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 Diclofenac is indicated for use in the treatment of pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and akylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma. It is often used in combination with [misoprostol] as a gastro-protective agent in patients with high risk of developing NSAID-induced ulcers.
Marketing Status approved; vet_approved
ATC Code D11AX18; M02AA15; S01BC03; M01AB05
DrugBank ID DB00586
KEGG ID D00904
MeSH ID D004008
PubChem ID 5018304
TTD Drug ID D0TG1H
NDC Product Code 80425-0056; 58602-603; 69344-203; 50436-3340; 57896-142; 68788-7270; 71205-811; 48589-0002; 58602-601; 55700-675; 63187-762; 76420-012; 80425-0335; 71335-0371; 72162-2031; 11014-0416; 65162-833; 70518-0871; 73469-2053; 62512-0051; 42291-256; 69344-204; 69238-2053; 46122-711; 65162-683; 55700-735; 65162-911; 50090-3316; 58602-602
UNII QTG126297Q
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
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)
Hyperaesthesia23.03.03.080; 17.02.06.004--Not Available
Hyperchlorhydria07.11.03.001--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkinesia17.01.02.008--Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypertonia17.05.02.001; 15.05.04.007--Not Available
Hyperventilation22.02.01.006; 19.01.02.004--Not Available
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypoglycaemia05.06.03.001; 14.06.03.001--
Hypokinesia17.01.02.009--Not Available
Hypotension24.06.03.002--
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
Influenza11.05.03.001; 22.07.02.001--Not Available
Injection site abscess12.07.03.021; 11.01.08.023; 08.02.03.021--Not Available
Injection site induration12.07.03.007; 08.02.03.007--Not Available
Injection site necrosis12.07.03.020; 08.02.03.020--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intestinal perforation07.04.06.002--Not Available
Intestinal ulcer07.04.06.003--Not Available
Iritis10.02.01.022; 06.04.03.002--Not Available
Irritability19.04.02.013; 08.01.03.011--
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.004--Not Available
Keratitis06.04.02.002--
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