ORIGINAL RESEARCH article
Front. Psychiatry
Sec. Psychopharmacology
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1637471
Arrhythmic events pertinent with antidepressants: A Bayesian disproportional analysis mining the FDA Adverse Event Reporting System (FAERS) database
Provisionally accepted
- 1Department of Cardiology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
- 2Third Xiangya Hospital of Central South University, Changsha, China
- 3Zhejiang University School of Public Health, Hangzhou, China
- 4Brooks College, Sunnyvale, United States
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Objective: To investigate pharmacovigilance (PV) and make pairwise comparisons on arrhythmic events among antidepressants from the US Food and Drug Administration Adverse Event Reporting System (FAERS). Method: Records regarding antidepressants treating depression and major depression from 2015 1st quarter to 2023 3rd quarter documented in FAERS database were harvested. The primary endpoint of this study was PV for arrhythmic events, including QT prolongation/ Torsades de Pointes (TdP), atrial fibrillation (AF), heart block, and ventricular arrhythmia. The secondary endpoints comprised the pairwise comparisons on constituent ratio and severity of outcomes of drugs of interest on the above 4 diseases. Result: Ultimately, 746,507 records were eligible for analysis. PV for QT interval prolongation/TdP were identified for citalopram (PRR=2.13,95%CI: 1.89 to 2.40,ROR= 2.14,95%CI: 1.90 to 2.40,IC= 0.98, 95%CI:0.80 to 1.12), escitalopram (ROR=1.72, 95%CI: 1.52 to 1.96, IC= 0.71, 95%CI: 0.51 to 0.86), fluoxetine (ROR=1.39, 95%CI: 1.21 to 1.60, IC=0.43, 95%CI: 0.21 to 0.60) and quetiapine (ROR= 1.58, 95%CI:1.30 to 1.91, IC=0.63, 95%CI: 0.31 to 0.85). In terms of AF, PV were detected in citalopram (ROR=1.82, 95%CI: 1.44 to 2.30, IC=0.78,95%CI: 0.41 to 1.05), escitalopram (ROR= 1.34, 95%CI:1.03 to 1.74), sertraline (ROR=1.32, 95%CI: 1.07 to 1.64, IC= 0.35, 95%CI: 0.01 to 0.59), and fluoxetine (ROR= 1.68, 95%CI: 1.32 to 2.13, IC= 0.68, 95%CI: 0.29 to 0.95). With regard to heart block, PV were detected in citalopram (ROR= 1.37, 95%CI: 1.05 to 1.80) and mirtazapine (ROR= 1.40, 95%CI: 1.03 to 1.90). Regarding to ventricular arrhythmia, PV were detected in citalopram (ROR=1.55, 95%CI:1.19 to 2.02, IC= 0.58, 95%CI: 0.15 to 0.88), escitalopram (ROR=1.51,95%CI: 1.16 to 1.97, IC= 0.54, 95%CI: 0.12 to 0.85). and quetiapine (PRR=2.39,95%CI: 1.75 to 3.25, ROR=2.39, 95%CI: 1.75 to 3.26, IC=1.17, 95%CI: 0.67 to 1.54). Conclusion: Citalopram and escitalopram (classified as SSRIs), exhibited the strongest correlations with arrhythmic occurrences. Quetiapine (classified as SGA) demonstrated higher risk and worse prognosis on QT prolongation/TdP and ventricular arrhythmic events. Instead, venlafaxine and duloxetine (classified as SNRIs) did not show any PV of any arrhythmia, and had lower risks and slighter degree of adverse events compared with the rests. Certainly, more head-to-head related studies are merited.
Keywords: Arrhythmic events, Antidepressants, Bayesian disproportional analysis, FAERS database, Pharmacovigilance
Received: 29 May 2025; Accepted: 02 Sep 2025.
Copyright: © 2025 曹, Huang, Yang, Yang, Chen, Qian and Xie. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Xujing Xie, Department of Cardiology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
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