Selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor use and sexual dysfunction: a pharmacovigilance analysis.

Abstract

Background: In clinical practice, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) remain commonly used owing to their proven antidepressant efficacy, however, they are also associated with a considerable risk of sexual adverse effects.

Aim: To examine the relationship between individual SSRIs/SNRIs and distinct sexual dysfunction symptoms.

Methods: Using the Food and Drug Administration's Adverse Event Reporting System (FAERS) database, we performed a pharmacovigilance analysis of adverse drug events. Disproportionality signals were detected using reporting odds ratios (RORs) and information components (ICs), with Bayesian shrinkage transformation applied to mitigate random variability.

Outcomes: The primary outcome indicators are RORs and ICs, which were employed to evaluate the association between SSRIs and SNRIs and the development of sexual dysfunction.

Results: Comparative analysis of antidepressant-related adverse events in the FAERS database showed that while sexual dysfunction was associated with all studied SSRIs/SNRIs (sertraline, citalopram/escitalopram, paroxetine, fluoxetine, venlafaxine, and duloxetine), symptom profiles varied markedly. Sertraline presented the most diverse array of sexual dysfunction manifestations, contrasting with duloxetine's relatively restricted adverse effect profile.

Clinical implications: This study provides valuable real-world evidence to assist clinicians in optimizing antidepressant selection, proactively identifying high-risk populations for sexual dysfunction, and improving patient compliance and quality of life during antidepressant treatment.

Strengths and limitations: The use of FAERS offers large-scale real-world data on antidepressant-related sexual dysfunction to enhance generalizability. But the limitation is FAERS' passive surveillance nature, which may involve underreporting or insufficient clinical context, restricting causal inference.

Conclusion: While previous studies have not fully elucidated antidepressant-related sexual dysfunction, our findings delineate distinct sexual adverse effect profiles between SSRIs and SNRIs, contributing valuable evidence for personalized treatment approaches.