FDA label

What is finasteride used for?

The FDA-approved uses of finasteride, 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 finasteride (tablet, film coated) lists 2 uses: Monotherapy; Combination with Alpha-Blocker.

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Finasteride, tablet, film coated

Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA090061). Cross-references to other label sections are left out.

Monotherapy

Finasteride tablets 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 -Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

Combination with Alpha-Blocker

Finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score).

Limitations of Use

Finasteride tablets are not approved for the prevention of prostate cancer.

Source: DailyMed label, set id cc9709ce-2d29-48bd-b46b-3f72114f2527, version 10, effective January 24, 2025. NDC 31722-525, one of 60 listings for this product.

Finasteride, tablet, coated

Indications and Usage, quoted from the label by Ascend Laboratories, LLC (ANDA207750). Cross-references to other label sections are left out.

Finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.

Efficacy in bitemporal recession has not been established.

Finasteride tablets is not indicated for use in women.

Source: DailyMed label, set id ecd2fbb2-a4bd-44f2-831d-179e7dbf0741, version 16, effective April 24, 2025. NDC 67877-455, one of 7 listings for this product.

Questions

What is finasteride used for?

The FDA label for finasteride (tablet, film coated) lists 2 uses: Monotherapy; Combination with Alpha-Blocker.

What drug class is finasteride?

FDA lists finasteride 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.

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