{"shortAnswer":"Finasteride is FDA-approved as a pill for an enlarged prostate (Proscar) and for male hair loss (Propecia). For both uses the evidence grade is strong-human. It can harm a male fetus, and lasting sexual problems and depression have been reported. No topical form is FDA-approved.","url":"https://peptideindex.ai/compound/finasteride","status":"fda-approved","statusCheckedAt":"2026-10-26T13:43:55.201Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T13:43:55.231Z","primarySourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020180","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"97b6fd29-0f7c-43be-87e6-d26fe8f43e13","object":"compound","slug":"finasteride","name":"Finasteride","attrs":{"name":"Finasteride","class":"non-peptide","access":[{"type":"approved-product","detail":"Approved by FDA as a prescription tablet taken by mouth once a day for an enlarged prostate, alone or with doxazosin.","indication":"Symptoms of an enlarged prostate (benign prostatic hyperplasia), and lower risk of urine retention and surgery.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020180","brand_names":["Proscar"],"manufacturer":"Organon"},{"type":"approved-product","detail":"Approved by FDA as a prescription tablet taken by mouth once a day for male pattern hair loss, in men only.","indication":"Male pattern hair loss (androgenetic alopecia) in men only.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020788","brand_names":["Propecia"],"manufacturer":"Organon"},{"type":"lawful-compounding","detail":"Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug. No topical form is FDA-approved.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"}],"dosing":"From the Proscar and Propecia labels. Proscar, for an enlarged prostate: one 5 mg tablet once a day, alone or with doxazosin, with or without food. Propecia, for male hair loss: one 1 mg tablet once a day, with or without food. The Propecia label says hair benefit usually takes three months or more of daily use, and stopping reverses it within 12 months. The prescriber sets the dose.","trials":[{"nct":"NCT07742553","url":"https://clinicaltrials.gov/study/NCT07742553","phase":"Phase 2/Phase 3","title":"Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial","status":"not-yet-recruiting","sponsor":"VA Office of Research and Development","countries":["United States"],"us_states":["Colorado","Florida","New York"]},{"nct":"NCT07870759","url":"https://clinicaltrials.gov/study/NCT07870759","phase":"Phase 3","title":"Efficacy and Safety of Combination Therapy Compared With Monotherapy in Patients With Benign Prostatic Hyperplasia","status":"not-yet-recruiting","sponsor":"Il-Yang Pharm. Co., Ltd.","countries":[],"us_states":[]},{"nct":"NCT07731802","url":"https://clinicaltrials.gov/study/NCT07731802","phase":"Phase 4","title":"Finasteride and Cutibacterium","status":"not-yet-recruiting","sponsor":"University of Washington","countries":[],"us_states":[]},{"nct":"NCT07435012","url":"https://clinicaltrials.gov/study/NCT07435012","phase":"Phase 3","title":"Androgenic Alopecia TH07 Clinical Trial","status":"recruiting","sponsor":"Triple Hair Inc","countries":["Canada"],"us_states":[]},{"nct":"NCT06944145","url":"https://clinicaltrials.gov/study/NCT06944145","phase":"Phase 2","title":"New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia","status":"recruiting","sponsor":"Beth Israel Deaconess Medical Center","countries":["United States"],"us_states":["Massachusetts"]},{"nct":"NCT06826001","url":"https://clinicaltrials.gov/study/NCT06826001","phase":"Phase 2","title":"Various Procedural Treatment Options for Androgenetic Alopecia","status":"not-yet-recruiting","sponsor":"Sheikh Zayed Medical College","countries":["Pakistan"],"us_states":[]},{"nct":"NCT04594018","url":"https://clinicaltrials.gov/study/NCT04594018","phase":"Phase 3","title":"Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia","status":"recruiting","sponsor":"EMS","countries":["Brazil"],"us_states":[]},{"nct":"NCT06001619","url":"https://clinicaltrials.gov/study/NCT06001619","phase":"Phase 4","title":"Prostate Medication, Metabolism and Gut Microbiota","status":"recruiting","sponsor":"Turku University Hospital","countries":["Finland"],"us_states":[]},{"nct":"NCT04288427","url":"https://clinicaltrials.gov/study/NCT04288427","phase":"Not applicable","title":"5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy","status":"recruiting","sponsor":"Beth Israel Deaconess Medical Center","countries":["United States"],"us_states":["Massachusetts"]},{"nct":"NCT02703220","url":"https://clinicaltrials.gov/study/NCT02703220","phase":"Phase 4","title":"Sleep Apnea in Elderly","status":"recruiting","sponsor":"VA Office of Research and Development","countries":["United States"],"us_states":["Michigan"]}],"aliases":["Proscar","Propecia"],"summary":"A prescription pill that lowers the hormone DHT, approved as Proscar for an enlarged prostate and as Propecia for male hair loss.