Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Diclofenac epolamine
Drug ID BADD_D00654
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
ATC Code D11AX18; M01AB05; M02AA15; S01BC03
DrugBank ID DB00586
KEGG ID D07818
MeSH ID C064142
PubChem ID 114753
TTD Drug ID Not Available
NDC Product Code 46438-0628; 63629-4762; 64032-0017; 0093-3727; 71858-0305; 54871-1093; 0093-3225; 55700-886; 71858-0405; 59762-0411; 60793-411; 62512-0046; 55700-801; 60793-132; 55700-807; 70518-3000; 59762-0707
Synonyms diclofenac hydroxyethylpyrrolidine | diclofenac 1-(2-hydroxyethyl)pyrrolidinium salt | N-(2-hydroxyethyl)pyrrolidinium (2-((2,6-dichlorophenyl)amino)phenyl)acetate | diclofenac-N-(2-hydroxyethyl) pyrrolidine | DIEP | DHEP | diclofenac-epolamine | Flector
Chemical Information
Molecular Formula C20H24Cl2N2O3
CAS Registry Number 119623-66-4
SMILES C1CCN(C1)CCO.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
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain upper07.01.05.003--
Application site reaction12.07.01.006; 08.02.01.006--Not Available
Atrophy08.03.04.001--Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Burning sensation08.01.09.029; 17.02.06.001--Not Available
Constipation07.02.02.001--
Dermatitis23.03.04.002--Not Available
Dermatitis allergic23.03.04.003; 10.01.03.014--Not Available
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.007--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Erythema23.03.06.001--Not Available
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.001--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkinesia17.01.02.008--Not Available
Hypoaesthesia17.02.06.023--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Paraesthesia17.02.06.005--
Pruritus23.03.12.001--
Sensory disturbance17.02.07.006--Not Available
Skin irritation23.03.04.009--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Tongue discolouration07.14.02.006--Not Available
Vomiting07.01.07.003--
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