# Minoxidil 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. Status checked: 2026-10-26. Last verified: 2026-10-26. Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501 This page has not been individually reviewed by a clinician. Information, not medical advice. | Fact | Value | Tier | Checked | Source | |---|---|---|---|---| | Also called | Rogaine, Loniten | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf) | | Class | non-peptide | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf) | | Regulatory status | fda-approved | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501) | | Status source read | 2026-10-26 | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501) | | Evidence grade | strong-human | our assessment | 2026-10-26 | [source](https://peptideindex.ai/methodology#evidence-grade) | | Label 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. | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf) | ## Name Minoxidil Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf ## 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. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf ## 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. Source: https://peptideindex.ai/methodology#short-answer ## 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]. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf ## What nobody knows yet - 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]. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf ## 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]. Today 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]. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf ## Where it stands legally 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. Loniten, 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]. Pharmacies 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]. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501 ## What the evidence shows 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]. For 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]. The 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]. Source: https://clinicaltrials.gov/study/NCT07529977 ## Legitimate ways to get it 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]. Minoxidil 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]. Pharmacies 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]. One 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. Source: https://clinicaltrials.gov/study/NCT05417308 ## How people are getting it anyway This section describes what happens and is not a recommendation. 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]. Some 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]. In 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]. Source: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded ## Access routes Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf ### Approved product Detail: Approved by FDA as a 2% solution put on the scalp, for men and for women, sold without a prescription. Brand names: Rogaine (for men), Rogaine (for women) Manufacturer: Kenvue Brands Indication: To regrow hair on the scalp. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501 ### Approved product Detail: Approved by FDA as a 5% solution put on the scalp, for men, sold without a prescription. Brand names: Rogaine Extra Strength (for men) Manufacturer: Kenvue Brands Indication: To regrow hair on the top of the scalp in men. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020834 ### Approved product Detail: Approved by FDA as a 5% foam put on the scalp, for men and for women, sold without a prescription. Brand names: Men's Rogaine, Women's Rogaine Manufacturer: Kenvue Brands Indication: To regrow hair on the top of the scalp. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021812 ### 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. Brand names: Loniten Manufacturer: Pfizer 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: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018154 ### 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: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ## Unofficial channels Source: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded ### Telehealth What it is: Online prescribers and compounders that sell scalp products mixing minoxidil with finasteride for hair loss. Legal position: 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: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded) Documented risks: - FDA got 32 reports of harm tied to compounded topical finasteride from 2019 to 2024, alone or mixed with other drugs. (source: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded) Enforcement: - 2025-04-22: FDA alerted prescribers, compounders and consumers to reports of harm tied to compounded topical finasteride, including mixes with minoxidil. (source: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded) Source: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded ### Compounding outside the rules What it is: Compounded hair loss products that hold minoxidil the label does not list. Legal position: FDA says compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before sale. (source: https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs) Documented risks: - 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: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared) Enforcement: - 2020-05-11: FDA posted a nationwide recall of compounded hair loss capsules that held minoxidil not listed on the label. (source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared) Source: https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs ## Recruiting trials Snapshot date: 2026-10-26. A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record. - 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 none listed, us states none listed - 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 none listed - 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 none listed - 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 none listed, us states none listed - 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 none listed, us states none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed, us states none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed, us states none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed, us states none listed - 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 none listed - 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 Source: 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 ## Sources Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf ### 