Dutasteride
Testosterone-5-Alpha Reductase Inhibitors
Sold as JALYN · AVODART
- Drug class
- Testosterone-5-Alpha Reductase Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 37
- FDA reports (12 mo)
- 706
Overview
Dutasteride is an active pharmaceutical ingredient in the Testosterone-5-Alpha Reductase Inhibitors group (G04CB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 18 | May 29, 2026 |
| CA Canada | Health Canada | 17 | February 3, 2026 |
| US United States | FDA | 2 | January 13, 2026 |
GBUnited Kingdom· MHRA
18 products
Uses
Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. 1.
How to take
CACanada· Health Canada
17 products
Uses
5 mg gelatin For a complete listing see Dosage Forms, Composition and Packaging section.
INDICATIONS AND CLINICAL USE Monotherapy:
AVODART® (dutasteride) is indicated for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates.
Combination therapy:
AVODART® (dutasteride) in combination with the alpha blocker, tamsulosin, is indicated for the treatment of moderate to severe symptomatic BPH in men with enlarged prostates. AVODART® administered alone or in combination with the alpha blocker, tamsulosin, has been shown to reduce prostate size, improve urinary flow and symptoms of BPH.
AVODART® administered as monotherapy has been shown to reduce the risk of acute urinary retention (AUR) and the need for BPH related surgery. Combination therapy was statistically significant to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery (see Clinical Trials).
USUnited States· FDA
2 products
Uses
1 INDICATIONS AND USAGE Dutasteride and tamsulosin hydrochloride capsules are a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
1 ) Limitations of Use: Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. 1 Benign Prostatic Hyperplasia (BPH) Treatment Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
2 Limitations of Use Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer.
Drug interactions
Known interactions involving Dutasteride. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 299. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL194940006 · revised December 12, 2025
- [2]Health Canada (DPD) · 02247813 · revised March 22, 2025
- [3]FDA DailyMed · 0a334eb9-cacf-f2… · revised January 13, 2026 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.