Erectile Dysfunction Rates with Proscar (Finasteride)
Approximately 8.1% of patients taking Proscar (finasteride) experience erectile dysfunction in the first year of treatment, compared to 3.7% on placebo, representing an absolute drug-attributable increase of 4.4%. 1, 2
Year-by-Year Breakdown
First Year of Treatment:
- Impotence/erectile dysfunction occurs in 8.1% of finasteride-treated patients versus 3.7% on placebo 1, 2
- This represents the highest risk period for developing sexual side effects 1
- The absolute increase attributable to finasteride is approximately 4.4% 1
Years 2-4 of Treatment:
- The incidence equalizes to 5.1% in both finasteride and placebo groups, with no significant difference between treatments 1, 2
- New sexual adverse events occur in only 7% of both finasteride and placebo groups during this period 3
Important Clinical Context
Baseline Sexual Dysfunction:
- 46% of men in clinical trials had pre-existing sexual dysfunction at baseline, making attribution to finasteride challenging in individual cases 1, 3
- Men with or without baseline sexual dysfunction showed similar drug-related sexual adverse event profiles 3
Discontinuation Rates:
- Only 3.7% of finasteride patients discontinued therapy due to sexual adverse reactions (versus 2.1% on placebo) 2
- Among those who discontinued, approximately 50% experienced resolution of sexual dysfunction after stopping finasteride 3
Resolution While Continuing Therapy:
- 12% of finasteride patients experienced resolution of sexual adverse events while continuing treatment (compared to 19% on placebo) 3
Critical Caveats
Nocebo Effect:
- The nocebo phenomenon significantly inflates reported rates in clinical practice 4
- Patients informed about sexual side effects reported 43.6% incidence versus 15.3% in uninformed patients taking the same medication 4
- This explains the discrepancy between controlled trial data (8.1%) and higher rates sometimes reported in clinical practice 4
Duration-Dependent Risk:
- Longer exposure (>205-208 days) may increase risk of persistent erectile dysfunction that continues after discontinuation 5
- Among men who developed erectile dysfunction on finasteride, 31.5% experienced persistent dysfunction lasting beyond 90 days after stopping the medication 5
Magnitude of Effect: