目的 挖掘和分析苏泽曲林的药品不良事件信号，为临床安全用药提供参考。方法 收集美国食品药品管理局不良事件报告系统（FAERS）数据库2025年第1季度—2026年第1季度的苏泽曲林不良事件数据，采用报告比值比法（ROR）、比例报告比值法（PRR）、贝叶斯置信区间神经传播网络法（BCPNN）和多重伽马–泊松收缩估计法（MGPS）进行信号挖掘。结果 最终筛选以苏泽曲林为主要怀疑药物的不良事件涉及人群918例，获得33个可分析的信号，共842份。发生频次较高的PT包括瘙痒、皮疹、皮肤异常感觉、头晕、肌痉挛、嗜睡等。其中感受异常、脑雾、异常做梦、面部肿胀和口腔感觉减退未收录于药品说明书中。结论 苏泽曲林在真实世界中的不良事件主要涉及神经系统、皮肤及胃肠道，总体安全性良好。需特别关注其可能引发的脑雾、异常做梦等药品说明书中未载入的神经精神系统潜在风险，建议临床用药时加强监测与评估。

Objective To explore and analyze the adverse drug event signals of suzetrigine, so as to provide a reference for the safe clinical use of the drug. Methods Adverse drug event data of suzetrigine from the first quarter of 2025 to the first quarter of 2026 were collected from the FAERS database. ROR, PRR, BCPNN, and MGPS methods were used for signal mining. Results 918 Cases of adverse drug events with suzetrigine as the primary suspect drug were screened out. A total of suzetrigine-related adverse drug event reports were mined, and 33 analyzable signals involving 842 reports were obtained. PTs with high occurrence frequency included itching, rash, paresthesia, dizziness, muscle spasm, and somnolence. Among them, paresthesia, brain fog, abnormal dreams, and peripheral swelling were not included in the drug label. Conclusion Adverse events of suzetrigine in the real world mainly involve the nervous system, skin, and gastrointestinal tract, with good overall safety. Special attention should be paid to the potential neuropsychiatric risks not listed in the drug label, such as brain fog and abnormal dreams. It is recommended to strengthen clinical monitoring during medication.