Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Diclofenac potassium
Drug ID BADD_D00655
Description Diclofenac is a phenylacetic acid derivative and non-steroidal anti-inflammatory drug (NSAID).[label] NSAIDs inhibit cyclooxygenase (COX)-1 and-2 which are the enzyme responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes. Diclofenac was the product of rational drug design based on the structures of [phenylbutazone], [mefenamic acid], and [indomethacin].[A180796] The addition of two chlorine groups in the ortho position of the phenyl ring locks the ring in maximal torsion which appears to be related to increased potency. It is often used in combination with [misoprostol] to prevent NSAID-induced gastric ulcers. Diclofenac was first approved by the FDA in July 1988 under the trade name Voltaren, marketed by Novartis (previously Ciba-Geigy).[L7360]
Indications and Usage For the acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Marketing Status Prescription; Discontinued
ATC Code D11AX18; M01AB05; M02AA15; S01BC03
DrugBank ID DB00586
KEGG ID D00903
MeSH ID D004008
PubChem ID 23667642
TTD Drug ID D0TG1H
NDC Product Code 17337-0408; 70518-2185; 0480-9435; 66267-070; 0378-2474; 61474-4181; 63629-4108; 48589-0004; 35356-713; 46438-0058; 69315-275; 52935-0016; 43063-848; 13913-008; 61919-072; 51407-443; 63629-7969; 59651-353; 73684-150; 50090-1535; 67296-1746; 70518-3072; 58747-0450; 72789-051; 50090-5893; 71335-0369; 50742-279; 72819-151; 70934-906; 0093-0948; 74157-007; 49884-905; 13913-011; 15370-180; 53002-1176; 69292-550; 72888-086; 71335-2052; 67296-1316; 13913-012; 68071-2625; 62512-0048; 72888-073; 50090-0646
Synonyms Diclofenac | Diclophenac | Dicrofenac | Dichlofenal | Diclofenac Sodium | Sodium Diclofenac | Diclofenac, Sodium | Diclonate P | Feloran | Voltarol | Novapirina | Orthofen | Ortofen | Orthophen | SR-38 | SR 38 | SR38 | Voltaren | Diclofenac Potassium | GP-45,840 | GP 45,840 | GP45,840
Chemical Information
Molecular Formula C14H10Cl2KNO2
CAS Registry Number 15307-81-0
SMILES C1=CC=C(C(=C1)CC(=O)[O-])NC2=C(C=CC=C2Cl)Cl.[K+]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HepatotoxicityCytochrome P450 3A4P08684T37848Not Available
HepatotoxicityCytochrome P450 2C9P11712T19244Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dysuria20.02.02.002--
Ecchymosis01.01.03.001; 24.07.06.002; 23.06.01.001--Not Available
Eosinophilia01.02.04.001--
Eructation07.01.02.003--
Erythema multiforme23.03.01.003; 10.01.03.015--
Flatulence07.01.04.002--
Flushing08.01.03.025; 24.03.01.002; 23.06.05.003--
Gastric ulcer07.04.03.002--
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Glossitis07.14.01.001--Not Available
Haematemesis07.12.02.002; 24.07.02.011--Not Available
Haematuria24.07.01.047; 20.02.01.006--
Haemolytic anaemia01.06.03.002--Not Available
Hallucination19.10.02.002--
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Infection11.01.08.002--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Leukopenia01.02.02.001--Not Available
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.003--
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