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Adverse Effects http://promini.medscape.com/drugdb/drug_u…D452&DrugName=RANITIDINE+ORAL&DrugType=1 RANITIDINE ORAL Adverse Effects List & Discussion Adverse Effects List from First Data Bank Incidence more frequent Incidence less frequent (Uses not currently included in the labeling approved by the US Food and Drug Administration.) CONSTIPATION DIARRHEA DIZZINESS DROWSINESS HEADACHE NAUSEA SKIN RASH VOMITING AGRANULOCYTOSIS BRADYCARDIA BRONCHOSPASM CONFUSION, DRUG INDUCED FEVER TACHYCARDIA THROMBOCYTOPENIA None listed Adverse Effects List from AHFS DITM Nervous System Effects from AHFS DITM Headache (sometimes severe) occurs in approximately 3% of patients receiving ranitidine. Malaise, dizziness, somnolence, insomnia, and vertigo have been reported less frequently with ranitidine therapy. Reversible mental confusion, agitation, mental depression, hallucinations have occurred, mainly in debilitated geriatric patients. A child who was receiving prolonged, high-dose oral ranitidine therapy (8 mg/kg once daily for 10 months) developed altered consciousness, drowsiness, dysarthria, hyporeflexia, positive Babinski's sign, diaphoresis, and bradycardia, which resolved within 24 hours after discontinuance of the drug. Headache has been reported in 5% of patients receiving combined therapy with ranitidine bismuth citrate and clarithromycin and in 1% of those receiving ranitidine bismuth citrate alone in clinical trials. Sleep disorder occurred in 2% of patients receiving combined ranitidine bismuth citrate and clarithromycin and in less than 1% of those receiving ranitidine bismuthcitrate alone. Tremors have been reported rarely with ranitidine bismuth citrate therapy; the relationship to the drug is unclear. GI Effects from AHFS DITM Constipation, nausea, vomiting, and abdominal discomfort or pain have occurred in patients receiving ranitidine. Pancreatitis has been reported rarely. Diarrhea, nausea and vomiting, or constipation was reported in 8, 1% of those receiving ranitidine bismuth citrate alone in clinical trials. Hepatic Effects from AHFS DITM Increases in serum aminotransferase (transaminase) (AST [SGOT] and ALT [SGPT]), alkaline phosphatase, LDH, total bilirubin, and Gamma-glutamyl transferase (Gamma-glutamyltranspeptidase, GOT, GGTP) concentrations have been reported and reversible hepatitis, which may behepatocellular, hepatocanalicular, or both and may or may not be accompanied by jaundice has occurred occasionally in individuals receiving ranitidine and usually was reversible; however, death has been reported rarely. In several multiple-dose studies in healthy individuals, increases in serum AST and ALT concentrations from pretreatment concentrations were greater in individuals receiving IV ranitidine dosages of 100 mg 4 times daily for 7 days than in those receiving 50 mg 4 times daily for 5 days; the manufacturers state that this apparent dose-related effect of IV ranitidine may indicate that ranitidine has some potential hepatotoxicity. (See Cautions: Precautions and Contraindications.) Transient changes in AST (SGOT) and ALT (SGPT) werereported in less than 1% of patients receiving ranitidine bismuth citrate in clinical trials. Ocular Effects from AHFS DITM Adverse Effects http://promini.medscape.com/drugdb/drug_u…D452&DrugName=RANITIDINE+ORAL&DrugType=1 Reversible blurred vision suggestive of a change in accommodation has occurred rarely in patients receiving ranitidine. Exacerbation of ocular pain and blurred vision associated with increased intraocular pressure and chronic glaucoma have been reported in at least one patient during ranitidine therapy. Loss of color vision, which recurred following rechallenge, also has occurred in at least one patient. Endocrine Effects from AHFS DITM The manufacturers state that ranitidine has not been associated with clinically important effects on endocrine or gonadal function, (See Pharmacology: Endocrine and Gonadal Effects.) Sexual impotence has occurred in at least one male during ranitidine therapy, but disappeared following discontinuance of the drug; impotence recurred upon rechallenge. Painful gynecomastia also has occurred during oral administration of ranitidine, but disappeared gradually following discontinuance of the drug; gynecomastia reappeared upon rechallenge. Cardiovascular Effects from AHFS DITM As with other histamine H2-receptor antagonists, cardiac arrhythmias have occurred rarely in patients receiving ranitidine. Bradycardia, sometimes associated with dyspnea, has occurred. Because bradycardia has been associated with rapid IV injection of the drug in some cases, usually in patients with underlying conditions predisposing to cardiac rhythm disturbances, recommended rates of IV administration should not be exceeded. Tachycardia, AV block, asystole, and ventricular premature complexes have also been reported rarely. Other Adverse Effects List from AHFS DITM Arthralgias and myalgias have been reported rarely with ranitidine therapy. Rare reports suggest that ranitidine may precipitate acute attacks of porphyria in patients with acute porphyria; therefore, the drug should be avoided in patients with a history of acute porphyria. Chest symptoms were reported in 2% of patients receiving combined therapy with ranitidine bismuth citrate and clarithromycin in clinical trials. Mutagenicity and Carcinogenicity from AHFS DITM It is not known if ranitidine is mutagenic or carcinogenic in humans. In vitro tests have generally not shown ranitidine or its Af-oxide, Soxide, and desmethyl metabolites to be mutagenic. No evidence of carcinogenicity was seen in long-term studiesin dogs, mice, or rats receiving ranitidine dosages up to 2 g/kg daily; evidence of gastric neoplasm or premalignant gastric changes was not observed in these studies. Like cimetidine, ranitidine increases nitrate-reducing bacterial flora in the GI tract; however, the clinical importance of this effect is not known. In a 24-month oral carcinogenicity study in mice, ranitidine bismuth citrate at daily doses up to 1000 mg/kg demonstrated no evidence of carcinogenicity. For a 50-kg individual of average height (1.46 m2 body surface area), this dose represents 5 times the recommended clinical dose of 400 mg twice daily (592 mg/m2). In a 24-month oral carcinogenicity study in Sprague-Dawley rats, ranitidine bismuth citrate at daily doses up to 500 mg/kg, 5 times the recommended human dose based on body surface area, was not carcinogenic. Ranitidine bismuth citrate was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK±) forward mutation test, the ex vivo rat gastric mucosal unscheduled DNA synthesis (UDS) test, or the in vivo rat micronucleus test. However, evidence of genotoxicity was found in the in vitro human lymphocyte chromosomal aberration assay. Adverse Effects http://promini.medscape.com/drugdb/drug_u…D452&DrugName=RANITIDINE+ORAL&DrugType=1