Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Indomethacin
Drug ID BADD_D01156
Description Indometacin, or indomethacin, is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic properties. NSAIDs consist of agents that are structurally unrelated; the NSAID chemical classification of indometacin is an indole-acetic acid derivative with the chemical name 1- (p-chlorobenzoyl)25-methoxy-2-methylindole-3-acetic acid.[A177871] The pharmacological effect of indometacin is not fully understood, however, it is thought to be mediated through potent and nonselective inhibition of the enzyme cyclooxygenase (COX), which is the main enzyme responsible for catalyzes the rate-limiting step in prostaglandin and thromboxane biosynthesis via the arachidonic acid (AA) pathway. Indometacin was first discovered in 1963 and it was first approved for use in the U.S. by the Food and Drug Administration in 1965, [A486] along with other acetic acid derivatives such as [diclofenac] and [sulindac] that were also developed during the 1960s.[A177871] Since then, indometacin has been extensively studied in clinical trials as one of the most potent NSAIDs in blocking prostaglandin synthesis and was among the first NSAIDs to be used in the symptomatic treatment of migraine and for headaches that eventually became known as “indomethacin-responsive” headache disorders.[A177871] Most commonly used in rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute shoulder pains, and acute gouty arthritis, indometacin is currently available as oral capsules as well as other methods of administration, including rectal and intravenous formulations. Intravenous indometacin is administered to close a hemodynamically significant patent ductus arteriosus, as indicated by clinical evidence, in premature infants.[L10553] Ophthalmic indometacin has been studied and used in the symptomatic treatment of postoperative ocular inflammation and pain and/or complications after cataract surgery. Although deemed effective in reducing ocular inflammation in clinical studies, topical NSAIDs were also associated with a potential reduction in corneal sensitivity accompanied by an increased risk of superficial punctate keratitis and subjective symptoms of discomfort, including pain, burning or pricking, or a tingling sensation after instillation into the cul‐de‐sac.[A177949]
Indications and Usage For moderate to severe rheumatoid arthritis including acute flares of chronic disease, ankylosing spondylitis, osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis.
Marketing Status Prescription; Discontinued
ATC Code C01EB03; M01AB01; M02AA23; S01BC01
DrugBank ID DB00328
KEGG ID D00141
MeSH ID D007213
PubChem ID 3715
TTD Drug ID D0R1RS
NDC Product Code 33342-502; 63629-1913; 43063-773; 68462-302; 63629-1915; 69344-101; 71335-0756; 63323-659; 63629-8066; 55700-537; 71335-0992; 76420-029; 68071-3277; 48087-0069; 50090-0054; 50090-0053; 68788-6448; 48087-0070; 0713-0176; 71335-0107; 68788-6983; 63629-1914; 50090-0051; 68462-325; 71335-1568; 70518-1512; 71335-0747; 43063-368; 50090-0052; 50090-2987; 70518-3324; 70518-0254; 53002-3051; 67296-0886; 68462-406; 70518-0515; 73308-349; 70771-1004; 67296-0954; 66267-120; 55289-469; 71205-159; 68382-371; 68071-3060; 71205-215; 51552-0262; 43063-930; 35356-697; 63629-7679; 50268-431; 71335-0355; 53002-3050; 50268-430; 68071-5269; 65162-506; 61919-526; 43063-777; 70518-1458; 68788-8117; 11014-0418; 68084-411; 59746-347; 71052-550; 50090-0050; 43063-929; 60760-294; 61919-130; 63187-948; 31722-542; 67296-0723; 68071-4394; 63629-8993; 68788-8092; 72578-038; 50090-2803; 71335-1250; 49452-3670; 69344-102; 70934-395; 10702-016; 61919-129; 51655-329; 69597-350; 63629-3201; 72578-039; 50742-234; 50090-0055; 72865-149; 0409-1113; 70771-1203; 72865-148; 63187-282; 66267-119; 67296-1525; 59746-346; 61919-164; 31722-543; 63629-8994; 70771-1005; 11014-0419; 61919-985; 73308-350; 68382-470; 31722-565; 63187-852; 65977-0130; 53002-3500
Synonyms Indomethacin | Indometacin | Osmosin | Indocid | Metindol | Indomet 140 | Indomethacin Hydrochloride | Amuno | Indocin
Chemical Information
Molecular Formula C19H16ClNO4
CAS Registry Number 53-86-1
SMILES CC1=C(C2=C(N1C(=O)C3=CC=C(C=C3)Cl)C=CC(=C2)OC)CC(=O)O
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatitis09.01.07.004--Not Available
Hepatitis toxic09.01.07.017; 12.03.01.016--Not Available
Hepatotoxicity09.01.07.009; 12.03.01.008--Not Available
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hyperkalaemia14.05.03.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypoglycaemia05.06.03.001; 14.06.03.001--
Hyponatraemia14.05.04.002--
Hypotension24.06.03.002--
Ileus07.13.01.001--
Insomnia17.15.03.002; 19.02.01.002--
Intestinal ischaemia07.15.02.001; 24.04.08.0010.000290%Not Available
Intestinal obstruction07.13.01.002--Not Available
Intestinal perforation07.04.06.0020.000556%Not Available
Intestinal stenosis07.13.01.003--Not Available
Intestinal ulcer07.04.06.003--Not Available
Intraventricular haemorrhage17.08.01.017; 24.07.04.0080.000362%Not Available
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030--Not Available
Leukaemia01.10.03.001; 16.01.03.001--
Leukopenia01.02.02.001--Not Available
Listless08.01.01.012; 19.04.04.003--Not Available
Loss of consciousness17.02.04.004--Not Available
Malaise08.01.01.003--
Menopausal symptoms21.02.02.002--Not Available
Mouth ulceration07.05.06.004--Not Available
Muscular weakness15.05.06.001; 17.05.03.005--
Nausea07.01.07.001--
Necrotising fasciitis11.01.17.002; 15.03.03.004--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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