02/28/01ISR Number: 3671474-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000462 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Aphonia Blood Glucose Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Cellulitis MG, TID), PER Disturbance In Attention ORAL Dizziness Baclofen (Baclofen) SS (Insulin) Aleve (Naproxen Sodium) C ORAL 75 MG (25 MG, Headache TID), PER Nausea ORAL Tremor Vision Blurred C Date:02/28/01ISR Number: 3671767-5Report Type:Expedited (15-DaCompany Report #044-0945-M0100043 Age:62 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Bronchopneumonia Metastases To Lung Respiratory Arrest Foreign Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Analgesia Chemotherapy C C Duration Date:02/28/01ISR Number: 3671832-2Report Type:Periodic Age:35 YR Gender:Female I/FU:I Company Report #001-0945-990640 Route Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Pancreatitis Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route MG, TID), PER ORAL Date:02/28/01ISR Number: 3671833-4Report Type:Periodic Age:69 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG, Company Report #001-0945-M0001337 PT Report Source Product Role Manufacturer Hypoventilation Respiratory Failure Literature Health Neurontin PS Parke Davis Pharmaceuticals Ltd Professional UNKNOWN Albuterol (Salbutamol) Ipratropium (Ipratropium) Clonazepam (Clonazepam) Zolpidem (Zolpidem) 22-Aug-2005 Page: 474 10:40 AM C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671834-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Angioneurotic Oedema Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Company Report #001-0945-M0100029 PT Report Source Product Role Manufacturer Alopecia Deafness Visual Acuity Reduced Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Depo-Medrol (Methylprednisolone Acetate) Cardura (Doxazosin Mesilate) SS Route Duration Date:02/28/01ISR Number: 3671836-XReport Type:Periodic Age:87 YR Gender:Male I/FU:F Outcome Dose Disability Route Duration Date:02/28/01ISR Number: 3671835-8Report Type:Periodic Age:77 YR Gender:Female I/FU:I Outcome Dose Disability Other Company Report #001-0945-M0001344 C Company Report #001-0945-980074 PT Report Source Product Role Manufacturer Route Dizziness Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 MG, TID), PER ORAL Synthroid (Levothyroxine Sodium) Mutivitamins (Ergocalciferol, Ascorbic Acid, Thiamine Hydrochloride, Furosemide C C C Date:02/28/01ISR Number: 3671837-1Report Type:Periodic Age:55 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 - 1200 MG Company Report #001-0945-991016 PT Report Source Product Role Manufacturer Route Pyrexia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route (DAILY), PER ORAL Amitriptyline Date:02/28/01ISR Number: 3671838-3Report Type:Periodic Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 475 10:40 AM C Company Report #001-0945-991017 PT Report Source Product Role Manufacturer Stevens-Johnson Syndrome Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671839-5Report Type:Periodic Age:35 YR Gender:Male I/FU:F Outcome Dose Other Company Report #001-0945-991099 PT Report Source Product Role Manufacturer Blindness Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Flexeril (Cyclobenzaprine Hydrochloride) C Route Duration 1200 MG (300 MG, QID), UNKNOWN Date:02/28/01ISR Number: 3671840-1Report Type:Periodic Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1600 MG (400 Company Report #001-0945-991197 PT Report Source Product Role Manufacturer Route Dental Caries Drug Interaction Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Fatigue MG, QID), PER Hypotension ORAL Oral Intake Reduced Sedation Stupor Thinking Abnormal Tylenol Pm (Diphenhydramine, Paracetamol) Propulsid (Cisapride) Prevacid (Lansoprazole) Calcium Estratest (Methyltestosterone, Estrogens Esterified) Baclofen Celebrex (Clecoxib) Multivitamins (Ergocalciferol, Ascorbic Acid, Folic SS C C C C C C Acid, Thiamine Hydrochloride, Celexa (Citalopram Hydrobromide) Xanax (Alprazolam) Vistaril (Hydroxyzine Embonate) Date:02/28/01ISR Number: 3671841-3Report Type:Periodic Age:20 YR Gender:Female I/FU:F Outcome Dose Death C C C C Company Report #001-0945-991268 PT Report Source Product Role Manufacturer Route Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 2700 MG (900 MG, TID), PER ORAL Depakote (Valproate Semisodium) 22-Aug-2005 Page: 476 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671842-5Report Type:Periodic Age:26 YR Gender:Male I/FU:I Outcome Dose Other Company Report #001-0945-990606 PT Report Source Product Role Manufacturer Route Blindness Transient Convulsion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1800 MG (300 MG, 2TID), PER ORAL Neurontin Capsules 100 Mg (Gabapentin) SS ORAL 600 MG, (100 MG, 2TID), PER ORAL Lamictal (Lamotrigine) Magnesium (Magnesium) Vitamin C And 3 (Ascorbic Acid, Tocopherol) Vitamin B6 (Pyridoxine Hydrochloride) Date:02/28/01ISR Number: 3671843-7Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Death C C C Company Report #001-0945-M0001186 PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Role Manufacturer Route Duration Date:02/28/01ISR Number: 3671844-9Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose C PT Duration Company Report #001-0945-M0001187 Report Source Product Route Death Death Health Professional Date:02/28/01ISR Number: 3671845-0Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Death 22-Aug-2005 Page: 477 Parke Davis Pharmaceuticals Ltd Company Report #001-0945-M0001188 PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Company Report #001-0945-M0001189 PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration Date:02/28/01ISR Number: 3671847-4Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Death PS Duration Date:02/28/01ISR Number: 3671846-2Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Death Neurontin Company Report #001-0945-M0001190 PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671848-6Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1) 300 MG Company Report #001-0945-M0001192 PT Report Source Product Role Manufacturer Route Confusional State Dysarthria Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Headache (100 MG, Insomnia TID), PER Memory Impairment ORAL; 2) Paranoia 1600 MG (400 Speech Disorder Zoloft (Sertraline Hydrochloride) SS ORAL PER ORAL (Lithium) Lortab (Paracetamoll, Hydrocodone Bitartrate) Estrogen (Estrogen Nos) Cafergot (Caffeine, Ergotamine Tartrate) Date:02/28/01ISR Number: 3671849-8Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged C C C C Company Report #001-0945-M0001223 PT Report Source Product Role Manufacturer Amnesia Blood Pressure Decreased Laboratory Test Abnormal Pneumonia Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Zyban (Amfebutamone Hydrochloride) SS (Nifedipine) (Atenolol) SS SS 300 MG (150 Sedation MG, BID), PER Speech Disorder ORAL Route ORAL Date:02/28/01ISR Number: 3671850-4Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Death Company Report #001-0945-M0001246 PT Report Source Product Role Manufacturer Sudden Death Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Date:02/28/01ISR Number: 3671851-6Report Type:Periodic Age:68 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-M0001266 PT Report Source Product Role Manufacturer Route Blindness Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1) 900 MG (300 MG, TID, PER ORAL; Route Duration 2) 600 MG (300 MG, BID), PER Novolin 70/30 (Insulin Human, Insulin Human Injection, Isophane) Lipitor 22-Aug-2005 Page: 478 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin) Monopril (Fosinopril Sodium) (Furosemide) Zantac (Ranitidine Hydrochloride) Date:02/28/01ISR Number: 3671852-8Report Type:Periodic Age:81 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG TO C C C C Company Report #001-0945-M0001286 PT Report Source Product Role Manufacturer Route Amnesia Disturbance In Attention Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Hypersensitivity 2400 MG Mood Altered (PRN), PER Myeloid Metaplasia ORAL Pneumonia INTRAVENOUS Unspecified Antibiotic Altace (Ramipril) Revacid (Lansoprazole) (Triamterene) (Theophylline) Date:02/28/01ISR Number: 3671853-XReport Type:Periodic Age: Gender: I/FU:I Outcome Dose Other SS INTRAVENOUS C C C C Company Report #001-0945-M0000994 PT Report Source Product Role Manufacturer Hypertension Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Ativan (Lorazepam) Unspecified Medications C Duration C Date:02/28/01ISR Number: 3671854-1Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Pyrexia Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Date:02/28/01ISR Number: 3671855-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other Outcome Other PT Report Source Product Role Manufacturer Renal Failure Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd PT Alopecia Arthralgia Hair Colour Changes 10:40 AM Route Company Report #001-0945-M0001133 Duration Date:02/28/01ISR Number: 3671856-5Report Type:Periodic Age:56 YR Gender:Male I/FU:I 22-Aug-2005 Page: 479 Company Report #001-0945-M0001132 Company Report #001-0945-M0001141 Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Rash Pruritic Dose Report Source Product Role Manufacturer Route Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration UNK PER ORAL Unspecified Opiates Date:02/28/01ISR Number: 3671857-7Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 SS Company Report #001-0945-M0001176 PT Report Source Product Role Manufacturer Route Deep Vein Thrombosis Uterine Haemorrhage Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL MG BID) PER ORAL Depo-Provera (Medroxyprogesterone Acetate) Risperdal (Risperidone) SS SS ORAL 4 MG (2 MG, BID) PER ORAL Serzone (Nefazodone Hydrochloride) (Trazodone) Date:02/28/01ISR Number: 3671858-9Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Death C C Company Report #001-0945-M0001179 PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Route Date:02/28/01ISR Number: 3671859-0Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd 22-Aug-2005 Page: 480 Company Report #001-0945-M0001183 PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration Date:02/28/01ISR Number: 3671861-9Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Death Route Duration Date:02/28/01ISR Number: 3671860-7Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Death Company Report #001-0945-M0001182 Company Report #001-0945-M0001184 PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671862-0Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Death Company Report #001-0945-M0001185 PT Report Source Product Role Manufacturer Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration Date:02/28/01ISR Number: 3671863-2Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2700 MG (900 Company Report #001-0945-M0000685 PT Report Source Product Role Manufacturer Route Intentional Misuse Loss Of Consciousness Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL MG, TID), PER ORAL Ag-1549 Combivir Viracept Date:02/28/01ISR Number: 3671864-4Report Type:Periodic Age:52 YR Gender:Male I/FU:I Outcome Dose Other C C C Company Report #001-0945-M0000697 PT Report Source Product Role Manufacturer Route Brain Neoplasm Dizziness Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dysphemia Company Intentional Misuse Petit Mal Epilepsy Tremor Representative Duration SEE TEXT, PER ORAL Date:02/28/01ISR Number: 3671865-6Report Type:Periodic Age: Gender:Male I/FU:I Company Report #001-0945-M0000792 Outcome Dose Other PT Report Source Product Role Manufacturer Route Anorgasmia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 200 MG (DAILY), PER ORAL Date:02/28/01ISR Number: 3671866-8Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Death Company Report #001-0945-M0000817 PT Report Source Product Role Manufacturer Drug Level Above Therapeutic Sudden Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Hydrocodone C Duration Date:02/28/01ISR Number: 3671867-XReport Type:Periodic Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PRN;1500 MG Company Report #001-0945-M0000821 PT Report Source Product Role Manufacturer Route Coordination Abnormal Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL (DAILY), PER ORAL Percocet (Paracetamol, 22-Aug-2005 Page: 481 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxycodone Hydrochloride SS ORAL Tylenol (Paracetamol) SS ORAL Coumadin C 2 TABLET(S) (DAILY), PER ORAL 2 TABLET(S) (DAILY), PER ORAL Date:02/28/01ISR Number: 3671869-3Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other Company Report #001-0945-M0000877 PT Report Source Product Role Manufacturer Brain Neoplasm Intentional Misuse Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration 5200 MG (DAILY) Date:02/28/01ISR Number: 3671870-XReport Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Company Report #001-0945-M0000884 PT Report Source Product Role Manufacturer Route Asthenia Blood Pressure Decreased Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Circulatory Collapse MG TID), PER Hallucination ORAL Muscle Twitching Speech Disorder Syncope Tremor Cefalexin Percocet Sr Morphine (Morphine) Ativan (Lorazepam) C C C C Zoloft (Sertraline Hydrochloride) Nitrostat (Glyceryl Trinitrate) Date:02/28/01ISR Number: 3671874-7Report Type:Periodic Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 C C Company Report #001-0945-M0000897 PT Report Source Product Role Manufacturer Route Suicide Attempt Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL MG, TID), PER ORAL Sinemet Digoxin Date:02/28/01ISR Number: 3671875-9Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #001-0945-M0000938 PT Report Source Product Role Manufacturer Route Breast Cancer Female Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 Company MG QAM 600 MG Representative QPM), PER ORAL Wellbutrin 22-Aug-2005 Page: 482 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671876-0Report Type:Periodic Age:31 YR Gender:Female I/FU:I Outcome Dose Death Company Report #001-0945-M0000967 PT Report Source Product Role Manufacturer Sudden Death Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration 600 MG Company Representative Date:02/28/01ISR Number: 3671883-8Report Type:Periodic Age:33 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (100 Company Report #001-0945-M0000460 PT Report Source Product Role Manufacturer Route Hallucination Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL MG, TID), PER ORAL Buspar Date:02/28/01ISR Number: 3671884-XReport Type:Periodic Age:21 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL C Company Report #001-0945-M0000497 PT Report Source Product Role Manufacturer Route Abnormal Behaviour Impulse-Control Disorder Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Irritability Mood Altered Pressure Of Speech Prolixin Cogentin Zyprexa Vitamin E Tegretol Buspar Carbatrol C C C C C C C Date:02/28/01ISR Number: 3671886-3Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Encephalopathy Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Date:02/28/01ISR Number: 3671889-9Report Type:Periodic Age:58 YR Gender:Male I/FU:I Outcome Dose Other Company Report #001-0945-M0000530 Company Report #001-0945-M0000547 PT Report Source Product Role Manufacturer Route Ageusia Blindness Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300 MG (100 Cataract MG, TID), PER Condition Aggravated ORAL Visual Disturbance 22-Aug-2005 Page: 483 Route 10:40 AM Glucophage Prilosec Niaspan Vasotec Lipitor Elavil C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671890-5Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Encephalopathy Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Date:02/28/01ISR Number: 3671895-4Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Death Other 1200 MG (300 Company Report #001-0945-M0000573 Route Company Report #001-0945-M0000575 PT Report Source Product Role Manufacturer Weight Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Serzone Serevent Atrovent Symmetrel Risperdal Zyprexa Klonopin Effexor Xr Dalmane C C C C C C C C C Route MG BID, 600 MG MG QHS) Date:02/28/01ISR Number: 3671898-XReport Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Death Other SEE IMAGE Company Report #001-0945-M0000577 PT Report Source Product Role Manufacturer Ammonia Increased Weight Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Depakote Risperdal Ditropan C C C Duration Route Pepcid Albuterol Inhaler Cipro Eye Drops Haldol Decanoate Haldol Date:02/28/01ISR Number: 3671901-7Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Duration Death Other 1500 MG (600 C C C C C Company Report #001-0945-M0000578 PT Report Source Product Role Manufacturer Blood Glucose Increased Mania Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Depakote Cogentin Valium Serentil Albuterol Atrovent Depo Provera C C C C C C C MG AM AND 900 MG QHS) 22-Aug-2005 Page: 484 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671904-2Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Leukocytosis Health Professional Company Representative Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration Date:02/28/01ISR Number: 3671905-4Report Type:Periodic Age:76 YR Gender:Male I/FU:I Outcome Dose Other Company Report #001-0945-M0000642 Company Report #001-0945-M0000681 PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG (300 Blood Alkaline MG, TID), PER Phosphatase Increased ORAL Coordination Abnormal Dizziness Glyburide Glucophage Procrit Vasotec Prilosec Vitamin E Multivitamin Calcium Many Unspecified Medications Date:02/28/01ISR Number: 3671910-8Report Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE TEXT PER C Company Report #001-0945-M0000199 PT Report Source Product Role Manufacturer Route Exostosis Gingival Bleeding Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Haematocrit Decreased ORAL, 800 MG C C C C C C C C Haemoglobin Decreased (DAILY) PER Rectal Haemorrhage ORAL, SEE TEXT PER ORAL Lanoxin (Digoxin) Premarin (Estrogens Conjugated) Oxygen Via Nasal Cannula (Oxygen) Darvocet (Paracetamol) Darvocet (Paracetamol, Dextropropoxyphene) Requip (Digoxin) Prilosec (Omeprazole) (Meprobamate) 22-Aug-2005 Page: 485 10:40 AM C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671912-1Report Type:Periodic Age:25 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Company Report #001-0945-M0000262 PT Report Source Product Role Manufacturer Route Abdominal Pain Deafness Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Vomiting MG TID ) PER ORAL Depakote (Valproate Semisodium) Dhea (Prasterone) Phenergan (Promethazine Hydrochloride) Zithromax (Azithromycin) Narcotics Date:02/28/01ISR Number: 3671914-5Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other C C C C C Company Report #001-0945-M0000282 PT Report Source Product Role Manufacturer Crying Suicide Attempt Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Elavil (Amitriptyline Hydrochloride) C Duration 1500 MG Date:02/28/01ISR Number: 3671915-7Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Other 600 MG( 300 Company Report #001-0945-M0000295 PT Report Source Product Role Manufacturer Route Asthenia Dizziness Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Dysarthria MG BID) PER Hypertension ORAL Vomiting Neurontin Capsules 400 Mg (Gabapentin) SS Oxycontin (Oxycodone Hydrochloride) (Atenolol) C C ORAL 400 MG (DAILY) PER ORAL Date:02/28/01ISR Number: 3671917-0Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 Company Report #001-0945-M0000323 PT Report Source Product Role Manufacturer Route Pancreatitis Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL MG BID) PER ORAL Lopressor (Metoprolol Tartrate) 22-Aug-2005 Page: 486 10:40 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671919-4Report Type:Periodic Age:10 YR Gender:Male I/FU:I Outcome Dose Other Company Report #001-0945-M0000330 PT Report Source Product Role Manufacturer Route Asthenia Back Pain Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 100 MG DAILY Dysarthria PER ORAL Facial Palsy Hiccups Hypotonia Micturition Urgency Muscle Rigidity Muscle Twitching Date:02/28/01ISR Number: 3671921-2Report Type:Periodic Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 700 MG Other (DAILY) PER Company Report #001-0945-M0000332 PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Aspartate Aminotransferase ORAL Increased Ambien (Zolpidem Tartrate) Benadryl (Diphenhydramine Hydrochloride) Multivitamins(Vitami ns Nos, Minerals Nos) (Docusate) Nicotine Patch(Nicotine) Nicorette Gum (Nicotine Resin) C C C C C C Date:02/28/01ISR Number: 3671922-4Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-M0000334 PT Report Source Product Role Manufacturer Route Hypoaesthesia Tunnel Vision Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 300 MG (DAILY) PER ORAL Glucophage (Metformin Hydrochloride) Diabeta (Glibenclamide) Date:02/28/01ISR Number: 3671923-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG 10:40 AM C Company Report #001-0945-M0000367 PT Report Source Product Role Manufacturer Oedema Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Company Representative 22-Aug-2005 Page: 487 C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3671924-8Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-M0000386 PT Report Source Product Role Manufacturer Diplopia Disturbance In Attention Intentional Misuse Vision Blurred Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Trileptal (Oxcarbazepine) SS Kepra (Lefitracetam) C Route Duration 2700 MG (DAILY), UNKNOWN; 5400 MG (DAILY) UNKNOWN; 3600 Date:02/28/01ISR Number: 3671925-XReport Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other Company Report #001-0945-M0000025 PT Report Source Product Role Manufacturer Pancreatitis Other Neurontin PS Parke-Davis Pharm. Research Route Duration Date:02/28/01ISR Number: 3671926-1Report Type:Periodic Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG Company Report #001-0945-M0000028 PT Report Source Product Role Manufacturer Pancreatitis Health Professional Neurontin PS Parke-Davis Pharm. Research (DAILY) Zoloft(Sertraline Hydrochloride) Vicodin (Paracetamol, Hydrocodone C Route Bitartrate) Date:02/28/01ISR Number: 3671927-3Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE Company Report #001-0945-M0000085 PT Report Source Product Role Manufacturer Route Convulsion Pain Consumer Neurontin PS Parke-Davis Pharm. Research ORAL Sedation (Lithium) Synthroid (Levothyroxine Sodium) Serax (Oxazepam) Premarin (Estrogens Conjugated) Dilantin (Phenytoin Sodium) Date:02/28/01ISR Number: 3671928-5Report Type:Periodic Age:38 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 488 PT Deafness 10:40 AM C Company Report #001-0945-M0000127 Report Source Health Professional Company C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Dose Product Role Manufacturer Neurontin 100 Mg (Gabapenn) PS Parke-Davis Pharm. Research Route Duration 200 MG (100 MG, BID), UNK Procardia (Nifedipine) Monopril (Fosinopril Sodium) Lipitor (Atorvastin) Date:02/28/01ISR Number: 3671938-8Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose Other C C C Company Report #001-0945-M0000132 PT Report Source Product Role Manufacturer Route Visual Disturbance Health Professional Neurontin PS Parke-Davis Pharm. Research ORAL Route Duration 400 MG (QHS), PER ORAL Ativan(Lorazepam) Date:02/28/01ISR Number: 3671941-8Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other C Company Report #001-0945-M0000149 PT Report Source Product Role Manufacturer Hepatomegaly Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Date:02/28/01ISR Number: 3671943-1Report Type:Periodic Age:60 YR Gender:Male I/FU:I Company Report #001-0945-M0000158 Outcome Dose Other PT Report Source Product Role Manufacturer Eye Haemorrhage Vitreous Disorder Health Professional Neurontin PS Parke-Davis Pharm. Research Route Duration 300 MG TID OR QID Rezulin(Troglitazone ) Accupril (Quinapril Hydrochloride) Date:02/28/01ISR Number: 3671945-5Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Other 22-Aug-2005 Page: 489 C C Company Report #001-0945-M0000164 PT Report Source Product Role Manufacturer Cerebrovascular Accident Health Professional Company Representative Neurontin PS Parke-Davis Pharm. Research Duration 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3672024-3Report Type:Periodic Age:10 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE Company Report #001-0945-M0000181 PT Report Source Product Role Manufacturer Abnormal Behaviour Anxiety Consumer Neurontin PS Parke-Davis, Pharm. Research Aphasia Attention Deficit/Hyperactivity Disorder Cognitive Disorder Conversion Disorder Convulsion Euphoric Mood Hallucination Insomnia Mania Memory Impairment Psychotic Disorder Stupor Urinary Incontinence Tegretol (Carbamazepine) Dexedrine Dexampetamine Sulfate) Risperdal (Risperidone) Date:02/28/01ISR Number: 3672025-5Report Type:Periodic Age:79 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG C C C Company Report #001-0945-M0000183 PT Report Source Product Role Manufacturer Blood Pressure Increased Coordination Abnormal Consumer Neurontin PS Parke-Davis Pharm. Research Eye Movement Disorder (DAILY); 300 Fatigue MG (DAILY) Haemorrhage Intracranial Hallucination Lethargy Speech Disorder Route Norvasc (Amlodipine Resilate) Coumadin (Warfarin Sodium) Synthroid (Levothyroxine Sodium) C C C Route Date:02/28/01ISR Number: 3672714-2Report Type:Periodic Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100.00 Required TOTAL:DAILY:O Intervention to RAL Prevent Permanent 900.00 MG Impairment/Damage TOTAL:DAILY:O Company Report #A037638 PT Report Source Product Role Manufacturer Route Depression Suicide Attempt Other Zoloft PS Pfizer Pharmaceuticals Inc ORAL Gabapentin SS Naproxen Chlorzoxazone C C ORAL RAL Date:02/28/01ISR Number: 3676281-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #A028832 PT Report Source Product Role Manufacturer Route Liver Function Test Abnormal Health Professional Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration ORAL Neurontin 22-Aug-2005 Page: 490 10:40 AM SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin Date:02/28/01ISR Number: 3677190-1Report Type:Periodic Age:21 YR Gender:Male I/FU:I Outcome Dose Other SS Company Report #A007753 PT Report Source Product Role Manufacturer Route Diarrhoea Drug Ineffective Consumer Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration 100.00 MG Insomnia TOTAL;BID; ORAL Neurontin SS Trazodone C ORAL 600.00 MG TOTAL;DAILY;O RAL Date:02/28/01ISR Number: 3677336-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #A035591 PT Report Source Product Role Manufacturer Myalgia Health Professional Zoloft PS Pfizer Pharmaceuticals Inc Neurontin Insulin Ambien Estradiol Synthroid SS C C C C Duration 75.00 MG TOTAL:DAILY Date:02/28/01ISR Number: 3677404-8Report Type:Periodic Age:14 YR Gender:Female I/FU:I Company Report #A004325 Route Outcome Dose Other PT Report Source Product Role Manufacturer Route Tachycardia Health Professional Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration 25.00 MG TOTAL:DAILY:O RAL Adderall SS ORAL Neurontin SS ORAL ORAL ORAL Date:02/28/01ISR Number: 3677522-4Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose Other Company Report #A001056 PT Report Source Product Role Manufacturer Route Abdominal Pain Agitation Health Professional Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration 25.00 MG Drug Ineffective TOTAL: DAILY Dysgeusia ORAL Hypertonia Lithium SS ORAL Neurontin SS ORAL Haldol SS ORAL Adderall C 300.00 MG Muscle Twitching TOTAL:DAILY:O Myalgia RAL Osteoarthritis 900.00 MG Pain TOTAL:TID:ORA Thinking Abnormal L Vasodilatation 1.00 MG TOTAL:BID:ORA L 22-Aug-2005 Page: 491 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tenex Claritin Date:02/28/01ISR Number: 3677651-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Company Report #A032315 PT Report Source Product Role Manufacturer Agitation Apathy Drug Ineffective Consumer Zoloft PS Pfizer Pharmaceuticals Inc Neurontin SS Date:02/28/01ISR Number: 3677680-1Report Type:Periodic Age:81 YR Gender:Female I/FU:I Outcome Dose Disability C C Route Company Report #A037371 PT Report Source Product Role Manufacturer Route Hypoaesthesia Myasthenic Syndrome Consumer Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration 25.00 MG TOTAL:DAILY:O RAL Neurontin SS ORAL 1800.00 MG TOTAL:DAILY:O RAL Date:02/28/01ISR Number: 3679439-8Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other Company Report #A031899 PT Report Source Product Role Manufacturer Depersonalisation Speech Disorder Health Professional Zoloft PS Pfizer Pharmaceuticals Inc Duration Route Gabapentin Medication Unspecified Date:02/28/01ISR Number: 3679763-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other SS C Company Report #A037782 PT Report Source Product Role Manufacturer Anxiety Health Professional Zoloft PS Pfizer Pharmaceuticals Inc Gabapentin SS Clonazepam C Route Duration 80.00 MG TOTAL:DAILY Date:03/02/01ISR Number: 3672875-5Report Type:Expedited (15-DaCompany Report #001-0945-M0100193 Age:44 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Drug Dependence Feeling Abnormal Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Unspecified Allery/Sinus C Duration 400 MG (100 MG, QID) SEE IMAGE 22-Aug-2005 Page: 492 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Celebrex (Celecoxib) C Date:03/02/01ISR Number: 3673093-7Report Type:Expedited (15-DaCompany Report #049-0945-M0100016 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Extrapyramidal Disorder Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Product Role Manufacturer Route Blood Alkaline Vasotec PS Merck & Co., Inc ORAL Phosphatase Increased Blood Bilirubin Increased Blood Lactate Vioxx Gabapentin Floxacillin Sodium SS SS SS ORAL ORAL ORAL Dehydrogenase Increased Blood Potassium Increased Leflunomide Furosemide SS SS ORAL ORAL Cardiomegaly Metronidazole SS ORAL Culture Urine Positive Depressed Level Of Consciousness Electroencephalogram Abnormal Fatigue Headache Infection Liver Disorder Pain Pharyngolaryngeal Pain Proteus Infection Renal Failure Skin Ulcer Varicose Ulceration Morphine Vitamin E [Therapy Unspecified] Albuterol Sulfate And Ipratropium Bromide Calcium Carbonate And Cholecalciferol Loperamide Prednisolone Acetaminophen Cisapride Cetirizine Hydrochloride Morphine C C Duration Date:03/05/01ISR Number: 3672613-6Report Type:Expedited (15-DaCompany Report #WAES 01027276 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 7 DAY Initial or Prolonged 9 PT Report Source DAY 7 DAY 9 DAY C C C C C C C C C Folic Acid Lansoprazole Zolpidem Tartrate C C C Date:03/05/01ISR Number: 3673975-6Report Type:Expedited (15-DaCompany Report #358-0945-M0100001 Age:75 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 PT Report Source Product Role Manufacturer Route Asthenia Confusional State Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Difficulty In Walking Professional MG, TID), PER Dizziness ORAL Drug Interaction Pneumonia 22-Aug-2005 Page: 493 10:40 AM Panacod (Codeine Phosphate Paracetamol) Diltiazem Hydrochloride Nizax (Nizatidine) Amitriptyline Hydrochloride Levofloxacin C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tazoabactim Sodium Klexane (Heparin-Fraction, Sodium Salt) Lactulose C C C Date:03/05/01ISR Number: 3673978-1Report Type:Expedited (15-DaCompany Report #061-0945-M0100004 Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Circulatory Collapse Loss Of Consciousness Pulse Absent Foreign Health Professional Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL Route 1200 MG (600 MG, BID) , PER ORAL Date:03/05/01ISR Number: 3674648-6Report Type:Expedited (15-DaCompany Report #2001SE01042 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Cardiac Failure Coma Overdose Respiratory Disorder Foreign Health Professional Other Pulmicort PS Astrazeneca Pharmaceuticals Lp Allopurinol Choay Hemi-Daonil SS SS Fonzylane SS Lasilix Neurontin SS SS Acuitel Burinex Monicor Aspirine C C C C 2.5 MG BID 300 MG DAILY 400 MG TID Date:03/06/01ISR Number: 3674822-9Report Type:Expedited (15-DaCompany Report #WAES 01027276 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG, PO 7 PT Report Source Product Role Manufacturer Route Blood Alkaline Phosphatase Increased Cardiomegaly Foreign Other Vasotec PS Merck Research Laboratories Div Merck Co Inc ORAL DAY Culture Urine Positive Depressed Level Of Tab Vioxx (Rofecoxib) SS ORAL Consciousness Tab Metronidazole SS ORAL Fatigue Cap Gabapentin SS ORAL Headache Tab Furosemide SS ORAL Hepatic Enzyme Increased Tab Leflunomide SS ORAL Hypervolaemia Liver Disorder Tab Floxacillin Sodium SS ORAL Metabolic Disorder Pharyngolaryngeal Pain Proteus Infection Renal Failure Urinary Tract Infection [Therapy Unspecified] Acetaminophen Albuterol Sulfate (+) Ipratropium Bromid Calcium Carbonate (+) Cholecalciferol Cetirizine Hydrochloride 25 MG, PO 800 MG, PO 9 DAY 2400 MEQ, PO 40 MG, PO 7 DAY 20 MG, PO 2200 MG, PO 22-Aug-2005 Page: 494 9 DAY 10:40 AM C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Folic Acid Lansoprazole Loperamide Morphine Prednisolone Vitamin E Zolpidem Tartrate C C C C C C Date:03/06/01ISR Number: 3675378-7Report Type:Expedited (15-DaCompany Report #049-0945-M0100012 Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Other PT Report Source Product Role Manufacturer Coma Hypoglycaemia Foreign Consumer Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Date:03/06/01ISR Number: 3675381-7Report Type:Expedited (15-DaCompany Report #002-0945-M0100017 Age:15 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Hyperacusis Movement Disorder Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Poverty Of Speech Professional Duration 600 MG (300 MG, BID), PER ORAL (Amitriptyline) C Date:03/07/01ISR Number: 3675532-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100219 Age:85 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3200-3600 MG PT Report Source Product Role Manufacturer Route Disorientation Mental Impairment Musculoskeletal Stiffness Health Professional Neurontin (Gabapentin) PS Parke Davis Pharmaceuticals Ltd ORAL Myalgia (DAILY), PER ORAL Vicodin (Paracetamol, Hydrocodone Bitartrate) C Date:03/07/01ISR Number: 3675614-7Report Type:Expedited (15-DaCompany Report #2001COU0301 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PO PT Report Source Product Role Manufacturer Route Drug Interaction International Normalised Consumer Coumadin PS Dupont Merck Pharmaceutical Co ORAL Ratio Decreased International Normalised 0-300 MG Ratio Increased Prothrombin Time Prolonged 22-Aug-2005 Page: 495 10:40 AM Neurontin (Gabapentin) SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/01ISR Number: 3676588-5Report Type:Expedited (15-DaCompany Report #049-0945-M0100013 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400 (DAILY), Required PER ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Difficulty In Walking Malaise Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Oedema Peripheral Oral Intake Reduced Pain In Extremity Date:03/08/01ISR Number: 3676590-3Report Type:Expedited (15-DaCompany Report #358-0945-M0100001 Age:75 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (400 PT Report Source Product Role Manufacturer Route Asthenia Confusional State Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Difficulty In Walking Professional MG, TID), PER Dizziness ORAL Drug Interaction Pneumonia Amitriptyline Hydrochloride SS ORAL Panacod (Codeine Phosphate, Paracetamol) SS ORAL PER ORAL PER ORAL Diltiazem Hydrochloride Nizax (Nizatidine) Levofloxacin Tazobactam Sodium Klexane (Heparin-Fraction, Sodium Salt) Lactulose C C C C C C Date:03/08/01ISR Number: 3676647-7Report Type:Expedited (15-DaCompany Report #A101296 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 200.00 MG : PT Report Source Product Role Manufacturer Route Depression Oedema Peripheral Health Professional Zoloft PS Pfizer Pharmaceuticals Inc ORAL Post-Traumatic Stress BID : ORAL Disorder Neurontin SS Vicodin Colace Seroquel C C C ORAL 1600.00 M G TOTAL: QID : ORAL Date:03/08/01ISR Number: 3676695-7Report Type:Expedited (15-DaCompany Report #001-0945-M0100231 Age:43 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Facial Palsy Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ... Tylenol W/Codeine C Duration 300 MG (100 MG, TID); 600 MG (200 MG, TID) 22-Aug-2005 Page: 496 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Codeine Phosphate, Paracetamol) Flexaril (Cyclobenzaprine Hydrochloride) Paxil (Paroxetine Hydrochloride) Trazodone Date:03/09/01ISR Number: 3676428-4Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT C C C C Company Report #USP 081393 Report Source Product Role Manufacturer Neurontin Noroxin PS SS Parke-Davis Merck & Co Route Duration Medication Error Date:03/09/01ISR Number: 3678203-3Report Type:Expedited (15-DaCompany Report #044-0945-M0100053 Age:59 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Diabetes Mellitus Diabetes Mellitus Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Inadequate Control Professional Duration 900 MG (DAILY), PER Company ORAL Representative Date:03/09/01ISR Number: 3678205-7Report Type:Expedited (15-DaCompany Report #044-0945-M0100052 Age:72 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Sepsis Urinary Tract Infection Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1800 MG Professional (DAILY), PER Other ORAL Tylex (Phenylephrine Hydrochloride, Paracetamol, Carbinoxamine Maleate) (Naproxen) (Temazepam) Oramorph (Morphine Sulfate) C C C C Date:03/09/01ISR Number: 3678208-2Report Type:Expedited (15-DaCompany Report #044-0945-M0100051 Age:84 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Sepsis Urinary Tract Infection Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 900 MG Professional (DAILY), PER Other ORAL (Amitriptyline) Co-Proxamol (Paracetamol, Dextropropoxyphene Hydrochloride) Frumil (Furosemide, 22-Aug-2005 Page: 497 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amiloride Hydrochloride) Asa (Acetylsalicylic Acid) Imdur (Isorbide Mononitrate) (Nicorandil) (Atenolol) C C C C C Date:03/09/01ISR Number: 3678210-0Report Type:Expedited (15-DaCompany Report #044-0945-M0100029 Age:79 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100 MG PT Report Source Product Role Manufacturer Route Drug Interaction Narcolepsy Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Professional (DAILY), PER Other ORAL Sinemet (Levodopa, Carbidopa) (Paroxetine) SS SS Date:03/12/01ISR Number: 3680258-7Report Type:Expedited (15-DaCompany