The antidepressants and sexual dysfunction: a pharmacovigilance-pharmacodynamic study of the FDA adverse event...

Sexual dysfunction (SD) is a commonly occurring yet often underestimated adverse event associated with the use of antidepressants. This study aimed to analyze the reporting of SD associated with the use of antidepressants in comparison with one another, and to explore potential receptor mechanisms based on the real-world data from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Disproportionality analysis was conducted based on FAERS reports (2004 Q1 to 2024 Q2) using reporting odds ratios (ROR) and information components (IC) methods. Spearman correlation analysis was performed to explore the relationship between ROR and the related receptor-binding properties.

In total, 233 significant signals involving 9767 cases were included. The analysis confirmed that the selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors exhibited significant signals, consistent with previous research. Additionally, unexpected signals were detected for vortioxetine (ROR = 13.60), suggesting a potential risk despite its low reported incidence rates of SD. Spearman correlation analysis revealed potential effects for the binding affinities of serotonin transporter, 5-HT1B, and 5-HT2A receptors on reduced sexual desire.

The present investigation has detected new and unexpected signals of antidepressant-related SDs. Further research is needed to validate and clarify the observed associations.