Safety assessment of cenobamate: real-world adverse event analysis from the FAERS database

This study aims to analyze adverse drug events (ADEs) associated with cenobamate from the FAERS database, covering the third quarter of 2020 to the second quarter of 2023. Data related to cenobamate-associated ADEs from the third quarter of 2020 to the second quarter of 2023 were collected. After st...

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Bibliographic Details
Published in:Frontiers in pharmacology 2024, Vol.15, p.1369384-1369384
Main Authors: Chen, Shihao, Fang, Wenqiang, Zhao, Linqian, Xu, Huiqin
Format: Article
Language:English
Subjects:
adverse drug events
cenobamate
epilepsy
FAERS database
real-world study
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Summary:This study aims to analyze adverse drug events (ADEs) associated with cenobamate from the FAERS database, covering the third quarter of 2020 to the second quarter of 2023. Data related to cenobamate-associated ADEs from the third quarter of 2020 to the second quarter of 2023 were collected. After standardizing the data, various signal quantification techniques, including ROR, MHRA, BCPNN, and MGPS, were employed for analysis. Among 2535 ADE reports where cenobamate was the primary suspected drug, 94 adverse reactions involving 11 different System Organ Class (SOC) categories were identified through the application of four signal quantification techniques. More specifically, neurological disorders and injuries resultant from complications are frequent adverse reactions associated with cenobamate. Our research findings align with established results, affirming the favorable safety profile of cenobamate. Effective prevention of adverse reactions induced by cenobamate can be achieved through the establishment of efficient blood concentration monitoring and dose adjustments.
ISSN:1663-9812
1663-9812
DOI:10.3389/fphar.2024.1369384