Cardiovascular safety of propranolol oral solution in infantile hemangiomas: a disproportionality analysis based on the FAERS database

Abstract

Abstract This study aims to explore the potential association between propranolol and cardiovascular adverse events (AEs) through real-world evidence. Reports from the FDA Adverse Event Reporting System (FAERS) database spanning from January 2014 to September 2024, identifying propranolol oral solution as the primary suspected (PS) drug, were analyzed. Disproportionality analysis employed four key metrics: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma-Poisson Shrinkage (MGPS) to identify positive signals of cardiovascular AEs potentially associated with propranolol oral solution. Among 7,518 AE reports where propranolol oral solution was the PS drug, 196 cardiovascular AEs were identified. Peripheral coldness (n = 131, ROR 85.58, PRR 84.11), cyanosis (n = 24, ROR 15.91, PRR 15.87), and pallor (n = 12, ROR 3.79, PRR 3.79) were potentially associated with propranolol oral solution use. However, no positive signals were observed for other cardiovascular AEs, such as hypotension, bradycardia, or arrhythmias. Apart from peripheral vascular changes, our analysis did not detect positive signals for severe cardiovascular AEs, suggesting a favorable cardiovascular safety profile, though FAERS limitations such as underreporting warrant cautious interpretation. To ensure safety, standardized use and monitoring remain crucial.