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Generic Name: ibuprofen (EYE bue PROE fen)
Brand Names: Advil, Genpril, Midol IB, Motrin IB, Proprinal, Smart Sense Children's Ibuprofen
What is ibuprofen?
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause
inflammation and pain in the body.
Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache,
toothache, back pain, arthritis, menstrual cramps, or minor injury.
Ibuprofen is used in adults and children who are at least 6 months old.
Important information
Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high
doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary
artery bypass graft, or CABG).
All Eyes On Ibuprofen: What You Need To Know
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur
without warning while you are using ibuprofen, especially in older adults.
Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or
intestines. Use only the smallest amount of medication needed to get relief from your pain, swelling, or fever.
Before taking this medicine
Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high
doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or
heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur
without warning while you are using ibuprofen, especially in older adults.
You should not use ibuprofen if you are allergic to it, or if you have ever had an asthma attack or severe
allergic reaction after taking aspirin or an NSAID.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

a history of heart attack, stroke, or blood clot;

a history of stomach ulcers or bleeding;

asthma;

liver or kidney disease;

fluid retention; or

a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, or lupus.
Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby. Do not use this
medicine without a doctor's advice if you are pregnant.
It is not known whether ibuprofen passes into breast milk or if it could harm a nursing baby. Do not use this
medicine without a doctor's advice if you are breast-feeding a baby.
Do not give ibuprofen to a child younger than 2 years old without the advice of a doctor.
How should I take ibuprofen?
Use ibuprofen exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or
for longer than recommended. Use the lowest dose that is effective in treating your condition.
Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or
intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4
maximum doses). Use only the smallest amount needed to get relief from your pain, swelling, or fever.
A child's dose of ibuprofen is based on the age and weight of the child. Carefully follow the dosing
instructions provided with your child's medicine for the age and weight of your child. Ask a doctor or
pharmacist if you have questions.
Take ibuprofen with food or milk to lessen stomach upset.
Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the
dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dosemeasuring device, ask your pharmacist for one.
The ibuprofen chewable tablet must be chewed before you swallow it.
If you use this medicine long-term, you may need frequent medical tests.
Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or
pharmacist if you have any questions.
See also: Dosage Information (in more detail)
What happens if I miss a dose?
Since ibuprofen is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the
missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.
Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may
include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow
breathing, fainting, or coma.
What should I avoid while taking ibuprofen?
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking ibuprofen.
Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin
less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen
at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).
Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over
the counter contain aspirin or other medicines similar to ibuprofen. Taking certain products together can cause
you to get too much of this type of medication. Check the label to see if a medicine contains aspirin,
ibuprofen, ketoprofen, or naproxen.
Ibuprofen side effects
Get emergency medical help if you have signs of an allergic reaction to ibuprofen: sneezing, runny or stuffy
nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw
or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using ibuprofen and call your doctor at once if you have:

changes in your vision;

shortness of breath (even with mild exertion);

swelling or rapid weight gain;

the first sign of any skin rash, no matter how mild;

signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee
grounds;

liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite,
dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles,
feeling tired or short of breath;

low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate,
trouble concentrating; or

severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin
pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes
blistering and peeling.
Common ibuprofen side effects may include:

upset stomach, mild heartburn, nausea, vomiting;

bloating, gas, diarrhea, constipation;

dizziness, headache, nervousness;

