Minoxidil

Other dermatologicals (topical); peripheral vasodilators (systemic)

ATC code: D11AX01

Brand names: Rogaine, Regaine, Loniten

Updated 24 Sep 2026 · Methodology

Indications

Androgenetic alopecia

First line

Topical minoxidil is first-line therapy for male and female androgenetic alopecia. Cochrane meta-analysis (van Zuuren 2016, 12 RCTs, n=3927) confirms significant hair count and patient satisfaction increases at 6–12 months. In men, 5% solution/foam outperforms 2%. Low-dose oral minoxidil (0.25–5 mg/day) has been studied since 2017: Vañó-Galván 2021 RCT (n=104) and multiple retrospective series show hair density gains comparable to topical, in patients intolerant or unresponsive to topical. The main side effect of oral minoxidil is facial hypertrichosis (60–90%). and BAD guidelines list topical minoxidil as first-line; low-dose oral minoxidil as second-line off-label.

Topical 5% minoxidil is approved in men aged 18+, 2% in women. Low-dose oral minoxidil is used off-label.

Sources

ICD-10: L64 · ICD-11: ED70.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Anti-aging and longevity

Not recommended

Minoxidil is a vasodilator (originally a systemic antihypertensive). Topical forms (solution, foam) are approved for androgenic alopecia in men and women (AEMPS Ficha Técnica). Low-dose oral minoxidil (0.25–5 mg) is widely used off-label for anti-aging of hair. Clinical studies of oral minoxidil for hair loss are limited; the has not approved the drug for this indication. Oral minoxidil carries serious risks: hypertrichosis (excessive hair growth on face, back), orthostatic hypotension, tachycardia, peripheral edema, and pericardial effusion (FDA boxed warning for systemic minoxidil). If oral minoxidil was prescribed for anti-aging of hair, consider seeking a second opinion.

Sources

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

Minoxidil is an ATP-sensitive potassium channel opener and vasodilator. The exact mechanism of hair growth stimulation is unknown. Hypothesized mechanisms include increased perifollicular blood flow, anagen phase prolongation, and follicular widening. Topical minoxidil (2% and 5%) was -approved in 1988 for androgenetic alopecia. Oral minoxidil was historically used for severe resistant hypertension; since 2017–2020 low-dose oral minoxidil (0.25–5 mg/day) has been revived in dermatology as off-label therapy for alopecia.

Safety

Contraindications

Hypersensitivity
Pregnancy and breastfeeding
Age under 18
Active scalp dermatoses (for topical form)
Severe cardiovascular disease (for oral form)
Pheochromocytoma (for oral form)

Serious adverse effects

Severe hypotension with systemic use
Pericardial effusion (classic complication of high-dose oral minoxidil; not reported at low alopecia doses)
Allergic contact dermatitis to propylene glycol vehicle

Common adverse effects

Topical: scalp irritation, itching, scaling, contact dermatitis, facial hypertrichosis (1–3%)
Telogen effluvium in the first 2–8 weeks
Oral: facial and body hypertrichosis (60–90%), lower limb edema, tachycardia, headache

Pregnancy: can you take Minoxidil?

AEMPS summary of product characteristics (section 4.6): minoxidil scalp solution (Regaxidil 20 and 50 mg/ml) is not recommended during pregnancy because there are no clinical data on its use in pregnant women, although animal studies showed no harmful effects on pregnancy, embryofetal development, delivery or postnatal development. For minoxidil tablets (Loniten 10 mg summary of product characteristics, section 4.6), data in pregnant women are limited and animal studies have shown reproductive toxicity. The tablets are not recommended during pregnancy or in women of childbearing potential who are not using contraception. The Loniten summary of product characteristics also reports neonatal hypertrichosis after exposure to minoxidil during pregnancy.

Breastfeeding: can you take Minoxidil?

Contraindicated during breastfeeding: minoxidil is excreted in breast milk.

Calculate RID Full profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

In Russia, topical minoxidil is sold both as a medicinal product and as a cosmetic. A 60 mL bottle of 5% solution costs 900–1800 ₽ (one month supply). Effect appears no earlier than 12–16 weeks; optimal assessment at 6 months. Increased shedding in the first 2–8 weeks is common and not a reason to stop. After discontinuation, acquired hair is lost over 3–4 months. Low-dose oral minoxidil is not registered in Russia for alopecia and is prescribed off-label at 0.25–2.5 mg/day (men) and 0.25–1.25 mg/day (women), starting at 0.625–1.25 mg with titration.

Drug interactions

Topical minoxidil has negligible systemic absorption – clinically significant interactions are not reported. Oral minoxidil potentiates antihypertensive effects of other drugs; combination with β-blockers and diuretics reduces sodium retention and tachycardia risk. Guanethidine-containing drugs are contraindicated due to severe hypotension risk.

Label mentions3 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

Betamethasone
«Estudios farmacocinéticos de interacciones en humanos, revelaron que la absorción percutánea de minoxidil se ve reforzada con el uso de tretinoína y ditranol, como resultado de un incremento en la…»
AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

MajorFinasteride
«Debido a la ausencia de datos para el uso concomitante de finasterida y minoxidil tópico en la pérdida masculina del cabello, no se recomienda su uso concomitante.»
AEMPS, section 4.5 · Open on CIMA
ModerateEtoricoxib
«Etoricoxib es un inhibidor de la actividad de la sulfotransferasa humana, particularmente la SULT1E1, y se ha demostrado que aumenta las concentraciones séricas de etinilestradiol. Mientras que el…»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Minoxidil used for?

Minoxidil is evaluated for the following indications with varying evidence strength: Androgenetic alopecia (evidence tier A), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Minoxidil?

Common side effects of Minoxidil (≥ 1 in 100): Topical: scalp irritation, itching, scaling, contact dermatitis, facial hypertrichosis (1–3%), Telogen effluvium in the first 2–8 weeks, Oral: facial and body hypertrichosis (60–90%), lower limb edema, tachycardia, headache. See the Safety section for uncommon and serious reactions.

Is Minoxidil safe during pregnancy?

Is Minoxidil compatible with breastfeeding?

Contraindicated during breastfeeding: minoxidil is excreted in breast milk.

Who should not take Minoxidil?

Minoxidil is contraindicated in: Hypersensitivity; Pregnancy and breastfeeding; Age under 18; Active scalp dermatoses (for topical form); Severe cardiovascular disease (for oral form). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 11/29/2025
FDA / DailyMedLabel dated 08/25/2026

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