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 For the acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Marketing Status Prescription; Discontinued
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 11014-0415; 42291-256; 45865-986; 0378-8750; 69238-2053; 70518-0871; 73480-242; 76420-012; 50090-3316; 71335-0371; 55700-675; 63187-762; 70518-1333; 50090-4621; 58602-602; 65162-833; 62512-0051; 57896-142; 68788-7270; 69344-203; 11014-0416; 55700-735; 58602-603; 17856-0833; 58602-601; 69344-204; 50090-2787; 50268-237; 48589-0002; 80425-0056; 65162-911
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
HepatotoxicityCytochrome P450 3A4P08684T3784810027798; 10027801; 10064567
HepatotoxicityCytochrome P450 2C9P11712T1924410027798; 10027801; 10064567
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Bone marrow failure01.03.03.005--
Liver injury12.01.02.003; 09.01.07.0220.000593%Not Available
Oral disorder07.05.01.0050.000119%Not Available
Hypertransaminasaemia09.01.02.0050.000178%Not Available
Oropharyngeal discomfort22.02.05.027; 07.05.05.0080.000296%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.000593%
Neurological decompensation17.02.05.0300.000119%Not Available
Kounis syndrome24.04.04.020; 10.01.03.037; 02.02.02.0200.001127%Not Available
Acute kidney injury20.01.03.0160.004388%
Posterior reversible encephalopathy syndrome17.13.02.0070.000119%
Macular fibrosis06.09.03.0140.000237%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.001127%Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.0210.000830%Not Available
Autoimmune haemolytic anaemia10.04.01.005; 01.06.01.0040.000296%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.000119%Not Available
Feeding intolerance14.02.01.006; 18.04.11.0030.000119%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000201%
Anal incontinence17.05.01.021; 07.01.06.0290.000119%
Liver function test increased13.03.01.044--Not Available
Alopecia areata23.02.02.008; 10.04.02.0110.000119%Not Available
Arterial rupture24.03.02.027; 12.01.11.0100.000119%Not Available
Concomitant disease aggravated08.01.03.0630.000296%Not Available
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.000119%Not Available
Ductus arteriosus stenosis foetal24.03.03.027; 03.07.09.0060.001423%Not Available
Ecthyma23.07.03.015; 11.01.12.0220.000119%Not Available
Ileal stenosis07.13.06.0060.000178%
Macroglossia03.04.09.003; 07.14.01.0110.000119%Not Available
Maternal drugs affecting foetus18.03.03.009; 12.03.03.0060.000593%Not Available
Neonatal respiratory acidosis22.11.01.009; 18.04.09.008; 14.01.04.0060.000119%Not Available
Neonatal respiratory distress syndrome18.04.10.003; 22.11.02.0100.000771%Not Available
The 20th Page    First    Pre   20 21    Next   Last    Total 21 Pages