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 Oral indometacin is indicated for symptomatic management of moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis.[A177871,L6778] Intravenous indometacin is indicated to induce closure of a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.[L10553]
Marketing Status approved; investigational
ATC Code C01EB03; M02AA23; M01AB01; S01BC01
DrugBank ID DB00328
KEGG ID D00141
MeSH ID D007213
PubChem ID 3715
TTD Drug ID D0R1RS
NDC Product Code 50090-0052; 61919-164; 63187-852; 68382-371; 68462-302; 68788-6448; 70518-1512; 70518-3324; 71335-0355; 72865-149; 76420-029; 51552-0262; 10702-016; 50090-2803; 50268-431; 62135-068; 63187-282; 70771-1005; 72578-039; 48087-0070; 65977-0130; 31722-542; 31722-565; 50268-430; 51655-596; 53002-3051; 68071-5269; 68382-470; 70934-181; 71335-1568; 60760-294; 63629-1913; 67296-0886; 69344-101; 72865-148; 43063-929; 50090-0051; 51655-963; 53002-3500; 53002-3501; 62135-067; 63323-659; 68462-406; 69344-102; 70518-0254; 80425-0271; 63629-1915; 68462-325; 72578-038; 76420-148; 48087-0069; 73301-005; 43063-368; 43063-773; 43063-930; 63629-3201; 63629-8993; 63629-8994; 67296-0723; 68788-8092; 68788-8117; 70771-1004; 71335-0107; 50090-0054; 50742-234; 55289-469; 61919-130; 63187-948; 63629-1914; 63629-7679; 65162-506; 67296-1525; 71205-159; 71335-0747; 71335-0992; 33342-502; 31722-543; 51655-329; 53002-3050; 61919-526; 68084-411; 70518-0515; 70771-1203; 43063-777; 50090-0053; 50090-2987; 51655-443; 55700-537; 70934-279; 71205-215; 71335-0756; 57821-012; 71052-550; 35356-697; 50090-0050
UNII XXE1CET956
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
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Post procedural haemorrhage24.07.01.014; 12.02.05.004--
Necrotising colitis07.08.01.0130.000725%Not Available
Periventricular leukomalacia18.04.07.003; 17.13.02.0050.000528%Not Available
Coronary artery insufficiency24.04.04.016; 02.02.01.0080.000462%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Protein urine present13.13.02.006--Not Available
Necrotising enterocolitis neonatal18.04.11.002; 07.08.03.0110.000528%Not Available
Haemorrhage24.07.01.002--Not Available
Rectal tenesmus15.05.03.011; 07.03.03.001--Not Available
Retinal injury12.01.04.002; 06.11.01.001--Not Available
Hot flush24.03.01.005; 08.01.03.027; 21.02.02.001--
Breast disorder21.05.04.004--Not Available
Haematotoxicity12.03.01.025; 01.05.01.007--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Ill-defined disorder08.01.03.049--Not Available
Psychotic disorder19.03.01.002--
Renal impairment20.01.03.0100.000132%Not Available
Post procedural oedema12.02.05.040--Not Available
Bone marrow failure01.03.03.005--
Nephritic syndrome20.05.01.006--Not Available
Post procedural swelling12.02.05.041--Not Available
Treatment failure08.06.01.017--Not Available
Anorectal discomfort07.03.03.003--Not Available
Acute kidney injury20.01.03.0160.000330%
Drug-induced liver injury12.03.01.044; 09.01.07.023--Not Available
Perforation08.01.03.058--Not Available
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Intraventricular haemorrhage neonatal24.07.04.029; 18.04.16.002; 17.08.01.0530.000989%Not Available
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ADReCS-Target
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