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 haemorrhage12.02.05.004; 24.07.01.014--
Necrotising colitis07.08.01.0130.000725%-
Periventricular leukomalacia17.13.02.005; 18.04.07.0030.000528%-
Coronary artery insufficiency02.02.01.008; 24.04.04.0160.000462%-
Musculoskeletal stiffness15.03.05.027---
Protein urine present13.13.02.006---
Necrotising enterocolitis neonatal07.08.03.011; 18.04.11.0020.000528%-
Haemorrhage24.07.01.002---
Rectal tenesmus07.03.03.001; 15.05.03.011---
Retinal injury06.11.01.001; 12.01.04.002---
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Breast disorder21.05.04.004---
Haematotoxicity01.05.01.007; 12.03.01.025---
Inflammation08.01.05.007; 10.02.01.089---
Mental disorder19.07.01.002---
Decreased appetite08.01.09.028; 14.03.01.005--
Ill-defined disorder08.01.03.049---
Psychotic disorder19.03.01.002--
Renal impairment20.01.03.0100.000132%-
Post procedural oedema12.02.05.040---
Bone marrow failure01.03.03.005--
Nephritic syndrome20.05.01.006---
Post procedural swelling12.02.05.041---
Treatment failure08.06.01.017---
Anorectal discomfort07.03.03.003---
Acute kidney injury20.01.03.0160.000330%
Drug-induced liver injury09.01.07.023; 12.03.01.044---
Perforation08.01.03.058---
Depersonalisation/derealisation disorder19.14.01.004---
Intraventricular haemorrhage neonatal17.08.01.053; 18.04.16.002; 24.07.04.0290.000989%-
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ADReCS-Target
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