目的 基于美国食品药品管理局（FDA）不良事件报告系统（FAERS）数据库挖掘cobenfy的药品不良事件信号，为临床安全用药提供参考。方法 收集FAERS数据库中2024年9月—2025年12月cobenfy的不良事件报告，利用比例失衡法中的报告比值比（ROR）和英国药品及保健品管理局（MHRA）综合标准法进行数据挖掘。结果 共收集到cobenfy为首要怀疑药物的不良事件报告1 410份，男女比例为1.49∶1，美国提交的报告数最多（96.67%）。共挖掘出cobenfy不良事件信号51个，累及10个SOC系统。最常见的3个系统分别是胃肠系统疾病、精神病类及各类神经系统疾病。不良事件信号数量排名前5位的有恶心、呕吐、便秘、尿潴留及头晕。信号强度排名前5位的分别为与暴力行为相关的症状、流口水、尿潴留、幻觉（听觉）及唾液分泌过多。值得关注的是，此次研究还甄别出部分说明书尚未提及的新信号，大多数为精神病类。结论 cobenfy相关的不良事件主要涉及胃肠道系统疾病与精神病类，除应注意药品说明书中提及的不良事件外，但需要警惕说明书未提及的不良事件，以保障治疗的安全性。

Objective To mine the drug adverse event signals of cobenfy based on the FAERS database, to provide a reference for clinical safe medication. Methods Data on cobenfy from September 2024 to December 2025 were collected from FAERS. Data mining was performed with the ROR and MHRA methods. Results A total of 1 410 adverse drug events of cobenfy was identified as the primary suspect drug, with a male-to-female ratio of 1.49:1, the majority of reports (96.67%) from the United States. Fifty-one adverse drug event signals associated with cobenfy were identified, affecting ten systems. The three most common systems were gastrointestinal disorders, psychiatric disorders, and nervous system disorders. The top 5 adverse drug event signals in terms of quantity were nausea, vomiting, constipation, urinary retention, and dizziness. The top 5 signals in terms of intensity were violence-related symptom, drooling, urinary retention, hallucinations (auditory), and salivary hypersecretion. It is worth noting that this study also identified some new signals not mentioned in the drug instructions, most of which were related to psychiatric disorders. Conclusions Adverse drug events related to cobenfy mainly involves gastrointestinal disorders and psychiatric disorders. In addition to paying attention to the adverse drug event mentioned in the drug instructions, it is also necessary to be vigilant about the adverse drug event not mentioned in the instructions to ensure the safety of the treatment.