Zhang Ying, Sun Shengzhu, Ning Yunhong
First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.
Front Psychiatry. 2025 Feb 24;16:1532803. doi: 10.3389/fpsyt.2025.1532803. eCollection 2025.
Vortioxetine hydrobromide is a widely prescribed medication for the treatment of major depressive disorder (MDD), primarily exerting its antidepressant effects by inhibiting the reuptake of serotonin (5-HT).The objective of this study was to investigate adverse events (AEs) associated with vortioxetine hydrobromide through data mining in the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety.
We collected FAERS data from Q3 2013 to Q1 2024 for data cleansing. Disproportionality analysis was employed to quantify relevant AEs associated with vortioxetine. Reported Ratio of Ratios (ROR) was utilized for identifying risk signals within the FAERS data. We employed the System Organ Classes (SOCs) and selected the Preferred Terms (PTs) from the Medical Dictionary for Regulatory Activities (MedDRA version 26.1).
A total of 11,298 cases were reported as "primary suspected (PS)" for vortioxetine hydrobromide. Notably, at the systemic organ level (SOC) level, the adverse effects associated with vortioxetine hydrobromide involved 27 systemic organoid classes (SOCs).We identified 150 significantly disproportionate Preferred Terms (PTs) that met all four algorithms.
This study identified adverse events (AEs) associated with vortioxetine. Our findings offer valuable insights for optimizing the use of vortioxetine hydrobromide and reducing potential side effects, serving as a reference for its rational and safe clinical application.
氢溴酸伏硫西汀是一种广泛用于治疗重度抑郁症（MDD）的药物，主要通过抑制5-羟色胺（5-HT）的再摄取发挥抗抑郁作用。本研究的目的是通过美国食品药品监督管理局不良事件报告系统（FAERS）中的数据挖掘来调查与氢溴酸伏硫西汀相关的不良事件（AE），以提高临床安全性。
我们收集了2013年第三季度至2024年第一季度的FAERS数据进行数据清理。采用不成比例分析来量化与伏硫西汀相关的相关AE。报告比值比（ROR）用于识别FAERS数据中的风险信号。我们使用了系统器官分类（SOC），并从监管活动医学词典（MedDRA版本26.1）中选择了首选术语（PT）。
共有11298例报告为氢溴酸伏硫西汀的“主要疑似（PS）”病例。值得注意的是，在系统器官水平（SOC）上，与氢溴酸伏硫西汀相关的不良反应涉及27个系统器官类（SOC）。我们确定了150个符合所有四种算法的显著不成比例的首选术语（PT）。
本研究确定了与伏硫西汀相关的不良事件（AE）。我们的研究结果为优化氢溴酸伏硫西汀的使用和减少潜在副作用提供了有价值的见解，为其合理安全的临床应用提供了参考。
