目的 基于美国食品药品管理局不良事件报告系统（FAERS）分析呋喹替尼不良事件，为临床安全用药提供参考。方法 收集FAERS数据库中2018年第1季度—2025年第1季度数据，筛选呋喹替尼为首要怀疑药物的不良事件报告，使用报告比值比法（ROR）分析不良事件。结果 共获取呋喹替尼为首要怀疑药物的不良事件报告病例1 632份，适应证结直肠癌（42.8%）最多，涉及3 073例不良事件，阳性首选术语（PT）101个，涉及16个系统器官分类。高发不良事件包括血压升高、发声困难、骨髓抑制等，与说明书所收载不良事件一致。新的不良事件如便秘、周围神经病、脱水、肾局限性血栓性微血管病等。呋喹替尼引起药品不良事件发生时间中位数为14 d，65.8%的不良事件发生在用药前30天内。结论 使用呋喹替尼应重点关注胃肠、血液及皮肤等方面不良反应，还需警惕新的不良反应。

Objective To analyze adverse events of fruquintinib based on FAERS, to provide a reference for safe clinical medication. Methods Data from the first quarter of 2018 to the first quarter of 2025 in the FAERS database were collected. Adverse event reports of fruquintinib as the primary suspected drug were screened, and adverse events were analyzed using the report odds ratio (ROR) method. Results A total of 1 632 adverse event reports with fruquintinib as the primary suspected drug were obtained. Colorectal cancer (42.8%) was the most common indication, involving 3 073 adverse events and 101 positive PTs, covering 16 system and organ classifications. High-incidence adverse events include elevated blood pressure, difficulty in speaking, bone marrow suppression, etc., which are consistent with the adverse events recorded in the instructions. New adverse events such as constipation, peripheral neuropathy, dehydration, and localized thrombotic microangiopathy of the kidney, etc. The median occurrence time of adverse drug events caused by fruquintinib was 14 days, and 65.8% of the adverse events occurred within 30 days before medication. Conclusion When using fruquintinib, special attention should be paid to adverse reactions in the gastrointestinal tract, blood and skin, and new adverse reactions should also be vigilant.

R979.1

国家自然科学基金青年基金资助项目（82404600）；扬州大学附属医院高层次人才引进科研启动项目（2023BS-LJJ）