{"shortAnswer":"Minoxidil is FDA-approved on the scalp as Rogaine to regrow hair, and as a tablet for severe high blood pressure. For the scalp products the evidence grade is strong-human. Pills for hair loss are not an approved use. The tablet label warns of fluid around the heart.","url":"https://peptideindex.ai/compound/minoxidil","status":"fda-approved","statusCheckedAt":"2026-10-26T13:43:56.039Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T13:43:56.075Z","primarySourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"7c4a751d-8585-47ec-bef6-6e16577c368d","object":"compound","slug":"minoxidil","name":"Minoxidil","attrs":{"name":"Minoxidil","class":"non-peptide","access":[{"type":"approved-product","detail":"Approved by FDA as a 2% solution put on the scalp, for men and for women, sold without a prescription.","indication":"To regrow hair on the scalp.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501","brand_names":["Rogaine (for men)","Rogaine (for women)"],"manufacturer":"Kenvue Brands"},{"type":"approved-product","detail":"Approved by FDA as a 5% solution put on the scalp, for men, sold without a prescription.","indication":"To regrow hair on the top of the scalp in men.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020834","brand_names":["Rogaine Extra Strength (for men)"],"manufacturer":"Kenvue Brands"},{"type":"approved-product","detail":"Approved by FDA as a 5% foam put on the scalp, for men and for women, sold without a prescription.","indication":"To regrow hair on the top of the scalp.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021812","brand_names":["Men's Rogaine","Women's Rogaine"],"manufacturer":"Kenvue Brands"},{"type":"approved-product","detail":"Approved by FDA as a prescription tablet taken by mouth. The brand is discontinued, not for safety or effectiveness reasons. Not approved for hair loss.","indication":"Severe high blood pressure that causes symptoms or organ damage and is not controlled by a diuretic plus two other blood pressure drugs.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018154","brand_names":["Loniten"],"manufacturer":"Pfizer"},{"type":"lawful-compounding","detail":"Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug. A compounded drug is not 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 Rogaine and Loniten labels. Rogaine 2% and 5% solution: 1 mL on the scalp 2 times a day. Men's Rogaine foam: half a capful on the scalp 2 times a day. Women's Rogaine foam: half a capful once a day. The labels say using more or more often will not improve results, and regrowth takes months. Loniten tablets for severe high blood pressure, over 12 years of age: 5 mg once a day to start, usually 10 to 40 mg a day, at most 100 mg a day, usually with a diuretic and a beta-blocker. The prescriber sets the dose.","trials":[{"nct":"NCT07529977","url":"https://clinicaltrials.gov/study/NCT07529977","phase":"Phase 3","title":"Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.","status":"not-yet-recruiting","sponsor":"Eurofarma Laboratorios S.A.","countries":[],"us_states":[]},{"nct":"NCT07758400","url":"https://clinicaltrials.gov/study/NCT07758400","phase":"Not applicable","title":"A Study on the Efficacy and Safety of Microneedling for Male Androgenetic Alopecia","status":"not-yet-recruiting","sponsor":"Cheng Zhou","countries":["China"],"us_states":[]},{"nct":"NCT07594678","url":"https://clinicaltrials.gov/study/NCT07594678","phase":"Phase 2","title":"Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients","status":"not-yet-recruiting","sponsor":"Ohio State University Comprehensive Cancer Center","countries":["United States"],"us_states":["Ohio"]},{"nct":"NCT07862374","url":"https://clinicaltrials.gov/study/NCT07862374","phase":"Not stated","title":"Oral Minoxidil With or Without a Multifactorial Drinkable Nutraceutical in Female Pattern Hair Loss: a Retrospective Study","status":"not-yet-recruiting","sponsor":"Olistic Research Labs S.L.","countries":["Spain"],"us_states":[]},{"nct":"NCT07716748","url":"https://clinicaltrials.gov/study/NCT07716748","phase":"Not stated","title":"For an Investigator-led Hair Study Comparing Between Healthy and Hair Loss Volunteers","status":"not-yet-recruiting","sponsor":"National Skin Centre","countries":[],"us_states":[]},{"nct":"NCT07548918","url":"https://clinicaltrials.gov/study/NCT07548918","phase":"Phase 