Proscar
An oral daily tablet used to treat enlarged prostate and male pattern baldness.
Where Finasteride is approved
All regulators →Of the three regulators tracked here, the first to approve Finasteride was the US, on 19 Jun 1992. It is approved in 2 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: post-authorisation measure for Finasteride / dutasteride, 12 Sep 2025
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Finasteride
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Finasteride works
All drug targets →- Steroid 5-alpha-reductase 2 inhibitor InhibitorTarget: SRD5A2 steroid 5 alpha-reductase 2✓ In ChEMBL and the Guide to Pharmacology
- HypogonadismPhase 3
- Lower urinary tract symptomPhase 3
- Prostate cancerPhase 2/3
- HematuriaPhase 2
- AcnePhase 2
- Central serous retinopathyPhase 2
- Non-small cell lung carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL710, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6818, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Finasteride
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 7 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Finasteride
- ChEMBL
- CHEMBL710
- DrugBank
- DB01216
- PubChem CID
- 57363
- CAS number
- 98319-26-7
- FDA UNII
- 57GNO57U7G
- Wikidata
- Q424167
- Wikipedia
- Finasteride
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Proscar is used for
PROSCAR, 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. PROSCAR 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) ( 1.2 ). Limitations of Use : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy PROSCAR ® is 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 f…
How it works
12.1 Mechanism of Action The development and enlargement of the prostate gland is dependent on the potent androgen, 5α-dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs. Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a stable enzyme complex. Turnover from this complex is extremely slow (t ½ ~ 30 days). This has been demonstrated both in vivo and in vitro . Finasteride has no affinity for the androgen receptor. In man, the 5α-reduced steroid metabolites in blood and urine…
Compare Proscar with
Explore more
How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 10 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.