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)
Nikolsky's sign23.03.07.0090.000031%Not Available
Placental insufficiency24.04.12.002; 18.05.02.0060.000119%Not Available
Renal failure neonatal20.01.03.024; 18.04.01.0190.000652%Not Available
Respiratory rate increased13.15.01.0040.000046%Not Available
Sciatic nerve injury17.09.02.013; 12.01.01.0040.000062%Not Available
Muscle abscess11.01.17.007; 15.05.01.0060.000119%Not Available
Renal impairment neonatal20.01.03.025; 18.04.01.0200.000119%Not Available
Neonatal anuria20.01.03.020; 18.04.01.0180.000119%Not Available
Ductus arteriosus premature closure24.03.03.026; 18.04.07.006; 03.07.09.005; 02.08.01.0050.000296%Not Available
Bradycardia neonatal02.03.02.019; 18.04.07.0040.000119%Not Available
Palatal oedema07.05.04.0080.000296%Not Available
Ear injury12.01.14.003; 04.03.01.0150.000119%Not Available
Gastrointestinal oedema07.11.01.0120.000119%Not Available
Troponin T increased13.04.01.0150.000119%
Embolia cutis medicamentosa08.02.03.052; 24.01.01.030; 12.07.03.0520.001245%Not Available
Spinal deformity15.10.04.0100.000119%Not Available
Pharyngeal hypoaesthesia22.04.05.017; 17.02.06.0340.000119%Not Available
Gastrointestinal erosion07.04.04.0090.000031%Not Available
Lymphocyte stimulation test positive13.01.06.0560.000119%Not Available
Perforated ulcer08.03.06.0020.000119%Not Available
Anal erosion07.04.01.0030.000119%Not Available
Quality of life decreased13.18.01.0130.000178%Not Available
Skin plaque23.03.03.0440.000119%Not Available
Dieulafoy's vascular malformation24.03.03.025; 07.15.04.0020.000119%Not Available
Large intestinal stenosis07.13.03.0040.000771%
Aspirin-exacerbated respiratory disease22.03.01.021; 10.01.01.0280.000237%Not Available
Internal haemorrhage24.07.01.0720.000119%Not Available
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