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf","tier":"primary","type":"label","title":"Proscar (finasteride) tablets label, revised March 2026"},{"n":2,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020788s030lbl.pdf","tier":"primary","type":"label","title":"Propecia (finasteride) tablets label, revised July 2022"},{"n":3,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020180","tier":"primary","type":"regulatory","title":"Drugs@FDA: Proscar (finasteride) tablets, application 020180"},{"n":4,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020788","tier":"primary","type":"regulatory","title":"Drugs@FDA: Propecia (finasteride) tablets, application 020788"},{"n":5,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215423","tier":"primary","type":"regulatory","title":"Drugs@FDA: Entadfi (finasteride and tadalafil) capsules, application 215423"},{"n":6,"url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded","tier":"primary","type":"regulatory","title":"FDA alert: potential risks of compounded topical finasteride products, April 2025"},{"n":7,"url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared","tier":"primary","type":"regulatory","title":"FDA-posted recall notice: compounded finasteride capsules with undeclared minoxidil, May 2020"},{"n":8,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":9,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list"},{"n":10,"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances that may present significant safety risks (Category 2)"},{"n":11,"url":"https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs","tier":"primary","type":"regulatory","title":"FDA: understanding the risks of compounded drugs"},{"n":12,"url":"https://pubmed.ncbi.nlm.nih.gov/12824459/","tier":"peer-reviewed","type":"rct","title":"Prostate Cancer Prevention Trial: finasteride and prostate cancer, 2003"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/14681504/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: doxazosin, finasteride or both for an enlarged prostate getting worse, 2003"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/9777765/","tier":"peer-reviewed","type":"rct","title":"Randomized trials: finasteride in men with male pattern hair loss, 1998"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/34634163/","tier":"peer-reviewed","type":"rct","title":"Randomized trial in Europe: topical finasteride spray for male hair loss, 2022"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/20956649/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review: finasteride for male pattern hair loss, 2010"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/33175100/","tier":"peer-reviewed","type":"human-trial","title":"Global safety database study: suicidal thoughts and mood problems reported with finasteride, 2021"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/30265917/","tier":"peer-reviewed","type":"animal","title":"Rat study: finasteride and lasting depression-like behavior, 2019"},{"n":19,"url":"https://clinicaltrials.gov/study/NCT04288427","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT04288427: 5-alpha reductase 2 as a marker of resistance to finasteride in an enlarged prostate"},{"n":20,"url":"https://www.fda.gov/media/170437/download","tier":"primary","type":"reference","title":"FDA patient listening session on post-finasteride syndrome, report by a patient group, June 2023"},{"n":21,"url":"https://www.upi.com/Health_News/2025/04/24/finasteride-Propecia-spray-FDA-warning/6171745508938/","tier":"established-news","type":"reference","title":"UPI: FDA warns of risks of compounded topical finasteride sold online, April 2025"}],"known_risks":["It can cause abnormal genitals in a male fetus. Women who are or may be pregnant must not take it or handle crushed or broken tablets [^1] [^2].","Topical forms have no coating, so the drug can pass to a woman by touch. FDA says this raises the risk to a pregnancy [^6].","Sexual problems are the most common harm. In the 4-year Proscar study, 8.1% on it had impotence in year one, against 3.7% on a dummy pill [^1].","Sexual problems that went on after stopping have been reported. They include erection, sex drive and ejaculation problems [^1] [^2].","Depression and thoughts of suicide have been reported in people on it. The Propecia label also lists suicidal acts [^1] [^2].","In a 7-year trial, high-grade prostate cancer was found in 1.8% of men on it and 1.1% on a dummy pill [^1] [^12].","It