American Urological Association (AUA) guidelines recommend selective serotonin reuptake inhibitors (SSRI) as first-line pharmacotherapy for premature ejaculation (PE). While previous studies have described sexual adverse events (AE) associated with each medication, there is limited data directly comparing rates of specific sexual AEs across SSRIs. This study investigates the Food and Drug Administration Adverse Event Reporting System (FAERS) database for reports of monotherapy use of fluoxetine 20 mg, paroxetine 20 mg, sertraline 50 mg, and sertraline 100 mg in males from January 2004–June 2021. We examined 2608 reports from patients using SSRIs for PE or other psychiatric conditions. The average number of AEs was significantly different (p < 0.01) with paroxetine 20 mg having the highest (5.1 AEs/case report). Changes in libido was the most common sexual AE for fluoxetine 20 mg (6.7% of reports), paroxetine 20 mg (4.2%), and sertraline 50 mg (7.2%) while orgasm disorder was the most reported for sertraline 100 mg (3.9%). The SSRIs had different rates of changes in libido, erection disorder, orgasm disorder, and other sexual dysfunction (outside those listed). The SSRIs also differed in the rates of fatigue, ear/hearing changes, headache, and psychological AEs. The differences in specific AEs warrant future studies to determine true differences that would affect patient counseling.
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Data analyzed for this project can be found in the FDA Adverse Event Reporting System (FAERS) Latest Quarterly Data Files repository, https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.
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The authors declare no competing interests.
This study was deemed non-human subjects research and exempt from approval by the Institutional Review Board at Albany Medical Center.
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Tram, M., Meyerson, B., Welliver, C. et al. Differences in sexual adverse events for premature ejaculation medications from a public federal database. Int J Impot Res (2023). https://doi.org/10.1038/s41443-023-00676-7