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Indomethacin

Endol, Endosetin, Inomet SR · ATC code M01AB01

Also known as: Indometacin, İndometazin

Key facts
Active substance
Indomethacin
ATC code
M01AB01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Cardiovascular Thrombotic Events

  • • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1) ].
  • • Indomethacin capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1) ].

Gastrointestinal Bleeding, Ulceration, and Perforation

  • • NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ].

Key facts

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID). Per this US label (capsules), it is used for inflammatory and degenerative joint disease, acute painful shoulder and acute gouty arthritis.

What it is used for

  • Moderate to severe rheumatoid arthritis, including acute flares
  • Moderate to severe ankylosing spondylitis and osteoarthritis
  • Acute painful shoulder (bursitis and/or tendinitis)
  • Acute gouty arthritis

Dosing

  • General: lowest effective dosage for the shortest duration
  • Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis: 25 mg two or three times a day; increase by 25 mg or 50 mg at weekly intervals up to 150 to 200 mg/day; do not exceed 200 mg daily
  • For night pain or morning stiffness, up to 100 mg of the daily dose may be given at bedtime
  • Acute painful shoulder: 75 to 150 mg daily in 3 or 4 divided doses, usually for 7 to 14 days
  • Acute gouty arthritis: 50 mg three times a day until pain is tolerable, then rapidly reduce to cessation
  • Use with greater care in the elderly

Contraindications

  • Known hypersensitivity to indomethacin or any component
  • History of asthma, urticaria or allergic-type reactions after aspirin or other NSAIDs
  • In the setting of coronary artery bypass graft (CABG) surgery

Important warnings

  • Boxed warning: increased risk of serious cardiovascular thrombotic events (myocardial infarction, stroke), which can be fatal
  • Boxed warning: serious gastrointestinal bleeding, ulceration and perforation, possibly without warning symptoms; greater risk in the elderly and with ulcer history
  • Hepatotoxicity, hypertension, heart failure and edema
  • Renal toxicity and hyperkalemia; anaphylactic and serious skin reactions, DRESS
  • Fetal toxicity from about 20 weeks of gestation

Side effects

  • Incidence greater than 1%: nausea with or without vomiting, dyspepsia, diarrhea, abdominal pain, constipation
  • Headache (11.7%), dizziness, somnolence
  • Less common: peptic ulcer, GI bleeding and perforation, toxic hepatitis

Interactions

  • Anticoagulants (e.g. warfarin), SSRIs/SNRIs: increased bleeding risk
  • ACE inhibitors, ARBs, beta-blockers: diminished antihypertensive effect; possible deterioration of renal function
  • Lithium: raised lithium levels; methotrexate: increased toxicity; cyclosporine: increased nephrotoxicity

Pregnancy and breastfeeding

  • Pregnancy: limit dose and duration between about 20 and 30 weeks; avoid from about 30 weeks (premature ductus arteriosus closure, oligohydramnios)
  • Lactation: may be present in human milk; weigh benefits and risks

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Turkey

  • EndolDEVA HOLDİNG A.Ş. · 4 register entries
  • EndosetinNOBEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • Inomet SRULKAR KİMYA SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • IndocinZyla Life Sciences US Inc., Zyla Life Sciences US LLC · 2 register entries

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Indomethacin (Glenmark Pharmaceuticals Inc., USA) – Prescribing Information, 2025-12-19. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f7ed39e2-5431-4e47-935c-c7441d058f94
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.