Report #001-0945-M0001041 Age:14 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Amnesia Anxiety Health Professional Neurontin PS Pfizer Pharmaceuticals Lamictal (Lamotrigine) C Duration 2400 MG (800 Condition Aggravated MG, TID) Convulsion Dizziness Mental Impairment Psychomotor Retardation Sedation Tearfulness Visual Acuity Reduced Date:03/12/01ISR Number: 3680317-9Report Type:Expedited (15-DaCompany Report #S01-USA-00393-01 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40 MG QD PO PT Report Source Product Role Manufacturer Route Anorectal Disorder Colitis Health Professional Celexa PS Forest Laboratories Inc ORAL Colitis Ulcerative Diarrhoea Haemorrhagic Celexa (Citalopram Hydrobromide) Haematocrit Decreased Haemoglobin Decreased Rectal Haemorrhage Sinusitis Neurontin (Gabapentin) Risperdal (Risperidone) SS ORAL 30 MG QD PO SS SS Date:03/12/01ISR Number: 3681439-9Report Type:Expedited (15-DaCompany Report #055-0945-M0100003 Age: Gender:Male I/FU:I Outcome Dose Death 400 MG (DAILY), PER ORAL 22-Aug-2005 Page: 498 PT Report Source Product Role Manufacturer Route Condition Aggravated Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/01ISR Number: 3680117-XReport Type:Expedited (15-DaCompany Report #002-0945-M0100020 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG PT Report Source Product Role Manufacturer Route Asthenia Dizziness Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Movement Disorder (DAILY), PER Syncope ORAL; SEE Visual Disturbance IMAGE (Clonazepam) C Date:03/14/01ISR Number: 3682986-6Report Type:Expedited (15-DaCompany Report #044-0945-M0100066 Age:60 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Pulmonary Embolism Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Date:03/19/01ISR Number: 3684201-6Report Type:Expedited (15-DaCompany Report #001-0073-M0100097 Age:58 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Convulsion Drug Ineffective Health Professional Dilantin PS Parke Davis Div Warner Lambert Co ORAL Duration 400 MG (DAILY), PER ORAL Neurontin (Gabapentin) 1100 MG (DAILY), PER SS ORAL ORAL Clozapine (Clozapine) SS 450 MG Levothyroxine (Levothyroxine) Lorazepam Zolpidem Celecoxib (Celecoxib) C C C C Date:03/19/01ISR Number: 3684352-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100041 Age:31 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE, PT Report Source Product Role Manufacturer Route Abnormal Behaviour Asthenia Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Blood Pressure Increased PER ORAL Dizziness Fatigue Feeling Jittery Malaise Medication Error Pain Palpitations Sedation Tremor 22-Aug-2005 Page: 499 10:40 AM Ultram (Tramadol Hydrochloride) C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/01ISR Number: 3684500-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100302 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Status Epilepticus Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Route Date:03/19/01ISR Number: 3684502-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100293 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged (DAILY), PER Other ORAL PT Report Source Product Role Manufacturer Route Arterial Disorder Chest Discomfort Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Myocardial Infarction Pain In Extremity Date:03/19/01ISR Number: 3684633-6Report Type:Expedited (15-DaCompany Report #033-0945-M0100008 Age:54 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Scintillating Scotoma Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Duration SEE IMAGE Date:03/20/01ISR Number: 3685701-5Report Type:Expedited (15-DaCompany Report #001-0945-M0100041 Age:31 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (600 PT Report Source Product Role Manufacturer Route Asthenia Blood Pressure Increased Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dizziness MG, BID), PER Drug Withdrawal Syndrome ORAL Fatigue Malaise Neurontin (Gabapentin) 600 Mg SS ORAL Neurontin (Gabapentin) 600 Mg SS ORAL Neurontin (Gabapentin) SS ORAL Ultram (Tramadol Hydrochloride) C (300 MG, Pain BID), PER Palpitations ORAL Tremor Visual Disturbance 300 MG, BID, PER ORAL PER ORAL Date:03/20/01ISR Number: 3685748-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100261 Age:68 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Blood Alkaline Phosphatase Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd (Unspecified Pain Pills) (Fluorouracil) C C Duration 3200 MG Liver Function Test (DAILY) Abnormal 22-Aug-2005 Page: 500 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/01ISR Number: 3685756-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100059 Age:93 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Apnoea Chronic Obstructive Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Pulmonary Disease MG, TID) PER Confusional State ORAL Dyspnoea Feeling Hot And Cold Gastrointestinal Disorder Lung Disorder Myocardial Infarction Pain Demerol Gabapentin Fosaxmax (Alendronate Sodium) Lotrel (Amlodipine Besylate, Benazepril Hydrochloride) Norvasc (Amlodipine Besilate) Levothyroxine SS SS C C C C Date:03/20/01ISR Number: 3685817-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100272 Age:21 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100MG (BID) PT Report Source Product Role Manufacturer Route Overdose Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL PER ORAL Naprosyn Motrin SS SS Neurontin (Gabapentin) SS 5MG 300 MG (HS), PER ORAL (Metronidazole) (Ciprofloxacin Hydrochloride) C C ORAL Date:03/20/01ISR Number: 3685820-3Report Type:Expedited (15-DaCompany Report #001-0945-M0001325 Age: Gender:Male I/FU:F Outcome Dose Disability PT Report Source Product Role Manufacturer Asthenia Hypoaesthesia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Narcotic (Narcotic) C Route Duration 1600 MG (400 MG ,4 TIMES DAILY) PER Date:03/20/01ISR Number: 3686136-1Report Type:Expedited (15-DaCompany Report #044-0945-M0100069 Age: Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Post Procedural Complication Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Duration UNKNOWN Professional 22-Aug-2005 Page: 501 10:40 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/01ISR Number: 3686137-3Report Type:Expedited (15-DaCompany Report #033-0945-M0100030 Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged INTRAVENOUS 600 MG PT Report Source Product Role Manufacturer Atrioventricular Block Cardiac Arrest Malaise Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Fosphenytoin Sodium SS (Carbamazepine) (Clonazepam) (Alprazolam) (Clobazam) (Valproate Sodium) (Lamotrigine) (Domperidone) (Topiramate) C C C C C C C C Route Ventricular Fibrillation (SINGLE DOSE), INTRAVENOUS Date:03/20/01ISR Number: 3686318-9Report Type:Expedited (15-DaCompany Report #044-0945-M0100067 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG, PER Other ORAL PT Report Source Product Role Manufacturer Route Grand Mal Convulsion Necrotising Fasciitis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Sepsis Professional Amitriptyline Fluoxetine Fentanyl Paracetamol Oxygen, Nitrous Oxide Diclofenac Sodium Potassium Chloride Potassium Chloride Diazepam C C C C C C C C C Date:03/20/01ISR Number: 3686337-2Report Type:Expedited (15-DaCompany Report #049-0945-M0100012 Age:65 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Other 900 MG 22-Aug-2005 Page: 502 10:40 AM PT Report Source Product Role Manufacturer Coma Hypoglycaemia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Professional Hynorex Retard Norvasc 5 (Lorazepam) (Belladonna Alkaloids) (Ass) (Risperidone) Clavulante Potassium, Amoxicillin Trihydrate) C C C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/01ISR Number: 3686375-XReport Type:Expedited (15-DaCompany Report #061-0945-M0100004 Age:45 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Pulse Absent Syncope Foreign Health Professional Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL 300 MG (BID), PER ORAL Citalopram C Date:03/21/01ISR Number: 3687004-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100237 Age:70 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Dizziness Gastrointestinal Disorder Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration DAILY, PER Nausea ORAL Nervousness Tremor Unknown Heart Medication C Date:03/21/01ISR Number: 3687108-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100300 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG PT Report Source Product Role Manufacturer Blood Albumin Decreased Cardiac Failure Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Zostrix (Capsaaicin) Morphine (Morphine) Glucophage (Metformin C C Congestive (QID);2400 Pco2 Increased MG(QID) Hydrochloride) Glucotrol (Glipizide) Potassium (Potassium) (Furosemide) Lomotil (Atropine Sulfate, Dihphenoxylate Hydrochloride) Ambien (Zolpidem Tartrate) C C C C C C Date:03/21/01ISR Number: 3687339-2Report Type:Expedited (15-DaCompany Report #001-0073-M0100097 Age:58 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Convulsion Drug Ineffective Health Professional Dilantin PS Parke Davis Div Warner Lambert Co ORAL Duration 400 MG DAILY Medication Error PER ORAL Neurontin (Gabapentin) SS Clozapine (Clozapine) SS 1100 MG DAILY PER ORAL 450 MG Levothyroxine 22-Aug-2005 Page: 503 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine) Lorazepam (Zolpidem) Celecoxib (Celecoxib) C C C C Date:03/21/01ISR Number: 3688104-2Report Type:Expedited (15-DaCompany Report #002-0945-M0000045 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Depression Feeling Jittery Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 300 MG Gastrointestinal Disorder (DAILY), PER Headache ORAL Insomnia Liver Disorder Vision Blurred Zoloft (Sertraline Hydrochloride) Celebrex (Celecoxib) Rivotril (Clonazepam) Antabuse (Disulfiram) Tylenol No. 1 (Cafeine, Codeine, Paracetamol) 222 (Acetylsalicylic Acid, Caffeine, Phenacetin, Codeine) Depo-Medrol (Methylprednisolone Acetate) C C C C C C C Date:03/21/01ISR Number: 3688167-4Report Type:Expedited (15-DaCompany Report #04-0945-M0100070 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Neutropenia Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Date:03/22/01ISR Number: 3688350-8Report Type:Expedited (15-DaCompany Report #044-0945-M0100043 Age:64 YR Gender:Male I/FU:F Outcome Dose Death Other 900 MG, PER PT Report Source Product Role Manufacturer Route Bronchopneumonia Metastases To Lung Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Pulmonary Function Test Professional Abnormal Company Respiratory Arrest Representative Duration ORAL; 1800 MG, PER ORAL 22-Aug-2005 Page: 504 10:40 AM Analgesia Chemotherapy Ramipril Diamorphine Temazepam Midazolam C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/01ISR Number: 3689728-9Report Type:Expedited (15-DaCompany Report #001-0945-M0001276 Age:52 YR Gender:Female I/FU:F Outcome Dose Disability PT Report Source Product Role Manufacturer Route Condition Aggravated Corneal Oedema Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 900 MG (TID), Dizziness PR ORAL Eye Disorder Photophobia Sedation Vision Blurred Celebrex (Celecoxib) Enbrel Prilosec (Omeprazole) Estratest (Methyltestosterone, Estrogens Esterfied) Folic Acid Methotrexate Pindolol C C C C C C C Date:03/26/01ISR Number: 3689865-9Report Type:Expedited (15-DaCompany Report #044-0945-M0100072 Age: Gender:Male I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Hallucination Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Amitriptyline (Amitriptyline) Carbamazepine (Carbamazepine) Opioids C C C Date:03/26/01ISR Number: 3689925-2Report Type:Expedited (15-DaCompany Report #044-0945-M0100053 Age:59 YR Gender:Female I/FU:F Outcome Dose Other 900 MG PT Report Source Product Role Manufacturer Route Diabetes Mellitus Inadequate Control Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Professional (DAILY), PER Company ORAL Representative Insulin Capsaicin Solfadeine C C C Date:03/26/01ISR Number: 3690205-XReport Type:Expedited (15-DaCompany Report #PHRM2000FR01473 Age:25 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG/DAY, PT Report Source Product Role Manufacturer Route Drug Interaction Grand Mal Convulsion Foreign Health Tegretol-Xr PS Novartis Pharmaceuticals Corp ORAL Professional ORAL Other Neurontin (Gabapentin) Capsule SS ORAL Nutrtional Supplements SS ORAL Urbanyl (Clobazam) C 2400 MG/DAY, ORAL ORAL 22-Aug-2005 Page: 505 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/01ISR Number: 3690667-8Report Type:Direct Age:15 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged X 46 TABS Required ORAL Intervention to Prevent Permanent X 50 TABS Impairment/Damage ORAL PT Company Report # Report Source Convulsion Intentional Misuse Product Role Manufacturer Route Wellbutrin 150mg Glaxo-Wellcome PS Glaxo-Wellcome ORAL Neurontin 300mg Parke-Davis SS Parke-Davis ORAL Celexa C Manufacturer Route Vomiting Date:03/27/01ISR Number: 3690780-5Report Type:Expedited (15-DaCompany Report #049-0945-M0000031 Age:65 YR Gender:Male I/FU:F Outcome Dose Duration Death 1600 MG Life-Threatening (DAILY), PER Hospitalization ORAL Initial or Prolonged Other 10 MG, Required UNKNOWN Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Abdominal Pain Foreign Neurontin PS Arterial Disorder Health Bronchopneumonia Professional Gangrene Hepatic Failure Other Atorvastatin (Atorvastatin) SS Beloc-Zok C Liver Disorder Oral Intake Reduced Pancreatitis Necrotising Pulmonary Oedema Refusal Of Treatment By Patient Respiratory Failure Sepsis Thrombotic Microangiopathy Vomiting White Blood Cell Count Decreased ORAL Date:03/28/01ISR Number: 3690399-6Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Neurontin 300mg Depakote 500 Mg PS SS Duration Dermatitis Date:03/28/01ISR Number: 3691281-0Report Type:Expedited (15-DaCompany Report #001-0945-M0000751 Age:70 YR Gender:Male I/FU:F Outcome 22-Aug-2005 Page: 506 PT Abdominal Pain Abdominal Tenderness Autoantibody Positive Benign Prostatic Hyperplasia Blister Ear Pain Electric Shock Eye Irritation Eye Pain Facial Pain Fatigue Feeling Abnormal 10:40 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Finger Deformity Inflammation Lichen Planus Report Source Product Role Manufacturer Pain In Extremity Paraesthesia Consumer Health Neurontin PS Parke Davis Pharmaceuticals Ltd Peripheral Sensory Professional Duration 900-1200 MG (TID OR QID) Neuropathy Red Blood Cell Sedimentation Rate Increased Sensitivity Of Teeth Skin Discolouration Skin Exfoliation Sleep Apnoea Syndrome Snoring Trigeminal Neuralgia Lipitor (Atorvastatin) Vioxx (Rofecoxib) Hytrin (Terazosin Hydrochloride) Thyroid (Thyroid) Soma (Carisoprodol) Valium (Diazepam) Imitrex (Sumatriptan Succinate) Viagra (Sildenafil Citrate) Synthroid (Levothyroxine Sodium) Rhinocort (Budesonide) Levsin (Hyoscyamine Sulfate) Miralax (Macrogol) Vicadin (Vicadin) Patanol (Olopatadine Hydrochloride) Livostin (Levocabastine Hydrochloride) Lomonin (Lomonin) Prilosec (Omeprazole) Allegra (Fexofenadine Hydrochloride) Advil (Ibuprofen) Vitamin C (Ascorbic Acid) Vitamin E (Tocopherol) Vitamin B SS C C C C C C C C C C C C C C C C C C C C C Route B12 (Cyanocobalamin) Folate (Folate Sodium) Zinc (Zinc) Chromium (Chromium) Saw Palmetto (Serenoa Repens) Coenzyme (Q12) Ginseng (Ginseng) Ginko (Ginko Tree Leaves Extract) Selenium (Selenium) Glutathione (Glutathione) 22-Aug-2005 Page: 507 10:40 AM C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/01ISR Number: 3691987-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100314 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Conversion Disorder Grand Mal Convulsion Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Phenytoin SS Sertraline SS Route Duration 1800 MG (600 MG, THREE TIMES DAILY) THREE TIMES DAILY (200 MG) 200 UNKNOWN (200 UNKNOWN, ONE EVERY MORNING) Date:03/29/01ISR Number: 3692443-9Report Type:Expedited (15-DaCompany Report #A105990 Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to 200.00 MG Prevent Permanent TOTAL:DAILY:O Impairment/Damage RAL PT Report Source Product Role Manufacturer Route Hypertrophy Breast Weight Increased Consumer Zoloft PS Pfizer Pharmaceuticals Inc ORAL Neurontin Lipitor Celebrex Clonazepam Desipramine Seroquel SS SS SS C C C Date:03/29/01ISR Number: 3692446-4Report Type:Expedited (15-DaCompany Report #001-0945-M0001276 Age:52 YR Gender:Female I/FU:F Outcome Dose Disability PT Report Source Product Role Manufacturer Route Condition Aggravated Corneal Oedema Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 900 MG (TID), Dizziness PER ORAL Eye Disorder Photosensitivity Reaction Sedation Vision Blurred Celebrex (Celecoxib) Enbrel Prilosec (Omeprazole) Estratest (Methyltestosterone, Estrogens Esterified) Folic Acid Methotrexate Pindolol C C C C C C C Date:03/29/01ISR Number: 3692727-4Report Type:Expedited (15-DaCompany Report #044-0945-M0100072 Age: Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 508 10:40 AM PT Report Source Product Role Manufacturer Hallucination Foreign Neurontin PS Parke Davis Pharmaceuticals Ltd Amitriptyline Carbamazepine Opioids C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/01ISR Number: 3692768-7Report Type:Expedited (15-DaCompany Report #047-0945-M0100002 Age: Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Manufacturer Benign Congenital Hypotonia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Cleft Lip Professional Cleft Palate Other Frisium (Clobazam) SS Rivotril (Clonazepam) C Route 2400 MG, PLACENTAL 40 MG, Complications Of Maternal PLACENTAL Exposure To Therapeutic Drugs Date:03/29/01ISR Number: 3692769-9Report Type:Expedited (15-DaCompany Report #055-0945-M0100008 Age: Gender:Male I/FU:I Outcome Dose Death Other 800 MG PT Report Source Product Role Manufacturer Pneumonia Throat Cancer Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Product Role Manufacturer Neurontin Neurontin PS SS Parke-Davis Parke-Davis Role Manufacturer Route Duration (DAILY) Date:04/02/01ISR Number: 3693514-3Report Type:Direct Age: Gender: I/FU:I Outcome Dose Other PT Company Report #USP 081400 Report Source Route Duration Medication Error Date:04/02/01ISR Number: 3698078-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100322 Age:5 YR Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Route Other Aggression Agitation Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL 600 MG Condition Aggravated (DAILY), PER Disturbance In Social ORAL Behaviour Drug Effect Decreased Emotional Disorder Levothyroxine (Levothyroxine) C Date:04/03/01ISR Number: 3695126-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100336 Age: Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Confusional State Difficulty In Walking Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 200 MG (100 Speech Disorder MG, PER ORAL Duragesic (Fentanyl) Vicodin (Paracetamol, Hydrocodone Bitartrate) Neurontin SS SS SS 400MG (DAILY) PO Lipitor (Atorvastatin) Premarin (Estrogens Conjugated) Detrol (Tolterodine 22-Aug-2005 Page: 509 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) Vioxx (Rofecoxib) Sinemet (Levodopa, Carbidopa) C C C Date:04/03/01ISR Number: 3695127-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100365 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Oedema Peripheral Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 