A real-world data analysis of piroxicam in the FDA Adverse Event Reporting System (FAERS) database.

ABSTRACT:

Background

Piroxicam is a widely used antipyretic and analgesic. Due to an increasing number of adverse event (AE) reports, effective pharmacovigilance is essential for evaluating its benefit-risk profile.

Methods

We assessed the safety profile of piroxicam through disproportionality analysis based on all AE reports involving the drug in the FDA Adverse Event Reporting System (FAERS) from 2004 till 2024. Signal detection was performed using the reporting odds ratio, proportional reporting ratio, multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network methods. The Weibull distribution was applied to model time-to-onset of AEs. Analyses were stratified by age and sex, and subgroup patterns were examined. AE outcomes were categorized accordingly.

SUBMITTER: Wang Y 

PROVIDER: S-EPMC12549246 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature