Updated Insights on Levetiracetam-Associated Severe Cutaneous Adverse Reactions: A Real-World Pharmacovigilance Analysis

Previous studies have explored the association between levetiracetam (LEV) and severe cutaneous adverse reactions (SCARs). However, most investigations have relied on clinical trial data or case reports from individual medical centers. Consequently, the precise relationship between LEV and SCARs in real-world settings remains elusive. Data from the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases were analyzed, focusing on LEV-associated SCAR events utilizing disproportionality analysis methods. This study identified a significant correlation between LEV and SCARs (<i>p</i> &lt; 0.05). However, combined analyses with other antiepileptic drugs revealed that the association of LEV with SCARs was comparatively weaker (<i>p</i> &lt; 0.05). Univariate logistic regression analysis indicated that males, individuals aged 45 ~ 65 years, and combination therapy with eslicarbazepine, phenytoin, carbamazepine, and lamotrigine significantly increased the risk of developing SCARs (<i>p</i> &lt; 0.05). Notably, SCARs were most likely to occur within the initial week of LEV treatment (39.39%). Despite certain limitations, this study offers updated insights into the association between LEV and SCARs. These findings underscore the significance of monitoring and actively managing LEV-associated SCARs to promote its safe and effective use.