Indomethacin
Indocin (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 D2 receptor 2, peroxisome proliferator-activated receptor gamma, proton-coupled folate transporter, prostaglandin G/H synthase 2, prostaglandin G/H synthase 1, and aldo-keto reductase family 1 member C3.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| musculoskeletal diseases | D009140 |
| cardiovascular diseases | D002318 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| skin and connective tissue diseases | D017437 |
| nutritional and metabolic diseases | D009750 |
| immune system diseases | D007154 |
| signs and symptoms pathological conditions | D013568 |
| wounds and injuries | D014947 |
| psychological phenomena | D011579 |
| musculoskeletal and neural physiological phenomena | D055687 |
Trade Name
FDA
EMA
Indocin (generic drugs available since 1986-03-05, discontinued: Indo-lemmon, Indocin, Tivorbex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indomethacin
Indomethacin sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INDOCIN | Recordati | N-018878 DISCN | 1985-01-30 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| indocin | ANDA | 2020-03-24 |
| indomethacin | ANDA | 2023-06-07 |
| tivorbex | New Drug Application | 2018-01-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ankylosing spondylitis | EFO_0003898 | D013167 | M45 |
| bursitis | EFO_1000941 | D002062 | M71.9 |
| gouty arthritis | — | D015210 | — |
| inflammation | MP_0001845 | D007249 | — |
| osteoarthritis | EFO_0002506 | D010003 | M15-M19 |
| pain | EFO_0003843 | D010146 | R52 |
| patent ductus arteriosus | HP_0001643 | D004374 | Q25.0 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
| tendinopathy | EFO_1001434 | D052256 | M77.9 |
Agency Specific
FDA
EMA
No data
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
225 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 11 | 3 | 1 | 11 | 27 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 6 | 2 | 2 | 3 | 12 |
| Lymphedema | D008209 | Q82.0 | 1 | 1 | — | 1 | 2 | 5 | |
| Hypoparathyroidism | D007011 | E20 | — | — | 1 | 1 | 2 | 4 | |
| Prostatic neoplasms | D011471 | C61 | 2 | — | 1 | 1 | — | 4 | |
| Lymphatic metastasis | D008207 | EFO_1001364 | — | 1 | 1 | 1 | 2 | 4 | |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | 1 | — | — | 2 | — | 3 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | 1 | 1 | 2 | |
| Sarcoma | D012509 | — | 1 | — | 1 | — | 2 | ||
| Hypocalcemia | D006996 | HP_0002901 | E83.51 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 8 | 4 | 1 | — | — | 11 | |
| Colorectal neoplasms | D015179 | 1 | 3 | 1 | — | 4 | 8 | ||
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 1 | — | 6 | 8 | |
| Melanoma | D008545 | 2 | — | 2 | — | 3 | 7 | ||
| Rectal neoplasms | D012004 | 2 | 2 | 1 | — | 4 | 7 | ||
| Head and neck neoplasms | D006258 | 1 | 3 | 1 | — | 2 | 6 | ||
| Uterine cervical neoplasms | D002583 | 1 | — | 1 | — | 3 | 5 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | 2 | — | 1 | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | — | 1 | 2 |
| Vulvar neoplasms | D014846 | C51 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | C34.90 | 5 | 3 | — | — | 3 | 9 | |
| Cholecystitis | D002764 | HP_0001082 | K81 | — | 1 | — | — | 5 | 6 |
| Non-small-cell lung carcinoma | D002289 | 3 | 2 | — | — | 1 | 5 | ||
| Esophageal neoplasms | D004938 | C15 | 2 | 1 | — | — | 3 | 5 | |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | 2 | — | — | 2 | 5 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 1 | — | — | 2 | 5 |
| Lymph node excision | D008197 | — | 1 | — | — | 1 | 2 | ||
| Peritoneal neoplasms | D010534 | — | 2 | — | — | — | 2 | ||
| Adenocarcinoma | D000230 | 1 | 1 | — | — | — | 2 | ||
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | — | — | — | 1 | 4 |
| Solitary pulmonary nodule | D003074 | R91.1 | 1 | — | — | — | 2 | 3 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | 1 | 2 |
| Plastic surgery procedures | D019651 | 1 | — | — | — | 1 | 2 | ||
| Laparoscopy | D010535 | 1 | — | — | — | 1 | 2 | ||
| Ductal carcinoma | D044584 | 1 | — | — | — | 1 | 2 | ||
| Mesothelioma | D008654 | C45 | 1 | — | — | — | — | 1 | |
| Rotator cuff injuries | D000070636 | M75.1 | 1 | — | — | — | — | 1 | |
| Paraneoplastic syndromes | D010257 | 1 | — | — | — | — | 1 | ||
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anastomotic leak | D057868 | — | — | — | — | 4 | 4 | ||
| Colonic neoplasms | D003110 | C18 | — | — | — | — | 3 | 3 | |
| Gallstones | D042882 | EFO_0004210 | — | — | — | — | 2 | 2 | |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | — | — | 2 | 2 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 2 | 2 | |
| Macular edema | D008269 | — | — | — | — | 1 | 1 | ||
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | — | 1 | 1 | |
| Burns | D002056 | T30.0 | — | — | — | — | 1 | 1 | |
| Intracranial aneurysm | D002532 | EFO_0003870 | I67.1 | — | — | — | — | 1 | 1 |
| Necrotizing fasciitis | D019115 | M72.6 | — | — | — | — | 1 | 1 |
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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 |
Target
Agency Approved
No data
Alternate
PTGDR2
PTGDR2
PPARG
PPARG
SLC46A1
SLC46A1
PTGS2
PTGS2
PTGS1
PTGS1
AKR1C3
AKR1C3
Organism
Homo sapiens
Gene name
PTGDR2
Gene synonyms
CRTH2, DL1R, GPR44
NCBI Gene ID
Protein name
prostaglandin D2 receptor 2
Protein synonyms
CD294, chemoattractant receptor homologous molecule expressed on T helper type 2 cells, Chemoattractant receptor-homologous molecule expressed on Th2 cells, G-protein coupled receptor 44, putative G-protein coupled receptor 44
Uniprot ID
Mouse ortholog
Ptgdr2 (14764)
prostaglandin D2 receptor 2 (Q9Z2J6)
Variants
Clinical Variant
No data
Financial
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Indocin - Zyla Life Sciences
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 46,289 documents
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Safety
Black-box Warning
Black-box warning for: Indocin, Indomethacin, Tivorbex
Adverse Events
Top Adverse Reactions
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83 adverse events reported
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