Pharmacovigilance analysis of vonoprazan: a disproportionality analysis based on the FDA adverse event reporting system database.

OBJECTIVE

Vonoprazan is a novel potassium-competitive acid blocker whose expanding clinical application necessitates comprehensive evaluation of its real-world safety profile.

METHODS

Utilizing the FAERS database, this study collected adverse event (AE) data associated with vonoprazan therapy from the first quarter of 2013 to the second quarter of 2025. Disproportionality analysis was performed using both the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) methods. Furthermore, a Weibull distribution model was employed to characterize the temporal risk patterns of the identified adverse events.

RESULTS

A total of 1315 reports of adverse events (AEs) associated with vonoprazan were identified in this study. Analysis revealed several potential safety signals, including: gastric cancer (ROR = 9.26, 95%CI: 5.48-15.65; IC = 3.21, IC025 = 1.83), dysgeusia (ROR = 2.31, 95%CI: 1.24-4.29; IC = 1.2, IC025 = 0.17), and esophageal candidiasis (ROR = 36.36, 95%CI: 18.16-72.82; IC = 5.18, IC025 = 1.92).

CONCLUSION

Although signal detection analysis based on the FAERS database cannot establish causality, our study suggests that vonoprazan treatment may significantly increase the risks of nausea, hypertension, and gastric cancer, highlighting the need for enhanced monitoring in clinical practice. Future research should validate these signals through prospective trials and mechanistic studies to optimize the risk-benefit profile of vonoprazan therapy.