Cyclobenzaprine-related adverse events: a comprehensive pharmacovigilance analysis using the FDA Adverse Event Reporting System.

ABSTRACT:

Background

Cyclobenzaprine, a centrally-acting muscle relaxant, is widely used for the treatment of musculoskeletal pain. Despite its efficacy, concerns regarding its safety profile, particularly adverse events (AEs), have been increasingly reported. This study aims to comprehensively analyze cyclobenzaprine-related AEs using the FDA Adverse Event Reporting System (FAERS) database to identify potential safety signals and inform clinical practice.

Methods

A retrospective pharmacovigilance study was conducted using FAERS data from Q1 2004 to Q3 2024. Reports involving cyclobenzaprine as the primary suspect drug were analyzed. Descriptive statistics and disproportionality analyzes, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Pro

SUBMITTER: Tu J 

PROVIDER: S-EPMC12497723 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature