Non-peptide
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.
This page has not been individually reviewed by a clinician.
Fact sheet · 6 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Rogaine, Loniten | primary | accessdata.fda.gov | |
| Class | non-peptide | primary | accessdata.fda.gov | |
| Regulatory status | fda-approved | primary | accessdata.fda.gov | |
| Status source read | 2026-10-26 | primary | accessdata.fda.gov | |
| Evidence grade | strong-human | our assessment | peptideindex.ai | |
| 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 | accessdata.fda.gov |
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.
Our assessment, drawn from the sources below.
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].
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].
What the evidence shows
Evidence grade: strong-human · our assessment
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].
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].
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].
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.
Approved product
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.
Approved product
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.
Approved product
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.
Approved product
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.
Lawful compounding
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.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT07529977
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Phase: Phase 3 · Sponsor: Eurofarma Laboratorios S.A. · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07758400
A Study on the Efficacy and Safety of Microneedling for Male Androgenetic Alopecia
Phase: Not applicable · Sponsor: Cheng Zhou · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07594678
Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
Phase: Phase 2 · Sponsor: Ohio State University Comprehensive Cancer Center · Status: Not yet recruiting
Countries: United States
US states: Ohio
NCT07862374
Oral Minoxidil With or Without a Multifactorial Drinkable Nutraceutical in Female Pattern Hair Loss: a Retrospective Study
Phase: Not stated · Sponsor: Olistic Research Labs S.L. · Status: Not yet recruiting
Countries: Spain
US states: none listed
NCT07716748
For an Investigator-led Hair Study Comparing Between Healthy and Hair Loss Volunteers
Phase: Not stated · Sponsor: National Skin Centre · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07548918
Comparative Study of Microneedling With Topical Minoxidil 5% ± NB-UVB in Stable Vitiligo"
Phase: Phase 2 · Sponsor: Sohag University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07536100
VENEZE Peptide Factor Hair Serum Compared With Topical 2% Minoxidil for Androgenetic Alopecia
Phase: Not applicable · Sponsor: Institute of Dermatology, Thailand · Status: Recruiting
Countries: Thailand
US states: none listed
NCT07435012
Androgenic Alopecia TH07 Clinical Trial
Phase: Phase 3 · Sponsor: Triple Hair Inc · Status: Recruiting
Countries: Canada
US states: none listed
NCT07518342
The Effect of Nanofat Injection on Androgenetic Alopecia
Phase: Phase 4 · Sponsor: Assiut University · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07264790
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon
Phase: Phase 1 · Sponsor: Duke University · Status: Recruiting
Countries: United States
US states: North Carolina
NCT07459933
Topical Methotrexate vs Minoxidil for Localized Alopecia Areata
Phase: Phase 4 · Sponsor: Jinnah Postgraduate Medical Centre · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07563036
JAK2 Expression in Androgenetic Alopecia Before and After Topical Minoxidil
Phase: Not applicable · Sponsor: Kasr El Aini Hospital · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07370519
Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia
Phase: Phase 2 · Sponsor: Shenzhen People's Hospital · Status: Recruiting
Countries: China
US states: none listed
NCT07502976
Topical 2-Deoxy-D-ribose Hydrogel Versus Minoxidil 5% Solution for Androgenetic Alopecia
Phase: Not applicable · Sponsor: Kasr El Aini Hospital · Status: Recruiting
Countries: Egypt
US states: none listed
NCT07248410
A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia
Phase: Not applicable · Sponsor: Chang Gung Memorial Hospital · Status: Recruiting
Countries: Taiwan
US states: none listed
NCT07273799
Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia
Phase: Phase 3 · Sponsor: Sheikh Zayed Federal Postgraduate Medical Institute · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07203599
A Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
Phase: Phase 1/Phase 2 · Sponsor: Shenzhen People's Hospital · Status: Recruiting
Countries: China
US states: none listed
NCT07056933
Effect of Minoxidil Solution Iontophoresis on Androgenic Alopecia
Phase: Not applicable · Sponsor: Cairo University · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07018349
Low Dose Oral Minoxdil in Androgenic Alopecia
Phase: Not applicable · Sponsor: Jinnah Postgraduate Medical Centre · Status: Not yet recruiting
Countries: Pakistan
US states: none listed
NCT07012486
Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia
Phase: Early phase 1 · Sponsor: Shanghai Zhongshan Hospital · Status: Recruiting
Countries: China
US states: none listed
NCT07080931
Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia
Phase: Phase 3 · Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Status: Recruiting
Countries: China
US states: none listed
NCT06826001
Various Procedural Treatment Options for Androgenetic Alopecia
Phase: Phase 2 · Sponsor: Sheikh Zayed Medical College · Status: Not yet recruiting
Countries: Pakistan
US states: none listed
NCT06501924
Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss
Phase: Phase 3 · Sponsor: Applied Biology, Inc. · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT05417308
Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
Phase: Early phase 1 · Sponsor: Ohio State University Comprehensive Cancer Center · Status: Recruiting
Countries: United States
US states: Ohio
NCT04594018
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
Phase: Phase 3 · Sponsor: EMS · Status: Recruiting
Countries: Brazil
US states: none listed
NCT04207931
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
Phase: Phase 4 · Sponsor: Wake Forest University Health Sciences · Status: Recruiting
Countries: United States
US states: North Carolina
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].
