Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Voltaren
Drug ID BADD_D02367
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 D00904
MeSH ID D004008
PubChem ID 5018304
TTD Drug ID D0TG1H
NDC Product Code 50090-2787; 55700-675; 58602-603; 70518-0871; 11014-0415; 55700-735; 57896-142; 58602-602; 65162-911; 68788-7270; 17856-0833; 69344-203; 76420-012; 62512-0051; 42291-256; 58602-601; 71335-0371; 80425-0056; 50090-3316; 11014-0416; 63187-762; 69238-2053; 0378-8750; 45865-986; 50268-237; 70518-1333; 50090-4621; 69344-204; 73480-242; 48589-0002; 65162-833
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 C14H10Cl2NNaO2
CAS Registry Number 15307-79-6
SMILES C1=CC=C(C(=C1)CC(=O)[O-])NC2=C(C=CC=C2Cl)Cl.[Na+]
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)
Pruritus23.03.12.001--
Punctate keratitis06.04.02.003--Not Available
Purpura01.01.04.003; 24.07.06.005; 23.06.01.004--
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.004--
Rash pustular23.03.10.003; 11.01.12.002--
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal failure20.01.03.005--Not Available
Renal papillary necrosis05.07.02.001; 20.01.07.002; 14.07.02.001--Not Available
Respiratory depression22.02.01.010; 17.02.05.047--Not Available
Rheumatoid arthritis15.01.03.001; 10.04.06.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Scab23.03.03.004--Not Available
Seborrhoeic dermatitis23.03.04.018--Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
Shock24.06.02.002--Not Available
Sinus congestion22.04.06.001--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin cancer23.08.02.002; 16.03.02.002--Not Available
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Skin hypertrophy23.01.04.002--Not Available
Skin irritation23.03.04.009--Not Available
Skin odour abnormal23.03.03.012--
Skin ulcer23.07.03.003; 24.04.03.007--
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.003--Not Available
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