300 MG (TID), Pain In Extremity PER ORAL Levbid (Hyoscyamine Sulfate) Coumadin (Warfarin Sodium) Elavil (Amitriptyline Hydrochloride) Allegra D (Pseudoephedrine, Fexofenadine Hydrochloride) C C C C Date:04/03/01ISR Number: 3695193-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100363 Age:58 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Breast Cancer Female Mania Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Diazepam Nefazodone Oxycodone Hydrochloride Hydroxychloroquine Sulfate Celecoxib C C Duration 1800 MG TID C C C Date:04/03/01ISR Number: 3695277-4Report Type:Expedited (15-DaCompany Report #A101069 Age:42 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 150.00 MG Required TOTAL DAILY Intervention to 400.00 MG Prevent Permanent TOTAL BID Impairment/Damage 375.00 MG PT Report Source Product Role Manufacturer Blood Pressure Decreased Decreased Appetite Health Professional Zoloft PS Pfizer Pharmaceuticals Inc Neurontin SS Serzone SS Proamatine Ambien Blood Pressure Medication Klonopin SS C Dehydration Depression Disorientation Dizziness Fall TOTAL BID Insomnia Syncope 22-Aug-2005 Page: 510 10:40 AM C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/01ISR Number: 3695691-7Report Type:Expedited (15-DaCompany Report #044-0945M0100051 Age:84 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG Other (DAILY), PER PT Report Source Product Role Manufacturer Route Sepsis Urinary Tract Infection Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional ORAL Amitriptyline Co-Proxamol (Paracetamol, Dextropropoxyphene Hydrochloride) Frumil (Furosemide) Frumil (Furosemide, Amiloride Hydrochloride) Asa (Acetylsalicylic Acid) Imdur (Isosorbide Mononitrate) Nicorandil Atenolol C C C C C C C C Date:04/03/01ISR Number: 3695711-XReport Type:Expedited (15-DaCompany Report #044-0945-M0100052 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG Other (DAILY), PER PT Report Source Product Role Manufacturer Route Sepsis Urinary Tract Infection Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional ORAL Tylex (Phenylephrine Hydrochloride, Paracetamol, Carbinoxamine Maleate C Naproxen Temazepam Oramorph (Morphine Sulfate) C C C Date:04/03/01ISR Number: 3696066-7Report Type:Expedited (15-DaCompany Report #2001SIN0055 Age:78 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged "1000 MG" DLY PT Report Source Product Role Manufacturer Route Drug Interaction Narcolepsy Foreign Health Sinemet PS Dupont Pharmaceuticals Co ORAL Professional PO Other Neurontin (Gabapentin) SS ORAL Seroxat "Smith Kline Beecham" (Paroxetine Hydrochloride) SS ORAL 100 MG QHS PO 20 MG DLY PO 22-Aug-2005 Page: 511 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/01ISR Number: 3696166-1Report Type:Expedited (15-DaCompany Report #044-0945-M0100117 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Route Dermatitis Pruritus Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional Oxycodone C Date:04/03/01ISR Number: 3696878-XReport Type:Expedited (15-DaCompany Report #001-0945-M0100326 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (TID) PT Report Source Product Role Manufacturer Route Condition Aggravated Confusional State Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL , PER ORAL Unspecified Chemotherapy Agent (Oxycodone Hydrochloride) C C Date:04/03/01ISR Number: 3696883-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100327 Age:68 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Diabetes Mellitus Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 600 MG (BID), PER ORAL Tenormin (Atenolol) Accupril (Quinapril Hydrochloride) Megace (Megestrol Acetate) Darvocet (Paracetamol, Dextropropoxyphene) C C C C Dalmane (Flurazepam Hydrochloride) C Date:04/04/01ISR Number: 3698070-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100345 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Chondropathy Hypertrophy Breast Knee Arthroplasty Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd (Sertraline) SS 200 MG Weight Increased (DAILY), PER ORAL Lipitor (Atorvastatin Calcium) Celecoxib (Celecoxib) Clonazepam (Clonazepam) Desipramine (Desipramine) Quetiapine (Quentiapine) 22-Aug-2005 Page: 512 10:40 AM SS SS SS SS SS Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/01ISR Number: 3698083-XReport Type:Expedited (15-DaCompany Report #001-0945-M0100328 Age: Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Dyspepsia Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 1000 MG Dyspnoea (DAILY), PER Flatulence ORAL Influenza Muscle Spasms Myalgia Pain Trazodone (Trazodone) Diphenhydramine (Diphenhydramine) Zolpidem (Zolpidem) Buspirone (Buspirone) C C C C Date:04/04/01ISR Number: 3698211-6Report Type:Expedited (15-DaCompany Report #001-0073-M0100016 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Condition Aggravated Visual Acuity Reduced Consumer Health Dilantin PS Parke Davis Div Warner Lambert Co ORAL Route Duration 500 MG, PER Professional ORAL Gabapentin (Gabapentin) SS 900 MG (THREE TIMES A DAY) Date:04/06/01ISR Number: 3700189-3Report Type:Expedited (15-DaCompany Report #S01-USA-00393-01 Age:38 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Abnormal Faeces Health Celexa PS Forest Laboratories Initial or Prolonged 40 MG QD PO Colitis Ulcerative Professional Inc Dehydration Diarrhoea Haemorrhagic Celexa (Citalopram Hydrobromide) Haematocrit Decreased Haemoglobin Decreased Haemorrhage Pain Rectal Haemorrhage Sinusitis Vomiting Neurontin (Gabapentin) Risperdal (Risperidone) Asacol (Mesalazine) Prednisone SS ORAL ORAL 30 MG QD PO SS SS SS SS Date:04/06/01ISR Number: 3700210-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100354 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Parkinson'S Disease Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 300 MG (DAILY) PER ORAL Date:04/06/01ISR Number: 3700215-1Report Type:Expedited (15-DaCompany Report #002-0945-M0100044 Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 513 10:40 AM PT Dizziness Mood Altered Report Source Foreign Health FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Dose Product Role Manufacturer Route Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 1100 MG (TWICE DAILY); PER ORAL Date:04/06/01ISR Number: 3700447-2Report Type:Expedited (15-DaCompany Report #044-0945-M0100090 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Cardiac Failure Hypoglycaemia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Lower Respiratory Tract Infection Transient Ischaemic Attack Professional Duration UNKNOWN Date:04/06/01ISR Number: 3700448-4Report Type:Expedited (15-DaCompany Report #044-0945-M0100088 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Hypoglycaemia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Duration UNKNOWN Professional Date:04/06/01ISR Number: 3718580-8Report Type:Periodic Age:58 YR Gender:Female I/FU:F Company Report #2000036882US Route Outcome Dose PT Report Source Product Role Manufacturer Route Alopecia Drug Interaction Consumer Detrol PS Pharmacia And Upjohn Co ORAL Route Duration 4 MG, ORAL Neurontin (Gabapentin) SS Date:04/09/01ISR Number: 3701075-5Report Type:Expedited (15-DaCompany Report #001-0945-M0100366 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG (TID) PT Report Source Product Role Manufacturer Dysphagia Vomiting Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Clonidine C Date:04/09/01ISR Number: 3701084-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100367 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 7200 MG (TID) 9600 MG (QID) 22-Aug-2005 Page: 514 10:40 AM PT Report Source Product Role Manufacturer Unevaluable Event Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Neurontin(Gabapentin ) SS Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/01ISR Number: 3701116-5Report Type:Expedited (15-DaCompany Report #031-0945-M0100007 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Condition Aggravated Dyspnoea Lung Disorder Foreign Consumer Health Professional Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL 900 MG (TID), PER ORAL Other Pulmonal Medication C Date:04/09/01ISR Number: 3701432-7Report Type:Expedited (15-DaCompany Report #046-0945-M0100016 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (TID), Other PER ORAL PT Report Source Product Role Manufacturer Route Coagulopathy Drug Interaction Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Pain In Extremity Professional Route Warfarin (Warfarin Sodium) SS Date:04/10/01ISR Number: 3702446-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100390 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (TID) Other PT Report Source Product Role Manufacturer Cardiac Failure Congestive Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Dyazide (Hydrochloroathiazid e, Triamterene) .. C C Disorientation Fluid Retention Renal Failure Date:04/10/01ISR Number: 3702449-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100386 Age:9 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Hypertension Nephrotic Syndrome Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd (Valproate Semisodium) (Clonidine) C C Route Duration Date:04/10/01ISR Number: 3702575-4Report Type:Expedited (15-DaCompany Report #2011851 Age:47 YR Gender:Female I/FU:I Outcome Dose Other PO 22-Aug-2005 Page: 515 PT Report Source Product Role Manufacturer Route Dysarthria Consumer Oxycontin PS Purdue Pharma Lp ORAL Encephalopathy Health Professional Other Neurontin (Gabapentin) Urecholine(Bethanech ol Chloride) Percocet Robaxin (Methocarbamol) Paxil (Paroxetine) Betaseron Baclofen (Lioresal) Duration 10:40 AM SS SS C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin (Gabapentin) Celexa(Citalopram Hydrobromide) Valium (Diazepam) Urecholine (Bethanechol Chloride) Verapamil Hcl Trazodone Hcl Imodium Prilosec (Omeprazole) C C C C C C C C Date:04/10/01ISR Number: 3702748-0Report Type:Expedited (15-DaCompany Report #049-0945-M0100013 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG Required (DAILY), PER Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Difficulty In Walking Malaise Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Oedema Peripheral Oral Intake Reduced Pain In Extremity Date:04/10/01ISR Number: 3703611-1Report Type:Expedited (15-DaCompany Report #002-0945-M0100045 Age:17 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Therapeutic Professional Zyprexia (Olanzapine) Hydromorphone(Hydrom orphone) Duration PER ORAL SS SS Date:04/10/01ISR Number: 3703612-3Report Type:Expedited (15-DaCompany Report #002-0945-M0100047 Age: Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Coma Drug Interaction Drug Level Above Therapeutic Overdose Respiratory Depression Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Oxycodone(Oxycodone) Clonazepam (Clonazepam) SS Route Duration SS Date:04/11/01ISR Number: 3703250-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100398 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL Other 22-Aug-2005 Page: 516 10:40 AM PT Report Source Product Role Manufacturer Route Blood Pressure Increased Emotional Disorder Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Hypoaesthesia Palpitations Fluphenazine (Fluphenazine) Alprazolam (Alprazolam)` C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levothyroxine (Levothyroxine) Conjugated Estrogen(Medroxyprog esterone Acetate, Estrogens Conjugated) Aspirin (Acetylsalicylic Acid) Soy Acetaminophen W/ Codeine (Codeine, Paracetamol) Rolaids (Dyhydroxyaluminum Sodium Carbonate) Temazepam(Temazepam) Albuterol (Salbutamol) C C C C C C C C Date:04/11/01ISR Number: 3703742-6Report Type:Expedited (15-DaCompany Report #200112306EU Age:47 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Blood Alkaline Initial or Prolonged Phosphatase Increased 800 MG/DAY PO 9 DAY Cardiomegaly 20 MG /D AY Chest Pain PO Depressed Level Of Consciousness 2.4 G /D AY Ear Pain 40 MG/DAY PO Electroencephalogram Abnormal 20 MG/ DAY PO 1 WK Fatigue Gamma-Glutamyltransferase 2.2 G / DAY 9 DAY Report Source Product Role Manufacturer Route Foreign Other Noritate PS Dermik Laboratories Inc ORAL Leflunomide (Arava) SS Gabapentin (Neurontin) SS Furosemide (Furix) SS ORAL Enalapril Maleate (Renitec) SS ORAL Flucloxacillin Sodium (Heracillin) SS ORAL Increased Rofecoxib (Vioxx) Headache Hepatic Enzyme Increased Hypocalcaemia Infected Skin Ulcer Pharyngolaryngeal Pain Pleural Effusion Proteus Infection Renal Failure Weight Decreased Folic Acid, Calcium Phosphate (Folacin) Vitamin E Paracetamol (Alvedon) Prednisone Morfin Cisapride (Prepulsid) Cetirizine (Zyrlex) Lansoprazole (Lanzo) Zolpidem Tartrate (Stilnoct) Loperamide Colecalciferol, Calcium Carbonate (Calcichew D3) Ipratropium Bromide, Salbutamol Sulfate (Combivent) Spironolactone SS 25 G/DAY PO 22-Aug-2005 Page: 517 10:40 AM C C C C C C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/01ISR Number: 3714040-9Report Type:Periodic Age:68 YR Gender:Male I/FU:I Outcome Dose Company Report #2001-BP-00558 PT Report Source Product Role Manufacturer Route Dizziness Fatigue Consumer Flomax PS Boehringer Ingelheim Pharmaceuticals Inc ORAL Duration 0.4 MG/1 CAPSULES/QD/P O Neurontin SS Aspirin C ORAL 600 MG/PO Date:04/12/01ISR Number: 3704357-6Report Type:Expedited (15-DaCompany Report #044-0945-M0100069 Age: Gender: I/FU:F Outcome Dose Death Other PT Report Source Product Role Manufacturer Post Procedural Complication Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Route Duration Date:04/13/01ISR Number: 3704672-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100410 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG PT Report Source Product Role Manufacturer Depression Mood Swings Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Zoloft (Sertraline) SS Uterine Leiomyoma (DAILY) 150 MG (DAILY); 200 MG (DAILY) Route Date:04/13/01ISR Number: 3704705-7Report Type:Expedited (15-DaCompany Report #044-0945-M0100130 Age: Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Optic Neuritis Foreign Other Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration PER ORAL Dosulepin Paracetamol Diclofenac Sodium C C C Date:04/13/01ISR Number: 3704707-0Report Type:Expedited (15-DaCompany Report #044-0945-M0100131 Age: Gender:Male I/FU:I Outcome Dose Disability 22-Aug-2005 Page: 518 PT Report Source Product Role Manufacturer Corneal Disorder Visual Field Defect Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Epanuon (Phenytoin) Prednisolone (Prednisolone) Cipramil (Citalopram Hydrobromide) SS Duration 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/01ISR Number: 3705117-2Report Type:Expedited (15-DaCompany Report #A107350 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 150.00 MG PT Report Source Product Role Manufacturer Depression Uterine Leiomyoma Consumer Zoloft PS Pfizer Pharmaceuticals Inc Gabapentin SS Route TOTAL:DAILY 600.00 MG TOTAL:DAILY Date:04/13/01ISR Number: 3705196-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100413 Age:37 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Grand Mal Convulsion Rib Fracture Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 1800 MG (TID), PER ORAL Date:04/13/01ISR Number: 3705203-7Report Type:Expedited (15-DaCompany Report #055-0945-M0100008 Age: Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization 800 MG Initial or Prolonged (DAILY) Other PT Report Source Product Role Manufacturer Cerebrovascular Accident Pneumonia Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Throat Cancer Date:04/13/01ISR Number: 3705245-1Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other Company Report #HQ3421409NOV2000 PT Report Source Product Role Manufacturer Convulsion Visual Disturbance Health Professional Diamox PS Lederle Laboratories Div American Cyanamid Co Depakote (Valproate Semisodium) Neurontin (Gabapentin) Imitrex (Sumatriptan Succinate) Loratadine (Loratadine) Fluticansoe Propionate (Fluticasone Propionate) Montelukast (Montelukast) Date:04/18/01ISR Number: 3706466-4Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 519 10:40 AM PT Suicide Attempt Route SS SS C C C C Company Report # Report Source Product Role Ativan Clonopine Prozac Trazodone PS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid Gabapentin "Silver Bullet" Otc SS SS SS Date:04/19/01ISR Number: 3708150-XReport Type:Expedited (15-DaCompany Report #001-0945-M0100442 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Bleeding Time Prolonged Ecchymosis Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration SEE IMAGE Epistaxis Platelet Adhesiveness Abnormal Date:04/19/01ISR Number: 3708319-4Report Type:Expedited (15-DaCompany Report #061-0945-M0100019 Age:48 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Dementia Hospitalization Pneumonitis Initial or Prolonged INTRAVENOUS INTRAVENOUS Report Source Product Role Manufacturer Foreign Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Voriconazole SS Ambisome (Amphotericine B, Liposome) Effexor (Fenlafaxine Hydrochloride) SS SS Date:04/19/01ISR Number: 3708320-0Report Type:Expedited (15-DaCompany Report #044-0945-M0100084 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Aggression Depression Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Paranoia Professional Non-Opiate Pain Killers C Duration 400 MG PER Route Date:04/20/01ISR Number: 3708654-XReport Type:Expedited (15-DaCompany Report #044-0945-M0100136 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Hypoglycaemia Foreign Other Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 2.4 GM, PER ORAL (Morphine Sulfate) C Date:04/20/01ISR Number: 3708658-7Report Type:Expedited (15-DaCompany Report #033-0945-M0100052 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG (BID), PT Report Source Product Role Manufacturer Route Bradycardia Haematemesis Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Hypotension Other PER ORAL Melaena Ulcer 22-Aug-2005 Page: 520 10:40 AM Feldene (Piroxicam) Aspegic (Acetylsalicylate Lysine) C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lioresal (Baclofen) Sotalex (Sotalol Hydrochloride) Chronadalate (Nifedipine) C C C Date:04/20/01ISR Number: 3708885-9Report Type:Expedited (15-DaCompany Report #044-0945-M0100070 Age:89 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Other 600 MG, PER PT Report Source Product Role Manufacturer Route Neutropenia Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Professional ORAL Frumil (Furosemide Amiloride) Bumetanide (Bumetanide) Lansoprazole (Lansoprazole) Warfarin (Warfarin) C C C C Date:04/20/01ISR Number: 3708895-1Report Type:Expedited (15-DaCompany Report #200110296BFR Age:81 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100 MG DAILY Initial or Prolonged YR PT Report Source Product Role Manufacturer Chorea Foreign Precose PS Bayer Corp Difficulty In Walking Other Ikorel SS Sectral SS Furosemide SS Vastarel "Biopharma" SS Neurontin Amlor Kardegic Nitriderm Tts SS C C C Dysphagia YR YR YR Biopharma Temesta C Date:04/24/01ISR Number: 3710542-XReport Type:Expedited (15-DaCompany Report #NSADSS2001011239 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required SEE IMAGE Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Colectomy Total Colitis Ulcerative Dehydration Health Professional Risperdal Celexa (Citalopram Hydrobromide) PS Janssen