Severe Cutaneous Adverse Reactions Associated With Newer-Generation Antiseizure Medications: A Real-World Pharmacovigilance Study Based on FAERS and JADER
Abstract
Background: Severe cutaneous adverse reactions (SCARs) are rare but potentially fatal immune-mediated toxicities associated with antiseizure medications (ASMs). Phenotype-resolved post-marketing safety profiles for newer-generation ASMs have not been comprehensively characterized across pharmacovigilance systems.
Methods: A cross-database disproportionality analysis was conducted using FAERS and JADER (January 2004-September 2025). Twenty-two newer-generation ASMs coded as primary-suspect drugs were included; outcomes were the four SCAR phenotypes (Stevens-Johnson syndrome, SJS; toxic epidermal necrolysis, TEN; drug reaction with eosinophilia and systemic symptoms, DRESS; acute generalized exanthematous pustulosis, AGEP) defined using MedDRA preferred terms. Signals were evaluated using reporting odds ratios (RORs) and Bayesian information component metrics. Time-to-onset (TTO) was characterized by Weibull modeling with confidence-interval-based failure-pattern classification and Kaplan-Meier analysis. Pre-specified sensitivity analyses excluded reports with concomitant valproic acid or other SCAR-inducing co-medications, applied multivariate logistic regression, and restricted FAERS reports to healthcare professionals.
Results: In total, 10,073 SCAR reports were included (SJS, 3776; TEN, 1762; DRESS, 4298; AGEP, 237). Lamotrigine and zonisamide showed the strongest, most reproducible associations across SJS/TEN/DRESS (FAERS RORs for lamotrigine, 35.60/22.35/27.30;…
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