2","title":"Comparative Study of Microneedling With Topical Minoxidil 5% ± NB-UVB in Stable Vitiligo\"","status":"not-yet-recruiting","sponsor":"Sohag University","countries":[],"us_states":[]},{"nct":"NCT07536100","url":"https://clinicaltrials.gov/study/NCT07536100","phase":"Not applicable","title":"VENEZE Peptide Factor Hair Serum Compared With Topical 2% Minoxidil for Androgenetic Alopecia","status":"recruiting","sponsor":"Institute of Dermatology, Thailand","countries":["Thailand"],"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":"NCT07518342","url":"https://clinicaltrials.gov/study/NCT07518342","phase":"Phase 4","title":"The Effect of Nanofat Injection on Androgenetic Alopecia","status":"not-yet-recruiting","sponsor":"Assiut University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07264790","url":"https://clinicaltrials.gov/study/NCT07264790","phase":"Phase 1","title":"Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon","status":"recruiting","sponsor":"Duke University","countries":["United States"],"us_states":["North Carolina"]},{"nct":"NCT07459933","url":"https://clinicaltrials.gov/study/NCT07459933","phase":"Phase 4","title":"Topical Methotrexate vs Minoxidil for Localized Alopecia Areata","status":"not-yet-recruiting","sponsor":"Jinnah Postgraduate Medical Centre","countries":[],"us_states":[]},{"nct":"NCT07563036","url":"https://clinicaltrials.gov/study/NCT07563036","phase":"Not applicable","title":"JAK2 Expression in Androgenetic Alopecia Before and After Topical Minoxidil","status":"recruiting","sponsor":"Kasr El Aini Hospital","countries":["Egypt"],"us_states":[]},{"nct":"NCT07370519","url":"https://clinicaltrials.gov/study/NCT07370519","phase":"Phase 2","title":"Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia","status":"recruiting","sponsor":"Shenzhen People's Hospital","countries":["China"],"us_states":[]},{"nct":"NCT07502976","url":"https://clinicaltrials.gov/study/NCT07502976","phase":"Not applicable","title":"Topical 2-Deoxy-D-ribose Hydrogel Versus Minoxidil 5% Solution for Androgenetic Alopecia","status":"recruiting","sponsor":"Kasr El Aini Hospital","countries":["Egypt"],"us_states":[]},{"nct":"NCT07248410","url":"https://clinicaltrials.gov/study/NCT07248410","phase":"Not applicable","title":"A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia","status":"recruiting","sponsor":"Chang Gung Memorial Hospital","countries":["Taiwan"],"us_states":[]},{"nct":"NCT07273799","url":"https://clinicaltrials.gov/study/NCT07273799","phase":"Phase 3","title":"Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia","status":"not-yet-recruiting","sponsor":"Sheikh Zayed Federal Postgraduate Medical Institute","countries":[],"us_states":[]},{"nct":"NCT07203599","url":"https://clinicaltrials.gov/study/NCT07203599","phase":"Phase 1/Phase 2","title":"A Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes","status":"recruiting","sponsor":"Shenzhen People's Hospital","countries":["China"],"us_states":[]},{"nct":"NCT07056933","url":"https://clinicaltrials.gov/study/NCT07056933","phase":"Not applicable","title":"Effect of Minoxidil Solution Iontophoresis on Androgenic Alopecia","status":"not-yet-recruiting","sponsor":"Cairo University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07018349","url":"https://clinicaltrials.gov/study/NCT07018349","phase":"Not applicable","title":"Low Dose Oral Minoxdil in Androgenic Alopecia","status":"not-yet-recruiting","sponsor":"Jinnah Postgraduate Medical Centre","countries":["Pakistan"],"us_states":[]},{"nct":"NCT07012486","url":"https://clinicaltrials.gov/study/NCT07012486","phase":"Early phase 1","title":"Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia","status":"recruiting","sponsor":"Shanghai Zhongshan Hospital","countries":["China"],"us_states":[]},{"nct":"NCT07080931","url":"https://clinicaltrials.gov/study/NCT07080931","phase":"Phase 3","title":"Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia","status":"recruiting","sponsor":"Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.","countries":["China"],"us_states":[]},{"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":"NCT06501924","url":"https://clinicaltrials.gov/study/NCT06501924","phase":"Phase 3","title":"Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss","status":"not-yet-recruiting","sponsor":"Applied