Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Diclofenac
Drug ID BADD_D00653
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 D07816
MeSH ID D004008
PubChem ID 3033
TTD Drug ID D0TG1H
NDC Product Code 11014-0415; 42291-256; 45865-986; 0378-8750; 69238-2053; 70518-0871; 73480-242; 76420-012; 50090-3316; 71335-0371; 55700-675; 63187-762; 70518-1333; 50090-4621; 58602-602; 65162-833; 62512-0051; 57896-142; 68788-7270; 69344-203; 11014-0416; 55700-735; 58602-603; 17856-0833; 58602-601; 69344-204; 50090-2787; 50268-237; 48589-0002; 80425-0056; 65162-911
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 C14H11Cl2NO2
CAS Registry Number 15307-86-5
SMILES C1=CC=C(C(=C1)CC(=O)O)NC2=C(C=CC=C2Cl)Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HepatotoxicityCytochrome P450 2C9P11712T1924410027798; 10027801; 10064567
HepatotoxicityCytochrome P450 3A4P08684T3784810027798; 10027801; 10064567
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dermatitis exfoliative10.01.01.004; 23.03.07.0010.000178%
Diarrhoea07.02.01.001--
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.000119%Not Available
Dilatation ventricular02.04.02.0260.000711%Not Available
Diplopia17.17.01.005; 06.02.06.0020.000296%Not Available
Disorientation17.02.05.015; 19.13.01.002--Not Available
Diverticulitis11.01.07.003; 07.10.02.0010.000237%Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.003972%
Drug abuse19.07.02.010--Not Available
Drug dependence19.07.02.009--Not Available
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.000711%Not Available
Drug hypersensitivity10.01.01.0010.009842%Not Available
Dry eye06.08.02.0010.000178%
Dry mouth07.06.01.002--
Dry skin23.03.03.0010.000534%
Duodenal perforation07.04.02.0010.000119%
Duodenal ulcer07.04.02.0020.000711%
Duodenal ulcer haemorrhage24.07.02.020; 07.04.02.0040.000108%Not Available
Duodenal ulcer perforation07.04.02.0030.000108%Not Available
Dysaesthesia17.02.06.0030.000119%
Dysgeusia17.02.07.003; 07.14.03.0010.000652%
Dyspepsia07.01.02.0010.001482%
Dysphagia07.01.06.0030.001245%
Dysphonia19.19.03.002; 17.02.08.004; 22.02.05.0050.000474%
Dyspnoea22.02.01.004; 02.01.03.0020.005929%
Dyspnoea exertional22.02.01.005; 02.01.03.0030.000178%Not Available
Dysuria20.02.02.002--
Ectropion23.07.05.001; 06.06.04.0010.000237%Not Available
Eczema23.03.04.0060.000593%
Electrocardiogram abnormal13.14.05.0010.000119%Not Available
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