Side Effects of Dutasteride
Common Sexual Side Effects
- Erectile dysfunction occurs in approximately 4.7% of patients during the first 6 months of treatment, with decreasing incidence over time, according to the American Urological Association 3
- Decreased libido is reported in 3% of patients in the first 6 months, decreasing to 0.3% by 19-24 months, as noted by the American Urological Association 3
- Ejaculation disorders, including decreased ejaculate volume, occur in 1.4% of patients initially, decreasing to 0.1% by 19-24 months, as reported by the American Urological Association 3
Endocrine Side Effects
- Gynecomastia occurs in 2.3% of patients in mid-term studies compared to 0.74% in placebo groups, with a relative risk of 3.11, according to the American Urological Association 3
- Dutasteride reduces PSA levels by approximately 50% after 12 months of therapy, which must be considered when screening for prostate cancer, as recommended by the American College of Radiology and the American Urological Association 2, 4
Discontinuation Rates
- The overall discontinuation rate is approximately 15% in both dutasteride and placebo groups, as reported by the American Urological Association and the American Society of Clinical Oncology 1, 2
- Discontinuation due to adverse events occurs in approximately 6-7% in both dutasteride and placebo groups, according to the American Urological Association and the American Society of Clinical Oncology 1, 2
- The most common reason for discontinuation is impotence, occurring in 1-1.5% of patients, as noted by the American Urological Association and the American Society of Clinical Oncology 1, 2
Clinical Considerations
- PSA monitoring is crucial, as healthcare providers should account for the PSA-lowering effect of dutasteride when interpreting PSA results for prostate cancer screening, as recommended by the American College of Radiology and the American Society of Clinical Oncology 2
- A risk-benefit assessment should be performed, weighing the benefits of dutasteride in BPH symptom relief, reduced risk of acute urinary retention, and reduced need for surgical intervention against potential side effects, as suggested by the American Urological Association and the American Society of Clinical Oncology 2, 5