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)
Abdominal discomfort07.01.06.0010.002550%Not Available
Abdominal distension07.01.04.0010.000652%
Abdominal pain07.01.05.0020.002372%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.003439%
Abdominal tenderness07.01.05.0040.000119%Not Available
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.0010.000296%Not Available
Acute febrile neutrophilic dermatosis01.02.01.006; 23.03.03.0330.000119%Not Available
Acute hepatic failure09.01.03.0010.000093%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Adrenal insufficiency14.11.01.004; 05.01.02.0010.000031%
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.0010.000296%Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Alopecia totalis23.02.02.0060.000119%Not Available
Altered state of consciousness19.07.01.003; 17.02.04.0010.000652%Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.0010.002727%
Anaphylactic reaction24.06.03.006; 10.01.07.0010.003202%
Anaphylactic shock24.06.02.004; 10.01.07.0020.003735%Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.0030.000237%Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema23.04.01.001; 10.01.05.0090.003913%Not Available
Anuria20.01.03.0020.000119%Not Available
Anxiety19.06.02.002--
Aortic aneurysm rupture24.02.03.0030.000031%Not Available
Aphonia22.02.05.024; 19.19.01.002; 17.02.08.0090.000178%
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