Research Fdn Haematocrit Decreased Haemoglobin Decreased Laboratory Test Abnormal Sinusitis Vomiting Neurontin (Gabapentin) SS Route ORAL SS Date:04/24/01ISR Number: 3710807-1Report Type:Expedited (15-DaCompany Report #PHBS2001NO03843 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Complications Of Maternal Initial or Prolonged Exposure To Therapeutic TRANSPLACENTAL TRANSPLACENTA Drugs L Exomphalos 22-Aug-2005 Page: 521 10:40 AM Report Source Product Role Manufacturer Foreign Health Tegretol PS Novartis Pharmaceuticals Corp Professional Other Neurontin Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Gabapentin) TRANSPLACENTAL SS TRANSPLACENTA L Date:04/25/01ISR Number: 3710837-XReport Type:Direct Age:70 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Sedation Product Role Gabapentin PS Manufacturer Route Date:04/26/01ISR Number: 3711898-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100479 Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG DAILY Other PER ORAL; PT Report Source Product Role Manufacturer Route Suicidal Ideation Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route 2400 MG DAILY PER ORAL Ibuprofen (Ibuprofen) Lorazepam (Lorazepam) Acetylsalicylic Acid (Acetylsalicylic Acid) C C C Date:04/26/01ISR Number: 3711901-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100486 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Colitis Ulcerative Health Neurontin PS Parke Davis Initial or Prolonged UNKNOWN Other Required DAILY PER Intervention to ORAL Prevent Permanent Impairment/Damage UNKNOWN Dehydration Professional Diarrhoea Haemorrhagic Haematocrit Decreased Pharmaceuticals Ltd Celexa (Citalopram Hydrobromide) SS Pain Rectal Haemorrhage Risperdal (Risperidone) SS Vomiting Asacol (Mesalazine) SS Prednisone (Prednisone) SS Solu-Medrol (Methylprednisolone Sodium Succinate) SS Cyclosporine SS ORAL Haemoglobin Decreased UNKNOWN UNKNOWN UNKNOWN UNKNOWN Date:04/26/01ISR Number: 3712600-2Report Type:Periodic Age:56 YR Gender:Male I/FU:I Outcome Dose Other Company Report #A105423 PT Report Source Product Role Manufacturer Route Back Pain Drug Ineffective Consumer Viagra PS Pfizer Agricultural Div ORAL Duration 50 MG TOTAL Pain PRN ORAL Sedation Neurontin SS Baby Aspirin Vitamin E C C 600.00 MG TOTAL, BID, ORAL 22-Aug-2005 Page: 522 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Folic Acid One A Day Date:04/27/01ISR Number: 3715572-XReport Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #001-0945-M0000251 PT Report Source Product Role Manufacturer Route Dysgeusia Glossodynia Consumer Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL Duration 1200 MG (BID), PER ORAL Toprol (Metoprolol Sucinate) Date:04/27/01ISR Number: 3715573-1Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Other C Company Report #001-0945-M0100403 PT Report Source Product Role Manufacturer Route Hyperacusis Consumer Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL Route Duration 600 MG (BID), PER ORAL Temazepam Date:04/27/01ISR Number: 3715574-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C Company Report #001-0945-M0100203 PT Report Source Product Role Manufacturer Nausea Consumer Neurontin PS Parke Davis Pharmaceutical Duration Research Div Warner Lambert Co ORAL 1200 MG (600 MG, BID), PER ORAL Date:04/27/01ISR Number: 3715576-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #001-0945-M0100178 PT Report Source Product Role Manufacturer Route Drug Withdrawal Syndrome Intentional Misuse Consumer Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL Route Duration 7000 MG (DAILY), PER ORAL Date:04/27/01ISR Number: 3715577-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other 22-Aug-2005 Page: 523 PT Company Report #001-0945-M0100113 Report Source Product Role Manufacturer Neurontin PS Parke Davis Pharmaceutical Research Div Warner Duration Herpes Zoster 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lambert Co Date:04/30/01ISR Number: 3714079-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100487 Age:34 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 9000 MG PT Report Source Product Role Manufacturer Balance Disorder Blood Pressure Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Valium (Diazepam) Extra Strength Tylenol Pm SS Depression Dysphagia Nausea SS Route ORAL 25-30 (HS) , Overdose PER ORAL Renal Failure Suicidal Ideation Tremor Unspecified Antidepressants C Date:04/30/01ISR Number: 3714180-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100502 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (300 PT Report Source Product Role Manufacturer Route Asthenia Blood Potassium Decreased Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Blood Sodium Decreased MG,BID) PER Convulsion ORAL Dizziness Muscle Spasms Neurontin (Gabapentin) SS 600 MG (300 Weight Increased MG, BID) PER ORAL Depakote (Valproate Semisodium) Mysoline (Primidone) Klonopine(Klonazepam ) C C C ORAL Date:04/30/01ISR Number: 3714350-5Report Type:Expedited (15-DaCompany Report #039-0945-M0100003 Age:83 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization UNKNOWN, PER Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Bradycardia Cardiac Pacemaker Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Insertion Professional Date:04/30/01ISR Number: 3714402-XReport Type:Expedited (15-DaCompany Report #HQ0164626APR2001 Age:37 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Hypotension Hypothermia Health Professional Other Artane PS Lederle Laboratories Div American Cyanamid Co ORAL 5 MG 1XPER 1 DAY ORAL Depakine (Valproate Sodium) SS ORAL Haldol (Haloperidol) SS ORAL Neurontin (Gabapantin) SS ORAL 1000 MG 1X PER 1 DAY ORAL 1 MG 1XPER 1 DAY ORAL 1600 MG 1 X 22-Aug-2005 Page: 524 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PER 1 DAY ORAL Tranxene (Clorazepate Dipotassium) SS ORAL ORAL Date:05/01/01ISR Number: 3714483-3Report Type:Direct Age:86 YR Gender:Female I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Gabapentin PS Manufacturer Route Route Duration Dizziness Date:05/01/01ISR Number: 3714688-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100134 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Nephritis Interstitial Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Unspecified Antibiotic C Duration Date:05/01/01ISR Number: 3714695-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000724 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 50 MG Other (DAILY), UNKNOWN PT Report Source Product Role Manufacturer Tooth Discolouration Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Route Date:05/01/01ISR Number: 3714705-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100112 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (300 PT Report Source Product Role Manufacturer Route Drug Ineffective Dysphemia Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Hypoxia MG, TID), PER Mental Impairment ORAL Lasix (Furosemide) Seroquel (Quentiapine) Depakote (Valproate Semisodium) Colace (Docusate Sodium) Protonix (Pantoprazole) K-Dur (Potasium Chloride) Ferrous Sulfate (Ferrous Sulfate) Thorazine (Chlorpromazine Hydrochloride) Prozac (Fluoxetine Hydrochloride) Cogentin (Benzatropine 22-Aug-2005 Page: 525 10:40 AM C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate0 Oxygen (Oxygen) C C Date:05/01/01ISR Number: 3715162-9Report Type:Expedited (15-DaCompany Report #047-0945-M0100003 Age: Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Manufacturer Complications Of Maternal Exposure To Therapeutic Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd Drugs Umbilical Hernia Professional Other Tegretol (Carbamazepine) SS Route PLACENTAL PLACENTAL Date:05/01/01ISR Number: 3722785-XReport Type:Periodic Age:51 YR Gender:Male I/FU:I Outcome Dose Company Report #2001049457US PT Report Source Product Role Manufacturer Route Weight Increased Consumer Celebrex PS Gd Searle And Co ORAL Clonazepam SS ORAL Desipramine SS ORAL Seroquel SS ORAL Zoloft SS ORAL Neurontin SS ORAL Lipitor(Atorvastatin ) C Duration ORAL ORAL ORAL ORAL 200MG. QD. ORAL ORAL Date:05/03/01ISR Number: 3716959-1Report Type:Expedited (15-DaCompany Report #055-0945-M0100012 Age:52 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other Cerebrovascular Accident Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL 400 MG (DAILY), PER ORAL Date:05/03/01ISR Number: 3716974-8Report Type:Expedited (15-DaCompany Report #055-0945-M0100013 Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG PT Report Source Product Role Manufacturer Route Blood Pressure Increased Cough Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Dyspnoea (DAILY), PER ORAL (Insulin) C Date:05/03/01ISR Number: 3716980-3Report Type:Expedited (15-DaCompany Report #049-0945-M0100044 Age:75 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Angioneurotic Oedema Dyspnoea Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Renal Failure Other Duration 300 MG, PER ORAL Stevens-Johnson Syndrome 22-Aug-2005 Page: 526 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/01ISR Number: 3717418-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100522 Age:37 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Priapism Literature Health Neurontin PS Parke Davis Pharmaceuticals Ltd Risperidone (Risperidone) SS Olanzapine (Olanzapine) SS Fluvoxamine (Fluvoxamine) SS Oxazepam (Oxazepam) SS Route Duration 900 MG Professional (DAILY) 6 MG (DAILY) 7.5 MG (DAILY) 300 MG (DAILY) 25 MG (DAILY) Date:05/03/01ISR Number: 3717419-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100390 Age: Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization 900 MG Initial or Prolonged (TID);300 MG PT Report Source Product Role Manufacturer Cardiac Failure Congestive Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Condition Aggravated Disorientation (100 MG, TID) Fluid Retention Renal Failure Nitrostat (Glyceryl Trinitrate) Lasix (Furosemide) Toprol-Xl (Metoprolol Succinate) K-Dur (Potassium C C C Route Chloride) Allopurinol (Allopurinol) Bufferin (Acetylsalicylic Acid, Magnesium Carbonate, Aluminium Glycinate) Paxil (Paroxetine Hydrochloride) Zaroxolyn (Metolazone) Digoxin (Digoxin) C C C C C C Date:05/04/01ISR Number: 3717938-0Report Type:Expedited (15-DaCompany Report #002-0945-M0100056 Age:65 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Facial Palsy Headache Foreign Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration PER ORAL Date:05/04/01ISR Number: 3718208-7Report Type:Expedited (15-DaCompany Report #044-0945-M0100051 Age:84 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 527 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose PT Report Source Product Role Manufacturer Route Sepsis Urinary Tract Infection Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration 900 MG Professional (DAILY), PER Other ORAL Amitriptyline Co-Proxamol (Paracetamol, Dextropropoxyphene Hydrochloride) Frumil (Furosemide, Amiloride Hydrochloride) Asa (Acetylsalicylic Acid) Imdur (Isosorbide Mononitrate) Nicorandil Atenolol C C C C C C C Date:05/04/01ISR Number: 3718351-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100513 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Malaise Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Duration Date:05/04/01ISR Number: 3718352-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100514 Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG (TID) PT Report Source Product Role Manufacturer Route Cardiac Failure Congestive Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Other PER ORAL Dizziness Dysuria Fall Head Banging Malaise Memory Impairment Myocardial Infarction Renal Failure Syncope Urinary Incontinence Lasix (Furosemide) Thyroid (Thyroid) Premarin (Estrogens Conjugated) Allopurinol (Allopurinol) Flexeril (Cyclobenzaprine Hydrochloride) Prilosec (Omeprazole) Potassium (Potassium) Duragesic Patches Date:05/04/01ISR Number: 3718395-0Report Type:Expedited (15-DaCompany Report #001-0945-M0100197 Age:43 YR Gender:Male I/FU:F Outcome Other 22-Aug-2005 Page: 528 PT Anxiety Condition Aggravated Dizziness 10:40 AM C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Drug Dependence Drug Withdrawal Syndrome Medication Error Report Source Product Role Manufacturer Route Nausea Pain Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Route Duration SEE IMAGE Pruritus Prozac (Fluoxetine Hydrochloride) C Date:05/04/01ISR Number: 3718677-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100228 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to 900 MG, (300 Prevent Permanent MG, TID) Impairment/Damage PT Report Source Product Role Manufacturer Coordination Abnormal Difficulty In Walking Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Celebrex (Celecoxib) Vitamin C (Ascorbin Acid) C Muscular Weakness C Date:05/07/01ISR Number: 3719036-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100525 Age: Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Manufacturer Cleft Palate Complications Of Maternal Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd Tegretol (Carbamazepine) SS 1600 MG, Exposure To Therapeutic PLACENTAL Drugs 1600 MG PLACENTAL; 1500 MG, PLACENTAL Route Synthroid (Levothyroxine Sodium) C Date:05/08/01ISR Number: 3719663-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100059 Age:93 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 Other MG, TID) PER PT Report Source Product Role Manufacturer Route Abnormal Behaviour Apnoea Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Chronic Obstructive Pulmonary Disease ORAL Confusional State Drug Effect Decreased Dyspnoea Feeling Hot And Cold Gastrointestinal Disorder Myocardial Infarction Refusal Of Treatment By Patient 22-Aug-2005 Page: 529 10:40 AM Fosamax (Alendronate Sodium) Lotrel (Amlodipine Besylate, Benazepril Hydrochloride) Norvasc (Amlodipine Besilate) Syntrhoid (Levothyroxine Sodium) Oxygen (Oxygen) Beta Blocker Eye Drops Unspecified Eye Drops SS C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/01ISR Number: 3719822-5Report Type:Expedited (15-DaCompany Report #046-0945-M0100018 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG, PER PT Report Source Product Role Manufacturer Route Cardiomegaly Chest Pain Foreign Other Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Ear Pain ORAL Fatigue Headache Hypervolaemia Liver Function Test Abnormal Pharyngolaryngeal Pain Pleural Effusion Proteus Infection Renal Impairment Sedation Skin Ulcer Urinary Tract Infection Wound Infection Furix (Furosemide) Arava (Leflunomide) Vioxx (Rofecoxib) Folacin (Folic Acid, Calcium Phosphate) E-Vimin (Tocopheryl Acetate) Alvedon (Paracetamol) Prednisolon (Prednisolone) Morfin (Morphine) Prepulsid (Cisapride) Zyrlex (Cetirizine) Dolcontin (Morphine Sulfate) Lanzo (Lansoprazole) Stilnoct (Zolpidem Tartrate) Loperamid (Loperamide) Calcichew-D3 (Colecalciferol, Calcium Carbonate) Combivent (Ipratropium Bromide, Salbutamol Sulfate) Spironolactone Date:05/08/01ISR Number: 3720629-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100261 Age:68 YR Gender:Male I/FU:F C C C C C C C C C C C C C C C C C Outcome Dose Other PT Report Source Product Role Manufacturer Route Aspartate Aminotransferase Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration 3200 MG Increased (DAILY), PER Blood Alkaline ORAL Phosphatase Increased Vicodin (Paracetamol, Hydrocodone Bitartrate) (Unspecified Pain Pills) (Fluorouracil) Date:05/09/01ISR Number: 3720379-3Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other C C Company Report #PHEH2000US03955 PT Report Source Product Role Manufacturer Route Convulsion Drug Interaction Health Professional Tegretol PS Novartis Pharmaceuticals Corp ORAL Duration QD, ORAL 22-Aug-2005 Page: 530 C 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin (Gabapentin) Capsule, 400 Mg. SS ORAL Celebrex (Celecoxib) Capsule SS ORAL 400 MG, TID, ORAL QD, ORAL Date:05/10/01ISR Number: 3720729-8Report Type:Expedited (15-DaCompany Report #001-0945-M0001145 Age:16 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 12000 MG Other (3000 MG, PT Report Source Product Role Manufacturer Route Clonic Convulsion Drug Level Above Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Therapeutic Respiratory Distress QID), PER Status Epilepticus ORAL Neurontin (Gabapentin) SS Clonazepam SS Clonazepam SS Valproic Acid SS 1200 MG (400 MG, TID) 1 MG (0.5 MG, BID) .5 MG (0.25 MG, BID) 3500 MG (EVERY 6 HOURS), PER ORAL ORAL Date:05/10/01ISR Number: 3721425-3Report Type:Expedited (15-DaCompany Report #047-0945-M0000004 Age:32 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 2400 MG Disability (DAILY), PER Other ORAL PT Report Source Product Role Manufacturer Route Blindness Optic Neuritis Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Professional Rivotril (Clonazepam0 Several Unspecified Medications C C Date:05/10/01ISR Number: 3721458-7Report Type:Expedited (15-DaCompany Report #033-0945-M0100061 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE Other PT Report Source Product Role Manufacturer Route Alopecia Haematoma Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Haemorrhage Intracranial Professional Zocor (Simvastatin) Route C Date:05/10/01ISR Number: 3721512-XReport Type:Expedited (15-DaCompany Report #044-0945-M0000083 Age:6 YR Gender:Female I/FU:F Outcome Dose Death 22-Aug-2005 Page: 531 PT Report Source Product Role Manufacturer Brain Neoplasm Malignant Rhinorrhoea Sarcoma Foreign Health Professional Neurontin Carbamazepine PS C Pfizer Inc Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/01ISR Number: 3721888-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100542 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Abdominal Distension Anaemia Dyspnoea Eructation Consumer Neurontin PS Parke Davis Pharmaceutical Research Div Warner Lambert Co ORAL 600 MG Flatulence (DAILY), PER Gastritis ORAL Pleural Effusion Weight Increased Lopressor (Metoprolol Tartrate) Norvasc (Amlodipine Besilate) Glucotrol (Glipizide) Asa (Acetylsalicylic Acid) Iron Lipitor (Atorvastatin) Prevacid (Lansoprazole) C C C C C C C Date:05/11/01ISR Number: 3722533-3Report Type:Expedited (15-DaCompany Report #002-0945-M0100037 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Other PER ORAL (SEE PT Report Source Product Role Manufacturer Route Balance Disorder Foreign Neurontin PS Pfizer Inc ORAL Blood Pressure Decreased Health Condition Aggravated Dysarthria Hypotonia Lower Respiratory Tract Infection Prostration Renal Impairment Professional (Clozapine) (Haloperidol) (Lithium) (Procyclidine) C C C C IMAGE) Sedation Date:05/14/01ISR Number: 3723775-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100247 Age:63 YR Gender:Female I/FU:I Outcome Dose Disability UNKNOWN PT Report Source Product Role Manufacturer Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd Multivitamins Naproxen B-Complex C C C Duration Dry Mouth Feeling Abnormal 900 MG (300 Movement Disorder MG, TID), Muscle Twitching UNKNOWN Sensory Loss Vision Blurred Date:05/14/01ISR Number: 3723808-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100554 Age:36 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 532 10:40 AM PT Blood Pressure Increased Body Temperature Increased Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Pain Dizziness