Comparative safety analysis of baloxavir marboxil and oseltamivir based on the FAERS database

Expert Opin Drug Saf. 2025 Apr 17. doi: 10.1080/14740338.2025.2495854. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to analyze adverse drug events (ADEs) of oseltamivir or baloxavir marboxil monotherapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing a valuable reference for clinical drug safety.

RESEARCH DESIGN AND METHODS: FAERS data for oseltamivir and baloxavir marboxil from their market approval in the United States until the third quarter of 2023 were retrieved. Signal detection was performed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods. ADEs were classified according to the System Organ Class (SOC) in the Medical Dictionary for Regulatory Activities (MedDRA) version 25.0.

RESULTS: A total of 1,727 and 12,607 ADE reports were retrieved for baloxavir marboxil and oseltamivir, respectively, involving 17 and 26 SOC categories. Baloxavir marboxil demonstrated a strong association with ischemic colitis, melena, delirium febrile, enterocolitis, febrile convulsion, and altered state of consciousness. Oseltamivir exhibited a strong association with pathological personality, thinking abnormal, agitation, abnormal behavior, somnambulism, delirium febrile,and spinal cord hemorrhage.

CONCLUSIONS: When using oseltamivir and baloxavir marboxil clinically, attention should be paid not only to common ADEs but also to those not mentioned on the drug label.

PMID:40244175 | DOI:10.1080/14740338.2025.2495854