FDA label
What is dutasteride used for?
The FDA-approved uses of dutasteride, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for dutasteride lists 2 uses: Monotherapy; Combination with Alpha-adrenergic Antagonist.
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Dutasteride, capsule, liquid filled
Indications and Usage, quoted from the label by Epic Pharma, LLC (ANDA209909). Cross-references to other label sections are left out.
Monotherapy
Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- improve symptoms,
- reduce the risk of acute urinary retention (AUR), and
- reduce the risk of the need for BPH-related surgery.
Combination with Alpha-adrenergic Antagonist
Dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
Limitations of Use
Dutasteride capsules are not approved for the prevention of prostate cancer.
Source: DailyMed label, set id 2ee1eef5-8ec7-46c1-b4fa-13184915448f, version 3, effective January 8, 2025. NDC 42806-549, one of 18 listings for this product.
Questions
What is dutasteride used for?
The FDA label for dutasteride lists 2 uses: Monotherapy; Combination with Alpha-adrenergic Antagonist.
What drug class is dutasteride?
FDA lists dutasteride in the 5-alpha Reductase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.