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)
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000581%
Synovitis15.04.02.0010.000026%Not Available
Systolic hypertension24.08.02.0070.000026%Not Available
Tachypnoea22.02.01.0140.000115%Not Available
Telangiectasia24.03.03.003; 23.06.03.0010.000038%
Tenderness08.01.08.0050.000069%Not Available
Tendonitis15.07.01.003; 12.01.07.0070.000051%Not Available
Therapeutic response decreased08.06.01.016--Not Available
Therapeutic response unexpected08.06.01.0010.000604%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.000087%Not Available
Throat irritation07.05.05.037; 22.12.03.0290.000169%Not Available
Throat tightness22.12.03.031; 19.01.02.0050.000192%Not Available
Thrombosis24.01.01.006--Not Available
Thrombotic thrombocytopenic purpura24.07.06.014; 23.06.01.011; 01.08.01.0050.000115%
Thyrotoxic crisis19.07.03.006; 06.09.04.004; 14.11.01.016; 05.02.02.0040.000026%Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue disorder07.14.01.002--Not Available
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.0070.000128%Not Available
Tongue ulceration07.14.01.003--Not Available
Tonic convulsion17.12.03.0110.000026%Not Available
Toothache07.09.06.0010.000026%
Torsade de pointes02.03.04.0050.000026%Not Available
Toxic epidermal necrolysis10.01.01.006; 23.03.01.008; 12.03.01.015; 11.07.01.0060.000256%
Tricuspid valve incompetence02.07.05.0010.000166%Not Available
Type I hypersensitivity10.01.03.0060.000256%Not Available
Ulcer08.03.06.0010.000243%Not Available
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.0060.000474%
Urinary incontinence17.05.01.008; 20.02.02.0100.000090%
Urinary retention20.02.02.0110.000159%
Urticaria23.04.02.001; 10.01.06.0010.002614%
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ADReCS-Target
Drug Name ADR Term Target
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