mild itching or rash; or

ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
Ibuprofen dosing information
Usual Adult Dose for Dysmenorrhea:
200 to 400 mg orally every 4 to 6 hours as needed.
Usual Adult Dose for Osteoarthritis:
Initial dose: 400 to 800 mg orally every 6 to 8 hours.
Maintenance dose: May be increased to a maximum daily dose of 3200 mg based on patient response and
tolerance.
Usual Adult Dose for Rheumatoid Arthritis:
Initial dose: 400 to 800 mg orally every 6 to 8 hours.
Maintenance dose: May be increased to a maximum daily dose of 3200 mg based on patient response and
tolerance.
Usual Adult Dose for Headache:
Study (n=34) - Prevention of Electroconvulsive therapy (ECT)-induced headache:
600 mg orally 90 minutes prior to the initial ECT session
Usual Adult Dose for Pain:
Oral: Mild to moderate pain:
200 to 400 mg orally every 4 to 6 hours as needed. Doses greater than 400 mg have not been proven to provide
greater efficacy.
IV: (Patients should be well hydrated before IV ibuprofen administration):
Pain: 400 to 800 mg intravenously over 30 minutes every 6 hours as needed.
Usual Adult Dose for Fever:
Oral:
200 to 400 mg orally every 4 to 6 hours as needed.
IV: (Patients should be well hydrated before IV ibuprofen administration):
Fever: Initial: 400 mg intravenously over 30 minutes
Maintenance: 400 mg every 4 to 6 hours or 100 to 200 mg every 4 hours as needed.
Usual Pediatric Dose for Fever:
Greater than 6 months to 12 years:
5 mg/kg/dose for temperature less than 102.5 degrees F (39.2 degrees C) orally every 6 to 8 hours as needed.
10 mg/kg/dose for temperature greater than or equal to 102.5 degrees F (39.2 degrees C) orally every 6 to 8
hours as needed.
The recommended maximum daily dose is 40 mg/kg.
OTC pediatric labeling (analgesic, antipyretic): 6 months to 11 years: 7.5 mg/kg/dose every 6 to 8 hours;
Maximum daily dose: 30 mg/kg
Usual Pediatric Dose for Pain:
Infants and Children: 4 to 10 mg/kg orally every 6 to 8 hours as needed.
The recommended maximum daily dose is 40 mg/kg.
OTC pediatric labeling (analgesic, antipyretic): 6 months to 11 years: 7.5 mg/kg/dose every 6 to 8 hours;
Maximum daily dose: 30 mg/kg
Usual Pediatric Dose for Rheumatoid Arthritis:
6 months to 12 years:
Usual: 30 to 40 mg/kg/day in 3 to 4 divided doses; start at lower end of dosing range and titrate; patients with
milder disease may be treated with 20 mg/kg/day; doses greater than 40 mg/kg/day may increase risk of
serious adverse effects; doses greater than 50 mg/kg/day have not been studied and are not recommended.
Maximum dose: 2.4 g/day
Usual Pediatric Dose for Cystic Fibrosis:
Oral: Chronic (greater than 4 years) twice daily dosing adjusted to maintain serum concentration of 50 to 100
mcg/mL has been associated with slowing of disease progression in pediatric patients with mild lung disease.
Usual Pediatric Dose for Patent Ductus Arteriosus:
Ibuprofen lysine:
Gestational age 32 weeks or less, birth weight: 500 to 1500 g:
Initial dose: 10 mg/kg, followed by two doses of 5 mg/kg after 24 and 48 hours
Note: Use birth weight to calculate all doses. Hold second or third doses if urinary output is less than 0.6
mL/kg/hour; may give when laboratory studies indicate renal function is back to normal. A second course of
treatment, alternative pharmacologic therapy, or surgery may be needed if the ductus arteriosus fails to close
or reopens following the initial course of therapy.
What other drugs will affect ibuprofen?
Ask your doctor before using ibuprofen if you take an antidepressant such as citalopram, escitalopram,
fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these
medicines with an NSAID may cause you to bruise or bleed easily.
Ask a doctor or pharmacist if it is safe for you to use ibuprofen if you are also using any of the following
drugs:

lithium;

methotrexate;

a blood thinner (warfarin, Coumadin, Jantoven);

heart or blood pressure medication, including a diuretic or "water pill"; or

steroid medicine (such as prednisone).
This list is not complete. Other drugs may interact with ibuprofen, including prescription and over-the-counter
medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
In Summary
Commonly reported side effects of ibuprofen include: hemorrhage, vomiting, anemia, decreased
hemoglobin, eosinophilia, and hypertension. Other side effects include: upper gastrointestinal hemorrhage,
upper gastrointestinal tract ulcer, dizziness, and dyspepsia. See below for a comprehensive list of adverse
effects.
For the Consumer
Applies to ibuprofen: oral capsule, oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable
Other dosage forms:

intravenous solution
In addition to its needed effects, some unwanted effects may be caused by ibuprofen. In the event that any of
these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking
ibuprofen:
More common:

