Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cenobamate
Drug ID BADD_D02542
Description Cenobamate, or YKP-3089, is an antiepileptic drug developed by SK Pharmaceuticals and used to treat partial onset seizures.[A188442,L10653] The exact mechanism of action has not been described in the literature, though it positively modulates GABAA and inhibits voltage gated sodium channels.[L10653] Cenobamate was granted FDA approval on 21 November 2019.[L10653]
Indications and Usage Cenobamate is indicated for the treatment of partial onset seizures in adults.[L10653]
Marketing Status approved; investigational
ATC Code N03AX25
DrugBank ID DB06119
KEGG ID D11150
MeSH ID C000654784
PubChem ID 11962412
TTD Drug ID DU8CF6
NDC Product Code 71699-150; 71699-200; 71699-050; 71699-999; 71699-100; 71699-203; 71699-104; 74436-0223; 71699-103; 71699-202; 71699-201
UNII P85X70RZWS
Synonyms Cenobamate | 2H-tetrazole-2-ethanol, alpha-(2-chlorophenyl)-, carbamate (ester), (alphaR)- | carbamic acid (R)-(+)-1-(2-chlorophenyl)-2-(2h-tetrazol-2-yl)ethyl ester | XCOPRI | YKP3089 | YKP-3089
Chemical Information
Molecular Formula C10H10ClN5O2
CAS Registry Number 913088-80-9
SMILES C1=CC=C(C(=C1)C(CN2N=CN=N2)OC(=O)N)Cl
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)
Oral mucosal blistering07.05.05.0170.000423%-
Rash23.03.13.0010.001482%-
Rash pruritic23.03.13.0300.000423%-
Seizure17.12.03.0010.006588%
Somnolence17.02.04.006; 19.02.05.0030.002453%
Status epilepticus17.12.03.0050.000125%-
Stomatitis07.05.06.0050.000635%
Suicidal ideation19.12.01.0030.000436%
Suicide attempt19.12.01.0040.000187%
Tachycardia02.03.02.0070.000423%-
Tremor17.01.06.0020.000672%
Vision blurred06.02.06.007; 17.17.01.0100.000336%
Visual impairment06.02.10.0130.000423%-
Peripheral swelling02.05.04.015; 08.01.03.0530.000423%-
Balance disorder08.01.03.081; 17.02.02.0070.000423%-
Adverse event08.06.01.0100.001756%-
Eye movement disorder06.05.02.008; 17.02.05.0250.000423%-
Abnormal behaviour19.01.01.0010.000274%-
Decreased appetite08.01.09.028; 14.03.01.0050.000486%
Adverse drug reaction08.06.01.0090.000697%-
Drug intolerance08.06.01.0130.001482%-
Seizure cluster17.12.03.0290.000486%-
Behaviour disorder19.01.01.0050.000423%-
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