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
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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 |
Show 9 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| indocin | New Drug Application | 2023-07-27 |
| indocin sr | ANDA | 2010-01-12 |
| indomethacin | ANDA | 2024-11-20 |
| 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
186 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatitis | D010195 | HP_0001733 | K85 | 2 | 5 | 10 | 8 | 20 | 42 |
| Patent ductus arteriosus | D004374 | HP_0001643 | Q25.0 | 1 | 9 | 7 | 1 | 8 | 24 |
| Premature birth | D047928 | EFO_0003917 | O60 | 2 | 5 | 4 | 2 | 5 | 17 |
| Premature obstetric labor | D007752 | — | O60 | 2 | 3 | 2 | 4 | 5 | 14 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | 2 | 3 | 9 |
| Postoperative pain | D010149 | — | G89.18 | — | 1 | 2 | 1 | 1 | 5 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 1 | 2 | 1 | — | 5 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 1 | 2 | 2 | — | 5 |
| Gouty arthritis | D015210 | — | — | — | 1 | 1 | 2 | — | 4 |
| Gout | D006073 | EFO_0004274 | M10 | 1 | — | 1 | 2 | — | 4 |
Show 27 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | — | 2 | 3 |
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | 1 | — | — | 3 |
| Squamous cell carcinoma | D002294 | — | — | — | 2 | 1 | — | — | 3 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | 2 | 1 | — | — | 3 |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | 1 | 1 | 2 | — | — | 3 |
| Covid-19 | D000086382 | — | — | 1 | 1 | 1 | — | — | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | 1 | 1 | — | — | 2 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | 1 | 2 | 1 | — | — | 2 |
| Embryo transfer | D004624 | — | — | — | 1 | 2 | — | — | 2 |
| Newborn infant diseases | D007232 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endoscopic retrograde cholangiopancreatography | D002760 | — | — | — | 1 | — | — | 4 | 5 |
| Prostatic neoplasms | D011471 | — | C61 | 3 | 3 | — | — | — | 4 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 3 |
| Adenocarcinoma | D000230 | — | — | 1 | 2 | — | — | — | 2 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 1 | 1 | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Recurrence | D012008 | — | — | 1 | 1 | — | — | 1 | 2 |
| Regional blood flow | D012039 | — | — | — | 1 | — | — | 1 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 1 | — | — | 1 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 1 | — | — | — | 1 |
Show 28 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 1 | — | — | — | 1 | 2 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | 1 | — | — | — | 1 | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 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 |
| Cerebral arterial diseases | D002539 | EFO_1000859 | — | 1 | — | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 4 | 4 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 3 | 3 |
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | — | — | 2 | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | — | — | — | 1 | 1 |
| Pancreas divisum | D000092142 | — | — | — | — | — | — | 1 | 1 |
| Rotator cuff injuries | D000070636 | — | M75.1 | — | — | — | — | 1 | 1 |
| Femoracetabular impingement | D057925 | — | — | — | — | — | — | 1 | 1 |
| Headache disorders | D020773 | EFO_0009550 | G44 | — | — | — | — | 1 | 1 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | — | — | 1 | 1 |
Show 27 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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—
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
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Trends
PubMed Central
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Additional graphs summarizing 51,149 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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6,664 adverse events reported
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