Indomethacin is a nonsteroidal anti-inflammatory drug sold in the U.S. under 4 brand and generic names, for rheumatoid arthritis, bursitis and patent ductus arteriosus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Indocin SR (application NDA018185). Other indomethacin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs. Indomethacin is available as 25 mg and 50 mg capsules. Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient. Pediatric Use Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS ). Adult Use Dosage Recommendations for Active Stages of the Following: Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis. Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE…
The adverse reactions for indomethacin capsules listed in the following table have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence for group (1) was obtained from 33 double-blind controlled clinical trials reported in the literature (1,092 patients). The incidence for group (2) was based on reports in clinical trials, in the literature, and on voluntary reports since marketing. The probability of a causal relationship exists between indomethacin and these adverse reactions, some of which have been reported only rarely. Incidence greater than 1% GASTROINTESTINAL nausea 1 with or without vomiting dyspepsia 1 (including indigestion, heartburn and epigastric pain) diarrhea abdominal distress or pain constipation CENTRAL NERVOUS SYSTEM headache (11.7%) dizziness 1 vertigo somnolence depression and fatigue (including malaise and listlessness) SPECIAL SENSES tinnitus CARDIOVASCULAR none METABOLIC none INTEGUMENTARY none HEMATOLOGIC none HYPERSENSITIVITY none GENITOURINARY none MISCELLANEOUS none 1 Reactions occurring in 3% to 9% of patients treated with indomethacin. (Those reactions occurring in less than 3% of the patients are unmarked.) Incidence less than 1% GASTROINTESTINAL anorexia bloating (includes distention) flatulence peptic ulcer gastroenteritis rectal bleeding proctitis single or multiple ulcerations, including…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | Generic | $4 | View → | |
| 2 | Not yet rated | Prescription | Suppository | Generic | $4 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| G302;G | 50 mg | green | capsule | — |
| G302;G | 50 mg | green | capsule | — |
| G406;G | 25 mg | green | capsule | — |
| H;103 | 25 mg | green | capsule | — |
| H;104 | 50 mg | green | capsule | — |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Indomethacin Extended-Release Capsules
cGMP deviations
Amerisource Health Services LLC · May 15, 2025
Indomethacin Extended-Release Capsules USP
cGMP deviations
KVK Tech, Inc. · May 9, 2025
Indomethacin Extended-Release Capsules
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Indomethacin Extended-Release Capsules
Failed Dissolution Specifications: below specification results
Glenmark Pharmaceuticals Inc., USA · Jul 31, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Indomethacin is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION ). Indomethacin should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic/anaphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactic/Anaphylactoid Reactions , and PRECAUTIONS: General: Preexisting Asthma ). Indomethacin is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
ACE Inhibitors and Angiotensin II Antagonists Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors and angiotensin II antagonists. Indomethacin can reduce the antihypertensive effects of captopril and losartan. These interactions should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors or angiotensin II antagonists. In some patients with compromised renal function, the coadministration of an NSAID and an ACE inhibitor or an angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Aspirin When indomethacin is administered with aspirin, its protein binding is reduced, although the clearance of free indomethacin is not altered. The clinical significance of this interaction is not known. The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. In a clinical study of the combined use of indomethacin and aspirin, the incidence of gastrointestinal side effects was significantly increased with combined therapy. In a study in normal volunteers, it was found that chronic concurrent administration of 3.6 g…
| View → |
| 3 | Not yet rated | Prescription | Capsule | Generic | $4 | View → |
| 4 | Not yet rated | Prescription | Capsule | Generic | $4 | View → |