1. Rogaine (minoxidil) topical solution and foam labeling, January 2026 Type: label Tier: primary Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf ### 2. Loniten (minoxidil) tablets label, revised January 2015 Type: label Tier: primary Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf ### 3. Drugs@FDA: Rogaine (minoxidil) 2% topical solution, application 019501 Type: regulatory Tier: primary Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501 ### 4. Drugs@FDA: Rogaine Extra Strength (minoxidil) 5% topical solution, application 020834 Type: regulatory Tier: primary Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020834 ### 5. Drugs@FDA: Men's and Women's Rogaine (minoxidil) 5% foam, application 021812 Type: regulatory Tier: primary Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021812 ### 6. Drugs@FDA: Loniten (minoxidil) tablets, application 018154 Type: regulatory Tier: primary Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018154 ### 7. FDA draft product-specific guidance on minoxidil tablets, October 2024 Type: regulatory Tier: primary Source: https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018154.pdf ### 8. FDA alert: potential risks of compounded topical finasteride products, April 2025 Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded ### 9. FDA-posted recall notice: compounded finasteride capsules with undeclared minoxidil, May 2020 Type: regulatory Tier: primary Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared ### 10. FDA: bulk drug substances used in compounding under section 503A Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### 11. FDA: 503A bulk drug substances category list Type: regulatory Tier: primary Source: https://www.fda.gov/media/94155/download ### 12. FDA: bulk drug substances that may present significant safety risks (Category 2) Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ### 13. FDA: understanding the risks of compounded drugs Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs ### 14. Randomized trial: 5% against 2% topical minoxidil and placebo in men with hair loss, 2002 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/12196747/ ### 15. Randomized trial: 5% minoxidil foam against placebo in men with hair loss, 2007 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/17761356/ ### 16. Randomized trial in Iran: oral minoxidil tablets against topical minoxidil in women with hair loss, 2021 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/34529341/ ### 17. Systematic review: low-dose oral minoxidil for hair loss without scarring, 2020 Type: systematic-review Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/32516434/ ### 18. Multicenter study: safety of low-dose oral minoxidil for hair loss in 1404 patients, 2021 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/33639244/ ### 19. Case series: topical minoxidil exposures and poisoning in dogs and cats, 2021 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/34370845/ ### 20. ClinicalTrials.gov NCT05417308: topical or oral minoxidil for hair loss from endocrine therapy in breast cancer Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT05417308 ### 21. ClinicalTrials.gov NCT07529977: phase 3 study of oral minoxidil in men with hair loss Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT07529977 ### 22. Associated Press: low-dose minoxidil pills prescribed off label for hair loss, March 2025 Type: reference Tier: established-news Source: https://www.boston.com/news/health/2025/03/19/this-cutting-edge-hair-loss-treatment-is-a-repurposed-drug-from-the-1990s/ Last verified: 2026-10-26. 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 [^1]: Rogaine (minoxidil) topical solution and foam labeling, January 2026 https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019501Orig1s036,020834Orig1s021,021812Orig1s020lbl.pdf [^2]: Loniten (minoxidil) tablets label, revised January 2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf [^3]: Drugs@FDA: Rogaine (minoxidil) 2% topical solution, application 019501 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501 [^4]: Drugs@FDA: Rogaine Extra Strength (minoxidil) 5% topical solution, application 020834 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020834 [^5]: Drugs@FDA: Men's and Women's Rogaine (minoxidil) 5% foam, application 021812 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021812 [^6]: Drugs@FDA: Loniten (minoxidil) tablets, application 018154 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018154 [^7]: FDA draft product-specific guidance on minoxidil tablets, October 2024 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018154.pdf [^8]: FDA alert: potential risks of compounded topical finasteride products, April 2025 https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded [^9]: FDA-posted recall notice: compounded finasteride capsules with undeclared minoxidil, May 2020 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared [^10]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act [^11]: FDA: 503A bulk drug substances category list https://www.fda.gov/media/94155/download [^12]: FDA: bulk drug substances that may present significant safety risks (Category 2) https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks [^13]: FDA: understanding the risks of compounded drugs https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs [^14]: Randomized trial: 5% against 2% topical minoxidil and placebo in men with hair loss, 2002 https://pubmed.ncbi.nlm.nih.gov/12196747/ [^15]: Randomized trial: 5% minoxidil foam against placebo in men with hair loss, 2007 https://pubmed.ncbi.nlm.nih.gov/17761356/ [^16]: Randomized trial in Iran: oral minoxidil tablets against topical minoxidil in women with hair loss, 2021 https://pubmed.ncbi.nlm.nih.gov/34529341/ [^17]: Systematic review: low-dose oral minoxidil for hair loss without scarring, 2020 https://pubmed.ncbi.nlm.nih.gov/32516434/ [^18]: Multicenter study: safety of low-dose oral minoxidil for hair loss in 1404 patients, 2021 https://pubmed.ncbi.nlm.nih.gov/33639244/ [^19]: Case series: topical minoxidil exposures and poisoning in dogs and cats, 2021 https://pubmed.ncbi.nlm.nih.gov/34370845/ [^20]: ClinicalTrials.gov NCT05417308: topical or oral minoxidil for hair loss from endocrine therapy in breast cancer https://clinicaltrials.gov/study/NCT05417308 [^21]: ClinicalTrials.gov NCT07529977: phase 3 study of oral minoxidil in men with hair loss https://clinicaltrials.gov/study/NCT07529977 [^22]: Associated Press: low-dose minoxidil pills prescribed off label for hair loss, March 2025 https://www.boston.com/news/health/2025/03/19/this-cutting-edge-hair-loss-treatment-is-a-repurposed-drug-from-the-1990s/