Finasteride 5 mg Tablets — Generic for Proscar — Aurobindo Brand — Aurobindo

These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS.

FINASTERIDE tablets, for oral use

Initial U.S. Approval: 1992

Indications And Usage

Finasteride, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1):

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.

Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2).

Limitations of Use: Finasteride tablets are not approved for the prevention of prostate cancer (1.3).

Dosage And Administration

Finasteride tablets may be administered with or without meals (2).

Monotherapy: One tablet (5 mg) taken once a day (2.1).

Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin (2.2).

Dosage Forms And Strengths

5 mg film-coated tablets (3).

Contraindications

Hypersensitivity to any components of this product (4).

Females who are or may potentially be pregnant (4, 5.3, 8.1, 16).

Warnings And Precautions

• Finasteride reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on finasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.1).
• Finasteride may increase the risk of high-grade prostate cancer (5.2, 6.1).
• Females should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.3, 8.1, 16).
• Finasteride is not indicated for use in pediatric patients or females (5.4, 8.1, 8.2, 8.4, 12.3).
• Prior to initiating treatment with finasteride for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.6).

• Finasteride reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on finasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.1).
• Finasteride may increase the risk of high-grade prostate cancer (5.2, 6.1).
• Females should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.3, 8.1, 16).
• Finasteride is not indicated for use in pediatric patients or females (5.4, 8.1, 8.2, 8.4, 12.3).
• Prior to initiating treatment with finasteride for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.6).

Finasteride reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on finasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.1).

Finasteride may increase the risk of high-grade prostate cancer (5.2, 6.1).

Females should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.3, 8.1, 16).

Finasteride is not indicated for use in pediatric patients or females (5.4, 8.1, 8.2, 8.4, 12.3).

Prior to initiating treatment with finasteride for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.6).

Adverse Reactions

­The drug-related adverse reactions, reported in ≥1% in patients treated with finasteride and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 5/2026