Adverse event reporting of mirtazapine: A disproportionality analysis of FDA adverse event reporting system (FAERS) database from 2004-2024.

ABSTRACT:

Background

Mirtazapine is a pharmacological agent commonly utilized as a first-line treatment for major depressive disorder, exhibiting both noradrenergic and selective serotonergic activity. Currently, there is an absence of a comprehensive and systematic review of the adverse events (AEs) associated with mirtazapine. Consequently, this study aims to assess the safety profile of mirtazapine in real-world clinical practice by performing an in-depth analysis of data from the Food and Drug Administration's Adverse Event Reporting System (FAERS).

Methods

This study collected all real-world adverse event data related to mirtazapine from the FAERS database spanning from Q1 2004 to Q4 2024. Disproportionality analysis methods were employed, including Reporting Odds Ratio (ROR), Pr

SUBMITTER: Guo K 

PROVIDER: S-EPMC12716765 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature