Comparative safety analysis of baloxavir marboxil and oseltamivir based on the FAERS database.
Expert opinion on drug safety April 24, 2025 Yingqiu Tu, Xin Lai, Qing Wan et al. 2 citations
An analysis of the FDA Adverse Event Reporting System database found that baloxavir marboxil is strongly associated with ischemic colitis, melena, febrile delirium, enterocolitis, febrile convulsion, and altered consciousness, while oseltamivir is strongly associated with pathological personality, abnormal thinking, agitation, abnormal behavior, sleepwalking, febrile delirium, and spinal cord hemorrhage. The study reviewed 1,727 adverse event reports for baloxavir marboxil and 12,607 for oseltamivir from US market approval through the third quarter of 2023. Clinicians should monitor for both common and label-unlisted adverse events when using these anti-influenza drugs.