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Generic Name: ibuprofen

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An NSAID - treats Cystic Fibrosis, Fever, Dysmenorrhea, Acute Gout, Headache, Rheumatoid Arthritis, ... more

FDA Alerts

Special Alerts:

[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough and http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.

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Ibuprofen
IP 131 / 400 400 mg	800 / IP 137 800 mg	IP 132 / 600 600 mg	IBU 600 600 mg
400 / IP 131 400 mg	IBU 800 800 mg	IBU 400 400 mg	IBU 400 400 mg
SCHEIN 0765/400 400 mg	unmarked 100 mg/5 mL	SCHEIN 0766/600 600 mg

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(eye byoo PROE fen)

What should I discuss with my healthcare provider before taking ibuprofen?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to ibuprofen, aspirin or other NSAIDs.

Before taking ibuprofen, tell your doctor if you are allergic to any drugs, or if you have:

a history of heart attack, stroke, or blood clot;
heart disease, congestive heart failure, high blood pressure;
a history of stomach ulcers or bleeding;
asthma;
polyps in your nose; or
liver or kidney disease,
systemic lupus erythematosus (SLE);
a bleeding or blood clotting disorder; or
if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take ibuprofen.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby during early pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. However, taking ibuprofen during the last 3 months of pregnancy may result in birth defects. Do not take ibuprofen during pregnancy unless your doctor has told you to. It is not known whether ibuprofen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

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