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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: indomethacin (in doe METH a sin)
Brand name(s): INDOCIN, TIVORBEX
GENERIC: available FAMILY: Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

See aspirin or ibuprofen.

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]

Do Not Use: This drug is no more effective than related drugs and causes a higher rate of ulcers.

Indomethacin (INDOCIN) belongs to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), which are often used to treat arthritis in older adults. It relieves the pain and inflammation of rheumatoid arthritis, osteoarthritis, acute gout, acute painful shoulder (bursitis and/or tendinitis) and ankylosing sponditis (a form of arthritis affecting the spine and large joints).

...

Do Not Use: This drug is no more effective than related drugs and causes a higher rate of ulcers.

Indomethacin (INDOCIN) belongs to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), which are often used to treat arthritis in older adults. It relieves the pain and inflammation of rheumatoid arthritis, osteoarthritis, acute gout, acute painful shoulder (bursitis and/or tendinitis) and ankylosing sponditis (a form of arthritis affecting the spine and large joints).

This drug is not recommended for older adults.[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. Older people are more likely to experience adverse effects from bleeding.

Because older adults also are more likely to have reduced liver and kidney function, they are more likely to suffer the adverse effects of NSAIDs. Therefore, some doctors recommend people over age 70 be started on half the usual dose of drugs in this group.[2]

Indomethacin can cause depression, mood changes and confusion. Indomethacin also may make epilepsy or Parkinson’s disease worse, cause more stomach and intestinal bleeding than aspirin, and hide the signs of any infection you might have. Indomethacin is included on a well-recognized list of drugs that are inappropriate for use in older adults because of all of the available NSAIDs, this drug produces the most central nervous system adverse effects.[1]

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.[3]

Information from another article in the BMJ 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 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 take NSAIDs

In cases of advanced kidney disease, treatment with NSAIDs is not recommended. However, if NSAID therapy must be initiated, close monitoring of the patient’s kidney function is advisable.

NSAIDs also are contraindicated in patients in whom aspirin or other nonsteroidal anti-inflammatory/analgesic drugs induce asthma, rhinitis and nasal polyps. These reactions have the potential to be fatal. Therefore, careful questioning of patients for asthma, nasal polyps, urticaria (hives) and low blood pressure associated with NSAIDs before starting therapy is important. In addition, if such symptoms occur during therapy, treatment should be discontinued.

Better options available

Among the NSAIDs, evidence shows that ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN) is less toxic than other drugs in this family to the gastrointestinal tract, which is one of the main safety concerns with NSAIDs.[6],[7],[8],[9],[10]

Aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPIRIN) is just as effective as and less costly than other NSAIDs and 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 indomethacin

2005: The Food and Drug Administration (FDA) requested that manufacturers of NSAIDs, both prescription and over-the-counter, revise the drugs’ labels to include the potentially increased risks of cardiovascular events (read the information noted with COX-2 inhibitors) and gastrointestinal bleeding (see “Warnings” box at top of page). The FDA also required a Medication Guide be provided to patients with each dispensed prescription.

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.[12]

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.[13],[14] 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.

last reviewed February 28, 2021