Biology, Inc.","countries":[],"us_states":[]},{"nct":"NCT05417308","url":"https://clinicaltrials.gov/study/NCT05417308","phase":"Early phase 1","title":"Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer","status":"recruiting","sponsor":"Ohio State University Comprehensive Cancer Center","countries":["United States"],"us_states":["Ohio"]},{"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":"NCT04207931","url":"https://clinicaltrials.gov/study/NCT04207931","phase":"Phase 4","title":"Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study","status":"recruiting","sponsor":"Wake Forest University Health Sciences","countries":["United States"],"us_states":["North Carolina"]}],"aliases":["Rogaine","Loniten"],"summary":"A drug that widens small blood vessels, approved as Rogaine on the scalp to regrow hair and as a prescription tablet for severe high blood pressure.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf","tier":"primary","type":"label","title":"Rogaine (minoxidil) topical solution and foam labeling, January 2026"},{"n":2,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","tier":"primary","type":"label","title":"Loniten (minoxidil) tablets label, revised January 2015"},{"n":3,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501","tier":"primary","type":"regulatory","title":"Drugs@FDA: Rogaine (minoxidil) 2% topical solution, application 019501"},{"n":4,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020834","tier":"primary","type":"regulatory","title":"Drugs@FDA: Rogaine Extra Strength (minoxidil) 5% topical solution, application 020834"},{"n":5,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021812","tier":"primary","type":"regulatory","title":"Drugs@FDA: Men's and Women's Rogaine (minoxidil) 5% foam, application 021812"},{"n":6,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018154","tier":"primary","type":"regulatory","title":"Drugs@FDA: Loniten (minoxidil) tablets, application 018154"},{"n":7,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018154.pdf","tier":"primary","type":"regulatory","title":"FDA draft product-specific guidance on minoxidil tablets, October 2024"},{"n":8,"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":9,"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":10,"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":11,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list"},{"n":12,"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":13,"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":14,"url":"https://pubmed.ncbi.nlm.nih.gov/12196747/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: 5% against 2% topical minoxidil and placebo in men with hair loss, 2002"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/17761356/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: 5% minoxidil foam against placebo in men with hair loss, 2007"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/34529341/","tier":"peer-reviewed","type":"rct","title":"Randomized trial in Iran: oral minoxidil tablets against topical minoxidil in women with hair loss, 2021"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/32516434/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review: low-dose oral minoxidil for hair loss without scarring, 2020"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/33639244/","tier":"peer-reviewed","type":"human-trial","title":"Multicenter study: safety of low-dose oral minoxidil for hair loss in 1404 patients, 2021"},{"n":19,"url":"https://pubmed.ncbi.nlm.nih.gov/34370845/","tier":"peer-reviewed","type":"animal","title":"Case series: topical minoxidil exposures and poisoning in dogs and cats, 2021"},{"n":20,"url":"https://clinicaltrials.gov/study/NCT05417308","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT05417308: topical or oral minoxidil for hair loss from endocrine therapy in breast cancer"},{"n":21,"url":"https://clinicaltrials.gov/study/NCT07529977","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT07529977: phase 3 study of oral minoxidil in men with hair loss"},{"n":22,"url":"https://www.boston.com/news/health/2025/03/19/this-cutting-edge-hair-loss-treatment-is-a-repurposed-drug-from-the-1990s/","tier":"established-news","type":"reference","title":"Associated Press: low-dose minoxidil pills prescribed off label for hair loss, March 2025"}],"known_risks":["The tablet label opens with its strongest warning. The tablet can cause fluid around the heart, sometimes pressing on it, and can make chest pain worse [^2].","Fluid around the heart was seen in about 3% of tablet users who were not on dialysis [^2].","The tablet makes the body hold salt and water. Without a water pill, this can cause swelling and heart failure [^2].","The tablet speeds up the heart. Chest pain may start or get worse [^2].","About 8 in 10 people on the tablet grow longer, darker body hair, often first on the face [^2].","Extra hair on newborns has been reported after tablet use in pregnancy. The label says not to give it to a nursing woman [^2].","The scalp products say to stop and ask a doctor for chest pain, a fast heartbeat, faintness, dizziness, sudden weight gain or swollen hands or feet [^1].","Itching and skin irritation are the most common problems with the scalp products. Unwanted facial hair can grow [^1].","The scalp product labels say it may be harmful in pregnancy or breast-feeding. It is not for anyone under 18 [^1].","Pets can be poisoned by contact with scalp products. In one review of poison center cases, 8 of 62 sick cats died [^19].","In a study of 1,404 people on low-dose pills for hair loss, 15.1% grew extra body hair. Light-headedness, fluid build-up and a fast heartbeat were less common [^18].","In 2020, compounded hair loss capsules were recalled because they held minoxidil not listed on the label. The notice cited 33 reports of a fast heart rate, dizziness or low blood pressure [^9]."],"short_answer":"Minoxidil is FDA-approved on the scalp as Rogaine to regrow hair, and as a tablet for severe high blood pressure. For the scalp products the evidence grade is strong-human. Pills for hair loss are not an approved use. The tablet label warns of fluid around the heart.","evidence_grade":"strong-human","open_questions":["No pill has been through FDA review for hair loss. The tablet label says growing hair is not an approved use [^2].","The 2021 safety study of low-dose pills looked back at records and had no comparison group. Long-term heart effects in healthy people are not settled [^18].","Few trials compare pills with the scalp products. A 2021 trial in 72 women found no clear difference between them [^16] [^22].","The 5% solution label says regrowth has not been shown to last past 48 weeks in large trials [^1].","Minoxidil caused heart damage in dogs, rats and minipigs. The tablet label says what this means for people is not clear [^2].","It is not clear how well pills help women. A 2020 review of 10 studies counted 19,003 men and only 215 women [^17]."],"section_routes":"The legal way to use minoxidil for hair loss is a Rogaine product on the scalp, sold without a prescription [^1] [^3] [^4] [^5]. Each Rogaine product is a reference drug for generic copies [^3] [^4] [^5].\n\nMinoxidil tablets need a prescription, and they are approved only for severe high blood pressure [^2]. A doctor may prescribe them for hair loss, but that use is not approved [^2] [^22].\n\nPharmacies may compound with a raw substance that is part of an FDA-approved drug [^10]. A compounded drug is not FDA-approved, and FDA does not check it before sale [^13].\n\nOne US study in Ohio is recruiting people with breast cancer whose hormone treatment caused hair loss [^20]. It compares minoxidil taken by mouth with foam on the scalp [^20]. The trials block on this page lists open trials with their dates.","regulatory_as_of":"2026-10-26","section_channels":"Telehealth companies prescribe low-dose minoxidil pills for hair loss, often after an online form [^22]. The tablets are approved only for severe high blood pressure, so this use is not approved [^2]. Skin doctors quoted by AP said a visit in person, with a blood pressure check, is better [^22].\n\nSome pharmacies and online sites also sell scalp mixes of minoxidil and finasteride [^8]. FDA says no topical product with finasteride, alone or mixed, is FDA-approved [^8]. From 2019 to 2024, FDA got 32 reports of harm from these finasteride products, alone or mixed [^8].\n\nIn 2020, compounded finasteride capsules for hair loss were recalled [^9]. Testing found minoxidil not listed on the label, at levels above approved products [^9]. The notice cited 33 reports of a fast heart rate, fluid build-up, dizziness or low blood pressure [^9].","section_evidence":"The evidence grade is strong-human for the scalp products in hair loss [^1] [^14] [^15]. In a 48-week trial of 393 men, the 5% solution grew more hair than the 2% solution or a dummy liquid [^14]. Itching and irritation were more common with 5% [^14]. In a 16-week trial of 352 men, the 5% foam grew more hair than a dummy foam [^15]. In label studies of women, 19% saw moderate regrowth after 8 months, against 7% on a dummy liquid [^1].