Risk assessment of infections and infestations associated with second-generation antipsychotics: A comprehensive analysis of the FAERS database.

OBJECTIVES: This study aimed to distinguish infections and infestations-related adverse events (IIAEs) linked to second-generation antipsychotics (SGAs) within distinct efficacy signals. METHODS: Ten-year data on the main SGAs were extracted from the FDA adverse event reporting system (FAERS) database for the period spanning from 2016 to 2025. SGAs were categorized by dosage as low, medium, or high. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to quantify the signals. The Weibull distribution was used to evaluate the risk over time. RESULTS: The majority of these patients were female and aged 18 years or older. The primary outcomes for patients who experienced IIAEs included initial or prolonged hospitalization. Olanzapine (OLA) and quetiapine (QUE) had the shortest median onset times (30 days), whereas clozapine (CLO) exhibited the longest median onset time (2493 days). Further analysis using Weibull CDF modeling demonstrated an increasing hazard rate over time for the low- and medium-dose groups of ARI, the medium-dose group of OLA, and the high-dose group of RIS. Following disproportionality analysis, several positive signals (p‑IIAEs) were identified. Aspiration pneumonia was identified as the predominant p‑IIAE among CLO, OLA, QUE, RIS, and ARI, particularly for CLO. Additionally, the strong signal for sexually transmitted diseases associated with ARI also warrants attention. CONCLUSIONS: Through real‑world pharmacovigilance analysis, aspiration pneumonia associated with SGAs was identified as the most prominent p‑IIAE. The present findings are anticipated to offer valuable information to support the safe and rational use of SGAs in patients.