Abdominal pain, acid or sour stomach, belching, Bloating, cloudy urine, decrease in amount of urine,
decrease in urine output or decrease in urine-concentrating ability, diarrhea, difficulty having a bowel
movement (stool), excess air or gas in stomach or intestines, full feeling, heartburn, indigestion, itching skin,
pain or discomfort in chest, upper stomach, or throat, pale skin, passing gas, nausea, noisy, rattling breathing,
rash with flat lesions or small raised lesions on the skin, shortness of breath, swelling of face, fingers, hands,
feet, lower legs, or ankles, troubled breathing at rest, troubled breathing with exertion, unusual bleeding or
bruising, unusual tiredness or weakness, vomiting, weight gain

Less common:
Abdominal cramps, stomach soreness or discomfort
Rare

Agitation, back, leg, or stomach pains, bleeding gums, blistering, peeling, loosening of skin, blood in
urine or stools, bloody, black, or tarry stools, blurred vision, burning feeling in chest or stomach, change in
vision, chest pain, chills, clay-colored stools, coma, confusion, constipation, cough or hoarseness, dark urine,
decreased urine output, depression, difficulty breathing, difficulty swallowing, dilated neck veins, dizziness,
dry mouth, extreme fatigue, fast, irregular, pounding, or racing heartbeat or pulse, fever with or without chills,
frequent urination, general body swelling, general feeling of tiredness or weakness, hair loss, thinning of hair,
headache, hives or welts, hostility, impaired vision, increased blood pressure, increased volume of pale, dilute
urine, irregular breathing, irritability, itching, joint or muscle pain, lab results that show problems with liver,
lethargy, light-colored stools, loss of appetite, lower back or side pain, muscle twitching, nosebleeds, painful
or difficult urination, pains in stomach, side, or abdomen, possibly radiating to the back, pinpoint red spots on
skin, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, rash,red skin lesions, often
with a purple center, red, irritated eyes, redness of skin, seizures, severe abdominal pain, cramping, burning,
severe and continuing nausea, sore throat, sores, ulcers, or white spots in mouth or on lips, stiff neck or back,
stomach upset, stupor, swollen or painful glands, tenderness in stomach area, thirst, tightness in chest,
unpleasant breath odor, upper right abdominal pain, vomiting of blood, vomiting of material that looks like
coffee grounds, wheezing, yellow eyes and skin
Symptoms of overdose:

Bluish lips or skin, difficulty sleeping, Disorientation, dizziness, faintness, or lightheadedness when
getting up from a lying or sitting position suddenly, drowsiness to profound coma, Hallucination,
lightheadedness or fainting, mood or other mental changes, muscle tremors, not breathing, rapid, deep
breathing, restlessness, slow or irregular heartbeat, stomach cramps, sudden fainting, sweating
Minor Side Effects
Some of the side effects that can occur with ibuprofen may not need medical attention. As your body adjusts to
the medicine during treatment these side effects may go away. Your health care professional may also be able
to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects
continue, are bothersome or if you have any questions about them, check with your health care professional:
More common:

Continuing ringing or buzzing or other unexplained noise in ears, hearing loss, nervousness
Rare