\n\nFor severe high blood pressure, the tablet lowered blood pressure to the label's target in about 75% of patients [^2]. Most of them had blood pressure other drugs could not control [^2].\n\nThe evidence for pills for hair loss is thinner. A 2020 review of 10 studies found most people with common hair loss improved [^17]. A 2021 trial in Iran gave 72 women a low-dose pill or the 2% solution for 9 months [^16]. Hair density rose in both groups, with no clear difference between them [^16]. A 2021 study of 1,404 people on low-dose pills found few stopped because of harms, but it had no comparison group [^18]. A phase 3 trial of minoxidil taken by mouth in men is planned in Brazil [^21]. In dogs and cats, even small contact with scalp products caused illness [^19].","regulatory_status":"fda-approved","section_what_it_is":"Minoxidil is a drug that widens small blood vessels [^2]. It is not a peptide. FDA first approved it in 1979 as a tablet for high blood pressure [^6]. Researchers saw that people taking it grew extra hair [^2] [^22].\n\nToday it comes in two forms. Rogaine solution and foam go on the scalp to regrow hair, with no prescription needed [^1] [^3] [^5]. Rogaine was approved in 1988 and moved off prescription in 1996 [^3]. The tablet needs a prescription and is approved for severe high blood pressure [^2]. Some doctors now prescribe low-dose pills for hair loss, which is not an approved use [^2] [^22].","section_is_it_legal":"Minoxidil is FDA-approved: Drugs@FDA lists Rogaine products for the scalp and Loniten tablets taken by mouth [^3] [^4] [^5] [^6]. The scalp products are approved to regrow hair on the scalp, and they are sold without a prescription [^1] [^3]. The tablets are approved only for severe high blood pressure that other drugs did not control [^2]. The approval does not cover pills for hair loss. The tablet label says using it in any form to grow hair is not an approved use [^2]. Checked 26 October 2026.\n\nLoniten, the brand-name tablet, is listed as discontinued. Drugs@FDA notes a Federal Register finding that it was not stopped for safety or effectiveness reasons [^6]. In October 2024, FDA posted draft advice for companies that want to make generic minoxidil tablets [^7].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^10]. A compounded drug is not FDA-approved, and FDA does not review its quality before sale [^13]. Minoxidil is not on FDA's 503A category list [^11]. It is not among the substances FDA says may present significant safety risks [^12].","unofficial_channels":[{"type":"telehealth","what_it_is":"Online prescribers and compounders that sell scalp products mixing minoxidil with finasteride for hair loss.","enforcement":[{"date":"2025-04-22","text":"FDA alerted prescribers, compounders and consumers to reports of harm tied to compounded topical finasteride, including mixes with minoxidil.","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 product with finasteride, alone or mixed with other drugs, 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, alone or mixed with other drugs.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded"}]},{"type":"compounding-outside-the-rules","what_it_is":"Compounded hair loss products that hold minoxidil the label does not list.","enforcement":[{"date":"2020-05-11","text":"FDA posted a nationwide recall of compounded hair loss capsules that held 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"}],"legal_position":{"text":"FDA says compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before sale.