Indomethacin

Indomethacin has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of indomethacin capsules, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

• Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis Indomethacin capsules are nonsteroidal anti-inflammatory drug indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis ( 1 )ICD-10: M06.9, M10.9, M19.90

• Indomethacin capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9) ] . History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.contraindicated

Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. ( 2.1 ) The dosage for moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis is indomethacin capsules 25 mg two or three times a day. ( 2.2 ) The dosage for acute painful shoulder (bursitis and/or tendinitis) is 75 to 150 mg daily in 3 or 4 divided doses. ( 2.3 ) The dosage for acute gouty arthritis is indomethacin capsules 50 mg three times a day. ( 2.4 ) 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs. Adverse reactions generally appear to correlate with the dose of indomethacin. Therefore, every effort should be made to determine the lowest effective dosage for the individual patient. Dosage recommendations for active stages of the following: 2.2 Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis Indomethacin capsules 25 mg twice a day or three times a day.

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of indomethacin capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. ( 5.5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of indomethacin capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. ( 5.6 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs. ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Indomethacin capsules are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). ( 5.8 ) Serious Skin Reactions : Discontinue indomethacin capsules at first appearance of skin rash or other signs of hypersensitivity. ( 5.9 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue and evaluate clinically ( 5.10 ) Fetal Toxicity : Limit use of NSAIDs, including indomethacin capsules, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.1 )] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions ( 5.2 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Heart Failure and Edema [see Warnings and Precautions ( 5.5 )] Renal Toxicity and Hyperkalemia [see Warnings and Precautions ( 5.6 )] Anaphylactic Reactions [see Warnings and Precautions ( 5.7 )] Serious Skin Reactions [see Warnings and Precautions ( 5.9 )] Hematologic Toxicity [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (incidence ≥ 3%) are headache, dizziness, dyspepsia and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving indomethacin capsules than in the group taking indomethacin suppositories or placebo.

Infertility : NSAIDs are associated with reversible infertility. Consider withdrawal of indomethacin capsules in women who have difficulties conceiving. ( 8.3 ) 8.1 Pregnancy Risk Summary Use of NSAIDs, including indomethacin capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of indomethacin capsules use between about 20 and 30 weeks of gestation, and avoid indomethacin capsules use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including indomethacin capsules, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

Metabolism

Absorption Following single oral doses of indomethacin capsules, 25 mg or 50 mg, indomethacin is readily absorbed, attaining peak plasma concentrations of about 1 and 2 mcg/mL, respectively, at about 2 hours. Orally administered indomethacin capsules are virtually 100% bioavailable, with 90% of the dose absorbed within 4 hours.

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.6) ]. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

• Aug 6, 1984NDANDA018829Chartwell Molecules
• Oct 10, 1985NDANDA018332Zyla
• Mar 5, 1986ANDAANDA070651Chartwell Molecules
• Aug 31, 1992ANDAANDA073314Cosette
• Mar 6, 2009ANDAANDA079175Avanthi Inc
• Mar 17, 2010NDANDA022536Fresenius Kabi Usa
• Dec 1, 2010ANDAANDA091549Amneal Pharms
• Dec 22, 2010ANDAANDA091276Glenmark Pharms Ltd

1. 1Drug Ineffective1,38811%
2. 2Fatigue1,1238.6%
3. 3Arthralgia1,0177.8%
4. 4Headache1,0107.8%
5. 5Off Label Use9627.4%
6. 6Pain9337.2%
7. 7Nausea9197.1%
8. 8Diarrhoea8896.8%
9. 9Dizziness8796.8%
10. 10Dyspnoea7515.8%
11. 11Vomiting7485.7%
12. 12Asthenia6475.0%
13. 13Pyrexia6214.8%
14. 14Pruritus6154.7%
15. 15Malaise6024.6%

