The study analyzed the safety profile of vonoprazan using data from the FDA Adverse Event Reporting System (FAERS) for the period Q1 2023 to Q1 2025 and included 978 reports, with women comprising 62.0% of these reports and 34.3% of events classified as serious.[1] Reports in which vonoprazan was identified as the primary suspect drug were systematically extracted and duplicate records removed; adverse events were coded according to MedDRA version 24.0.[1] To detect potential security signals, the authors used four disproportionality methods: ROR, PRR, BCPNN and MGPS.[1] A total of 47 preferred terms (PTs) met predefined signaling criteria, and 16 of these PTs, including facial palsy and cholecystitis, are not listed in the current FDA-approved labeling of vonoprazan.[1] Serious adverse events were more frequently associated with renal impairment and hematemesis, while non-serious events dominated among gastrointestinal manifestations.[1] Stratified analyzes identified several potential high-risk signals, particularly in the general population and in the elderly.[1] The median time to onset of adverse events was 7 days, and most events occurred within the first 30 days of treatment initiation; Weibull Shape Parameter analysis suggested an "early failure" model.[1] The authors note that these findings represent safety signals that generate hypotheses and may inform further monitoring and advice for clinicians.[1]