Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Opicapone
Drug ID BADD_D02576
Description Opicapone is a potent, reversible, and peripherally-acting third-generation inhibitor of catechol-o-methyltransferase (COMT), an enzyme involved in the breakdown of various catecholamines including dopamine.[A36938, A203048] Many patients with Parkinson’s disease treated with levodopa plus a dopa decarboxylase (DDC) inhibitor (eg carbidopa) experience motor complications over time, which calls for the management of these symptoms through the use of a dopamine agonist, a monoamine oxidase B inhibitor (selegiline, rasagiline), a _catechol-O-methyl transferase (COMT)_ inhibitor, or amantadine, or using a modified-release formulation of levodopa.[L2336] Opicapone is used for adjunct therapy to levodopa and carbidopa in adult patients with Parkinson's disease and end-of-dose motor fluctuations. Opicapone was approved for use by the European Commission in June 2016 [L2339] and the FDA in April 2020.[L13772] It is marketed under the brand name Ongentys as once-daily oral capsules. Exhibiting a long duration of action that exceeds 24 hours, opicapone can be administered once-daily [L2336] and demonstrates the lowest risk for cytotoxicity compared to other catechol-O-methyltransferase inhibitors.[A203048]
Indications and Usage Opicapone is indicated as adjunctive therapy in adults with Parkinson’s disease and end-of-dose motor fluctuations or “off” episodes whose symptoms cannot be stabilized on the combination therapy of levodopa and DOPA decarboxylase inhibitor (e.g., carbidopa).[L2343, L13772]
Marketing Status approved; investigational
ATC Code N04BX04
DrugBank ID DB11632
KEGG ID D10825
MeSH ID C549349
PubChem ID 135565903
TTD Drug ID D01SGK
NDC Product Code 70370-3025; 45941-3057; 11014-0421; 17337-0088; 70370-3050
UNII Y5929UIJ5N
Synonyms opicapone | 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide | ongentys | BIA 9-1067
Chemical Information
Molecular Formula C15H10Cl2N4O6
CAS Registry Number 923287-50-7
SMILES CC1=C(C(=[N+](C(=C1Cl)C)[O-])Cl)C2=NOC(=N2)C3=CC(=C(C(=C3)O)O)[N+](=O)[O-]
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)
Akinesia17.01.02.0030.000367%-
Anxiety19.06.02.0020.000991%
Back pain15.03.04.0050.000991%
Confusional state17.02.03.005; 19.13.01.0010.002055%
Constipation07.02.02.0010.002495%
Delirium19.13.02.0010.000550%
Dementia19.20.02.001; 17.03.01.0010.000367%-
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.003669%
Drug ineffective08.06.01.0060.005357%-
Dry mouth07.06.01.0020.000991%
Dysgeusia17.02.07.003; 07.14.03.0010.000807%
Dyskinesia17.01.02.0060.013612%
Dysphagia07.01.06.0030.001541%
Dysphonia17.02.08.004; 22.12.03.006; 19.19.03.0020.000367%
Dystonia17.01.03.0010.000917%-
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.000367%
Hallucination19.10.04.0030.006274%
Hyperkinesia17.01.02.0080.000991%-
Hypotension24.06.03.0020.002055%
Hypothermia12.05.03.001; 08.05.01.0030.000367%
Insomnia19.02.01.002; 17.15.03.0020.004109%
Loss of consciousness17.02.04.0040.000367%-
Muscle spasms15.05.03.0040.000807%
Orthostatic hypotension24.06.03.004; 17.05.01.0200.001247%-
Restlessness19.11.02.002; 17.02.05.0210.000807%
Rhabdomyolysis15.05.05.0020.000367%
Somnolence19.02.05.003; 17.02.04.0060.002862%
Tachycardia02.03.02.0070.000367%-
Vomiting07.01.07.0030.001357%
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000367%-
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