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)
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.0090.000325%Not Available
Chest pain02.02.02.011; 22.12.02.003; 08.01.08.0020.000574%Not Available
Chills15.05.03.016; 08.01.09.0010.000218%
Choking22.12.03.0030.000051%Not Available
Chromaturia20.02.01.0020.000133%
Circulatory collapse24.06.02.0010.000064%Not Available
Coccydynia15.02.01.0040.000026%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.000082%Not Available
Colitis ischaemic24.04.08.012; 07.08.01.0040.000026%Not Available
Compartment syndrome24.04.05.006; 15.05.05.0050.000038%Not Available
Conjunctival haemorrhage24.07.05.001; 06.07.01.0010.000026%Not Available
Coombs positive haemolytic anaemia10.04.01.001; 01.06.01.0010.000026%Not Available
Coordination abnormal17.02.02.004--Not Available
Corneal perforation06.06.03.006; 12.01.04.0030.000026%Not Available
Coronary artery disease24.04.04.006; 02.02.01.0010.000077%Not Available
Crepitations08.01.03.0060.000038%Not Available
Cutaneous vasculitis24.12.04.008; 23.06.02.001; 10.02.02.0030.000064%Not Available
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.0070.000128%
Death neonatal18.04.01.002; 08.04.01.0020.000026%
Depressed level of consciousness17.02.04.0020.000115%
Dermatitis23.03.04.0020.000243%Not Available
Dermatitis allergic23.03.04.003; 10.01.03.0140.000184%Not Available
Dermatitis bullous23.03.01.0020.000064%
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.0030.000374%Not Available
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.000038%Not Available
Dilatation ventricular02.04.02.0260.000026%Not Available
Diplegia17.01.04.0150.000026%Not Available
Diplopia17.17.01.005; 06.02.06.0020.000108%Not Available
Discomfort08.01.08.003--Not Available
Dissociation19.14.01.002--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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