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

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.

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.

Our findings confirmed known label-reported AEs, such as hypersensitivity, urticaria, gastric ulcers, and gastrointestinal hemorrhage. Additionally, several potentially less well-known AEs were identified, such as acute generalized exanthematous pustulosis, blister formation, and urinary retention. Subgroup analyses revealed significant variations in AE patterns across different age groups and sexes. The majority of AEs occurred during the early stages of treatment, highlighting the importance of vigilant monitoring of AEs especially during initial dosing.

This real-world study reinforces established safety concerns related to piroxicam while identifying potentially less well-known safety signals. These findings offer valuable insights for clinicians aiming to optimize patient safety during piroxicam therapy.