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Drug Profile

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, CHILDREN’S ELIXSURE, IBU-TAB, IBU-TAB 200, IBUPROHM, MEDIPREN, MIDOL LIQUID GELS, MOTRIN, MOTRIN IB, NEOPROFEN, NUPRIN, PROFEN, 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

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, including heart attack and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • NSAIDs are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk of serious gastrointestinal events. (See WARNINGS)

Facts About This Drug [top]

Ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN) 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 e...

Ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN) 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 side 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]

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.[5]

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 should also 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.[6],[7],[8],[9],[10]

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.[11]

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."[12]

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.[13]

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.[14],[15] 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:

  • a severe allergic reaction to aspirin or any other NSAID
  • peptic ulcers
  • nasal polyps

Tell your doctor if you have or have had:

  • a mild allergic reaction to aspirin or other NSAIDs (runny nose, hives, skin rash)
  • heart, kidney, or liver problems
  • hemophilia or other bleeding problems
  • high blood pressure
  • anemia
  • asthma
  • active alcohol dependence
  • edema
  • diabetes
  • pregnancy or are breast-feeding
  • stomach or intestinal problems, including Crohn’s disease, peptic ulcer, and diverticulitis
  • tobacco use
  • inflammation of the mouth

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Get regular checkups when you take the drug for a long time.
  • Do not drink alcohol. It irritates the stomach lining and increases the risk of stomach bleeding.
  • Do not take two or more NSAID drugs at the same time.
  • Protect yourself from the sun.
  • Call your doctor immediately if you have flulike symptoms (chills, fever, muscle aches or pains) shortly before or at the same time as a skin rash. This may be a sign of a serious reaction to ibuprofen.
  • You may feel dizzy when rising from a lying or sitting position. If you are lying down, hang your legs over the side of the bed for a few minutes, then get up slowly. When getting up from a chair, stay by the chair until you are sure that you are not dizzy.
  • If you plan to have any surgery, including dental, tell your doctor that you take this drug.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as possible, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take with food or antacids to reduce stomach irritation.
  • Take with a full glass (eight ounces) of water. Do not lie down for 15 to 30 minutes afterward.
  • Read patient information provided if you buy ibuprofen without a prescription.
  • Store at room temperature, with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

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:

  • abdominal pain or swelling
  • appetite loss
  • bloody or black, tarry stools
  • increase or decrease in blood pressure
  • difficulty breathing
  • unusual bruising
  • chest pain
  • chills
  • confusion
  • cough or hoarseness
  • depression
  • drowsiness
  • pain, dryness, redness, irritation, or swelling of the eyes
  • facial skin color changes
  • fever
  • gastrointestinal pain, cramping, or burning
  • swollen glands
  • hallucinations
  • headache
  • hearing change or ringing or buzzing in the ears
  • heartburn
  • hives on face, eyelids, or tongue
  • indigestion
  • lower back, neck, or side pain
  • unusually heavy menstrual bleeding
  • muscle cramps or pain
  • nausea, vomiting
  • nosebleeds, runny nose, or sneezing
  • numbness, tingling, pain, or weakness in hands or feet
  • pinpoint red spots on skin
  • skin rash, blisters, hives, itching, scaling
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • swelling of face, lips, tongue, fingers, lower legs, or feet
  • unusual tiredness or weakness
  • difficulty urinating
  • bloody or cloudy urine
  • vision change
  • vomiting blood or material that looks like coffee grounds
  • rapid weight gain
  • yellow eyes or skin

Call your doctor if these symptoms continue:

  • dizziness
  • drowsiness
  • mild to moderate headache
  • pounding heartbeat
  • trouble sleeping
  • abdominal cramps, pain, or discomfort
  • bloated feeling or gas
  • constipation
  • decrease or loss of appetite
  • diarrhea
  • stomach pain or discomfort
  • heartburn
  • indigestion
  • nausea or vomiting
  • irritation, dryness, or soreness of mouth
  • nervousness or irritability
  • sunburn

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • kidney function tests
  • liver function tests
  • stool tests for possible blood loss
  • hematocrit and/or hemoglobin test
  • blood concentrations of creatinine, potassium, and urea nitrogen
  • white blood cell count
  • upper GI diagnostic tests
  • ophthalmologic exams

last reviewed February 28, 2021