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.