目的 基于美国食品药品管理局不良事件报告系统（FAERS）数据库挖掘他喷他多不良事件信号，为临床安全用药提供参考。方法 从FAERS数据库检索2008年第4季度—2025年第3季度主要与他喷他多相关的不良事件报告。保留单独使用他喷他多的报告，使用报告比值比（ROR）法和综合标准法（MHRA）进行信号检测，进一步采用韦伯分析检验评估他喷他多不良事件的发生时间规律。结果 共提取到他喷他多为主要怀疑药品的不良事件报告15 444例，其中他喷他多单药报告4 373例，涉及患者2 377人。男女比例为1∶1.53，患者中位年龄为55岁，严重不良事件报告占比41.9%，美国是报告例数最多的国家。挖掘到83个阳性信号，涉及16个系统器官类别（SOC），其中23个信号未在说明书收录，其中报告频次靠前的包括谵妄、血清素综合征、尿潴留、吞咽困难等。不良事件主要发生在用药后的首月，中位发生时间为20 d，IQR为1～790 d。结论 临床使用他喷他多存在潜在不良事件和风险，应注意用药后的首月后出现的谵妄、血清素综合征、尿潴留、吞咽困难等不良事件。

Objective To mine the adverse event signals of tapentadol based on the FAERS database, aiming to provide a reference for clinical safe medication. Methods To search the FAERS database for adverse event reports related to tapentadol in the fourth quarter of 2008 to the third quarter of 2025. To retain the reports that used tapentadol alone, and use the ROR and MHRA method for signal detection. Further, use the Weber analysis to evaluate the temporal pattern of adverse events caused by tapentadol. Results A total of 15 444 adverse event reports related to tapentadol were extracted, among which 4 373 were reports of tapentadol as a single drug. These reports involved 2 377 patients. The male-to-female ratio was 1:1.53. The median age of the patients was 55 years. The proportion of serious adverse events was 41.9%. The United States had the highest number of reports. 83 Positive signals were identified, involving 16 system organ categories (SOC). Among these, 23 signals were not included in the drug instructions. The signals with higher reporting frequency included delirium, serotonin syndrome, urinary retention, and dysphagia. Adverse events mainly occurred in the first month after medication administration, with a median occurrence time of 20 days, and the interquartile range was 1-790 days. Conclusion Clinical use of tapentadol may involve potential adverse events and risks. It is important to be aware of adverse events such as delirium, serotonin syndrome, urinary retention, and dysphagia that may occur within the first month after medication administration.

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