lowers the PSA blood test for prostate cancer by about half. Any confirmed rise in PSA while on it should be checked [^1] [^2].","Breast growth and tenderness, and male breast cancer, have been reported [^1] [^2].","Male infertility and poor semen quality have been reported. In some men it improved after stopping [^1] [^2].","Allergic reactions have been reported, including swelling of the lips, tongue, throat and face [^1] [^2].","Testicular pain and blood in the semen have been reported [^1] [^2].","It is not for children or women [^1] [^2].","From 2019 to 2024, FDA got 32 reports of harm tied to compounded topical finasteride. Most said the problems went on after stopping [^6].","In 2020, some compounded hair loss capsules were recalled. Tests found minoxidil in them, and the label did not list it [^7]."],"short_answer":"Finasteride is FDA-approved as a pill for an enlarged prostate (Proscar) and for male hair loss (Propecia). For both uses the evidence grade is strong-human. It can harm a male fetus, and lasting sexual problems and depression have been reported. No topical form is FDA-approved.","evidence_grade":"strong-human","open_questions":["Nobody knows if finasteride itself causes sexual problems that last after stopping. The Proscar label says its role is unknown [^1].","The labels say the link between long-term use and male breast cancer is unknown [^1] [^2].","It is not settled whether the drug or the way the study was run caused the higher rate of high-grade prostate cancer [^1].","A 2021 study of a global safety database found more suicide-related reports in people under 45 who took it for hair loss. The authors said this may come from how reports were made, or from younger people being more at risk [^17].","Nobody knows if a topical form is lower risk over years. The 2022 spray trial lasted 24 weeks [^15].","A 2019 rat study found lasting depression-like behavior after the drug was stopped. Nobody has shown the same cause in people [^18].","A patient group told FDA in 2023 that some men stay unwell after stopping. The group said how it happens is unclear and there is no treatment [^20]."],"section_routes":"The legal way to get finasteride is a prescription for the approved tablets [^1] [^2]. Proscar is approved for an enlarged prostate and Propecia for male hair loss [^3] [^4]. Both are reference drugs for generic copies [^3] [^4].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^8]. A compounded drug is not FDA-approved, and FDA does not check it before sale [^11].\n\nOne US study at a Boston hospital is recruiting men with an enlarged prostate [^19]. It is testing why some men do not respond to finasteride [^19]. The trials block on this page lists open trials with their dates.","regulatory_as_of":"2026-10-26","section_channels":"Topical finasteride is made by compounding pharmacies and sold online through telehealth companies [^6] [^21]. It is often mixed with minoxidil [^6]. FDA says no topical form is FDA-approved, and these products have no FDA-approved label [^6].\n\nFrom 2019 to 2024, FDA got 32 reports of harm tied to compounded topical finasteride [^6]. The reports named erection problems, anxiety, depression, suicidal thoughts and testicular pain [^6]. Most said the problems went on after stopping [^6]. Some people said their prescriber told them a topical form had no risk [^6]. FDA warns the drug can pass by touch to a woman and harm a male fetus [^6].\n\nIn 2020, compounded finasteride capsules for hair loss were recalled [^7]. Testing found minoxidil, a blood pressure drug, not listed on the label [^7]. There were 33 reports of a fast heartbeat, fluid build-up, dizziness or low blood pressure [^7].","section_evidence":"The evidence grade is strong-human for an enlarged prostate and for male hair loss [^1] [^2] [^13] [^14]. In a 4-year study of 3,040 men with an enlarged prostate, fewer men on it needed surgery than men on a dummy pill [^1]. In a trial of 3,047 men followed for about 4.5 years, it cut the risk of the disease getting worse by 34% [^13].\n\nIn two 1-year trials, 1,553 men aged 18 to 41 with hair loss took it or a dummy pill [^14]. Men on it had more hair at 1 and 2 years [^14]. A 2010 review of 12 trials with 3,927 men found more hair on it, from moderate-quality evidence [^16]. The same review found more erection problems [^16].\n\nIn a 7-year trial of 18,882 men, prostate cancer was found less often on it [^12]. But high-grade tumors were more common, and Proscar is not approved for this use [^1] [^12]. A 2022 trial in Europe tested a spray on the scalp for 24 weeks and found more hair than a dummy spray [^15]. No spray is FDA-approved [^6]. A 2019 study in rats found depression-like behavior after the drug [^18].","regulatory_status":"fda-approved","section_what_it_is":"Finasteride is a drug that blocks an enzyme called 5-alpha reductase [^1] [^2]. That lowers DHT, a hormone the body makes from testosterone [^1]. It is not a peptide.\n\nIt comes as a tablet taken by mouth once a day [^1] [^2]. As Proscar, it treats an enlarged prostate, which can make it hard to pass urine [^1]. As Propecia, it treats male pattern hair loss in men only [^2]. FDA approved Proscar in 1992 and Propecia in 1997 [^3] [^4]. A capsule that joined it with tadalafil, Entadfi, was approved in 2021 and is now discontinued [^5].","section_is_it_legal":"Finasteride is FDA-approved: Drugs@FDA lists Proscar and Propecia as approved prescription tablets taken by mouth [^3] [^4]. The approval covers those tablets for their labeled uses. It does not cover a cream, spray or other topical form, and FDA says no topical finasteride is FDA-approved [^6]. Checked 26 October 2026.\n\nProscar is approved for an enlarged prostate, and Propecia for male hair loss in men only [^1] [^2]. Proscar is not approved to prevent prostate cancer [^1].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^8]. A compounded drug is not FDA-approved, and FDA does not review its quality before sale [^11]. Finasteride is not on FDA's 503A category list [^9]. It is not among the substances FDA says may present significant safety risks [^10].","unofficial_channels":[{"type":"telehealth","what_it_is":"Online prescribers that sell compounded topical finasteride for hair loss, alone or mixed with minoxidil.","enforcement":[{"date":"2025-04-22","text":"FDA alerted prescribers, compounders and consumers to reports of harm tied to compounded topical finasteride.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded"}],"legal_position":{"text":"FDA says no topical finasteride is FDA-approved, and compounded topical products have no FDA-approved label.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded"},"documented_risks":[{"text":"FDA got 32 reports of harm tied to compounded topical finasteride from 2019 to 2024, and most said the problems went on after stopping.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded"},{"text":"FDA warns a topical form can pass by touch to a woman and harm a male fetus.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded"},{"text":"Compounded finasteride capsules for hair loss were recalled after testing found minoxidil not listed on the label.","source_url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared"}]}]},"provenance":{"name":{"fact_id":"e6ca46e5-9a3d-488f-a460-cfb76606eaad","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:30:38.994Z","checked_at":"2026-10-26T13:43:55.206Z","confidence":1,"stale":false},"class":{"fact_id":"233fc2b1-637f-4b03-818a-0859472d02cf","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:30:38.994Z","checked_at":"2026-10-26T13:43:55.208Z","confidence":1,"stale":false},"access":{"fact_id":"d1c1fa55-dac3-4b08-99e8-15d4f4dc9054","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020180","source_type":"primary","captured_at":"2026-10-26T12:29:47.356Z","checked_at":"2026-10-26T13:43:55.172Z","confidence":1,"stale":false},"dosing":{"fact_id":"81a3c40a-7dd6-4567-a5cd-3ade0600e5e0","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:30:38.994Z","checked_at":"2026-10-26T13:43:55.228Z","confidence":1,"stale":false},"trials":{"fact_id":"b5086192-8890-457d-aa9c-41a0915fbb32","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=finasteride&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","source_type":"primary","captured_at":"2026-10-26T13:44:12.895Z","checked_at":"2026-10-26T13:44:12.895Z","confidence":1,"stale":false},"aliases":{"fact_id":"1cec7749-77c7-4506-8e87-63e1958c5817","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:30:38.994Z","checked_at":"2026-10-26T13:43:55.180Z","confidence":1,"stale":false},"summary":{"fact_id":"3804506d-f34b-4b58-ab16-8140835d7b4c","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:30:38.994Z","checked_at":"2026-10-26T13:43:55.203Z","confidence":1,"stale":false},"citations":{"fact_id":"7b89f4fa-a4e9-4bdf-8d09-0a172d655293","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:30:38.994Z","checked_at":"2026-10-26T13:43:55.183Z","confidence":1,"stale":false},"known_risks":{"fact_id":"ffcdf18f-d503-4bdf-bc95-58f067e12b27","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:30:38.994Z","checked_at":"2026-10-26T13:43:55.190Z","confidence":1,"stale":false},"short_answer":{"fact_id":"fcbfe7da-4322-42a9-b0ec-fb548eb6d452","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-26T13:43:55.210Z","confidence":1,"stale":false,"label":"our 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