A pharmacovigilance study of olanzapine/samidorphan based on FDA Adverse Event Reporting System (FAERS).

ABSTRACT:

Objects

The olanzapine/samidorphan (OLZ/SAM) combination is being regarded as a new strategy to combat weight gain induced by olanzapine (OLZ), and its safety is of significant concern. Specifically, as samidorphan is an opioid receptor-related drug, issues related to its potential for dependence and withdrawal symptoms deserve attention. This study aims to provide a comprehensive analysis of adverse events (AEs) associated with the OLZ/SAM.

Methods

This study is a pharmacovigilance study based on the analysis of reports from the FDA Adverse Event Reporting System (FAERS) utilizing the Openvigil online analysis platform for the period from January 1, 2023, to June 30, 2024. Signal results were reported as Reporting Odds Ratios (ROR) along with 95% confidence intervals. A bin

SUBMITTER: He L 

PROVIDER: S-EPMC11843756 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature