A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases.

ABSTRACT:

Objective

Paliperidone palmitate is a second-generation antipsychotic that has undergone extensive investigation in clinical trials. However, real-world studies assessing its safety in large populations are lacking. As such, this study aimed to comprehensively evaluate real-world adverse drug events (ADEs) linked to paliperidone palmitate by employing data mining techniques on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database.

Methods

The study retrieved ADE reports from the FAERS database covering the period from 2009 through the third quarter of 2024, and from the JADER database covering the period from 2013 through the second quarter of 2024. Utilizing disproportionality analys

SUBMITTER: Lou S 

PROVIDER: S-EPMC11744949 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature