Minoxidil
/api/v1/drug/minoxidilMechanism of action
Sourced from openFDAMechanism-of-action class: Potassium Channel Interactions.
Indications
Sourced from openFDA- Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Dosage & administration
Sourced from openFDADirections • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area • using more or more often will not improve results • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Warnings & precautions
Sourced from openFDAFor external use only. For use by men only. Flammable: Keep away from fire or flame Do not use if • you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your hair loss • you are under 18 years of age. Do not use on babies and children. • your scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product • do not apply on other parts of the body • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. • the amount of hair regrowth is different for each person. This product will not work for all men. Stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • unwanted facial hair growth occurs • you do not see hair regrowth in 4 months May be harmful if used when pregnant or breast-feeding. Keep out of reach of children.
Approval history
Sourced from openFDA- Mar 3, 1987ANDAANDA071344Watson Labs
- Mar 3, 1987ANDAANDA071345Watson Labs
- Aug 17, 1988NDANDA019501Kenvue Brands
- Nov 14, 1988ANDAANDA071826Ph Health
- Nov 14, 1988ANDAANDA071839Ph Health
- Dec 13, 1995ANDAANDA072709Sun Pharm Industries
- Nov 14, 1997NDANDA020834Kenvue Brands
- Jan 20, 2006NDANDA021812Kenvue Brands
FAERS reports
- 1Adverse Drug Reaction8,51219%
- 2Drug Ineffective7,71017%
- 3Alopecia3,7688.5%
- 4Application Site Pruritus2,9096.6%
- 5Off Label Use2,2475.1%
- 6Overdose1,4453.3%
- 7Application Site Irritation1,4013.2%
- 8Hair Texture Abnormal1,3973.2%
- 9Application Site Pain1,3943.2%
- 10Headache1,3203.0%
- 11Incorrect Dose Administered1,2892.9%
- 12Product Use In Unapproved Indication1,1732.7%
- 13Inappropriate Schedule Of Product Administration1,1672.6%
- 14Wrong Technique In Product Usage Process1,1502.6%
- 15Pruritus1,0052.3%
Literature
Recent PubMed references pinned to Minoxidil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- FEA-guided co-design of bubble microneedles: controlled tip separation for rapid transdermal and sublingual delivery.Drug delivery · 2026 · Jiang C, Yang J, Gao M, et al.PMID 42118678DOI 10.1080/10717544.2026.2667564
- Enhanced follicular delivery of minoxidil to human scalp skin using cetosomal formulation.Colloids and surfaces. B, Biointerfaces · 2026 · Jain GK, Mishra A, Garg V, et al.PMID 42070486DOI 10.1016/j.colsurfb.2026.115755
- Cardiovascular Complications of Minoxidil Toxicosis in Two Dogs.Journal of the American Animal Hospital Association · 2026 · O'Donnell AD, Rheingold CG, Stack J, et al.PMID 42014099DOI 10.5326/JAAHA-MS-7538
- Topical Minoxidil and Low-Dose Oral Minoxidil in Onychodystrophy: A Proposed Treatment Algorithm.Journal of cosmetic dermatology · 2026 · Gupta AK, Talukder M, Lipner SR, et al.PMID 42003048DOI 10.1111/jocd.70863
- Microneedle-Based Codelivery of Platycladus orientalis-Derived Extracellular Vesicles and Minoxidil Nanoparticles for Androgenetic Alopecia Treatment.ACS applied materials & interfaces · 2026 · Shang Y, Li Z, Lin J, et al.PMID 41922097DOI 10.1021/acsami.6c03910
- Low-dose oral minoxidil (LDOM) and topical minoxidil: consensus recommendations for managing male and female pattern hair loss in hair transplant patients using a modified Delphi process.Expert opinion on pharmacotherapy · 2026 · Gupta AK, Talukder M, Williams G, et al.PMID 41782304DOI 10.1080/14656566.2026.2642216
- Recyclable Polymerizable Deep Eutectic Solvent-Based Three-Dimensional-Printed Dissolving Microneedles with pH-Responsive Delivery of ZIF-8-Loaded Minoxidil for Hair Loss Therapy.ACS applied materials & interfaces · 2026 · Aminov N, Liu H, Meng D, et al.PMID 41779894DOI 10.1021/acsami.6c01834
- Efficacy and safety of topical 3% minoxidil for facial hair enhancement in transmen: a randomized, double-blind, placebo-controlled trial.The Journal of dermatological treatment · 2026 · Wattanawinitchai K, Pomsoong C, Ratanapokasatit Y, et al.PMID 41778417DOI 10.1080/09546634.2026.2638637
Clinical trials
The 10 most recently updated of 106 ClinicalTrials.gov registrations naming Minoxidil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer PatientsNot yet recruiting · Phase 2 · Interventional · 50 enrolled · Ohio State University Comprehensive Cancer CenterNCT07594678updated 2026-05-19
- Efficacy & Safety of Minoxidil SL Tablets in Men With AGACompleted · Phase 3 · Interventional · 142 enrolled · Samson Clinical Operations Pty LtdNCT06924632updated 2026-05-18
- VENEZE Peptide Factor Hair Serum Compared With Topical 2% Minoxidil for Androgenetic AlopeciaRecruiting · Interventional · 80 enrolled · Institute of Dermatology, ThailandNCT07536100updated 2026-05-13
- Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic AlopeciaRecruiting · Phase 3 · Interventional · 520 enrolled · Industrial Farmacéutica Cantabria, S.A.NCT05888922updated 2026-05-12
- JAK2 Expression in Androgenetic Alopecia Before and After Topical MinoxidilRecruiting · Interventional · 25 enrolled · Kasr El Aini HospitalNCT07563036updated 2026-05-01
- Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced AlopeciaActive not recruiting · Early phase 1 · Interventional · 14 enrolled · Northwestern UniversityNCT03831334updated 2026-04-30
- Comparative Study of Microneedling With Topical Minoxidil 5% ± NB-UVB in Stable Vitiligo"Not yet recruiting · Phase 2 · Interventional · 30 enrolled · Sohag UniversityNCT07548918updated 2026-04-29
- Clinical Study of PRP in the Treatment of Androgenetic AlopeciaCompleted · Interventional · 30 enrolled · The First Affiliated Hospital of Soochow UniversityNCT07551271updated 2026-04-24
- Minoxidil for Treating White Hair: A Randomized Controlled TrialCompleted · Phase 4 · Interventional · 141 enrolled · Southern Medical University, ChinaNCT06813963updated 2026-04-20
- Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.Not yet recruiting · Phase 3 · Interventional · 372 enrolled · Eurofarma Laboratorios S.A.NCT07529977updated 2026-04-14
Frequently asked questions
- How does Minoxidil work?
- Mechanism-of-action class: Potassium Channel Interactions.
- What is Minoxidil used for?
- According to FDA labeling, Minoxidil carries indications including: Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Minoxidil?
- Minoxidil is classified as Other dermatologicals, Pyrimidine derivatives, Arteriolar Vasodilator, Potassium Channel Interactions, Arteriolar Vasodilation, Cutaneous Arterial Vasodilation, Decreased Blood Pressure.
- What are the brand names for Minoxidil?
- Minoxidil is marketed under brand names including Regoxidine, Rogaine.
minoxidil is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.