Telehealth
Online prescribers and compounders that sell scalp products mixing minoxidil with finasteride for hair loss.
The lawFDA says no topical product with finasteride, alone or mixed with other drugs, is FDA-approved, and compounded topical products have no FDA-approved label.fda.gov
Documented riskFDA got 32 reports of harm tied to compounded topical finasteride from 2019 to 2024, alone or mixed with other drugs.fda.gov
Enforcement FDA alerted prescribers, compounders and consumers to reports of harm tied to compounded topical finasteride, including mixes with minoxidil.fda.gov
Compounding outside the rules
Compounded hair loss products that hold minoxidil the label does not list.
The lawFDA says compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before sale.fda.gov
Documented riskCompounded 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.fda.gov
Enforcement FDA posted a nationwide recall of compounded hair loss capsules that held minoxidil not listed on the label.fda.gov
Sources
- [1]Rogaine (minoxidil) topical solution and foam labeling, January 2026Label · primary
- [2]Loniten (minoxidil) tablets label, revised January 2015Label · primary
- [3]Drugs@FDA: Rogaine (minoxidil) 2% topical solution, application 019501Regulatory · primary
- [4]Drugs@FDA: Rogaine Extra Strength (minoxidil) 5% topical solution, application 020834Regulatory · primary
- [5]Drugs@FDA: Men's and Women's Rogaine (minoxidil) 5% foam, application 021812Regulatory · primary
- [6]Drugs@FDA: Loniten (minoxidil) tablets, application 018154Regulatory · primary
- [7]FDA draft product-specific guidance on minoxidil tablets, October 2024Regulatory · primary
- [8]FDA alert: potential risks of compounded topical finasteride products, April 2025Regulatory · primary
- [9]FDA-posted recall notice: compounded finasteride capsules with undeclared minoxidil, May 2020Regulatory · primary
- [10]FDA: bulk drug substances used in compounding under section 503ARegulatory · primary
- [11]FDA: 503A bulk drug substances category listRegulatory · primary
- [12]FDA: bulk drug substances that may present significant safety risks (Category 2)Regulatory · primary
- [13]FDA: understanding the risks of compounded drugsRegulatory · primary
- [14]Randomized trial: 5% against 2% topical minoxidil and placebo in men with hair loss, 2002Rct · peer-reviewed
- [15]Randomized trial: 5% minoxidil foam against placebo in men with hair loss, 2007Rct · peer-reviewed
- [16]Randomized trial in Iran: oral minoxidil tablets against topical minoxidil in women with hair loss, 2021Rct · peer-reviewed
- [17]Systematic review: low-dose oral minoxidil for hair loss without scarring, 2020Systematic review · peer-reviewed
- [18]Multicenter study: safety of low-dose oral minoxidil for hair loss in 1404 patients, 2021Human trial · peer-reviewed
- [19]Case series: topical minoxidil exposures and poisoning in dogs and cats, 2021Animal · peer-reviewed
- [20]ClinicalTrials.gov NCT05417308: topical or oral minoxidil for hair loss from endocrine therapy in breast cancerReference · primary
- [21]ClinicalTrials.gov NCT07529977: phase 3 study of oral minoxidil in men with hair lossReference · primary
- [22]Associated Press: low-dose minoxidil pills prescribed off label for hair loss, March 2025Reference · established-news
Last verified · 6 facts · 9 sources
- clinicaltrials.gov
- clinicaltrials.gov
- clinicaltrials.gov
- peptideindex.ai
- peptideindex.ai
- accessdata.fda.gov
- accessdata.fda.gov
- accessdata.fda.gov
- fda.gov
Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019501
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
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