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 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; M01AB05; M02AA15; S01BC03
DrugBank ID DB00586
KEGG ID D07816
MeSH ID D004008
PubChem ID 3033
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 144O8QL0L1
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
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)
Uveitis10.02.01.023; 06.04.03.003--
Ventricular extrasystoles02.03.04.0070.000026%Not Available
Ventricular hypertrophy02.04.02.0120.000038%Not Available
Visual impairment06.02.10.013--Not Available
Vitamin B12 deficiency14.12.02.004--Not Available
Vitamin D deficiency14.12.03.003--Not Available
Vomiting07.01.07.0030.002046%
Wheezing22.03.01.0090.000146%
Tubulointerstitial nephritis20.05.02.0020.000128%Not Available
Acute generalised exanthematous pustulosis23.03.10.002; 12.03.01.005; 11.07.01.018; 10.01.01.0340.000077%Not Available
Hypoacusis04.02.01.0060.000125%
Application site vesicles23.03.01.009; 12.07.01.009; 08.02.01.0090.000604%Not Available
Application site dryness12.07.01.011; 08.02.01.011; 23.03.03.0240.000087%Not Available
Retinal toxicity12.03.01.036; 06.09.03.0130.000077%Not Available
Localised oedema08.01.07.011; 14.05.06.009; 02.05.04.0060.000026%
Application site inflammation12.07.01.024; 08.02.01.0240.000100%Not Available
Application site papules23.03.03.022; 12.07.01.025; 08.02.01.025--Not Available
Anal haemorrhage24.07.02.029; 07.12.03.0040.000026%
Left ventricular dysfunction02.04.02.0110.000038%
Shock haemorrhagic14.05.05.003; 24.06.02.0140.000051%Not Available
Muscle tightness15.05.03.0070.000051%Not Available
Anal sphincter atony07.03.01.003; 17.05.02.0090.000038%Not Available
Application site paraesthesia17.02.06.012; 12.07.01.026; 08.02.01.026--Not Available
Application site urticaria08.02.01.028; 23.04.02.002; 12.07.01.028; 10.01.06.0020.000056%Not Available
Dysstasia15.03.05.011; 17.02.02.012; 08.01.03.089--Not Available
Intervertebral disc protrusion15.10.01.0040.000069%Not Available
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000051%
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000038%Not Available
Injection site discolouration08.02.03.038; 23.03.03.046; 12.07.03.0380.000051%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000038%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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