Levetiracetam and severe cutaneous adverse reactions: insights from FAERS database analysis

Abstract

ABSTRACT Objective To investigate the association between levetiracetam and severe cutaneous adverse reactions (SCARs) using data from the FDA Adverse Event Reporting System (FAERS). Methods Disproportionality analysis was performed using the Reporting Odds Ratio (ROR) and Information Component (IC) methods. Patient demographics, clinical outcomes, time to onset, and concomitant medication data were examined. Results A total of 1,188 SCAR cases with levetiracetam as the primary suspect were analyzed through disproportionality analysis. Female patients comprised 45.96% of cases, with 50.42% aged between 18 and 65 years. The analysis indicated a significant association with SCARs, showing an ROR of 4.47 and an IC of 2.14. The most common SCAR was Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), occurring in 540 cases. The median time to onset for SCARs was 16 days, with DRESS having a longer median of 20 days, while Acute Generalized Exanthematous Pustulosis (AGEP) had a shorter median of 3 days. Concomitant medications, including phenytoin, valproate, and aspirin, were common, with some drugs indicating an increased SCAR risk when used alongside levetiracetam. Conclusion The findings suggest a notable risk of SCARs associated with levetiracetam, with an emphasis on monitoring patients, particularly females and those on concomitant medications.