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Minoxidil comes in two very different forms sold under the Regaine brand, and the difference matters. The liquid or foam rubbed into the scalp is a properly authorised medicine for male pattern hair loss in EU countries. Minoxidil also exists as a tablet, but in the EU those tablets are licensed only as a blood-pressure medicine — taking low-dose minoxidil tablets for hair is off-label.
Active ingredient: minoxidil · Dosages: 5% topical · 2.5–5 mg oral (off-label) · Indicated for androgenetic alopecia (pattern hair loss) in adult men

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What it is

An EU-authorised medicine for male pattern hair loss, sold both on prescription and over the counter. This is the form the hair-loss evidence below is based on.
Regaine holds national authorisations rather than a single centralised EU one. Topical minoxidil has been authorised for use in Spain since 1 May 1988 for moderate androgenetic alopecia. The Spanish Regaine foam (50 mg/g) is sold without a prescription. In the United Kingdom, McNeil Products Limited holds a wider Regaine range: 5% scalp foam and 5% scalp solution for men, plus a 5% foam and a regular-strength solution for women aged 18 to 65. Rogaine is the same product under its United States name.

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How it works

Minoxidil opens potassium channels

Applied to the scalp, minoxidil acts on ATP-sensitive potassium channels.

Blood flow around follicles rises

This widens small blood vessels around the hair follicle.

The growing phase lasts longer

Minoxidil appears to keep hair follicles in their growing (anagen) phase for longer and increases hair diameter, although exactly how it acts on hair is still not fully understood.

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What the studies reported

Results are grouped by source and evidence grade so journal data and manufacturer announcements cannot be confused.
The main topical trial ran for 48 weeks in men aged 18–49 with vertex-pattern hair loss, so it does not establish results beyond one year or in other patterns of hair loss (Olsen et al., J Am Acad Dermatol 2002).

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What has been reported

Topical minoxidil, per the EU product information: Off-label oral minoxidil, from a 24-week randomised trial of oral minoxidil 5 mg vs topical minoxidil 5% (n=45 per arm): A separate retrospective study of 1,404 patients treated with off-label oral minoxidil for at least 3 months found hypertrichosis in 15.1% (causing withdrawal in 0.5%), lightheadedness in 1.7%, fluid retention in 1.3%, tachycardia in 0.9%, headache in 0.4%, periorbital oedema in 0.3% and insomnia in 0.2% — leading to discontinuation in 1.2% of patients overall.
EU-authorised oral minoxidil tablets are indicated only for severe resistant hypertension, and their product information states they must never be used alone or as initial therapy — always alongside a beta-blocker and a diuretic, and with warnings about fluid retention and fluid around the heart. None of that licensed dosing framework applies to the low doses used off-label for hair loss.

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Common questions

Regaine foam 5% and a regular-strength solution are authorised for women aged 18 to 65 in the United Kingdom. In Spain, Regaine foam (50 mg/g) is indicated for androgenetic alopecia in adult men. For women, the doctor may consider off-label options including oral minoxidil under medical supervision.
The main topical trial ran for 48 weeks in men aged 18–49 with vertex-pattern hair loss. Visible results take months — maximum visible results come at 6–12 months. Consistent daily use is needed before judging effectiveness. Photographs taken in the same light are more useful than day-to-day checking.
Regaine is available as a 5% scalp foam and a 5% scalp solution. Both contain minoxidil as the active ingredient. The foam dries faster and may be easier to apply. The choice between them depends on personal preference and scalp tolerance.
In the EU, minoxidil tablets are licensed only as a blood-pressure medicine for severe resistant hypertension. Taking low-dose tablets for hair is off-label — a doctor prescribing outside the licensed use. Off-label oral minoxidil requires close medical supervision for potential cardiovascular effects.
A temporary increase in shedding can occur when starting topical minoxidil. This is the hair follicle transitioning from resting to growing phase, and it does not predict the final outcome. Shedding usually settles within weeks as new growth begins.
Yes. Minoxidil combines well with finasteride or dutasteride. The two medicines work through different mechanisms — finasteride blocks DHT production while minoxidil stimulates the follicle — and a doctor may prescribe them together for a better response.
Regaine and Rogaine are the same product under different brand names. Rogaine is the name used in the United States. Both contain minoxidil as the active ingredient in the same concentrations.

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How Hi-Doctor handles it

Topical minoxidil or off-label oral minoxidil, depending on your case. Minoxidil combines well with finasteride or dutasteride. An EU-licensed doctor reviews your case and, if eligible, issues an electronic prescription valid at any EU pharmacy under Directive 2011/24/EU. Applied to a dry scalp, topical minoxidil is typically used twice a day; tablets, if prescribed, once daily. See how a consultation works, the treatment areas Hi-Doctor covers, pricing, and eligibility checks in safety.

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Sources

  • AEMPS CIMA — Regaxidil 20 mg/ml solución cutánea, ficha técnica (Spain, registration 57597, authorised 1 May 1988) — indicated for moderate androgenetic alopecia
  • AEMPS CIMA — Regaine 50 mg/g espuma cutánea, ficha técnica (Spain, registration 76483) — indicated for androgenetic alopecia in adult men
  • AEMPS CIMA — Loniten 10 mg comprimidos, ficha técnica (Spain, registration 55636) — oral minoxidil, indicated for severe hypertension only
  • AEMPS CIMA — Minogal 2,5/5/10 mg comprimidos EFG, ficha técnica (Spain, registration 91045-91047, authorised 2026) — oral minoxidil, indicated for severe resistant hypertension only
  • Olsen et al., J Am Acad Dermatol 2002;47(3):377-385 (PMID 12196747)
  • Penha MA, Miot HA, Kasprzak M, Muller Ramos P. Oral minoxidil vs topical minoxidil for male androgenetic alopecia: a randomized clinical trial. JAMA Dermatol. 2024;160(6):600-605 (PMID 38598226)
  • Vaño-Gálvan S, Pirmez R, Hermosa-Gelbard A, et al. Safety of low-dose oral minoxidil for hair loss: a multicenter study of 1,404 patients. J Am Acad Dermatol. 2021;84(6):1644-1651 (PMID 33639244)
  • Rodrigues Dias F, Yong SS, FitzGerald H, Sinclair RD, Bhoyrul B. Expanding the therapeutic landscape of minoxidil for androgenetic alopecia. Front Pharmacol. 2026;16:1718208 — reproduces the Olsen 2002 hair-count figures and states oral minoxidil is not formally approved for androgenetic alopecia

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This page is reference information, not medical advice and not a prescription. Whether a medicine is appropriate for you is decided by a registered doctor after reviewing your consultation.