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Ibuprofen

"May 2, 2011 -- Many Americans may be unaware of the active ingredients and potential side effects of popular over-the-counter pain relievers, according to a new study.

Tylenol contains acetaminophen, Bayer contains aspirin,"...

Motrin

Ibuprofen Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Motrin (ibuprofen) is indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis, for relief of mild to moderate pain, and treatment of primary dysmenorrhea. A generic formulation is available. Motrin may cause stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. Other side effects may occur. Consult your physician if you experience any possible side effects.

The recommended dose of Motrin should be adjusted to suit individual patients needs but should not exceed 3200 mg in the total daily dose. Use of alcohol and smoking could increase side effects. Safe use of Motrin for use by children has not been established. It is not known whether ibuprofen is harmful to an unborn baby. However, taking ibuprofen during the last 3 months of pregnancy may result in birth defects. It is also not known whether ibuprofen passes into breast milk or if it could harm a nursing baby.

Our Motrin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ibuprofen in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ibuprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • bruising, severe tingling, numbness, pain, muscle weakness; or
  • severe headache, neck stiffness, chills, increased sensitivity to light, and/or seizure (convulsions).

Less serious side effects may include:

  • upset stomach, mild heartburn, diarrhea, constipation;
  • bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • blurred vision; 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.

Read the entire detailed patient monograph for Ibuprofen (Ibuprofen) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ibuprofen Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, vomiting, headache, diarrhea, constipation, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, hearing changes (such as ringing in the ears), mental/mood changes, swelling of the ankles/feet/hands, sudden/unexplained weight gain, unexplained stiff neck, change in amount of urine, vision changes, unusual tiredness.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ibuprofen (Ibuprofen)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ibuprofen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequent type of adverse reaction occurring with MOTRIN (ibuprofen) tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%.

In controlled studies when MOTRIN (ibuprofen) tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients.

Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.

Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with MOTRIN (ibuprofen) tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with MOTRIN (ibuprofen) tablets has not been established.

Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the table.

Incidence Greater than 1% (but less than 3%) Probable Causal Relationship Precise Incidence Unknown (but less than 1%) Probable Causal Relationship* Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown*
GASTROINTESTINAL
Nausea?, epigastric pain?, heartburn?, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating and flatulence) Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis  
CENTRAL NERVOUS SYSTEM
Dizzinesst, headache, nervousness Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS) Paresthesias, hallucinations, dream abnormalities, pseudo-tumor cerebri
DERMATOLOGIC
Rasht (including maculopapular type), pruritus Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia Toxic epidermal necrolysis, photoallergic skin reactions
SPECIAL SENSES
Tinnitus Hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision) (see PRECAUTIONS) Conjunctivitis, diplopia, optic neuritis, cataracts
HEMATOLOGIC
  Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit (see PRECAUTIONS) Bleeding episodes (eg epistaxis, menorrhagia)
METABOLIC/ENDOCRINE
Decreased appetite   Gynecomastia, hypoglycemic reaction, acidosis

CARDIOVASCULAR

Edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS) Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations Arrhythmias (sinus tachycardia, sinus bradycardia)
ALLERGIC
  Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS) Serum sickness, lupuserythematosus syndrome. Henoch-Schonlein vasculitis, angioedema
RENAL Acute renal failure (see PRECAUTIONS), decreased creatinine clearance, polyuria, azotemia, cystitis, Hematuria Renal papillary necrosis
MISCELLANEOUS
  Dry eyes and mouth, gingival ulcer, rhinitis  
*Reactions are classified under "Probable Causal Relationship (PCR)" if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under "Causal Relationship Unknown" if seven or more events have been reported but the criteria for PCR have not been met.
?Reactions occurring in 3% to 9% of patients treated with MOTRIN (ibuprofen) . (Those reactions occurring in less than 3% of the patients are unmarked).

Read the entire FDA prescribing information for Ibuprofen (Ibuprofen) »

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Motrin - User Reviews

Motrin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Motrin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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