The real-world safety profile of sertraline: Pharmacovigilance analysis of the FAERS database.

Objective: Sertraline is a widely used antidepressant, and its safety characteristics in elderly and adolescent patients have not been fully clarified. The purpose of this study was to comprehensively evaluate the characteristics of adverse effects of sertraline through a large-scale analysis of real-world data and to add to the evidence in the elderly and adolescent populations.

Methods: The data were extracted from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database from the first quarter (Q1) 2004 to Q1 2024 for data cleaning and analysis. Adverse drug events were analyzed using the Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), Proportional Reporting Ratio (PRR), and Multi-Item Gamma Poisson Shrinker (MGPS) methods.

Results: A total of 49,359 sertraline-related adverse event reports were included in this study. In addition to known adverse events (AEs), the study identified new potential safety signals for bruxism, microscopic colitis and genital anaesthesia. Intentional self-injury was the common adverse event in patients under 18 years of age and hyponatremia in patients 65 years of age and older. 26.77 % of adverse reactions occurred within one week of administration.

Conclusion: Sertraline requires special attention to the risks associated with neurologic, psychiatric, and congenital disorders in clinical use. In addition to common AEs such as nausea, and tremor, newly identified adverse reactions such as genital anaesthesia, bruxism, and microscopic colitis should be guarded against. For adolescents, suicide risk monitoring should be strengthened. In elderly patients, the risk of falls and electrolyte disturbances should be emphasized.