Dysphagia Dose Report Source Product Role Manufacturer Route Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Duration Dysphemia Headache 2700 MG Pneumonia (DAILY), PER Skin Test Positive ORAL Tuberculosis Vision Blurred Neurontin (Gabapentin) SS 1800 MG DAILY Humalog (Insulin Lispro) Pancrease (Pancrelipase) Lorcet (Paracetamol, Hydrocodone Bitartrate) Valium (Diazepam) Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acide, Thiamine Hydrochloride, Vitamin E (Tocopherol) C C C C C C Date:05/14/01ISR Number: 3723817-5Report Type:Expedited (15-DaCompany Report #001-0945-M0100553 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Weight Increased Consumer Neurontin PS Pfizer Inc ORAL Depakote (Valporate Semisodium) Eskalith (Lithium) C C Date:05/14/01ISR Number: 3724116-8Report Type:Expedited (15-DaCompany Report #049-0945-M0100046 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged PT Report Source Product Role Blood Creatinine Foreign Neurontin PS Increased Blood Urea Increased Glomerular Filtration Rate Decreased Renal Transplant Health Professional Manufacturer Route ORAL Date:05/15/01ISR Number: 3723559-6Report Type:Expedited (15-DaCompany Report #061-0945-M0100019 Age:48 YR Gender:Male I/FU:F Outcome PT Dose Duration Life-Threatening Aspergilloma Hospitalization Dementia INTRAVENOUS "SEE IMAGE" Initial or Prolonged Hypoxia Nervous System Disorder Pneumonitis 22-Aug-2005 Page: 533 10:40 AM Report Source Product Role Manufacturer Foreign Consumer Neurontin Voriconazole PS SS Pfizer Inc Health Professional Ambisome (Amphotericine B, Liposome) Effexor (Venlafaxine Hydrochloride) Meropenem (Meropenem) SS SS C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ciprofloxacin (Ciprofloxacin) Zantac (Ranitidine Hydrochloride) Fluoxetine (Fluoxetine) Fentanyl (Fentanyl) Amitriptyline (Amitriptyline) Paracetamol (Paracetamol) Amikacin (Amikacin) Clindamycin (Clindamycin) Ceftazidime (Ceftazidime) Fusidic Acid (Fusidic Acid) C C C C C C C C C C Date:05/15/01ISR Number: 3723561-4Report Type:Expedited (15-DaCompany Report #002-0945-M0100044 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization 1100 MG Initial or Prolonged (TWICE PT Report Source Product Role Manufacturer Route Dizziness Foreign Neurontin PS Pfizer Inc ORAL Mood Altered Health Professional DAILY) , PER ORAL Date:05/15/01ISR Number: 3723567-5Report Type:Expedited (15-DaCompany Report #064-0945-M0100001 Age: Gender:Unknown I/FU:I Outcome Dose Duration Death PER ORAL Life-Threatening PT Report Source Product Role Manufacturer Route Myocardial Infarction Foreign Neurontin PS Pfizer Inc ORAL Neutropenia Pulmonary Embolism Health Professional Date:05/16/01ISR Number: 3724143-0Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT PT Product Role Ativan Clonopin Prozac Trazodone Synthroid Gabapentin "Silver Bullet" Otc PS SS SS SS SS SS SS Manufacturer Route Route Company Report #USP 54047 Report Source Product Role Manufacturer Neurontin PS Pfizer Duration Medication Error 22-Aug-2005 Page: 534 Report Source Suicide Attempt Date:05/17/01ISR Number: 3724359-3Report Type:Direct Age: Gender: I/FU:I Outcome Dose Company Report # 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/01ISR Number: 3724466-5Report Type:Direct Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Company Report # Report Source Adenocarcinoma Pancreatic Carcinoma Date:05/18/01ISR Number: 3724768-2Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 1650 MG PO X Hospitalization 1 Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Product Role Neurontin 400 Mgm. Q 8 Hr. PS Manufacturer Route Manufacturer Route Company Report # Report Source Confusional State Product Role Amitriptylline PS Bumetanide Loratidine Pseudoephedrine Clorazepam Temazepan Daypro Doxycycline Gabapentin C C C C C C C I ORAL Hallucination Overdose Pupillary Reflex Impaired Date:05/18/01ISR Number: 3725878-6Report Type:Expedited (15-DaCompany Report #049-0945-M0100033 Age: Gender:Female I/FU:I Outcome Dose Other 2700 MG PT Report Source Product Role Manufacturer Route Dialysis Foreign Neurontin PS Pfizer Inc ORAL Muscle Spasms Health Muscle Twitching Professional Duragesic (Fentanyl) SS Sandimmune (Ciclosporin) SS Duration (DAILY), PER ORAL Muscular Weakness TRANSDERMAL 75 Renal Failure Acute (TRANSDERMAL) Tremor Date:05/18/01ISR Number: 3725916-0Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Other Company Report #C2001-0126.01 PT Report Source Product Role Manufacturer Route Convulsion Health Professional Clozapine PS Mylan Pharmaceuticals Inc ORAL Duration 100MG Q AM, 100MG Q 4 PM, 250MG Q HS ORAL Neurontin Parke-Davis SS Parke-Davis ORAL Dilantin Parke-Davis SS Parke-Davis ORAL Celecoxib Levothyroxine Lorazepam Zolpidem C C C C 300MG Q AM, 800MG Q HS, ORAL 200MG Q AM, 200MG Q PM, ORAL 22-Aug-2005 Page: 535 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/01ISR Number: 3726255-4Report Type:Expedited (15-DaCompany Report #044-0945-M0100141 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 3000 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Manufacturer Route Pyelonephritis Chronic Foreign Neurontin PS Pfizer Inc ORAL (Ketamine) (Tramadol) (Morphine) (Trimethoprim) (Amitriptyline) Losec (Omeprazole) C C C C C C Consumer Other ORAL Date:05/21/01ISR Number: 3726922-2Report Type:Expedited (15-DaCompany Report #055-0945-M0100017 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 400 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Manufacturer Route Thrombosis Foreign Neurontin PS Pfizer Inc ORAL Unspecified Medications C Consumer ORAL Date:05/21/01ISR Number: 3726923-4Report Type:Expedited (15-DaCompany Report #032-0945-M0100002 Age:49 YR Gender:Female I/FU:I Outcome Dose Death 300 MG PT Report Source Product Role Manufacturer Route Petechiae Foreign Neurontin PS Pfizer Inc ORAL Duration Health (DAILY), PER Professional ORAL Date:05/22/01ISR Number: 3727194-5Report Type:Expedited (15-DaCompany Report #001-0981-M0103661 Age:47 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 10 MG (BID), Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Route Unevaluable Event Health Lipitor PS Pfizer Inc ORAL (Gabapentin) SS ORAL (Geodon) SS ORAL (Acetylsalicylic Acid) SS ORAL (Chlorpromazine) SS ORAL (Clonazepam) SS ORAL (Lorazepam) SS ORAL Professional 1200 MG (EVERY AM)'600 MG (EVERY NOON); 1200 MG 40 MG (DAILY);4O MG (BID);40 MG (DAILY); 20 MG (DAILY), 325 MG (DAILY), PER ORAL 100 MG (EVERY 4 HOURS PRN), PER ORAL 2 MG (AT BEDTIME), PER ORAL 2 MG (EVERY 6 22-Aug-2005 Page: 536 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report HOURS); 2 MG (EVERY 4 HR PRN), PER ORAL (Mesoridazine) SS ORAL (Mirtazapine) SS ORAL 50 MG (DAILY);75 MG (BID);75 MG (TID); 50 MG (EVERY 4 15 MG (AT BEDTIME), PER ORAL Date:05/22/01ISR Number: 3727203-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100590 Age:69 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 900 MG (300 Initial or Prolonged MG, TID), PT Report Source Product Role Manufacturer Anxiety Literature Neurontin PS Pfizer Inc Bronchospasm Health Chronic Obstructive Professional UNKNOWN Airways Disease Exacerbated Hypercapnia Hypoventilation Insomnia Respiratory Distress Respiratory Failure Respiratory Rate Increased Albuterol (Salbutamol) Ipratropium Bromide (Ipratropium Bromide) Clonazepam (Clonazepam) Zolpidem (Zolpidem) C C C C Route Date:05/22/01ISR Number: 3727204-5Report Type:Expedited (15-DaCompany Report #001-0981-M0103676 Age: Gender:Female I/FU:I Outcome Dose Duration Other 20 MG Required (DAILY) , Intervention to PER ORAL Prevent Permanent 900 TO Impairment/Damage 1200MG PT Report Source Product Role Manufacturer Route Amnesia Consumer Lipitor PS Pfizer Inc ORAL Neurotin SS ORAL Celebrex SS ORAL (Fentanyl) C Arthralgia Carpal Tunnel Syndrome Condition Aggravated Disorientation Feeling Abnormal (UNKNOWN), Mental Impairment PER ORAL Neck Pain UNKNOWN Oedema Peripheral (UNKNOWN) , Pain PER ORAL Date:05/23/01ISR Number: 3727887-XReport Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Mania Medication Error Consumer Health Geodon PS Pfizer Central Research ORAL Schizophrenia Professional Seroquel SS Neurontin (Gabapentin) SS Beer SS ORAL 300.00 MG TOTAL DAILY ORAL 3600.00 MG TOTAL TID ORAL ORAL 22-Aug-2005 Page: 537 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote Clonazepam C C Date:05/23/01ISR Number: 3728004-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100587 Age: Gender:Male I/FU:I Outcome Dose Other UNKNOWN PT Report Source Product Role Manufacturer Coma Health Neurontin PS Pfizer Inc Professional Phenytoin Suspension (Phenytoin Sodium) SS Route Duration UNKNOWN Date:05/24/01ISR Number: 3728409-XReport Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage 600MG BID PT Company Report # Report Source Sedation Speech Disorder Product Role Neurontin / 300mg Capsule / Park Davis, Lot No 16131va, PS Manufacturer Route ORAL ORAL Date:05/24/01ISR Number: 3728888-8Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to 600MG BID Prevent Permanent ORAL Impairment/Damage PT Depressed Level Of Consciousness Speech Disorder Company Report # Report Source Product Role Manufacturer Route Neurontin 300mg Capsule Park Davis PS Park Davis ORAL Date:05/25/01ISR Number: 3728942-0Report Type:Expedited (15-DaCompany Report #HQ7038409FEB2001 Age:31 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Convulsion Health Professional Ativan PS Wyeth Ayerst Laboratories ORAL Duration 0.5 MG AS NEEDED, ORAL Dilantin (Phenytoin Sodium) SS Neurontin (Gabapentin) SS DOSE UNKNOWN DOSE UNKNOWN Date:05/25/01ISR Number: 3729286-3Report Type:Expedited (15-DaCompany Report #061-0945-M0100019 Age:48 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening PER ORAL Hospitalization INTRAVENOUS 700 MG Initial or Prolonged INTRAVENOUS INTRAVENOUS PT Report Source Product Role Manufacturer Route Dementia Foreign Neurontin PS Pfizer Inc ORAL Liver Function Test (BID), Abnormal Consumer Voriconazole SS Pneumonitis Professional Ambisome (Amphotericine B, Liposome) SS Effexor (Venlafaxine Hydrochloride) SS Meropenem (Meropenem) C Health INTRAVENOUS PER ORAL 22-Aug-2005 Page: 538 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ciprofloxacin (Ciprofloxacin) Zantac (Ranitidine Hydrochloride) Fluoxetine (Fluoxetine) Fentanyl (Fentanyl) Amitriptyline (Amitriptyline) Paracetamol (Paracetamol) Amikacin (Amikacin) Clindamycin (Clindamycin) Ceftazidime (Ceftazidime) Fusidic Acid (Fusidic Acid) C C C C C C C C C C Date:05/25/01ISR Number: 3730605-2Report Type:Expedited (15-DaCompany Report #033-0945-M0100068 Age: Gender:Male I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Bone Density Decreased Osteonecrosis Foreign Consumer Other Neurontin Didanosine (Didanosine) PS Pfizer Inc Route Duration SS ORAL SS ORAL PER ORAL Efavirenz (Efavirenz) PER ORAL Abacavir (Abacavir) Bactrim (Sulfamethoxazole, Trimethoprim) SS SS ORAL PER ORAL Date:05/25/01ISR Number: 3730608-8Report Type:Expedited (15-DaCompany Report #055-0945-M0100011 Age: Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization 900 MG Initial or Prolonged (UNKNOWN), Other PER ORAL Oedema Peripheral Foreign Refusal Of Treatment By Consumer Neurontin PS Pfizer Inc ORAL Product Role Manufacturer Route Klonopin Tablets Neurontin Risperdal Cogentin Lopressor Heparin Inderal Pepcid Asa PS SS SS SS C C C C C Roche Patient Date:05/29/01ISR Number: 3729001-3Report Type:Expedited (15-DaCompany Report #260859 Age:64 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 539 10:40 AM PT Dysphagia Report Source FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3729952-XReport Type:Expedited (15-DaCompany Report #001-0945-M0100502 Age:47 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 600 MG (200 Initial or Prolonged MG, BID) PER PT Report Source Product Role Manufacturer Route Asthenia Health Neurontin PS Pfizer Inc ORAL Blood Potassium Decreased Professional Blood Sodium Decreased ORAL Convulsion Dizziness Muscle Spasms Peripheral Nerve Injury Weight Increased Depakote (Valproate Semisodium) Mysoline (Primidone) Klonopin (Clonazepam) C C C Date:05/29/01ISR Number: 3730228-5Report Type:Expedited (15-DaCompany Report #044-0945-M0100144 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG Initial or Prolonged (UNKNOWN) , PT Report Source Product Role Manufacturer Route Gastrointestinal Foreign Neurontin PS Pfizer Inc ORAL Obstruction Consumer Manufacturer Route Other PER ORAL Loperamide (Loperamide) Prednisolone (Prednisolone) Codeine Phosphate (Codeine Phosphate) Ranitidine (Ranitidine) C C C C Date:05/29/01ISR Number: 3730390-4Report Type:Expedited (15-DaCompany Report #055-0945-M0100013 Age:62 YR Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Hospitalization 800 MG Initial or Prolonged (DAILY), PER Blood Pressure Increased Foreign Cough Consumer Neurontin PS (Insulin) C Pfizer Inc ORAL Route Dyspnoea ORAL Date:05/29/01ISR Number: 3730810-5Report Type:Expedited (15-DaCompany Report #10838803 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRAVENOUS PT Report Source Product Role Manufacturer Agranulocytosis Leukopenia Foreign Health Professional Other Zerit PS Bristol Myers Squibb Co Pharmaceutical Research Institute Fungizone (Amphotericin B) SS Ancotil (Flucytosine) SS Fluconazole SS Gabapentin SS 50 MILLIGRAM, IV INTRAVENOUS IV 200 MILLIGRAM, 2/1 DAY 300 MILLIGRAM Lamivudine + Zidovudine Metoclopramide (Metoclopramide Hcl) Paracetamol 22-Aug-2005 Page: 540 10:40 AM SS SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trimethoprim + Sulfamethaxazole (Trimethoprim + Sulfam Didanosine (Didanosine) Thiamin (Thiamine) Kalii Chloridum (Potassium Chloride) Magnesium (Magnesium) Clonazepam (Clonazepam) Paracetamol + Codeine (Paracetamol + Codeine) Filgrastim (Granulocyte Csf) Nelfinavir (Nelfinavir Mesylate) Guaifenesin (Guaifenesin) 3tc (Lamivudine) SS C C C C C C C C C C Date:05/29/01ISR Number: 3730814-2Report Type:Expedited (15-DaCompany Report #10842557 Age:39 YR Gender:Male I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Arthralgia Bone Density Decreased Hip Deformity Foreign Health Professional Videx PS Bristol Myers Squibb Co Pharmaceutical Research Institute ORAL Hypertriglyceridaemia Lipodystrophy Acquired Osteonecrosis Other Zerit (Stavudine) Neurontin (Gabapentin) Ziagen (Abacavir) Bactrim Forte (Trimethoprim+Sulfam ethoxazole) Sustiva (Efavirenz) Lipur (Gemfibrozil) Lipur Duration ORAL SS SS SS SS SS C C Date:05/30/01ISR Number: 3730844-0Report Type:Expedited (15-DaCompany Report #001-0945-M0100355 Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Disability 2100 PER ORAL Other 22-Aug-2005 Page: 541 10:40 AM PT Report Source Product Role Manufacturer Route Asthenia Neurontin PS Pfizer Inc ORAL Coordination Abnormal Hyporeflexia Wellbutrin (Amfebutamone Hydrochloride) Doxepin (Doxepin) Tegretol (Carbamazepine) Synthroid (Levothyroxine Sodium) Premarin (Estrogens Conjugated) C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/01ISR Number: 3730845-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100593 Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 2000 MG Initial or Prolonged (DAILY), PER Disability ORAL PT Report Source Product Role Manufacturer Route Asthenia Consumer Neurontin PS Pfizer Inc ORAL Route Difficulty In Walking Fall Serzone (Nefazodone Hydrochloride) Klonopin (Clonazepam) Prilosec (Omeprazole) Analgesics SS C C C Date:05/30/01ISR Number: 3730855-5Report Type:Expedited (15-DaCompany Report #033-0945-M0100075 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Cholecystitis Dyspnoea Fatigue Hepatic Trauma Hypersensitivity Oedema Foreign Health Professional Neurontin PS Pfizer Inc Duration Date:05/30/01ISR Number: 3730856-7Report Type:Expedited (15-DaCompany Report #033-0945-M0100076 Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 200 MG Initial or Prolonged (DAILY) PER Other ORAL PT Report Source Product Role Manufacturer Route Blood Alkaline Foreign Neurontin PS Pfizer Inc ORAL Phosphatase Increased Literature Confusional State Consumer Disorientation Mental Impairment Pyrexia Rash Maculo-Papular Rash Pruritic Date:05/30/01ISR Number: 3730859-2Report Type:Expedited (15-DaCompany Report #049-0945-M0100051 Age: Gender:Male I/FU:I Outcome Dose Other UNKNOWN PT Report Source Product Role Manufacturer Foreign Neurontin PS Pfizer Inc Route Duration Haemosiderosis UNK {UNK), Hepatic Cirrhosis Health UNK Hepatitis Professional Date:05/30/01ISR Number: 3730925-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100592 Age:75 YR Gender:Female I/FU:I Outcome Dose Other 300 MG PT Report Source Product Role Manufacturer Route Ecchymosis Consumer Neurontin PS Pfizer Inc ORAL Duration Fall (DAILY), PER Laceration ORAL Pyrexia Sedation Vision Blurred 22-Aug-2005 Page: 542 10:40 AM Deltasone (Prednisone) Glucotrol (Glipizide) C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Avapro (Irbesartan) Hydrochlorothiazide (Hydrochlorothiazide ) C C Date:05/31/01ISR Number: 3731374-2Report Type:Expedited (15-DaCompany Report #260859 Age:64 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 6 MG DAILY PT Report Source Product Role Manufacturer Route Dysphagia Hyporeflexia Health Professional Klonopin PS Hoffmann La Roche Inc ORAL ORAL Neurontin (Gabapentin) SS Risperdal (Risperidone) SS Cogentin (Benztropine Mesylate) SS 800 MG DAILY 4 MG DAILY 2 MG DAILY Lopressor (Metoprolol Tartrate) Heparin (Heparin Sodium) Inderal (Propranolol Hydrochloride) Pepcid (Famotidine) Asa (Aspirin) C C C C C Date:06/01/01ISR Number: 3731216-5Report Type:Expedited (15-DaCompany Report #WAES 01027276 Age:47 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 7 DAY Initial or Prolonged PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Vasotec PS Merck & Co., Inc ORAL Increased Vioxx SS ORAL 9 DAY 7 DAY 9 DAY 22-Aug-2005 Page: 543 10:40 AM Aspartate Aminotransferase Gabapentin Metronidazole SS SS ORAL ORAL Increased Furosemide SS ORAL Blood Alkaline Floxacillin Sodium SS ORAL Phosphatase Increased Blood Bilirubin Increased Blood Lactate Dehydrogenase Increased Cardiomegaly Culture Urine Positive Depressed Level Of Consciousness Electroencephalogram Abnormal Fatigue Gamma-Glutamyltransferase Increased Headache Infected Skin Ulcer Pharyngolaryngeal Pain Pleural Disorder Proteus Infection Renal Failure Leflunomide Spironolactone Folic Acid Cisapride [Therapy Unspecified] Albuterol Sulfate And Ipratropium Bromide Calcium Carbonate And Cholecalciferol Loperamide Zolpidem Tartrate Acetaminophen Vitamin E Cetirizine Hydrochloride Lansoprazole Morphine Prednisolone SS SS C C ORAL ORAL C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Morphine C Date:06/01/01ISR Number: 3731734-XReport Type:Expedited (15-DaCompany Report #B0108767A Age:39 YR Gender:Male I/FU:F Outcome Dose Disability 1UNIT Twice PT Report Source Product Role Manufacturer Route Ziagen PS Glaxo Wellcome ORAL Hypertriglyceridaemia Sustiva SS ORAL Lipodystrophy Acquired Neurontin SS ORAL Bactrim Forte SS Videx SS Combivir Duration Aseptic Necrosis Bone Bone Density Decreased per day 3UNIT per day 1UNIT Three times per day Glaxo Wellcome ORAL C Glaxo Wellcome ORAL Epivir Retrovir Crixivan C C C Glaxo Wellcome Glaxo Wellcome ORAL ORAL Invirase C Viracept C Zerit C Depakine Chrono C 1UNIT per day UNKNOWN 60 DAY