Crying, Depersonalization, discouragement, dry eyes, dysphoria, euphoria, feeling sad or empty, lack
of appetite, loss of interest or pleasure, mental depression, paranoia, quick to react or overreact, rapidly
changing moods, runny nose, sleepiness or unusual drowsiness, sleeplessness, sneezing, stuffy nose, trouble
concentrating, trouble sleeping, unable to sleep
For Healthcare Professionals
Applies to ibuprofen: compounding powder, intravenous solution, oral capsule, oral suspension, oral tablet,
oral tablet chewable
General
The most frequently reported adverse effects were gastrointestinal (GI) in nature and included nausea,
vomiting, flatulence, and diarrhea.
Patent Ductus Arteriosus: The most frequently reported adverse effects were sepsis, anemia, intraventricular
bleeding, apnea, GI disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia,
hypocalcemia, and respiratory failure.[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 57%), vomiting (up to 22%), flatulence (up to 16%), diarrhea (up
to 10%)
Common (1% to 10%): Dyspepsia, abdominal discomfort, epigastric pain, heartburn, abdominal distress,
indigestion, constipation, abdominal cramps/pain, fullness of GI tract, bloating, GI hemorrhage, melena
Uncommon (0.1% to 1%): Abdominal distention, dyspepsia, gastritis
Very rare (less than 0.01%): Peptic ulcer, perforation, hematemesis, mouth ulceration, exacerbation of colitis,
exacerbation of Crohn's disease
Frequency not reported: Dry mouth, duodenitis, esophagitis, gastric ulcer, duodenal ulcer, GI bleeding,
glossitis, rectal bleeding, stomatitis, eructation, gingival ulcer, pancreatitis
Patent Ductus Arteriosus:
Very common (10% or more): GI disorders non-necrotizing enterocolitis (22%)
Common (1% to 10%): Necrotizing enterocolitis, intestinal perforation
Frequency not reported: Abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia
Postmarketing reports: GI perforation[Ref]
Cardiovascular
Very common (10% or more): Hemorrhage (up to 10%), hypertension (10%), hypotension (10%)
Very rare (less than 0.01%): Cardiac failure
Frequency not reported: Congestive heart failure, tachycardia, arrhythmia, myocardial infarction, palpitations,
vasculitis, sinus bradycardia, angina pectoris, thrombotic events
Patent Ductus Arteriosus:
Frequency not reported: Tachycardia, cardiac failure, hypotension[Ref]
Nervous system
Very common (10% or more): Headache (up to 12%)
Common (1% to 10%): Dizziness, nervousness
Very rare (less than 0.01%): Cerebrovascular accident
Frequency not reported: Syncope, drowsiness, paresthesia, somnolence, tremors, convulsions, coma
Patent Ductus Arteriosus:
Common (1% to 10%): Intraventricular hemorrhage, periventricular hemorrhage
Frequency not reported: Convulsions[Ref]
Renal
The number of total renal events in preterm infants within 30 days of therapy following IV use was 21% and
included increased blood urea (7%), renal insufficiency/impairment (6%), reduced urine output (3%),
increased blood creatinine (3%), renal failure (1%), and increased blood urea with hematuria (1%).[Ref]
Very rare (less than 0.01%): Acute renal failure, renal papillary necrosis, interstitial nephritis, nephrotic
syndrome, renal failure, renal insufficiency
Frequency not reported: Cystitis, azotemia, creatinine clearance decreased, glomerulitis, tubular necrosis,
nephrotoxicity
Patent Ductus Arteriosus:
Very common (10% or more): Renal events (21%)
Uncommon (0.1% to 1%): Acute renal failure[Ref]
Hematologic
The incidence of total bleeding events within 30 days of therapy with IV use in preterm infants was 32%. This
percentage included grade 1 and 2 intraventricular hemorrhage (15%), grade 3 and 4 intraventricular
hemorrhage (15%), and other bleeding (6%).[Ref]
Very common (10% or more): Anemia (up to 36%), eosinophilia (up to 26%), neutropenia (up to 13%),
thrombocythemia (up to 10%)
Common (1% to 10%): Hemoglobin decreased
Very rare (less than 0.01%): Leukopenia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic
anemia, pancytopenia, hematocrit decreased
Frequency not reported: lymphadenopathy, bleeding episodes
Patent Ductus Arteriosus:
Very common (10% or more): Anemia (32%), total bleeding (32%), intraventricular hemorrhage (29%),
