Yu Yong, Sun Xin, Hao Liqun, Zhang Xiaoyan, Guo Yankui
The First Clinical College of Medicine, Shandong University of Traditional Chinese Medicine, Jinan, 250013, Shandong Province, China.
Jinan Hospital of Guang an men Hospital, China Academy of Chinese Medical Sciences, Jinan, 250012, Shandong Province, China.
Sci Rep. 2025 Feb 13;15(1):5322. doi: 10.1038/s41598-025-89632-7.
To explore and analyze the potential adverse event (AE) signals of trazodone, with reference to the safe clinical use of drugs. Based on the FDA Adverse Event Reporting System (FAERS), the AE data of trazodone were extracted from the first quarter of 2004 to the second quarter of 2024, and the extracted data were statistically analyzed using the method, to identify valid AE signals that met our judgment, compare them with those recorded in the authorized information for trazodone thereby identifying unexpected potential adverse reactions. A total of 5199 AE reports with trazodone as the main suspect were extracted, with a higher reported proportion of females (52.68%) than males (38.83%). Many reports (31.47%) did not provide age information, although for those reports with identifiable age data, the 50-60 years age group was the most common (14.20%), and the country of reporting was predominantly the United States (82.58%). A total of 179 significant AE signals were unearthed, with suicide, formulation toxicity, abnormal penile erection, insomnia, and cardiac and respiratory arrest reported with high frequency, which was not entirely consistent with the specification record. The study unearthed 156 new potential AEs on the basis of trazodone drug inserts and suggested precautions for overdosing and dose adjustment, which is conducive to safeguarding the safety of patients' medication.
为参照药物临床安全使用情况，探索并分析曲唑酮潜在的不良事件（AE）信号。基于美国食品药品监督管理局不良事件报告系统（FAERS），提取2004年第一季度至2024年第二季度曲唑酮的AE数据，并采用该方法对提取的数据进行统计分析，以识别符合我们判断标准的有效AE信号，将其与曲唑酮批准信息中记录的信号进行比较，从而识别出意外的潜在不良反应。共提取了5199份以曲唑酮为主要怀疑对象的AE报告，报告中女性比例（52.68%）高于男性（38.83%）。许多报告（31.47%）未提供年龄信息，不过对于那些有可识别年龄数据的报告，50 - 60岁年龄组最为常见（14.20%），报告国家主要为美国（82.58%）。共发现179个显著的AE信号，其中自杀、制剂毒性、阴茎异常勃起、失眠以及心脏和呼吸骤停报告频率较高，这与说明书记录并不完全一致。该研究在曲唑酮药品说明书基础上发现了156个新的潜在AE，并提出了过量用药和剂量调整的建议，这有助于保障患者用药安全。
