The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.
Generic drug name:
ibuprofen
(eye byou PRO fen)
Brand name(s):
ADVIL,
CALDOLOR,
CHILDREN’S ELIXSURE,
IBU-TAB,
IBU-TAB 200,
JUNIOR STRENGH MOTRIN,
MIDOL LIQUID GELS,
MOTRIN,
MOTRIN IB,
TAB-PROFEN
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
NSAIDs have caused serious harm to human infants born to mothers taking these drugs during pregnancy, particularly the third trimester of pregnancy. Such infants have been born with damage to the heart, blood vessels, kidney, and gastrointestinal tract. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take these drugs.
Breast-feeding Warning
No information relating to breast-feeding is available from either human or animal studies.
Safety Warnings For This Drug [top]
FDA BLACK-BOX WARNINGS
Cardiovascular Risk
Gastrointestinal Risk
Facts About This Drug [top]
Ibuprofen (ADVIL, CHILDREN’S ELIXSURE, IBU-TAB, IBU-TAB 200, MIDOL LIQUID GELS, MOTRIN IB, TAB-PROFEN) belongs to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), often used to treat arthritis in older adults. Ibuprofen is used to treat fever and pain, including pain caused by two kinds of arthritis: osteoarthritis and rheumatoid arthritis.
Be cautious when administering ibuprofen to children. There have been cases of gastrointestinal bleeding reported in children...
Ibuprofen (ADVIL, CHILDREN’S ELIXSURE, IBU-TAB, IBU-TAB 200, MIDOL LIQUID GELS, MOTRIN IB, TAB-PROFEN) belongs to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), often used to treat arthritis in older adults. Ibuprofen is used to treat fever and pain, including pain caused by two kinds of arthritis: osteoarthritis and rheumatoid arthritis.
Be cautious when administering ibuprofen to children. There have been cases of gastrointestinal bleeding reported in children following the ingestion of low-dose ibuprofen.[1]
Adverse effects
NSAIDs can cause serious harm, even death, from bleeding in the stomach or intestines. Bleeding can occur at any time and without warning, and older people are more likely to experience adverse effects from bleeding. Normally, older adults often have reduced liver and kidney function, thereby limiting their ability to metabolize and/or excrete drugs. Some doctors therefore recommend that people over age 70 be started with half the usual dose of drugs in this group.[2] In general, patients over 60 should take less than the usual adult dose, especially patients with decreased kidney function from causes other than aging.
German authorities have received numerous reports of adverse effects involving ibuprofen. Twenty-two percent of these reports received between 1990 and 2004 involved neurological reactions; 13% involved psychiatric reactions.[3]
The British Medical Journal (BMJ) published a meta-analysis (a study that combines data from many other studies) looking at the use of NSAIDs and cardiovascular safety. The authors of the article stated that there is a risk of cardiovascular adverse effects associated with these drugs, and this risk must be considered when treating patients.
Information from another article in the BMJ also found that the use of NSAIDs was associated with the occurrence of abnormal heart rhythms called atrial fibrillation or flutter.[4]
NSAIDs rarely can cause serious adverse skin reactions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, which can be fatal.[5]
There have been reports of patients taking NSAIDs developing a potentially fatal disorder known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS can lead to fever; rash; swollen lymph glands; and inflammation in the liver, kidneys, heart and other organs.[5]
Interactions
Studies suggest a possible harmful interaction between nonsteroidal anti-inflammatory drugs (NSAIDs) and a class of osteoporosis drugs called bisphosphonates. Patients need to be alert to the fact that the combination can result in an increased risk of ulcers and other gastrointestinal adverse effects. Read more in the July 2010 issue of Worst Pills, Best Pills News.
Combining NSAIDs with anticoagulants (blood thinners for preventing blood clots) increases the risk of serious bleeding complications.[6]
When not to use ibuprofen
Treatment with NSAIDs is not recommended in patients with advanced kidney disease. However, if NSAID therapy must be initiated, close monitoring of the patient's kidney function is advisable.
NSAIDs also should not be used in patients in whom aspirin or other nonsteroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis and nasal polyps. Both types of reactions have the potential to be fatal. Therefore, it is important for patients with asthma, nasal polyps, hives and low blood pressure associated with NSAIDs to make their doctors aware of these conditions before starting therapy. In addition, if such symptoms occur during therapy, treatment should be discontinued.
Better options available
Among the NSAIDs, evidence shows that ibuprofen is less toxic to the gastrointestinal tract, the main safety concern with NSAIDs, than other drugs in this family.[7],[8],[9],[10],[11]
Still, aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPIRIN) is just as effective as and less costly than other NSAIDs. Aspirin is the drug of choice for treating pain, fever and inflammation in people who do not have ulcers, gastritis (inflammation of the stomach) or an allergy to aspirin. Some rheumatologists prefer aspirin to other NSAIDs for treating rheumatoid arthritis.[12]
Regulatory actions surrounding ibuprofen
2005: The Food and Drug Administration (FDA) requested that manufacturers of both prescription and over-the-counter NSAIDs revise the drugs' label to include information on the potentially increased risks of cardiovascular events (see the information noted with COX-2 inhibitors) and gastrointestinal bleeding. The FDA also required a Medication Guide be provided to patients with each dispensed prescription.
2006: The FDA added a warning statement to the drug facts label, advising patients to "ask a doctor or pharmacist before use if ... taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin."[13]
2015: The FDA announced that the agency is strengthening the existing warning for all non-aspirin NSAIDs concerning an increased risk of heart attack and stroke.[14]
2020: The FDA and Health Canada (an agency in Canada similar to the FDA) warned that use of NSAIDs at about 20 weeks or later in pregnancy rarely causes serious kidney problems in an unborn baby.[15],[16] These kidney problems can lead to oligohydramnios, a condition in which there are low levels of amniotic fluid surrounding the baby. Amniotic fluid normally provides a protective cushion and plays an important role in the development of a baby’s lungs, digestive system and muscles. Oligohydramnios in turn can lead to decreased range of motion in a baby’s arms and legs and delayed lung maturation.
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:
abciximab, ardeparin, bendroflumethiazide, BENEMID, CAPOTEN, captopril, certoparin, clopidogrel, COUMADIN, cyclosporine, digoxin, DILANTIN, enoxaparin, eptifibatide, GARAMYCIN, gentamicin, INDERAL, INDERAL LA, INTEGRILIN, ketorolac, labetalol, LANOXICAPS, LANOXIN, lithium, LITHOBID, LITHONATE, LOVENOX, methotrexate, MINIPRESS, nadroparin, NATURETIN, NEORAL, NORMODYNE, NORVIR, phenytoin, PLAVIX, prazosin, probenecid, propranolol, TREXALL DOSE PACK, ritonavir, SANDIMMUNE, TORADOL, TRANDATE, warfarin.
The NSAIDs may diminish the blood-pressure-lowering effect of the angiotensin converting enzyme (ACE) inhibitors. See listing of ACE inhibitors.
The NSAIDs may reduce the effect of furosemide (LASIX).
The NSAIDs may reduce the effect of the thiazide diuretics (water pills). See listing of thiazide diuretics.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed August 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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