Safety evaluation of baloxavir marboxil: analysis and discussion utilizing real adverse events from the FAERS database

This pharmacovigilance study identifies previously undercharacterized safety signals associated with baloxavir marboxil, including hemorrhagic complications, liver dysfunction, rhabdomyolysis, and life-threatening cardiorespiratory events. Pediatric populations and patients on anticoagulants may require heightened monitoring. While these findings provide critical pharmacovigilance insights, our study is inherently constrained by the spontaneous reporting system, which introduces potential underreporting, reporting biases, and confounding factors. Future research could employ more rigorous prospective study designs, integrating clinical trials and epidemiological studies, to more accurately assess the safety risks of baloxavir marboxil.