目的 通过对吗替麦考酚酯不良事件（ADE）的信号挖掘分析，为临床安全用药提供参考。方法 利用Open Vigil工具对美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中2004—2021年的吗替麦考酚酯ADE数据进行分析。结果 在数据库中以吗替麦考酚酯作为首要怀疑药物的ADE报告共52327例。采用比例失衡法提取到阳性信号2225个，累及24个系统和器官，ADE例次排序前50位中挖掘到9项说明书中未记录的信号，其中血栓性微血管病（TMA）和可逆性后部脑部综合征（RPLS）尤其值得关注。与硫唑嘌呤相比，吗替麦考酚酯引起的总体骨髓抑制和肝功能异常均较轻，但更容易出现单纯红细胞再生障碍性贫血和胆纤维化。结论 吗替麦考酚酯在临床应用中应定期监测相应指标，及时采取干预措施，确保安全合理用药。

Objective To provide reference for clinical safe drug use through the signal mining analysis of adverse drug event (ADE) of mycophenolate mofetil. Methods OpenVigil was used to analyze ADE data of mycophenolate mofetil from 2004 to 2021 in the US FDA adverse event reporting system (FAERS). Results There were 52327 ADE with mycophenolate mofetil as the primary suspected drug in the database. 2225 positive signals were extracted by using the disproportionality measurement, involving 24 systems organ classes. Among the top 50 signals of ADE, nine unrecorded signals were excavated, including thrombotic microangiopathy (TMA) and reversible posterior leukoencephalopathy syndrome (RPLS), which should be particularly concerned. Compared with azathioprine, mycophenolate mofetil caused less overall myelosuppression and severe liver function abnormalities, but was more prone to pure red cell aplasia and biliary fibrosis. Conclusion In clinical application of mycophenolate mofetil, corresponding indicators should be monitored regularly, and intervention measures should be taken in time to ensure safe and rational drug use.