UNKNOWN 738 DAY UNKNOWN 378 DAY UNKNOWN 378 DAY UNKNOWN 485 DAY UNKNOWN Date:06/01/01ISR Number: 3732111-8Report Type:Expedited (15-DaCompany Report #001-0945-M0000487 Age: Gender:Female I/FU:F Outcome Dose Duration Other BID, PER ORAL PT Report Source Product Role Manufacturer Route Ecchymosis Health Neurontin PS Pfizer Inc ORAL Gingival Bleeding Retinal Haemorrhage Professional Meclomen (Meclofen Amate Sodium) Premarin (Estrogens Conjugated) Claritin (Loratadine) Aleve (Naproxen Sodium) C C C C Date:06/01/01ISR Number: 3732129-5Report Type:Expedited (15-DaCompany Report #001-0945-M0100635 Age:24 YR Gender:Female I/FU:I Outcome Dose Other 600 MG PT Report Source Product Role Manufacturer Route Hepatic Steatosis Health Neurontin PS Pfizer Inc ORAL Hepatitis Professional Methergine (Methylergometrine Maleate) SS Skelaxin (Metaxalone) SS Prozac (Fluoxetine Hydrochloride) SS Duration (DAILY) PER Liver Function Test ORAL Abnormal UNKNOWN UNKNOWN UNKNOWN UNK, UNK UNK, UNK UNK, UNK Date:06/01/01ISR Number: 3732388-9Report Type:Expedited (15-DaCompany Report #044-0945-M0100153 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 544 10:40 AM PT Drug Ineffective Jaundice FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Acute Dose Report Source Product Role Manufacturer Route Foreign Neurontin PS Pfizer Inc ORAL Carbamazepine (Carbamazepine) C Route Duration 800 MG (BID) Health PER ORAL Professional Company Representative Date:06/01/01ISR Number: 3732618-3Report Type:Expedited (15-DaCompany Report #044-0945-M0100155 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Alopecia Foreign Health Professional Neurontin Cardiac Medications PS C Pfizer Inc Duration Date:06/04/01ISR Number: 3733093-5Report Type:Expedited (15-DaCompany Report #WAES 01027276 Age:47 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG PO 7 PT Report Source Product Role Manufacturer Route Blood Potassium Increased Cardiac Failure Congestive Foreign Company Representative Vasotec PS Merck Research Laboratories Div Merck Co Inc ORAL DAY Cardiomegaly Depressed Level Of Tab Vioxx (Rofecoxib) SS ORAL Consciousness Tab Metronidazole SS ORAL Electroencephalogram Tab Furosemide SS ORAL Abnormal Cap Gabapentin SS ORAL Fatigue Headache Tab Floxacillin Sodium SS ORAL 25 MG PO 800 MG PO 9 DAY 40 MG PO 7 DAY 2400 MG PO 2200 MG PO 9 DAY Hepatic Failure Tab Spironolactone SS ORAL Infected Skin Ulcer Tab Leflunomide SS ORAL Metabolic Disorder Pharyngolaryngeal Pain Proteus Infection Renal Failure Urinary Tract Infection (Therapy Unspecified) Zolpidem Tartrate Vitamin E Prednisolone Morphine Loperamide Acetaminophen Cetirizine Hydrochloride Cisapride Lansoprazole Folic Acid Albuterol Sulfate (+) Ipratropium Bromide Calcium Carbonate (+) Cholecalciferol 50 MG PO 20 MG PO C C C C C C C C C C C C C Date:06/04/01ISR Number: 3733305-8Report Type:Expedited (15-DaCompany Report #055-0945-M0100019 Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 400 MG, Initial or Prolonged (DAILY), PER 22-Aug-2005 Page: 545 10:40 AM PT Report Source Product Role Manufacturer Route Condition Aggravated Foreign Neurontin PS Pfizer Inc ORAL Varicose Vein Consumer FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Unspecified Antihypertensive Agent C Date:06/04/01ISR Number: 3733306-XReport Type:Expedited (15-DaCompany Report #055-0945-M0100016 Age: Gender:Male I/FU:I Outcome Dose Duration Other 800 MG (BID), PT Report Source Product Role Manufacturer Route Drug Toxicity Foreign Neurontin PS Pfizer Inc ORAL Photophobia Health Route PER ORAL Professional Date:06/04/01ISR Number: 3733495-7Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other Company Report #A107643 PT Report Source Product Role Manufacturer Dizziness Orthostatic Hypotension Health Professional Geodon PS Pfizer Central Research Neurontin Clonidine SS SS Duration 40.00 MG TOTAL:DAILY Date:06/04/01ISR Number: 3733772-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #A100681 PT Report Source Product Role Manufacturer Dizziness Thinking Abnormal Consumer Lithium Carbonate Gabapentin Divalproex PS SS SS Pfizer Inc Duration Route Date:06/05/01ISR Number: 3734189-4Report Type:Expedited (15-DaCompany Report #055-0945-M0100016 Age: Gender:Male I/FU:F Outcome Dose Duration Other 800 MG (BID), PT Report Source Product Role Manufacturer Route Photophobia Foreign Neurontin PS Pfizer Inc ORAL Health PER ORAL Professional Date:06/05/01ISR Number: 3735067-7Report Type:Expedited (15-DaCompany Report #B0108767A Age:39 YR Gender:Male I/FU:I Outcome Dose Disability 1 UNIT / PT Report Source Product Role Manufacturer Route Hypertriglyceridaemia Foreign Ziagen PS Glaxo Wellcome Inc ORAL Efavirenz (Efavirenz) SS ORAL Gabapentin (Gabapentin) SS ORAL Septra (Sulfamethoxazole/Tr imetho) SS ORAL Duration Lipodystrophy Acquired TWICE PER DAY Osteonecrosis / ORAL ORAL 1 UNIT / THREE TIMES PER DAY / ORAL ORAL Didanosine 22-Aug-2005 Page: 546 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Didanosine) Combivir Lamivudine Zidovudine Indinavir Sulfate Saquinavir Nelfinavir Mesylate Stavudine Depakine Chrono SS C C C C C C C C Date:06/05/01ISR Number: 3735322-0Report Type:Expedited (15-DaCompany Report #001-0945-M0100327 Age:68 YR Gender:Female I/FU:F Outcome Dose Duration Other 600 MG (BID), PT Report Source Product Role Manufacturer Route Diabetes Mellitus Consumer Neurontin PS Pfizer Inc ORAL Tenormin (Atenolol) Accupril (Quinapril Hydrochloride) Hydrocortisone (Hydrocortisone) Megace (Megestrol Acetate) Darvocet (Paracetamol, Dextropropoxyphene) Dalmane (Flurazepam Hydrochloride) C Non-Insulin-Dependent PER ORAL C C C C C Date:06/05/01ISR Number: 3735366-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100410 Age:47 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 1200 MG Initial or Prolonged (DAILY), PER Other ORAL PT Report Source Product Role Manufacturer Route Depression Consumer Neurontin PS Pfizer Inc ORAL Malabsorption Health Uterine Leiomyoma Professional Zoloft (Sertraline) SS Vicodin (Paracetamol, Hydrocodone Bitartrate) C 250 MG (DAILY) Date:06/05/01ISR Number: 3735548-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100645 Age: Gender:Female I/FU:I Outcome Dose Duration Other 2400 MG DAILY PT Report Source Product Role Manufacturer Route Gastroenteritis Consumer Neurontin PS Pfizer Inc ORAL Helicobacter PER ORAL ; Loss Of Libido 1200 MG DAILY Malaise PER ORAL Clonazepam (Clonazepam) Serzone (Nefazodone Hydrochloride) 22-Aug-2005 Page: 547 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3735579-6Report Type:Expedited (15-DaCompany Report #PHEH2001US04478 Age:24 YR Gender:Female I/FU:I Outcome Dose Other 2 2 2 2 2 PT Report Source Product Role Manufacturer Hepatic Steatosis Health Professional Methergine PS Novartis Pharmaceuticals Corp Pamelor (Nortriptyline Hydrochloride) SS Skelaxin (Metaxalone) SS Prozac (Fluoxetine Hydrochloride) SS Neurontin (Gabapentin) SS Route Duration MON MON MON MON MON Date:06/06/01ISR Number: 3735426-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100683 Age:72 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 200 MG Initial or Prolonged (DAILY), PER Other ORAL PT Report Source Product Role Manufacturer Route Blood Alkaline Foreign Neurontin PS Pfizer Inc ORAL Phosphatase Increased Literature Confusional State Culture Urine Positive Dermatitis Exfoliative Gamma-Glutamyltransferase Increased Hypersensitivity Mental Impairment Pyrexia Pyuria Rash Maculo-Papular Rash Pruritic Splenomegaly White Blood Cells Urine Positive Date:06/06/01ISR Number: 3735800-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100482 Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 7200 MG Initial or Prolonged (TID), PER PT Report Source Product Role Manufacturer Route Unevaluable Event Health Neurontin PS Pfizer Inc ORAL Professional ORAL Date:06/06/01ISR Number: 3735803-XReport Type:Expedited (15-DaCompany Report #001-0945-M0100657 Age:58 YR Gender:Female I/FU:I Outcome Dose Other SEE IMAGE PT Report Source Product Role Manufacturer Route Bone Density Decreased Consumer Neurontin PS Pfizer Inc ORAL Duration Prozac (Fluoxetine Hydrochloride) Unspecified Thyroid Medication 22-Aug-2005 Page: 548 10:40 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/01ISR Number: 3735750-3Report Type:Expedited (15-DaCompany Report #200112306EU Age:47 YR Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Blood Alkaline Initial or Prolonged Phosphatase Increased 800 MG/DAY PO 9 DAY Blood Bilirubin Increased 20 MG/DAY PO Cardiomegaly Chest Pain 2.4 G/DAY Depressed Level Of 40 MG/DAY PO Consciousness Ear Pain 20 MG/DAY PO 1 WK Fatigue Gamma-Glutamyltransferase 2.2 G/DAY 9 DAY Increased 25 G/DAY PO Headache Hypervolaemia Hypocalcaemia Infected Skin Ulcer Liver Disorder Metabolic Disorder Pharyngolaryngeal Pain Pleural Effusion Proteus Infection Renal Failure Weight Increased Report Source Product Role Manufacturer Route Foreign Other Noritate PS Dermik Laboratories Inc ORAL Leflunomide (Arava) SS Gabapentin (Neurontin) SS Furosemide (Furix) SS ORAL Enalapril Maleate (Renitec) SS ORAL Flucloxacillin Sodium (Heracillin) SS Rofecoxib (Vioxx) SS Folic Acid Calcium Phosphate (Folacin) Vitamin E Paracetamol (Alvedon) Prednisone Morfin Cisapride (Prepulsid) Cetirizine (Zyrlex) Morfin Lansoprazole (Lanzo) Zolpidem Tartrate (Stilnoct) Loperamide Colecalciferol Calcium Carbonate (Calcichew D3) Ipratropium Bromide Salbutamol Sulfate (Combivent) Spironolactone C C C C C C C C C C C C C C C C C ORAL ORAL Date:06/08/01ISR Number: 3736242-8Report Type:Expedited (15-DaCompany Report #A107350 Age:47 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 250.00 MG Required TOTAL:DAILY Intervention to 1200.00 MG Prevent Permanent TOTAL:QID:ORA Impairment/Damage L PT Report Source Product Role Manufacturer Depression Drug Effect Decreased Consumer Health Zoloft PS Pfizer Pharmaceuticals Inc Malabsorption Professional Gabapentin SS Vicodin C Uterine Leiomyoma Route ORAL Date:06/11/01ISR Number: 3737156-XReport Type:Expedited (15-DaCompany Report #001-0981-M0103661 Age:47 YR Gender:Unknown I/FU:F Outcome Dose Duration Hospitalization 10 MG (BID), Initial or Prolonged PER ORAL 1200 MG (EVERY AM); 600 MG (EVERY 22-Aug-2005 Page: 549 10:40 AM PT Report Source Product Role Manufacturer Route No Adverse Drug Effect Health Lipitor PS Pfizer Inc ORAL Gabapentin SS Professional ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report NOON); 1200 MG (EVERY HS. (Geodon) SS ORAL (Acetylsalicylic Acid) SS ORAL (Chlorpromazine) SS ORAL (Clonazepam) SS ORAL (Lorazepam) SS ORAL (Mesoridazine) SS ORAL 40 MG (DAILY); 40 MG (BID); 40 MG (DAILY); 20 MG (DAILY) 325 MG (DAILY), PER ORAL 100 MG (EVERY 4 HOURS PRN), PER ORAL 2 MG (AT BEDTIME), PER ORAL 2 MG (EVERY 6 HOURS); 2 MG (EVERY 8 HOURS AS NEEDED) PER 50 MG (DAILY); 75 MG (BID); 75 MG (TID) PER ORAL; 50 MG (Mirtazapine) SS ... .. ... ... ... ... ... ... ..... ... C C C C C C C C C C ORAL 15 MG (AT BEDTIME), PER ORAL Date:06/11/01ISR Number: 3737229-1Report Type:Expedited (15-DaCompany Report #001-0981-M0103676 Age: Gender:Female I/FU:F Outcome Dose Duration Other 10 MG Required (DAILY), PER Intervention to ORAL Prevent Permanent Impairment/Damage 900 MG (THREE PT Report Source Product Role Manufacturer Route Amnesia Consumer Lipitor PS Pfizer Inc ORAL Carpal Tunnel Syndrome Health Disorientation Professional Neurontin (Gabapentin) SS ORAL Celebrex SS ORAL Unspecified Narcotics Fentanyl SS C Drug Effect Decreased Mental Impairment TIMES DAILY), PER ORAL (DAILY), PER ORAL 22-Aug-2005 Page: 550 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/01ISR Number: 3737347-8Report Type:Expedited (15-DaCompany Report #055-0945-M0100020 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG Initial or Prolonged (DAILY), PER PT Report Source Product Role Manufacturer Route Haemorrhage Foreign Neurontin PS Pfizer Inc ORAL Product Role Manufacturer Route Gabapentin PS Route Consumer ORAL Date:06/11/01ISR Number: 3737797-XReport Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Hospitalization 300 MG BID Initial or Prolonged PT Company Report # Report Source Balance Disorder Emotional Disorder Lethargy Speech Disorder Tremor Date:06/11/01ISR Number: 3738019-6Report Type:Expedited (15-DaCompany Report #001-0945-M0100684 Age: Gender: I/FU:I Outcome Dose Other 3600 MG PT Report Source Product Role Manufacturer Accident Health Neurontin PS Pfizer Inc Concussion Professional Role Manufacturer Duration (UNKNOWN), UNKNOWN Date:06/11/01ISR Number: 3738020-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100671 Age: Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Route Other "SEE IMAGE" Blood Urea Increased Consumer Cataract Cataract Operation Eye Irritation Fatigue Pain In Extremity Peripheral Coldness Urinary Retention Vision Blurred Date:06/11/01ISR Number: 3740732-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other ORAL PS Tylenol (Paracetamol) Tramadol (Tramadol) C C Pfizer Inc Company Report #254373 PT Report Source Product Role Manufacturer Route Abdominal Distension Consumer Accutane PS Hlr Technology ORAL Duration Decreased Appetite Dry Skin Lip Dry Mood Swings Weight Decreased Date:06/12/01ISR Number: 3738135-9Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 551 Neurontin PT Blister Inflammation 10:40 AM Neurontin (Gabapentin) Wellbutrin (Bupropion Hydrochloride) Company Report # SS C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Report Source Dose Product Role Manufacturer Route Neurontin 200 Mg Parke-Davis PS Parke-Davis ORAL Effexor Allegra Zocor Vioxx Doxepin Hytrin Reglan Prevacid Chlorpromazine Risperdal C C C C C C C C C C Route Duration 400 MG TID ORAL Date:06/12/01ISR Number: 3738718-6Report Type:Expedited (15-DaCompany Report #044-0945-M0100161 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Haemolytic Anaemia RECTAL 2400 MG, PER Initial or Prolonged RECTAL Report Source Product Role Manufacturer Foreign Neurontin PS Pfizer Inc Consumer Other Sodium Valproate (Valproate Sodium) Folic Acid (Folic Acid) C C Date:06/12/01ISR Number: 3738736-8Report Type:Expedited (15-DaCompany Report #033-0945-M0100085 Age:38 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Alanine Aminotransferase Increased Asthenia Cholecystitis Foreign Consumer Other Neurontin PS Pfizer Inc Route Dyspnoea Hypersensitivity Oedema Pneumonia Date:06/12/01ISR Number: 3738899-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100514 Age:66 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 552 10:40 AM PT Amnesia Cardiac Failure Congestive Cerebrovascular Accident Coordination Abnormal Dizziness Excoriation Fall Head Injury Memory Impairment Myocardial Infarction Renal Failure Syncope FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Dose Report Source Product Role Manufacturer Route Consumer Neurontin PS Pfizer Inc ORAL Lasix (Furosemide) Thyroid Premarin (Estrogens Conjugated) Allopurinol Flexeril (Cyclobenzaprine Hydrochloride) Prilosec (Omeprazole) Potassium Duragesic Patches C C Route Duration 900 MG (TID), Health PER ORAL Professional C C C C C C Date:06/12/01ISR Number: 3738900-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100708 Age: Gender:Female I/FU:I Outcome Dose Other 1800 MG, PT Report Source Product Role Manufacturer Anorexia Consumer Neurontin PS Pfizer Inc Role Manufacturer Duration Concussion DAILY Diarrhoea Dysmenorrhoea Haemorrhage Nausea Syncope Thirst Visual Disturbance Date:06/12/01ISR Number: 3738930-6Report Type:Expedited (15-DaCompany Report #055-0945-M0100024 Age: Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Route Death PER ORAL Cerebrovascular Accident Foreign Neurontin PS Pfizer Inc ORAL Route Consumer Date:06/14/01ISR Number: 3740111-7Report Type:Expedited (15-DaCompany Report #044-0945-M0100161 Age: Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Haemolytic Anaemia RECTAL 2400 MG Initial or Prolonged (UNKNOWN) PER Report Source Product Role Manufacturer Foreign Neurontin PS Pfizer Inc Sodium Valproate Folic Acid C C Consumer Other RECTAL Date:06/15/01ISR Number: 3740172-5Report Type:Expedited (15-DaCompany Report #260859 Age:64 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 17 DAY Initial or Prolonged 28 DAY 28 DAY 28 DAY 22-Aug-2005 Page: 553 10:40 AM PT Dysphagia Report Source Product Role Manufacturer Klonopin Tablets PS Roche Neurontin SS Risperdal SS Cogentin C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lopressor Heparin Inderal Pepcid Asa C C C C C Isordil Flomax C C Colace Lotrimin Cream 1% C C TAKEN WITH A MEAL. TAKEN AT BEDTIME. 