Indomethacin
Indocin, Indomethacin (indomethacin) is a small molecule pharmaceutical. Indomethacin was first approved as Indocin on 1982-01-01. It is used to treat ankylosing spondylitis, bursitis, gouty arthritis, inflammation, and osteoarthritis amongst others in the USA. It is known to target prostaglandin G/H synthase 2, prostaglandin D2 receptor 2, proton-coupled folate transporter, prostaglandin G/H synthase 1, and peroxisome proliferator-activated receptor gamma.
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Trade Name
FDA
EMA
Indocin, Indomethacin (discontinued: Indo-lemmon, Indocin, Indomethacin, Tivorbex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indomethacin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INDOMETHACIN | Chartwell Pharmaceuticals | N-018829 RX | 1984-08-06 | 2 products |
| INDOMETHACIN | Fresenius Kabi | N-022536 RX | 2010-03-17 | 1 products, RLD, RS |
| INDOCIN | Zyla Life Sciences | N-018332 RX | 1985-10-10 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| indocin | ANDA | 2025-12-17 |
| indocin sr | ANDA | 2010-01-12 |
| indomethacin | ANDA | 2026-05-27 |
| indomethacin er | ANDA | 2010-04-16 |
| indomethacin extended-release | ANDA | 2017-12-20 |
| tivorbex | New Drug Application | 2018-01-31 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
INDOMETHACIN, INDOMETHACIN, ZYDUS | |||
| 2024-01-30 | CGT | ||
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01E: Other cardiac preparations in atc
— C01EB: Other plain cardiac preparations in atc
— C01EB03: Indometacin
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AB: Acetic acid derivatives and related substances
— M01AB01: Indometacin
— M01AB51: Indometacin, combinations
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AA: Antiinflammatory preparations, non-steroids for topical use
— M02AA23: Indometacin
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BC: Antiinflammatory agents, non-steroidal, ophthalmologic
— S01BC01: Indometacin
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CC: Antiinflammatory agents, non-steroids and antiinfectives in combination
— S01CC02: Indometacin and antiinfectives
HCPCS
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Clinical
Clinical Trials
598 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 9 | 18 | 21 | 38 | 18 | 99 |
| Pain | D010146 | EFO_0003843 | R52 | 4 | 8 | 8 | 24 | 13 | 56 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | 3 | 5 | 9 | 12 | 23 | 50 |
| Agnosia | D000377 | EFO_0007136 | F88 | 1 | 3 | 8 | 11 | 6 | 28 |
| Patent ductus arteriosus | D004374 | — | Q25.0 | 1 | 9 | 7 | 1 | 8 | 24 |
| Premature birth | D047928 | EFO_0003917 | O60 | 2 | 5 | 3 | 4 | 6 | 20 |
| Healthy volunteers/patients | — | — | — | 13 | 1 | — | 2 | 3 | 19 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 3 | 3 | 7 | 6 | 19 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 2 | 1 | 8 | 5 | 15 |
| Cataract | D002386 | EFO_0001059 | H26.9 | 2 | 1 | 1 | 10 | 2 | 15 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endoscopic retrograde cholangiopancreatography | D002760 | — | — | — | 1 | 1 | — | 6 | 8 |
| Prostatic neoplasms | D011471 | — | C61 | 3 | 4 | 1 | — | 1 | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | 2 | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | 2 | 3 | 1 | — | — | 5 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | 3 | — | 1 | 4 |
| Abdominal pain | D015746 | EFO_0003766 | R10.9 | — | — | 4 | — | — | 4 |
| Anterior cruciate ligament injuries | D000070598 | — | — | — | 1 | 3 | — | — | 3 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 1 | 1 | — | 1 | 3 |
| Squamous cell carcinoma | D002294 | — | — | — | 2 | 1 | — | — | 3 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | 2 | 1 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | 4 | — | — | 3 | 7 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | 2 | — | — | — | 3 |
| Bunion | D000071378 | — | M21.61 | — | 1 | — | — | 2 | 3 |
| Pathologic dilatation | D004108 | — | — | — | 1 | — | — | 2 | 3 |
| Adenocarcinoma | D000230 | — | — | 1 | 2 | — | — | — | 2 |
| Phimosis | D010688 | EFO_1001104 | N47.1 | 1 | 1 | — | — | — | 2 |
| Paraphimosis | D010263 | EFO_1001086 | N47.2 | 1 | 1 | — | — | — | 2 |
| Balanitis | D001446 | EFO_1000833 | N48.1 | 1 | 1 | — | — | — | 2 |
| Hypoxia | D000860 | — | R09.02 | 2 | 1 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | 1 | 2 |
Show 51 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | — | — | — | 1 | 3 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | 1 | — | — | — | 2 | 3 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | 1 | 2 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | — | — | — | 1 | 2 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | — | — | — | — | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | — | — | — | — | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | — | 1 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | — | — | 2 | 2 |
| Vomiting | D014839 | — | R11.1 | — | — | — | — | 2 | 2 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 2 | 2 |
| Regeneration | D012038 | — | — | — | — | — | — | 2 | 2 |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | — | — | — | — | 1 | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
| Epidural analgesia | D015360 | — | — | — | — | — | — | 1 | 1 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | — | — | 1 | 1 |
| Reperfusion injury | D015427 | — | — | — | — | — | — | 1 | 1 |
| Cryptorchidism | D003456 | EFO_0004562 | Q53.1 | — | — | — | — | 1 | 1 |
Show 48 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Indomethacin |
| INN | indometacin |
| Description | Indometacin is a member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis. It has a role as an EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor, an analgesic, a gout suppressant, a drug metabolite, a xenobiotic metabolite, a xenobiotic, an environmental contaminant and a non-steroidal anti-inflammatory drug. It is a N-acylindole, a member of monochlorobenzenes, an aromatic ether and a member of indole-3-acetic acids. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 53-86-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL6 |
| ChEBI ID | 49662 |
| PubChem CID | 3715 |
| DrugBank | DB00328 |
| UNII ID | XXE1CET956 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
AKR1C3
AKR1C3
Organism
Homo sapiens
Gene name
AKR1C3
Gene synonyms
DDH1, HSD17B5, KIAA0119, PGFS
NCBI Gene ID
Protein name
aldo-keto reductase family 1 member C3
Protein synonyms
17-beta-HSD 5, 17-beta-hydroxysteroid dehydrogenase type 5, 3-alpha hydroxysteroid dehydrogenase, type II, 3-alpha-HSD type 2, 3-alpha-HSD type II, brain, 3-alpha-hydroxysteroid dehydrogenase type 2, Chlordecone reductase homolog HAKRb, DD-3, DD3, Dihydrodiol dehydrogenase 3, Dihydrodiol dehydrogenase type I, dihydrodiol dehydrogenase X, HA1753, indanol dehydrogenase, PGFS, Prostaglandin F synthase, Testosterone 17-beta-dehydrogenase 5, trans-1,2-dihydrobenzene-1,2-diol dehydrogenase, type IIb 3-alpha hydroxysteroid dehydrogenase
Uniprot ID
Mouse ortholog
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Indocin – Assertio Therapeutics
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Indocin – Zyla Life Sciences
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Estimated US medical usage
Indomethacin
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Indocin, Indocin sr, Indomethacin, Indomethacin er, Indomethacin extended-release, Tivorbex
Adverse Events
Top Adverse Reactions
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8,046 adverse events reported
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