Yu Lurong, Xiang Qiumeng, Liu Limei
College of Traditional Chinese Medicine of Chongqing Medical University, Chongqing, China.
Pharmacy Department of Chongqing Youyoubaobei Women and Children's Hospital, Chongqing, China.
PLoS One. 2025 Feb 25;20(2):e0314970. doi: 10.1371/journal.pone.0314970. eCollection 2025.
Assessing the potential for oseltamivir-induced liver damage is essential to ensure its safe administration. The aim of this study was to examine the association between hepatotoxicity and oseltamivir use and to describe the features of oseltamivir-induced hepatotoxicity. Data were obtained from the Adverse Event Reporting System of the US Food and Drug Administration (FAERS). Disproportionality and proportionality analyses were performed to evaluate the safety profile of oseltamivir-related hepatotoxicity and the occurrence of hepatotoxicity-related adverse events across sex and age groups. The FAERS recorded 20,340,254 adverse event reports between 2004 and 2023, of which 16,960,996 reports were included in the analysis. We identified 14 types of oseltamivir-related adverse events that were hepatotoxic and showed positive signals. The most frequently reported adverse event was abnormal hepatic function (n = 54), and the most severe adverse event was fulminant hepatitis. Compared with that for male individuals, the reporting odds ratio (ROR) was 0.5 for female individuals; and for male individuals, the ROR, compared with that for female individuals, was 4.19. The median time to hepatotoxic adverse events, excluding mixed liver injury, was < 5 days. Oseltamivir can cause liver toxicity, which is influenced by sex and age. Liver function tests and monitoring for signs of liver disease are crucial when using oseltamivir.
评估奥司他韦引起肝损伤的可能性对于确保其安全用药至关重要。本研究的目的是探讨肝毒性与奥司他韦使用之间的关联，并描述奥司他韦所致肝毒性的特征。数据来自美国食品药品监督管理局（FAERS）的不良事件报告系统。进行了不成比例分析和比例分析，以评估奥司他韦相关肝毒性的安全性概况以及不同性别和年龄组中与肝毒性相关不良事件的发生情况。FAERS在2004年至2023年期间记录了20340254份不良事件报告，其中16960996份报告纳入分析。我们确定了14种与奥司他韦相关的肝毒性不良事件，并显示出阳性信号。报告最频繁的不良事件是肝功能异常（n = 54），最严重的不良事件是暴发性肝炎。女性个体的报告比值比（ROR）为0.5，而男性个体与女性个体相比，ROR为4.19。排除混合性肝损伤后，肝毒性不良事件的中位时间<5天。奥司他韦可导致肝毒性，且受性别和年龄影响。使用奥司他韦时，肝功能检查和监测肝病迹象至关重要。
