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)
Pharyngeal hypoaesthesia22.04.05.017; 17.02.06.0340.000026%Not Available
Gastrointestinal erosion07.04.04.0090.000064%Not Available
Eyelid erosion23.07.03.016; 06.06.04.0180.000026%Not Available
Hip deformity15.10.03.0080.000026%Not Available
Peritoneal disorder07.07.01.0100.000026%Not Available
Perforated ulcer08.03.06.0020.000026%Not Available
Erosive duodenitis07.04.02.0060.000026%Not Available
Spondylolisthesis12.04.04.008; 15.10.04.0040.000026%Not Available
Basal ganglia haemorrhage24.07.04.021; 17.08.01.0390.000026%Not Available
Anal erosion07.04.01.0030.000026%Not Available
Oral mucosal erythema07.05.05.0230.000038%Not Available
Pancreatic neuroendocrine tumour16.24.02.005; 07.21.09.009; 05.08.01.0140.000026%Not Available
Skin plaque23.03.03.0440.000038%Not Available
Dieulafoy's vascular malformation24.03.03.025; 07.15.04.0020.000026%Not Available
Lip pruritus07.05.05.0210.000026%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.030--Not Available
Sensitivity to weather change08.01.03.077--Not Available
Large intestinal stenosis07.13.03.0040.000179%
Internal haemorrhage24.07.01.0720.000026%Not Available
Cutaneous symptom23.07.04.0230.000026%Not Available
Abdominal rebound tenderness07.01.05.0130.000038%Not Available
Attention deficit hyperactivity disorder19.21.04.0040.000026%Not Available
Axial spondyloarthritis15.01.09.005; 10.04.04.0240.000026%Not Available
Blood loss anaemia24.07.01.088; 01.03.02.0180.000026%Not Available
Cardiac dysfunction02.11.01.0040.000026%Not Available
Discoloured vomit07.01.07.0170.000026%Not Available
Drug effect less than expected08.06.01.036--Not Available
Drug effective for unapproved indication12.09.02.001; 08.06.01.0370.000709%Not Available
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.002097%Not Available
Fixed eruption23.03.05.008; 10.01.01.037; 08.01.06.0250.000026%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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