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs"},"documented_risks":[{"text":"Compounded finasteride capsules were recalled after testing found minoxidil not listed on the label, with 33 reports of a fast heart rate, dizziness or low blood pressure.","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":"f0a41f20-af4a-4af5-ae0a-143ba99b80bb","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.210Z","checked_at":"2026-10-26T13:43:56.060Z","confidence":1,"stale":false},"class":{"fact_id":"35a3a192-5413-4a42-8fae-80d6854bf237","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.969Z","checked_at":"2026-10-26T13:43:56.062Z","confidence":1,"stale":false},"access":{"fact_id":"98b976cd-8810-4d7e-8666-75c9131b296b","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.210Z","checked_at":"2026-10-26T13:43:56.021Z","confidence":1,"stale":false},"dosing":{"fact_id":"d8c88b25-7cbe-4a89-988b-4914199cbde8","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.969Z","checked_at":"2026-10-26T13:43:56.033Z","confidence":1,"stale":false},"trials":{"fact_id":"e18660d7-b788-4c48-be98-df94ffd99e3d","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=minoxidil&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":"2026-10-26T13:44:14.626Z","checked_at":"2026-10-26T13:44:14.626Z","confidence":1,"stale":false},"aliases":{"fact_id":"6679f53d-e633-4cd5-ba6c-b78878a02c6c","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.210Z","checked_at":"2026-10-26T13:43:56.029Z","confidence":1,"stale":false},"summary":{"fact_id":"247d3159-9b2c-4399-b700-5e5c22e50a8c","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.969Z","checked_at":"2026-10-26T13:43:56.053Z","confidence":1,"stale":false},"citations":{"fact_id":"2eec5e4f-09f8-4d7c-bd3a-75afb3513f70","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.210Z","checked_at":"2026-10-26T13:43:56.073Z","confidence":1,"stale":false},"known_risks":{"fact_id":"c3095895-3868-4b43-8b71-c2b3bddb8a51","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.969Z","checked_at":"2026-10-26T13:43:56.064Z","confidence":1,"stale":false},"short_answer":{"fact_id":"10c3d96a-ac0f-431f-acd0-b15c090bb7c6","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-26T13:43:56.055Z","confidence":1,"stale":false,"label":"our assessment"},"evidence_grade":{"fact_id":"3268c9e7-02dc-44c0-9f5c-bf96e34706ea","source_url":"https://peptideindex.ai/methodology#evidence-grade","source_type":"reference","captured_at":"2026-10-25T00:14:45.193Z","checked_at":"2026-10-26T13:43:56.057Z","confidence":1,"stale":false,"label":"our assessment"},"open_questions":{"fact_id":"cad573d4-1af6-42ef-b57a-0a44236001df","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.969Z","checked_at":"2026-10-26T13:43:56.065Z","confidence":1,"stale":false},"section_routes":{"fact_id":"82c648c3-1d78-4427-ab4a-5a384c9daaa3","source_url":"https://clinicaltrials.gov/study/NCT05417308","source_type":"primary","captured_at":"2026-10-26T12:48:53.840Z","checked_at":"2026-10-26T13:43:56.049Z","confidence":1,"stale":false},"regulatory_as_of":{"fact_id":"745c311e-5061-4957-8295-af59d57adaf3","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501","source_type":"primary","captured_at":"2026-10-26T12:47:32.992Z","checked_at":"2026-10-26T13:43:56.036Z","confidence":1,"stale":false},"section_channels":{"fact_id":"7dabe1ff-1922-47bb-9026-760e162e9200","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded","source_type":"primary","captured_at":"2026-10-26T12:29:47.533Z","checked_at":"2026-10-26T13:43:56.075Z","confidence":1,"stale":false},"section_evidence":{"fact_id":"7e693ccd-208f-4cd6-9456-043c9c9bb54e","source_url":"https://clinicaltrials.gov/study/NCT07529977","source_type":"primary","captured_at":"2026-10-26T12:48:56.689Z","checked_at":"2026-10-26T13:43:56.044Z","confidence":1,"stale":false},"regulatory_status":{"fact_id":"adb2dab4-bdfb-4a91-9212-02fa6298964e","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501","source_type":"primary","captured_at":"2026-10-26T12:47:32.992Z","checked_at":"2026-10-26T13:43:56.039Z","confidence":1,"stale":false},"section_what_it_is":{"fact_id":"809e4936-19f8-4e23-b654-b5ab35030b91","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","source_type":"primary","captured_at":"2026-10-26T12:48:24.969Z","checked_at":"2026-10-26T13:43:56.067Z","confidence":1,"stale":false},"section_is_it_legal":{"fact_id":"7fb4b726-1c12-4d04-9bd5-ce1cb1748724","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501","source_type":"primary","captured_at":"2026-10-26T12:47:32.992Z","checked_at":"2026-10-26T13:43:56.069Z","confidence":1,"stale":false},"unofficial_channels":{"fact_id":"846725bb-b3d8-4452-8fd6-12b2f9e09bce","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded","source_type":"primary","captured_at":"2026-10-26T12:29:47.533Z","checked_at":"2026-10-26T13:43:56.070Z","confidence":1,"stale":false}},"citationsBySection":{"known_risks":[{"n":2,"title":"Loniten (minoxidil) tablets label, revised January 2015","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf"},{"n":1,"title":"Rogaine (minoxidil) topical solution and foam labeling, January 2026","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf"},{"n":19,"title":"Case series: topical minoxidil exposures and poisoning in dogs and cats, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/34370845/"},{"n":18,"title":"Multicenter study: safety of low-dose oral minoxidil for hair loss in 1404 patients, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/33639244/"},{"n":9,"title":"FDA-posted recall notice: compounded finasteride capsules with undeclared minoxidil, May 2020","url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared"}],"open_questions":[{"n":2,"title":"Loniten (minoxidil) tablets label, revised January 2015","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf"},{"n":18,"title":"Multicenter study: safety of low-dose oral minoxidil for hair loss in 1404 patients, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/33639244/"},{"n":16,"title":"Randomized trial in Iran: oral minoxidil tablets against topical minoxidil in women with hair loss, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/34529341/"},{"n":22,"title":"Associated Press: low-dose minoxidil pills prescribed off label for hair loss, March 2025","url":"https://www.boston.com/news/health/2025/03/19/this-cutting-edge-hair-loss-treatment-is-a-repurposed-drug-from-the-1990s/"},{"n":1,"title":"Rogaine (minoxidil) topical solution and foam labeling, January 2026","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf"},{"n":17,"title":"Systematic review: low-dose oral minoxidil for hair loss without scarring, 2020","url":"https://pubmed.ncbi.nlm.nih.gov/32516434/"}],"section_routes":[{"n":1,"title":"Rogaine (minoxidil) topical solution and foam labeling, January 2026","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf"},{"n":3,"title":"Drugs@FDA: Rogaine (minoxidil) 2% topical solution, application 019501","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501"},{"n":4,"title":"Drugs@FDA: Rogaine Extra Strength (minoxidil) 5% topical solution, application 020834","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020834"},{"n":5,"title":"Drugs@FDA: Men's and Women's Rogaine (minoxidil) 5% foam, application 021812","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021812"},{"n":2,"title":"Loniten (minoxidil) tablets label, revised January 2015","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf"},{"n":22,"title":"Associated Press: low-dose minoxidil pills prescribed off label for hair loss, March 2025","url":"https://www.boston.com/news/health/2025/03/19/this-cutting-edge-hair-loss-treatment-is-a-repurposed-drug-from-the-1990s/"},{"n":10,"title":"FDA: bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"n":13,"title":"FDA: understanding the risks of compounded drugs","url":"https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs"},{"n":20,"title":"ClinicalTrials.gov NCT05417308: topical or oral minoxidil for hair loss from endocrine therapy in breast cancer","url":"https://clinicaltrials.gov/study/NCT05417308"}],"section_channels":[{"n":22,"title":"Associated Press: low-dose minoxidil pills prescribed off label for hair loss, March 2025","url":"https://www.boston.com/news/health/2025/03/19/this-cutting-edge-hair-loss-treatment-is-a-repurposed-drug-from-the-1990s/"},{"n":2,"title":"Loniten (minoxidil) tablets label, revised January 2015","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf"},{"n":8,"title":"FDA alert: potential risks of compounded topical finasteride products, April 2025","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded"},{"n":9,"title":"FDA-posted recall notice: compounded finasteride capsules with undeclared minoxidil, May 2020","url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared"}],"section_evidence":[{"n":1,"title":"Rogaine (minoxidil) topical solution and foam labeling, January 2026","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf"},{"n":14,"title":"Randomized trial: 5% against 2% topical minoxidil and placebo in men with hair loss, 2002","url":"https://pubmed.ncbi.nlm.nih.gov/12196747/"},{"n":15,"title":"Randomized trial: 5% minoxidil foam against placebo in men with hair loss, 