14 DAY Date:06/18/01ISR Number: 3741508-1Report Type:Expedited (15-DaCompany Report #260859 Age:64 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 2 MG 2 PER PT Report Source Product Role Manufacturer Route Dysphagia Hyporeflexia Health Professional Clonopin PS Hoffmann La Roche Inc ORAL DAY ORAL Neurontin (Gabapentin) 400 Mg SS ORAL Risperdal (Risperdal) 2 Mg SS ORAL 400 MG 2 PER DAY ORAL 2 MG 2 PER DAY ORAL Cogentin (Benztropine Mesylate) Lopressor (Metoprolol Tartrate) Heparin (Heparin Sodium) C C C Inderal (Propranolol Hydrochloride) Pepcid (Famotidine) Asa (Aspirin) Isordil (Isosorbide Dinitrate) Flomax (Tamsulosin Hydrochloride) Colace (Docusate Sodium) Lotrimin Cream 1% (Clotrimazole) C C C C C C C Date:06/18/01ISR Number: 3741692-XReport Type:Expedited (15-DaCompany Report #055-0945-M0100025 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Death 1200 MG, PER Life-Threatening ORAL Hospitalization Initial or Prolonged 22-Aug-2005 Page: 554 10:40 AM PT Report Source Product Role Manufacturer Route Nosocomial Infection Foreign Neurontin PS Pfizer Inc ORAL Pneumonia Consumer FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3741700-6Report Type:Expedited (15-DaCompany Report #001-0073-M0100251 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Blood Glucose Increased Cerebrovascular Accident Convulsion Depression Drug Level Below Therapeutic Health Professional Dilantin-125 PS Parke Davis Div Warner Lambert Co Route Duration Neurontin (Gabapentin) Celexa (Citalopram Hydrobromide) SS SS Date:06/18/01ISR Number: 3741734-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100716 Age:48 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Akinesia Amnesia Consumer Neurontin (Gabapentin) PS Pfizer Inc ORAL Movement Disorder Muscle Twitching Sinequan (Doxipin Hcl) C ORAL Sedation Thirst Antivert (Nicotinic Acid,Meclozine Hcl) C ORAL Tremor Tylenol (Paracetamol) C ORAL Duration 300 MG Dry Mouth (DAILY), PER Fatigue ORAL PER ORAL PER ORAL PER ORAL Date:06/19/01ISR Number: 3742226-6Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Dysarthria Lethargy Overdose Company Report # Report Source Product Role Seroquel Gabapentin PS SS Manufacturer Route Date:06/19/01ISR Number: 3742450-2Report Type:Expedited (15-DaCompany Report #A113418 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 30.00 MG Prevent Permanent TOTAL:DAILY:O Impairment/Damage RAL PT Report Source Product Role Manufacturer Route Drug Ineffective Gingival Bleeding Consumer Procardia Xl PS Pfizer Laboratories Div Pfizer Inc ORAL Joint Stiffness Migraine Tongue Disorder Neurontin SS Coumadin Corzide Lipitor Folate Valium Aspirin Klor-Con Vitamin C B-Complex Vitamin E Soy Supplement C C C C C C C C C C C 900.00 MG TOTAL:TID:ORA L 22-Aug-2005 Page: 555 10:40 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/01ISR Number: 3742511-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100747 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 900 MG Initial or Prolonged PT Report Source Product Role Manufacturer Angiopathy Literature Neurontin PS Pfizer Inc Intentional Misuse Priapism Health Professional Olanzapine (Olanzapine) SS Paroxetine (Paroxetine) SS Route 5 MG (NIGHT), Suicide Attempt 20 MG (NIGHT), Date:06/19/01ISR Number: 3742771-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100731 Age:62 YR Gender:Female I/FU:I Outcome Dose Other UNKNOWN PT Report Source Product Role Manufacturer Route Embolism Consumer Neurontin PS Pfizer Inc ORAL Atenolol (Atenolol) Maxzide (Hydrochlorothiazide , Triamterene) C Duration Fatigue (TID), PER Oedema Peripheral ORAL Weight Increased C Date:06/19/01ISR Number: 3742955-4Report Type:Expedited (15-DaCompany Report #055-0945-M0100027 Age:58 YR Gender: I/FU:I Outcome Dose Other 400 MG PT Report Source Product Role Manufacturer Route Hypersensitivity Foreign Neurontin PS Pfizer Inc ORAL Injection Site Consumer Duration (DAILY), PER Extravasation ORAL Neuritis Theophylline Bamifylline Hydrochloride Chlorpromazine Amitriptyline Hydrochloride C C C C Date:06/21/01ISR Number: 3743970-7Report Type:Expedited (15-DaCompany Report #001-0073-M0100251 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Blood Glucose Increased Cerebrovascular Accident Convulsion Drug Level Below Therapeutic Health Professional Dilantin-125 PS Parke Davis Div Warner Lambert Co Route Duration Neurontin (Gabapentin) Celexa (Citalopram Hydrobromide) SS SS Date:06/21/01ISR Number: 3744743-1Report Type:Expedited (15-DaCompany Report #049-0945-M0100057 Age: Gender:Female I/FU:I Outcome Dose Other SEE IMAGE 22-Aug-2005 Page: 556 PT Report Source Product Role Manufacturer Route Adrenal Insufficiency Foreign Neurontin PS Pfizer Inc ORAL Blood Pressure Decreased Condition Aggravated Dizziness Fatigue Gait Disturbance Health Professional Duration 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/01ISR Number: 3745486-0Report Type:Expedited (15-DaCompany Report #001-0945-M0100732 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Surgery Consumer Neurontin Soma (Carisoprodol) Percocet (Oxycodone Hydrochloride, Paracetamol) Paxil (Paroxetine Hydrochloride) Valium (Diazepam) Trazodone (Trazodone) PS C Pfizer Inc Route Duration C C C C Date:06/22/01ISR Number: 3745487-2Report Type:Expedited (15-DaCompany Report #055-0945-M0100026 Age: Gender:Female I/FU:I Outcome Dose Other PER ORAL PT Report Source Product Role Manufacturer Route Blood Growth Hormone Foreign Neurontin PS Pfizer Inc ORAL Increased Erythema Multiforme Hypersensitivity Health Professional Route Duration Date:06/22/01ISR Number: 3745511-7Report Type:Expedited (15-DaCompany Report #001-0945-M0100722 Age:37 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization (SEE IMAGE) Initial or Prolonged PT Report Source Product Role Manufacturer Anorgasmia Consumer Neurontin PS Pfizer Inc Lopressor (Metoprolol Tartrate) SS Arterial Occlusive Disease Chest Pain PER ORAL Disturbance In Attention Hiatus Hernia Mania Memory Impairment Myocardial Infarction ORAL Date:06/22/01ISR Number: 3745512-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100486 Age:38 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other DAILY, PER Required ORAL Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 557 10:40 AM PT Report Source Product Role Manufacturer Anorectal Disorder Colitis Ulcerative Dehydration Health Professional Neurontin Celexa (Citalopram Hydrobromide) PS Pfizer Inc SS Diarrhoea Haemorrhagic Haematocrit Decreased Haemoglobin Decreased Large Intestinal Ulcer Nausea Pain Rectal Haemorrhage Rectal Ulcer Vomiting Risperdal (Risperidone) Asacol (Mesalazine) Prednisone (Prednisone) Solu-Medrol (Methylprednisolone Sodium Succinate) Cyclosporine SS SS SS SS SS Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/01ISR Number: 3747316-XReport Type:Expedited (15-DaCompany Report #001-0945-M0100729 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Convulsion Fatigue Medication Error Overdose Consumer Neurontin PS Pfizer Inc Route Duration Date:06/25/01ISR Number: 3747333-XReport Type:Expedited (15-DaCompany Report #001-0945-M0100761 Age:31 YR Gender:Female I/FU:I Outcome Dose Duration Other 2100 MG (QID) PT Report Source Product Role Manufacturer Circulatory Collapse Consumer Neurontin PS Pfizer Inc Prevacid (Lansoprazole) C Head Injury Headache Loss Of Consciousness Rash Pruritic Suicide Attempt Route Date:06/26/01ISR Number: 3748127-1Report Type:Expedited (15-DaCompany Report #031-0945-M0100017 Age: Gender:Female I/FU:I Outcome Dose Other PER ORAL PT Report Source Product Role Manufacturer Route Drug Interaction Foreign Neurontin PS Pfizer Inc ORAL Loss Of Consciousness Health Baclofen (Baclofen) SS Duration ORAL PER ORAL Professional Date:06/26/01ISR Number: 3748130-1Report Type:Expedited (15-DaCompany Report #055-0945-M0100029 Age:49 YR Gender:Female I/FU:I Outcome Dose Other 300 MG PT Report Source Product Role Manufacturer Route Abnormal Behaviour Foreign Neurontin PS Pfizer Inc ORAL Duration Pain Consumer (DAILY), PER ORAL Date:06/26/01ISR Number: 3748131-3Report Type:Expedited (15-DaCompany Report #044-0945-M0100175 Age: Gender:Male I/FU:I Outcome Dose Other 300 MG PT Report Source Product Role Manufacturer Route Chromaturia Foreign Neurontin PS Pfizer Inc ORAL Jaundice Consumer Oedema Peripheral Other Duration (DAILY), PER ORAL Sedation 22-Aug-2005 Page: 558 10:40 AM Oxycodone (Oxycodone) Omeprazole (Omeprazole) Meloxicam (Meloxicam) Amitriptyline (Amitriptyline) C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3748234-3Report Type:Expedited (15-DaCompany Report #049-0945-M0100033 Age: Gender:Female I/FU:F Outcome Dose Duration Other 2400 MG; 2700 PT Report Source Product Role Manufacturer Route Asthenia Foreign Neurontin PS Pfizer Inc ORAL Dialysis Health Muscle Spasms Professional Duragesic (Fentanyl) SS Sandimmune (Ciclosporin) SS MG (DAILY), PER ORAL Muscle Twitching 75 TRANSD Muscular Weakness Overdose Renal Failure Acute Tremor TRANSDERMAL Other Date:06/26/01ISR Number: 3748248-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100606 Age:77 YR Gender:Female I/FU:I Outcome Dose Other 600 MG (300 PT Report Source Product Role Manufacturer Route Mouth Ulceration Consumer Neurontin PS Pfizer Inc ORAL Duration MG, BID), PER ORAL Ambien (Zolpidem Tartrate) Atenolol (Atenolol) Ativan (Lorazepam) Atrovent (Ipratropium Bromide) Cardizem Cd (Diltiazem Hydrochloride) Claritin (Loratadine) Celexa (Citalopram Hydrobromide) Celebrex (Celecoxib) Diamox C C C C C C C C (Acetazolamide) Nitroglycerin Cr (Glyceryl Trinitrate) Plavix (Clopidogrel) Prempro (Medroxyprogesterone Acetate, Estrogens Conjugated) Prevacid (Lansoprazole) Requip Wellbutrin Sr (Amfebutamone Hydrochloride) Zocor (Simvastatin) Talacen (Paracetamol, Pentazocine Hydrochloride) Aspirin (Acetylsalicylic Acid) Diovan (Valsartan) 22-Aug-2005 Page: 559 10:40 AM C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3748463-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100754 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Hangover Suicide Attempt Consumer Neurontin PS Pfizer Inc Route Duration Date:06/28/01ISR Number: 3749482-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100758 Age:50 YR Gender:Female I/FU:I Outcome Dose Other 1500 MG PT Report Source Product Role Manufacturer Route Systemic Lupus Health Neurontin PS Pfizer Inc ORAL Erythematosus Professional Klonopin (Clonazepam) C Route Duration (BID), PER ORAL Date:06/28/01ISR Number: 3749850-5Report Type:Expedited (15-DaCompany Report #001-0981-M0104435 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 10 MG (DAILY) Initial or Prolonged Disability 2400 MG PT Report Source Product Role Manufacturer Drug Dependence Health Lipitor PS Pfizer Inc Drug Withdrawal Syndrome Myalgia Professional Gabapentin (Gabapentin) SS (Diltiazem Hydrochloride) C (DAILY) Date:06/28/01ISR Number: 3749855-4Report Type:Expedited (15-DaCompany Report #001-0945-M0100769 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Asthenia Disorientation Fall Tremor Consumer Neurontin PS Pfizer Inc Route Date:06/29/01ISR Number: 3750630-5Report Type:Expedited (15-DaCompany Report #033-0945-M0100075 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization SEE IMAGE Initial or Prolonged Other PT Report Source Product Role Manufacturer Asthenia Foreign Neurontin PS Pfizer Inc Cholecystitis Dyspnoea Encephalitis Fatigue Hepatocellular Damage Hypersensitivity Oedema Health Professional Route Date:06/29/01ISR Number: 3750679-2Report Type:Expedited (15-DaCompany Report #001-0981-M0103661 Age:47 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 10 MG (BID), Initial or Prolonged PER ORAL SEE IMAGE, 22-Aug-2005 Page: 560 10:40 AM PT Report Source Product Role Manufacturer Route Unevaluable Event Health Lipitor PS Pfizer Inc ORAL Gabapentin SS Professional ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PER ORAL Geodon SS ORAL Acetylsalicylic Acid SS ORAL Chlorpromazine SS ORAL Clonazepam SS ORAL Lorazepam SS ORAL Mesoridazine SS SEE IMAGE 325 MG (DAILY), PER ORAL 100 MG (EVERY 4 HOURS PRN), PER ORAL 2 MG (AT BEDTIME), PER ORAL 2 MG (EVERY 6 HOURS), PER ORAL, 2 MG (EVERY 8 HOURS AS SEE IMAGE Date:06/29/01ISR Number: 3750712-8Report Type:Expedited (15-DaCompany Report #2012999 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Death 20 MG BID PO MG PRN PO PT Report Source Product Role Manufacturer Route Death Health Oxycontin Cr PS Purdue Pharma Lp ORAL Professional Oxyir Capsules (Oxycodone Hydrochloride) SS ORAL Elavil (Amitriptylline) SS ORAL Neurontin (Gabapentin) SS ORAL Soma (Carisoprodol) Xanax (Alprazolam) SS SS 50 MG HS PO 24 MG QD PO Date:07/02/01ISR Number: 3750941-3Report Type:Expedited (15-DaCompany Report #001-0945-M0100779 Age: Gender:Female I/FU:I Outcome Dose Duration Other 1200 MG (BID) PT Report Source Product Role Manufacturer Cerebrovascular Accident Health Neurontin PS Pfizer Inc Dysarthria Speech Disorder Professional Klonopin (Clonazepam) Methylphenidate Wellbutrin (Bupropion) Date:07/02/01ISR Number: 3750959-0Report Type:Expedited (15-DaCompany Report #001-0945-M0100808 Age:52 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 561 10:40 AM PT Blood Potassium Decreased Depressed Level Of Consciousness Drug Level Above Therapeutic Eye Disorder Feeling Abnormal Hypoaesthesia Insomnia Paraesthesia Paralysis C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Speech Disorder Dose Report Source Product Role Manufacturer Route Consumer Neurontin PS Pfizer Inc ORAL Dilantin (Phenytoin Sodium) SS Duration 100 MG UNK PER ORAL UNKNOWN UNK, UNK, UNK Phenobartbital Synthroid (Levothyroxind Sodium) Inderal (Propranol Hydrochloride) Prilosec (Omeprazole) Albuterol (Salbutamol) Zyrtec (Cetirizine Hydrochloride) Singulair (Montelukast) Trimethoprim Allopurinol Viokase (Pancrelipase) Phazyme (Pancreatin, Dimeticone, Activated, Pepsin, Diastase) Climara (Estradiol) Unspecified Vitamins Hydrochlorothiazide Voixx (Rofecoxib) Colace (Docusate Sodium) Peri-Colace (Docusate Sodiu, Casanthranol) Date:07/02/01ISR Number: 3751045-6Report Type:Expedited (15-DaCompany Report #002-0945-990030 Age:10 YR Gender:Female I/FU:F C C C C C C C C C C C C C C C C C Outcome Dose Duration Death 1400 MG Other (DAILY), PER PT Report Source Product Role Manufacturer Route Cardio-Respiratory Arrest Foreign Neurontin PS Pfizer Inc ORAL Drug Interaction Health Viral Infection Professional Morphine (Morphine) SS Carbamazepine (Carbamazepine) SS ORAL INTRAVENOUS INTRAVENOUS ORAL PER ORAL Date:07/02/01ISR Number: 3751123-1Report Type:Expedited (15-DaCompany Report #044-0945-M0100172 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1500 MG, PER Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Burning Sensation Foreign Neurontin PS Pfizer Inc ORAL Muscle Spasms Health Nortriptyline (Nortriptyline) C Professional 22-Aug-2005 Page: 562 10:40 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751289-3Report Type:Expedited (15-DaCompany Report #048-0945-M0100003 Age:29 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1500 MG Initial or Prolonged (TID), PER PT Report Source Product Role Manufacturer Route Psychotic Disorder Foreign Neurontin PS Pfizer Inc ORAL Thinking Abnormal Health Carbamazepine SS Route Professional ORAL Date:07/02/01ISR Number: 3751295-9Report Type:Expedited (15-DaCompany Report #002-0945-M0100047 Age: Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Coma Drug Interaction Drug Level Above Therapeutic Overdose Respiratory Depression Foreign Health Professional Neurontin Oxycodone Clonazepam PS SS SS Pfizer Inc Duration Date:07/02/01ISR Number: 3751310-2Report Type:Expedited (15-DaCompany Report #002-0945-M0100045 Age:17 YR Gender:Female I/FU:F Outcome Dose Death PER ORAL PT Report Source Product Role Manufacturer Route Drug Interaction Foreign Neurontin PS Pfizer Inc ORAL Health Professional Zyprexia (Olanzapine) Hydromorphone SS SS Manufacturer Route Duration Date:07/02/01ISR Number: 3751433-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100592 Age:75 YR Gender:Female I/FU:F Outcome Dose PT Duration Report Source Product Role Other 300 MG Arthralgia Consumer Neurontin PS Pfizer Inc ORAL Route Asthenia (DAILY), PER Ecchymosis ORAL Fall Laceration Myalgia Pain In Extremity Paraesthesia Pyrexia Sedation Tremor Vision Blurred Deltasone (Prednisone) Glucotrol (Glipizide) Avapro (Irbesartan) Hydrochlorthiazide (Hydrochlorothiazide ) C C C C Date:07/02/01ISR Number: 3751451-XReport Type:Expedited (15-DaCompany Report #001-0945-M0100784 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization SEE IMAGE Initial or Prolonged 22-Aug-2005 Page: 563 10:40 AM PT Report Source Product Role Manufacturer Coma Consumer Neurontin PS Pfizer Inc Communication Disorder Peripheral Vascular Disorder FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751749-5Report Type:Expedited (15-DaCompany Report #044-0945-M0100153 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG (BID), PT Report Source Product Role Manufacturer Route Jaundice Sepsis Foreign Health Neurontin (Gabapentin) PS Pfizer Inc ORAL Carbamazepine C Route Professional PER ORAL Company Representative Date:07/02/01ISR Number: 3751812-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100621 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Blood Albumin Increased Blood Creatinine Increased Burning Sensation Csf Protein Increased Nerve Conduction Studies Abnormal Paraparesis Radiculopathy Literature Consumer Neurontin Amitriptyline (Amitriptyline) Cyclosporin A (Ciclosporin) Prednisone Furosemide Famotidine Glibenclamide Zolpidem PS Pfizer Inc Duration SS SS C C C C C Date:07/03/01ISR Number: 3752455-3Report Type:Expedited (15-DaCompany Report #01P-167-0108018-00 Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Disability 2.6 GM, 1 IN PT Report Source Product Role Manufacturer Route Coombs Positive Haemolytic Anaemia Foreign Health Professional Depakene PS Abbott Laboratories Pharmaceutical Products Div ORAL Other 1 D, PER ORAL; 2 GM, 1 IN 1 D, PER ORAL Gabapentin SS Folic Acid C ORAL 2400 MG, 1 IN 1 D, PER ORAL Date:07/05/01ISR Number: 3752526-1Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly 900MG PO Q 8H Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 564 10:40 AM PT Amniocentesis Abnormal Caesarean Section Complications Of Maternal Exposure To Therapeutic Drugs Movement Disorder Neonatal Disorder Premature Baby Renal Disorder Company Report # Report Source Product Role Neurontin 300mg Po PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/01ISR Number: 3753570-0Report Type:Direct Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 300 MG BID PO 14 MON Initial or Prolonged Required 300MG QID PO 16 MON Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Arrhythmia Cataract Seroquel 300 Mg Bid Po PS ORAL Diabetes Mellitus Difficulty In Walking Neurontin 300mg Qid Po SS ORAL Route Faecal Incontinence Hypertension Obesity Urinary Incontinence Weight Increased Date:07/06/01ISR Number: 3753572-4Report Type:Direct Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Death ONE PILL 4 X Manufacturer PT Company Report # Report Source Hypoglycaemia Product Role Neurontin 50 Mg PS Manufacturer Route ORAL Hypoglycaemic Coma A DAY ORAL Date:07/06/01ISR Number: 3753774-7Report Type:Expedited (15-DaCompany Report #001-0945-M0100793 Age: Gender:Male I/FU:I Outcome Dose Other 7200 MG PT Report Source Product Role Manufacturer Route Abnormal Behaviour Health Neurontin PS Pfizer Inc ORAL Convulsion Professional Ultram (Tramadol Hydrochloride) SS Duration (DAILY), PER Drug Interaction ORAL Hostility Date:07/06/01ISR Number: 3754158-8Report Type:Expedited (15-DaCompany Report #001-0945-M0100487 Age:33 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 9000 MG Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Route Blood Pressure Increased Consumer Neurontin PS Pfizer Inc Depression Valium (Diazepam) SS ORAL Drug Dependence Dysphagia Extra Strength Tylenol Pm SS ORAL Unspecified Antidepressants C 25-30 (HS), Feeling Jittery PER ORAL Gait Disturbance Nausea Overdose Sexual Assault Victim Suicidal Ideation Date:07/06/01ISR Number: 3754376-9Report Type:Expedited (15-DaCompany Report #044-0945-M0100158 Age: Gender:Male I/FU:I Outcome Dose Other 600 MG PT Report Source Product Role Manufacturer Hepatic Cirrhosis Foreign Neurontin PS Pfizer Inc Hepatitis B Health Professional Neurontin (Gabapentin) SS Duration 900 MG Amitriptyline (Amitriptyline) Magnesium Sulfate (Magnesium Sulfate) 22-Aug-2005 Page: 565 10:40 AM SS C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/01ISR Number: 3754520-3Report Type:Expedited (15-DaCompany Report #044-0945-M0100069 Age: Gender: I/FU:F Outcome Dose Death Other PT Report Source Product Role Manufacturer Meningioma Post Procedural Complication Foreign Health Professional Neurontin Valproate (Valproic Acid) PS Pfizer Inc Route Duration Date:07/09/01ISR Number: 3754389-7Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG 2 TID Initial or Prolonged 300 MG 3 TID PT C Company Report # Report Source Product Role Dyspnoea Gabapentin PS Neutropenia Gabapentin SS Manufacturer Route Route Night Sweats Pyrexia Date:07/09/01ISR Number: 3755095-5Report Type:Expedited (15-DaCompany Report #001-0945-M0100810 Age:12 YR Gender:Female I/FU:I Outcome Dose Other 600 MG PT Report Source Product Role Manufacturer Abnormal Behaviour Consumer Neurontin PS Pfizer Inc Duration Back Disorder (DAILY) Bipolar Disorder Disturbance In Social Behaviour Dysphagia Intervertebral Disc Protrusion Pollakiuria Paxil (Paroxetine Hydrochloride) Albuterol (Salbutamol) Date:07/09/01ISR Number: 3756246-9Report Type:Expedited (15-DaCompany Report #002-0945-M0100083 Age: Gender: I/FU:I SS C Outcome Dose Disability Other PT Report Source Product Role Manufacturer Retinitis Pigmentosa Foreign Health Professional Neurontin Phenytoin (Phenytoin) Hydrochlorothiazide (Hydrochlorothiazide ) Pravastatin (Pravastatin) PS Pfizer Inc Date:07/10/01ISR Number: 375603

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