Investigation into Safety Profiles of Antiepileptic Drugs and Identification of Predictors for Serious Adverse Events: Insights from National Pharmacovigilance Data.

ABSTRACT: Backgrounds/Objectives: This study aims to comprehensively characterize the prevalence and severity of antiepileptic drug (AED)-induced adverse drug events (ADEs) and to identify predictors strongly associated with serious adverse events (SAEs) in both general and geriatric populations. Methods: This cross-sectional study investigated AED-related ADEs reported to the KIDS KAERS DB from January 2014 to December 2023. Disproportionality analysis was performed to detect the association between reported SAEs, and multiple logistic regression was conducted to identify predictors associated with SAEs. Cox's proportional hazard model was utilized to assess ADE duration in elderly patients aged 60 years and older. Results: More than 50% of 36,809 AED-related ADEs were reported

SUBMITTER: Lee SH 

PROVIDER: S-EPMC12299243 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature