Age and Sex Differences in Adverse Events Associated With Antipsychotics: An Analysis of the FDA Adverse Events Database.

ABSTRACT:

Objectives

While the risks of antipsychotics in older adults are well recognized, clinical trials often exclude frail older patients, have short follow-up periods, and provide limited comparative data on specific drugs. This study aimed to explore age-related differences in the adverse effects of six commonly prescribed antipsychotics using a pharmacovigilance database, with additional analysis of sex-based variations.

Methods

We analyzed adverse event (AE) reports associated with aripiprazole, clozapine, olanzapine, quetiapine, risperidone, and haloperidol from the FDA Adverse Event Reporting System (FAERS) database between Q4 2003 and Q2 2024. We utilized Standardized MedDRA Queries (SMQs) and self-defined queries to categorize 18 groups of AEs. Adjusted logistic regressio

SUBMITTER: Ramin T 

PROVIDER: S-EPMC12356759 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature