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)
Protein-losing gastroenteropathy14.03.02.015; 07.11.01.0130.000026%Not Available
Extremity necrosis24.04.03.0120.000038%Not Available
Prostate cancer21.04.02.002; 16.25.01.001--Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000026%Not Available
Eyelid disorder23.03.03.028; 06.08.03.0100.000026%Not Available
Infarction24.04.02.0170.000026%Not Available
Inflammation08.01.05.007; 10.02.01.0890.000271%Not Available
Limb discomfort15.03.04.0140.000082%Not Available
Malnutrition14.03.02.0040.000038%Not Available
Motor dysfunction17.01.02.031; 15.05.06.0060.000026%Not Available
Mucosal erosion08.01.06.0090.000026%Not Available
Mucosal haemorrhage24.07.01.011; 08.01.06.0050.000026%Not Available
Sudden hearing loss04.02.01.0090.000038%Not Available
Gastrointestinal ulcer07.04.04.0020.000038%Not Available
Renal injury20.01.03.015; 12.01.05.0010.000102%Not Available
Ill-defined disorder08.01.03.049--Not Available
Intervertebral disc disorder15.10.01.003--Not Available
Lacrimal disorder06.08.02.0050.000026%Not Available
Sensation of foreign body08.01.09.0020.000090%Not Available
Ulcer haemorrhage24.07.01.040; 08.03.06.0030.000026%Not Available
Blood disorder01.05.01.0040.000026%Not Available
Disease recurrence08.01.03.0500.000077%Not Available
Diverticular perforation07.04.04.0080.000026%Not Available
Fat necrosis08.03.03.0040.000141%Not Available
Pigmentation disorder23.05.03.0010.000026%Not Available
Renal impairment20.01.03.0100.000589%Not Available
Application site discomfort08.02.01.034; 12.07.01.0340.000056%Not Available
Anaphylactoid shock24.06.02.005; 10.01.07.0040.000026%Not Available
Excessive granulation tissue23.07.04.012; 08.03.02.003--Not Available
Erosive oesophagitis07.04.05.0040.000026%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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