Supplementary file 2_Age-stratified signals and early onset of adverse events with pregabalin: a disproportionality analysis of the FDA adverse event reporting system.docx

However, comprehensive real-world evidence regarding its neuropsychiatric safety profile and age-specific risk variations remains insufficient.</p>Methods<p>Data were retrieved from the FDA Adverse Event Reporting System (FAERS) from Q1 2005 to Q1 2025. Four disproportionality algorithms—reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM)—were utilized to identify safety signals.

The Weibull distribution model characterized the time-to-onset (TTO) of adverse events (AEs) and compared risks across age subgroups.</p>Results<p>After analyzing 98,196 pregabalin-related reports, 279 preferred terms generated consistent signals using all four disproportionality methods. Confirmed AEs included dizziness, weight increased, and somnolence. Unexpected signals were identified, such as hypoacusis, dysgraphia, logorrhoea, and feeling of despair.