Adverse Reaction Signals Mining of Vonoprazan: A Pharmacovigilance Study Based on FAERS

Abstract

Background. Vonoprazan is a novel selective and noncompetitive oxidative-reduction state proton pump inhibitor (PPI), known as a potassium-competitive acid blocker (P-CAB). Due to its novelty, the clinical application of vonoprazan is relatively limited, and its long-term safety and adverse effects still need to be further studied and confirmed. Methods. We used the data from the FDA adverse eventreporting system (FAERS) from 2015 to 2022. Disproportionality method including calculation of the reporting odds ratio (ROR) and calculation of the information component (IC) was used to detect potential adverse drug reactions (ADRs). In preferred terms, the significant signals are ranked in the following order: Plateletcrit increased (ROR 1447.3 IC 36.62), benign duodenal neoplasm (ROR 11157.84 IC 36.40), gallbladder volvulus (ROR 964.77 IC 36.20), myopathy endocrine (ROR 723.58 IC 35.88), pernio-like erythema (ROR 723.58 IC 35.88), septic coagulopathy (ROR 723.58 IC 35.88), and so on. In SOCs, the significant signals are ranked in the following order: hepatobiliary disorders (ROR 5.65 IC 29.15), metabolism and nutrition disorders (ROR 2.78 IC 28.12), blood and lymphatic system disorders (ROR 2.73 IC 28.12), investigations (ROR 2.19 IC 27.76), endocrine disorders (ROR 2.09 IC27.76), gastrointestinal disorders (ROR 1.87 IC 27.52), and so on. Conclusion. Despite its potential advantages, there is still limited clinical experience with vonoprazan, and the long-term safety and adverse effects of this drug are not fully understood. Further studies are needed to confirm its safety and efficacy in a larger patient population and to establish its role in the management of acid-related disorders. In the meantime, careful monitoring and patient education are recommended for those who are prescribed vonoprazan.