Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Entacapone
Drug ID BADD_D00773
Description Entacapone is a selective, reversible catechol-O-methyl transferase (COMT) inhibitor for the treatment of Parkinson's disease. It is a member of the class of nitrocatechols. When administered concomittantly with levodopa and a decarboxylase inhibitor (e.g., carbidopa), increased and more sustained plasma levodopa concentrations are reached as compared to the administration of levodopa and a decarboxylase inhibitor.
Indications and Usage Used as an adjunct to levodopa / carbidopa in the symptomatic treatment of patients with idiopathic Parkinson's Disease who experience the signs and symptoms of end-of-dose "wearing-off".
Marketing Status approved; investigational
ATC Code N04BX02
DrugBank ID DB00494
KEGG ID D00781
MeSH ID C071192
PubChem ID 5281081
TTD Drug ID D0J1VY
NDC Product Code 47335-007; 62332-478; 64679-711; 52483-0014; 33342-260; 50268-295; 60687-188; 71610-247; 0781-5578; 64679-781; 48087-0080; 68022-7015; 65862-654; 0615-8298; 68554-0068; 65085-0050; 65862-611; 27241-049; 58032-2003; 65372-1149; 68022-7043; 46708-478; 0527-1830; 17511-109; 46438-0005; 49587-105; 48087-0109; 52427-800
UNII 4975G9NM6T
Synonyms entacapone | 2-cyano-N,N-diethyl-3-(3,4-dihydroxy-5-nitrophenyl)propenamide | Comtan | Comtess | OR 611 | OR-611
Chemical Information
Molecular Formula C14H15N3O5
CAS Registry Number 130929-57-6
SMILES CCN(CC)C(=O)C(=CC1=CC(=C(C(=C1)O)O)[N+](=O)[O-])C#N
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)
Faeces discoloured07.01.03.0020.005487%-
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.004115%-
Fibroadenoma of breast16.14.01.001; 21.05.01.005---
Fibroma15.09.01.004; 16.02.02.0100.002744%-
Flatulence07.01.04.002--
Fluid retention14.05.06.002; 20.01.02.003---
Fungal skin infection11.03.05.002; 23.11.03.006---
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.014267%
Gamma-glutamyltransferase increased13.03.04.024--
Gastric cancer07.21.02.001; 16.13.03.0010.002744%-
Gastric ulcer haemorrhage07.04.03.005; 24.07.02.0030.004115%-
Gastritis07.08.02.001--
Gastroenteritis07.19.03.001; 11.01.07.004---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Generalised oedema08.01.07.004; 14.05.06.007--
Haematemesis07.12.02.002; 24.07.02.0110.002744%-
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.047--
Haemoglobin13.01.05.018---
Hallucination19.10.04.0030.030180%
Hallucination, visual19.10.04.0070.008231%-
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatic function abnormal09.01.02.001---
Hepatitis09.01.07.004---
Hepatitis fulminant09.01.07.007; 11.07.01.0030.002744%-
Hepatocellular injury09.01.07.008---
Herpes simplex11.05.02.001; 23.11.05.004---
Hyperbilirubinaemia01.06.04.003; 09.01.01.003; 14.11.01.010---
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