2007","url":"https://pubmed.ncbi.nlm.nih.gov/17761356/"},{"n":2,"title":"Loniten (minoxidil) tablets label, revised January 2015","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf"},{"n":17,"title":"Systematic review: low-dose oral minoxidil for hair loss without scarring, 2020","url":"https://pubmed.ncbi.nlm.nih.gov/32516434/"},{"n":16,"title":"Randomized trial in Iran: oral minoxidil tablets against topical minoxidil in women with hair loss, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/34529341/"},{"n":18,"title":"Multicenter study: safety of low-dose oral minoxidil for hair loss in 1404 patients, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/33639244/"},{"n":21,"title":"ClinicalTrials.gov NCT07529977: phase 3 study of oral minoxidil in men with hair loss","url":"https://clinicaltrials.gov/study/NCT07529977"},{"n":19,"title":"Case series: topical minoxidil exposures and poisoning in dogs and cats, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/34370845/"}],"section_what_it_is":[{"n":2,"title":"Loniten (minoxidil) tablets label, revised January 2015","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf"},{"n":6,"title":"Drugs@FDA: Loniten (minoxidil) tablets, application 018154","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018154"},{"n":22,"title":"Associated Press: low-dose minoxidil pills prescribed off label for hair loss, March 2025","url":"https://www.boston.com/news/health/2025/03/19/this-cutting-edge-hair-loss-treatment-is-a-repurposed-drug-from-the-1990s/"},{"n":1,"title":"Rogaine (minoxidil) topical solution and foam labeling, January 2026","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf"},{"n":3,"title":"Drugs@FDA: Rogaine (minoxidil) 2% topical solution, application 019501","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501"},{"n":5,"title":"Drugs@FDA: Men's and Women's Rogaine (minoxidil) 5% foam, application 021812","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021812"}],"section_is_it_legal":[{"n":3,"title":"Drugs@FDA: Rogaine (minoxidil) 2% topical solution, application 019501","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501"},{"n":4,"title":"Drugs@FDA: Rogaine Extra Strength (minoxidil) 5% topical solution, application 020834","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020834"},{"n":5,"title":"Drugs@FDA: Men's and Women's Rogaine (minoxidil) 5% foam, application 021812","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021812"},{"n":6,"title":"Drugs@FDA: Loniten (minoxidil) tablets, application 018154","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018154"},{"n":1,"title":"Rogaine (minoxidil) topical solution and foam labeling, January 2026","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf"},{"n":2,"title":"Loniten (minoxidil) tablets label, revised January 2015","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf"},{"n":7,"title":"FDA draft product-specific guidance on minoxidil tablets, October 2024","url":"https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018154.pdf"},{"n":10,"title":"FDA: bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"n":13,"title":"FDA: understanding the risks of compounded drugs","url":"https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs"},{"n":11,"title":"FDA: 503A bulk drug substances category list","url":"https://www.fda.gov/media/94155/download"},{"n":12,"title":"FDA: bulk drug substances that may present significant safety risks (Category 2)","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"}]},"channelsOpener":"This section describes what happens and is not a recommendation.","sources":["https://clinicaltrials.gov/api/v2/studies?query.intr=minoxidil&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","https://clinicaltrials.gov/study/NCT05417308","https://clinicaltrials.gov/study/NCT07529977","https://peptideindex.ai/methodology#evidence-grade","https://peptideindex.ai/methodology#short-answer","https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf","https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501","https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded"],"verified_at":"2026-10-26T13:43:56.075Z","published_at":"2026-10-26T13:49:37.413Z","parent":null,"children":[],"snapshots":{"trials":{"snapshot_at":"2026-10-26T13:44:14.626Z","stale":false,"notice":"A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}