Pharmacovigilance of Vonoprazan: a Review of Safety and Adverse Event Profiles
Abstract
Vonoprazan is a novel potassium-competitive acid blocker (P-CAB) used to treat acid-related disorders, including gastroesophageal reflux disease (GERD) and Helicobacter pylori eradication therapy. Compared to traditional proton pump inhibitors (PPIs), vonoprazan exhibits a faster onset of action and sustained acid suppression. This pharmacovigilance review evaluates its safety profile based on post-marketing surveillance and clinical studies. Data from the Japanese Adverse Drug Event Report (JADER) database and systematic reviews indicate that vonoprazan has a generally comparable safety profile to PPIs. Common adverse events include diarrhea, liver function abnormalities, and rash. However, vonoprazan has been associated with an increased risk of hemorrhagic enterocolitis, necessitating further investigation. Unlike PPIs, it does not show a significant correlation with interstitial lung disease. Meta-analyses suggest no significant increase in overall adverse events compared to PPIs, with some studies reporting fewer gastrointestinal side effects. Despite its favorable tolerability, long-term safety data remain limited. Continuous pharmacovigilance efforts and real-world studies are crucial to identifying rare but serious adverse effects. Future research should focus on elucidating the mechanisms underlying vonoprazan-associated risks and optimizing its safe clinical use.
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