Male sexual dysfunction associated with selective serotonin reuptake inhibitors (SSRIs): A pharmacovigilance disproportionality analysis of FAERS data.

OBJECTIVE

To describe and compare the reporting patterns and signal strengths of male sexual dysfunction associated with six commonly prescribed SSRIs in the FDA Adverse Event Reporting System.

METHODS

Adverse event data for six representative SSRIs, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram, were retrieved from the FAERS database, spanning from the first quarter of 2004 to the first quarter of 2025. Disproportionality analysis was conducted using both the reporting odds ratio (ROR) and proportional reporting ratio (PRR) to identify potential signals of adverse drug events associated with these medications.

RESULTS

We analyzed 6,631,746 adverse drug event reports associated with SSRIs and detected significant disproportionality signals indicative of male sexual dysfunction in patients with depression. Across all SSRIs, erectile dysfunction was the most commonly reported adverse event [fluoxetine (ROR: 4.97, 95%CI: 4.25-5.82), paroxetine (ROR: 3.99, 95%CI: 3.53-4.5), sertraline (ROR: 6.11, 95%CI: 5.53-6.75), fluvoxamine (ROR: 1.08, 95%CI: 0.35-3.36), citalopram (ROR: 7.7, 95%CI: 6.81-8.69), and escitalopram (ROR: 7.93, 95%CI: 6.99-8.99)], followed by sexual dysfunction [fluoxetine (ROR: 11.94, 95%CI: 10.01-14.23), paroxetine (ROR: 11.39, 95%CI: 10.05-12.91), sertraline (ROR: 13.34, 95%CI: 11.86-15.01), fluvoxamine (ROR: 9.64, 95%CI: 5.01-18.56), citalopram (ROR: 15.09, 95%CI: 12.98-17.54), and escitalopram (ROR: 16.42, 95%CI: 14.11-19.12)].

CONCLUSION

This FAERS analysis detected significant disproportionality signals for male sexual dysfunction across SSRIs. Signal variation reflects reporting differences, not comparative risk, due to database limitations. These findings highlight the need for clinical vigilance and further investigation.