Neutropenia, thrombocytopenia[Ref]
Dermatologic
Common (1% to 10%): Rash, maculopapular rash, pruritus
Very rare (less than 0.01%): Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis
Frequency not reported: Ecchymosis, purpura, alopecia, sweating, photosensitivity, angioedema, exfoliative
dermatitis, urticaria, vesiculobullous eruptions, Henoch Schonlein vasculitis
Patent Ductus Arteriosus:
Very common (10% or more): Skin lesion/irritation (16%)[Ref]
Metabolic
Very common (10% or more): Hypokalemia (up to 19%), hypoproteinemia (up to 13%), blood urea increased
(10%), hypernatremia (10%), hypoalbuminemia (10%)
Common (1% to 10%): Appetite decreased, fluid retention
Frequency not reported: Appetite changes, hyperglycemia, hypoglycemic reaction, acidosis
Patent Ductus Arteriosus:
Very common (10% or more): Hypoglycemia (12%), hypocalcemia (12%), blood creatinine increased, blood
sodium decreased
Common (1% to 10%): Hypernatremia
Frequency not reported: Feeding problems, hyperglycemia[Ref]
Other
Very common (10% or more): Bacteremia (13%), blood LDH increased (up to 10%)
Common (1% to 10%): Peripheral edema, wound hemorrhage, tinnitus, hearing impairment, edema, fatigue
Very rare (less than 0.01%): Aseptic meningitis, vertigo, exacerbation of infection-related inflammations
Frequency not reported: Fever, infection, sepsis, weight changes, asthenia, malaise, pseudo-tumor, hearing
loss, drowsiness
Patent Ductus Arteriosus:
Very common (10% or more): Sepsis (43%)
Common (1% to 10%): Edema, fluid retention
Frequency not reported: Various infections[Ref]
Respiratory
Very common (10% or more): Bacterial pneumonia (up to 10%)
Common (1% to 10%): Cough
Very rare (less than 0.01%): Asthma, bronchospasm, dyspnea, wheezing
Frequency not reported: Apnea, respiratory depression, pneumonia, rhinitis, epistaxis
Patent Ductus Arteriosus:
Very common (10% or more): Apnea (28%), respiratory infection (19%), respiratory failure (10%),
bronchopulmonary dysplasia
Common (1% to 10%): Atelectasis, pulmonary hemorrhage
Uncommon (0.1% to 1%): Hypoxemia
Postmarketing reports: Pulmonary hypertension[Ref]
Hepatic
Very rare (less than 0.01%): Hepatitis, jaundice
Frequency not reported: Hepatorenal syndrome, liver necrosis, liver failure, abnormal liver function tests
Patent Ductus Arteriosus:
Frequency not reported: Cholestasis, jaundice[Ref]
Hypersensitivity
Hypersensitivity reactions have been reported and may consist of any of the following: a syndrome of
abdominal pain, fever, chills, nausea, vomiting, and anaphylaxis; respiratory tract reactivity comprising
bronchospasm, asthma/aggravated asthma, or dyspnea; skin reactions, which rarely included exfoliative and
bullous dermatoses, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, pruritus, and
urticaria.[Ref]
Frequency not reported: Anaphylactoid reactions, hypersensitivity reaction[Ref]
Ocular
Very rare (less than 0.01%): Visual disturbances
Frequency not reported: Blurred vision, amblyopia, diminished vision, scotomata, changes in color vision,
conjunctivitis, dry eyes, diplopia, optic neuritis, cataracts, optic neuritis, toxic optic neuropathy[Ref]
Musculoskeletal
Frequency not reported: Lupus erythematosus syndrome[Ref]
Psychiatric
Frequency not reported: Anxiety, confusion, depression, dream abnormalities, insomnia, emotional lability,
hallucinations[Ref]
Genitourinary
Common (1% to 10%): Urinary retention
Very rare (less than 0.01%): Proteinuria, hematuria
Frequency not reported: Dysuria, oliguria, polyuria, menorrhagia
Patent Ductus Arteriosus:
Very common (10% or more): Oliguria, hematuria
Common (1% to 10%): Urinary tract infection[Ref]
Immunologic
Frequency not reported: Serum sickness[Ref]
Local
Common (1% to 10%): Infusion site pain
Postmarketing reports: Transient sensation of burning in mouth/throat
Patent Ductus Arteriosus:
Frequency not reported: Injection site reactions[Ref]
Endocrine
Frequency not reported: Gynecomastia
Patent Ductus Arteriosus:
Common (1% to 10%): Adrenal insufficiency[Ref]
Not all side effects for ibuprofen may be reported. You should always consult a doctor or healthcare
professional for medical advice. Side effects can be reported to the FDA here.