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%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.004115%Not Available
Fibroadenoma of breast21.05.01.005; 16.14.01.001--Not Available
Fibroma16.02.02.010; 15.09.01.0040.002744%Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Fungal skin infection23.11.03.006; 11.03.05.002--Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.014267%
Gamma-glutamyltransferase increased13.03.04.024--
Gastric cancer07.21.02.001; 16.13.03.0010.002744%Not Available
Gastric ulcer haemorrhage07.04.03.005; 24.07.02.0030.004115%Not Available
Gastritis07.08.02.001--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.004--
Haematemesis24.07.02.011; 07.12.02.0020.002744%Not Available
Haematuria24.07.01.047; 20.02.01.006; 21.10.01.018--
Haemoglobin13.01.05.018--Not Available
Hallucination19.10.04.0030.030180%
Hallucination, visual19.10.04.0070.008231%Not Available
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatic function abnormal09.01.02.001--Not Available
Hepatitis09.01.07.004--Not Available
Hepatitis fulminant11.07.01.003; 09.01.07.0070.002744%Not Available
Hepatocellular injury09.01.07.008--Not Available
Herpes simplex11.05.02.001; 23.11.05.004--Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
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