Comparative safety analysis of baloxavir marboxil and oseltamivir based on the FAERS database.
Yingqiu Tu, Xin Lai, Qing Wan, Tiantian Xu
Expert opinion on drug safety April 24, 2025 DOI: 10.1080/14740338.2025.2495854 via PubMed
Summary
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.
Study at a glance
| Characteristics | Observational pharmacovigilance study using FAERS database Peer reviewed |
|---|---|
| Sample size | 14,334 |
| Population | Patients with adverse drug event reports for oseltamivir or baloxavir marboxil in the FAERS database |
| Keywords | Anti-influenza drugs Adverse drug events Baloxavir marboxil Oseltamivir Signal detection |
| Citations | 2 |
| Key finding | Baloxavir marboxil showed strong associations with ischemic colitis, melena, febrile delirium, enterocolitis, febrile convulsion, and altered consciousness; oseltamivir showed strong associations with pathological personality, abnormal thinking, agitation, abnormal behavior, sleepwalking, febrile delirium, and spinal cord hemorrhage. |
Abstract
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. 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. 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. 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.