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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Commercial
Therapeutic Areas
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 | 2026-01-29 |
| 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
No data
Clinical
Clinical Trials
586 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | — | 2 | — | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | 1 | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | 1 | — | 2 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | 1 | — | 1 |
| Hyperopia | D006956 | EFO_0006310 | H52.0 | — | — | — | 1 | — | 1 |
| Corneal opacity | D003318 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | — | 1 | — | — | 1 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | — | 1 | — | — | 1 |
| Cataract extraction | D002387 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular edema | D008269 | — | — | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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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Variants
No data
Financial
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Indocin – Assertio Therapeutics
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Indocin – Zyla Life Sciences
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Estimated US medical usage
Indomethacin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 55,564 documents
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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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7,864 adverse events reported
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