Recent PubMed references pinned to Indomethacin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Xenin-25 improves indomethacin-induced acute gastric injury in rats.
  Pflugers Archiv : European journal of physiology · 2026 · Arabacı Tamer S, Güney Eskiler G, Ercan F, et al.
  PMID 42260116DOI 10.1007/s00424-026-03186-9
• Prenatal Indomethacin Exposure Is Associated With Autism-Relevant Behavioral Alterations Linked to Oxidative Stress and Altered Autophagy-Related Signaling.
  Developmental neurobiology · 2026 · Akbaş B, Akbaş A, Hacım NA, et al.
  PMID 42136360DOI 10.1002/dneu.70041
• Incorporation of micronized poorly soluble drug into orodispersible tablets by aqueous fluid bed granulation of co-processed excipients.
  European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2026 · Badawi S, Lillotte T, Esser E, et al.
  PMID 42013942DOI 10.1016/j.ejpb.2026.115078
• Protective effect of magnesium on indomethacin-induced gastric ulcer in mice.
  Biometals : an international journal on the role of metal ions in biology, biochemistry, and medicine · 2026 · Rostami R, Eidi A, Mortazavi P, et al.
  PMID 42010200DOI 10.1007/s10534-026-00803-z
• Effect of Drug-Polymer Interaction on Solid-State Stability and In Vitro Drug Flux of Amorphous Solid Dispersions.
  Molecular pharmaceutics · 2026 · Kumar NSK, Jankovsky C, Zimny E, et al.
  PMID 42003393DOI 10.1021/acs.molpharmaceut.6c00196
• Ketorolac-induced peptic ulcer bleeding after cholecystectomy in a "healed" ulcer patient: A CARE case report.
  Medicine · 2026 · Jin L, Yang L, Qiu S, et al.
  PMID 41995504DOI 10.1097/MD.0000000000048355
• Stabilizing liquid-like drug-rich intermediates by bile salts to suppress phase transformation and promote rapid absorption of cocrystals.
  Journal of controlled release : official journal of the Controlled Release Society · 2026 · Ji X, Zhuang Z, Liu H, et al.
  PMID 41966337DOI 10.1016/j.jconrel.2026.114919
• Ketorolac tromethamine-loaded hydrogel-forming microneedles for pediatric pain relief.
  Journal of pharmaceutical sciences · 2026 · Huang G, Chen S, Zhang Y, et al.
  PMID 41935719DOI 10.1016/j.xphs.2026.104276

The 10 most recently updated of 595 ClinicalTrials.gov registrations naming Indomethacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF POST-ERCP PANCREATITIS -RCT
  Recruiting · Observational · 150 enrolled · Asian Institute of Gastroenterology, India
  NCT07574970updated 2026-06-12
• Human Cerebral Blood Flow Regulation
  Completed · Early phase 1 · Interventional · 42 enrolled · University of Wisconsin, Madison
  NCT04265053updated 2026-06-12
• Phase I Platinum Based Chemotherapy Plus Indomethacin
  Completed · Phase 1 · Interventional · 13 enrolled · UMC Utrecht
  NCT01719926updated 2026-06-04
• Autonomic Control of the Circulation and VDR
  Recruiting · Early phase 1 · Interventional · 18 enrolled · Milton S. Hershey Medical Center
  NCT03513770updated 2026-06-02
• Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy
  Terminated · Phase 2 · Phase 3 · Interventional · 58 enrolled · Wake Forest University Health Sciences
  NCT05597878updated 2026-06-01
• IV Ketorolac on Platelet Function Post-Cesarean Delivery
  Completed · Phase 4 · Interventional · 40 enrolled · Beth Israel Deaconess Medical Center
  NCT03805607updated 2026-05-29
• Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP
  Recruiting · Interventional · 130 enrolled · Zhejiang University
  NCT07607990updated 2026-05-27
• Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease
  Recruiting · Phase 1 · Phase 2 · Interventional · 80 enrolled · University of Texas Southwestern Medical Center
  NCT06158620updated 2026-05-27
• Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome
  Not yet recruiting · Early phase 1 · Interventional · 72 enrolled · University of Wisconsin, Madison
  NCT07218653updated 2026-05-26
• Evaluation of the Effects of Ketorolac Dose on Duration of Analgesia in Emergency Department (ED) Renal Colic Patients
  Recruiting · Phase 4 · Interventional · 86 enrolled · Hackensack Meridian Health
  NCT05776953updated 2026-05-22

CPIC-curated drug–gene pairs for Indomethacin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2C9CPIC CClinPGx 3
  CYP2C9 and NSAIDs

Frequently asked questions

How does Indomethacin work?

Indomethacin has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of indomethacin capsules, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

What is Indomethacin used for?

According to FDA labeling, Indomethacin carries indications including: Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis Indomethacin capsules are nonsteroidal anti-inflammatory drug indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis ( 1 ). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Indomethacin?

Indomethacin is classified as Acetic acid derivatives and related substances, Antiinflammatory agents, non-steroids, Antiinflammatory preparations, non-steroids for topical use, Other cardiac preparations, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors, Decreased Prostaglandin Production.

What are the brand names for Indomethacin?

Indomethacin is marketed under brand names including Indocin, Tivorbex.

What are the contraindications for Indomethacin?

Indomethacin labeling lists contraindications including: Indomethacin capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9) ] . History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.. Always consult the full prescribing information and a clinician.