Real-world safety profile of sonidegib: a disproportionality analysis based on the FDA adverse event reporting system.

ABSTRACT:

Background

Sonidegib is a novel treatment for locally advanced basal cell carcinoma (LaBCC) with demonstrated efficacy and safety in clinical trials. However, its real-world safety profile remains insufficiently characterized. This study aimed to evaluate the real-world safety of sonidegib by analyzing adverse event (AE) reports from the FDA Adverse Event Reporting System (FAERS), identifying both known and unexpected safety signals.

Methods

Data for this study were obtained from the FAERS, covering the period from the third quarter of 2015 to the fourth quarter of 2024. Four disproportionality analysis methods were employed to detect positive signals associated with sonidegib, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Prop

SUBMITTER: Zhao K 

PROVIDER: S-EPMC12588830 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature