Drug Notebook

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
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(eye byoo PROE fen)

What is the most important information I should know about ibuprofen?

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

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine 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 ibuprofen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to 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 of ibuprofen needed to get relief from your pain, swelling, or fever. 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). Do not drink alcohol while taking ibuprofen. Alcohol can increase your risk of stomach bleeding caused by ibuprofen.

What is ibuprofen?

Ibuprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen 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 may also be used for other purposes not listed in this medication guide.

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:

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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