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Abstract：
Esketamine nasal spray (ESK-NS) is a new drug for treatment-resistant depression, and we aimed to detect and characterize the adverse events (AEs) of ESK-NS using the Food and Drug Administration (FDA) adverse event reporting system (FAERS) database between 2019 Q1 and 2023 Q4. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and multi-item gamma Poisson shrinker (MGPS) were performed to detect risk signals from the FAERS data to identify potential ESK-NS-AEs associations. A total of 14,606 reports on AEs with ESK-NS as the primary suspected drug were analyzed. A total of 518 preferred terms signals and 25 system organ classes mainly concentrated in psychiatric disorders (33.20%), nervous system disorders (16.67%), general disorders and administration site conditions (14.21%), and others were obtained. Notably, dissociation (n = 1,093, ROR 2,257.80, PRR 899.64, EBGM 876.86) exhibited highest occurrence rates and signal intensity. Moreover, uncommon but significantly strong AEs signals, such as hand-eye coordination impaired, feeling guilty, and feelings of worthlessness, were observed. Additionally, dissociative disorder (n = 57, ROR 510.92, PRR 506.70, EBGM 386.60) and sedation (n = 688, ROR 172.68, PRR 155.53, and EBGM 142.05) both presented strong AE signals, and the former is not recorded in the Summary of Product Characteristics (SmPC). In clinical applications, close attention should be paid to the psychiatric disorders and nervous system disorders, especially dissociation. Meanwhile, clinical professionals should be alert for the occurrence of AEs signals not mentioned in the SmPC and take preventive measures to ensure the safety of clinical use.
摘要：
Esketamine鼻腔喷雾剂（ESK-NS）是一种治疗难治性抑郁症的新药，我们旨在使用美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库在2019年第一季度至2023年第四季度之间检测和表征ESK-NS的不良事件（AE）。报告赔率比(ROR)，比例报告比率(PRR)，和多项目伽玛泊松收缩器(MGPS)进行检测,以从FAERS数据中检测风险信号,从而确定潜在的ESK-NS-AE关联.共分析了以ESK-NS为主要可疑药物的14,606份AE报告。共有518个首选术语信号和25个系统器官类别，主要集中在精神疾病（33.20％），神经系统疾病（16.67%），一般疾病和给药部位状况(14.21%)，其他人得到了。值得注意的是,解离（n=1,093，ROR2,257.80，PRR899.64，EBGM876.86）表现出最高的发生率和信号强度。此外，不常见但明显强烈的AE信号，如手眼协调功能受损，感到内疚，和毫无价值的感觉，被观察到。此外,分离障碍（n=57，ROR510.92，PRR506.70，EBGM386.60）和镇静（n=688，ROR172.68，PRR155.53和EBGM142.05）均表现出强烈的AE信号，前者没有记录在产品特性摘要(SmPC)中。在临床应用中,密切关注精神疾病和神经系统疾病，尤其是分离。同时,临床专业人员应警惕SmPC中未提及的AE信号的发生，并采取预防措施，以确保临床使用的安全性。
