Objective To detect escitalopram-related adverse drug event (ADE) signals of QT interval prolongation and associated arrhythmias in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods ADE reports in which escitalopram was designated as the primary suspect (PS) drug were extracted from the FAERS database from the first quarter of 2004 through the first quarter of 2026. Standardized coding of ADEs was performed using the Medical Dictionary for Regulatory Activities. Fourteen prespecified preferred terms (PTs) related to QT interval prolongation and associated arrhythmias were categorized into core QT events and clinically relevant extended events. Signal detection was performed using the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. Time-to-onset (TTO) was also analyzed.

Results A total of 23,874 independent ADE reports associated with escitalopram were identified. Excluding reports with missing sex information, more reports involved females than males, and most patients were adults aged 18-64 years. At the system organ class (SOC) level, the three SOCs with the highest numbers of PT event records were psychiatric disorders, nervous system disorders, and general disorders and administration site conditions. Among the prespecified QT-related PTs, electrocardiogram QT prolonged had the highest number of reports (ROR = 10.05, IC025 = 3.15). Torsade de pointes was also identified as a robust positive signal (ROR = 9.26, IC025 = 2.81). TTO analysis showed that the median onset time for all independent ADE reports was 45.00 days, 52.00 days for drug-PT records of core QT events and 43.00 days for the composite QT-related events comprising both core and extended events.

Conclusion FAERS data mining identified disproportionate reporting signals for escitalopram-associated QT interval prolongation and related arrhythmias; however, these findings do not represent true incidence or establish causality. In clinical practice, attention should be paid to older patients and female patients, especially those with additional risk factors, and to patients with a history of arrhythmia or other underlying cardiovascular disease, abnormal baseline QTc, electrolyte disturbances, hepatic or renal dysfunction, and concomitant use of other QT-prolonging drugs. electrocardiographic and serum electrolyte monitoring should be implemented based on individual risk assessment when necessary.

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