Objective: This study aimed to identify hepatic and renal adverse events associated with potassium-competitive acid blockers (P-CABs) and to evaluate the safety profiles of individual agents.Methods: VigiBase data (2014-2024) were analyzed to identify adverse events associated with P-CABs.All other drugs and proton pump inhibitors (PPIs) were used as comparators.Adverse events were coded using Preferred Terms (PTs) for hepatic events (including cholestasis and jaundice, non-infectious hepatitis, hepatic failure, fibrosis and cirrhosis and other damage) and for renal events (including acute renal failure and chronic kidney disease).Disproportionality analyses were conducted, with signals considered significant when Reporting Oddss Ratios (RORs) 2, chi-squared 4 and the Information Component (IC) 0. Results: Of the 3,017 PCAB-AE pairs, most were reported in women (50.86%) and individuals aged 65 years (41.65%).For hepatic events, statistically significant RORs were observed compared to all other drugs (5.94 95% CI: 4.74-7.43)and to PPIs (15.82 12.55-19.97).In contrast, RORs for renal events were 1.62 (95% CI: 1.28-2.50)and 0.03 (95% CI: 0.02-0.03)for the comparators, indicating no significant signals.At the SMQ(Standardized MedDRA Queries) level, RORs were observed for hepatic events (cholestasis and jaundice: 8.11 95%CI: 5.59-11.76/Hepatitis, non-infectious: 6.74 4.56-9.98/Hepatic failure, fibrosis and cirrhosis and others: 5.80 4.42-7.61)but not for renal events (Acute renal failure: 1.47 1.05-2.04/Chronic kidney disease: 1.56 1.18-2.06).Analyses using PPIs yielded similar results.Conclusion: Significant signals for hepatic adverse events within the P-CAB class were driven primarily by Vonoprazan, underscoring the need for pharmacovigilance, for introduced P-CABs with limited long term safety data.(PeRM 2026;
Hong et al. (Mon,) studied this question.