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Hair-loss treatment is long-term, so its side effects matter more than they would for a short course. Some of the medicines used for hair loss in Europe are authorised for that purpose; several are not, and are prescribed off-label or not at all. That distinction changes how much is known about their risks.

Finasteride

Finasteride is a daily 1 mg tablet and one of the few hair-loss medicines formally authorised for this purpose in EU countries. It is authorised for men only, and it is not for women. In the phase III trials the overall sexual adverse reaction rate fell to 0.6% over the following four years. About 1% of men in each group stopped treatment for this reason in the first 12 months (EU SmPC, section 4.8). Decreased libido, erectile dysfunction and ejaculation disorder are each classified as uncommon (1 in 1,000 to 1 in 100) in the EU SmPC.
Mood. Depression is listed as uncommon; anxiety and suicidal ideation are listed with frequency not known. After an EU-wide Article 31 review (started October 2024, European Commission decision August 2025), suicidal ideation was confirmed as a side effect of finasteride 1 mg and 5 mg tablets at an unknown frequency, and a patient card is now included in 1 mg packs. Anyone who experiences mood changes should seek medical advice and, on finasteride 1 mg, stop treatment.
Two further points from the EU product information:
  • Persistence after stopping. Persistence of decreased libido, erectile dysfunction and ejaculation disorders after finasteride is stopped has been reported in post-marketing use. Frequency is not known, because these are spontaneous reports.
  • Contraindicated in women. Finasteride can cause abnormalities of the external genitalia in a male foetus if taken during pregnancy.
Male breast cancer has been reported during post-marketing use; frequency cannot be estimated from the available data.

Minoxidil

Minoxidil comes in two very different forms and the difference matters. The liquid or foam rubbed into the scalp is an authorised medicine for male pattern hair loss in EU countries. Minoxidil tablets also exist, but in the EU those are licensed only as a blood-pressure medicine, so taking low-dose minoxidil tablets for hair is off-label.

Topical minoxidil

There is no placebo column here — the EU product information records these by frequency band rather than against a comparator.

Low-dose oral minoxidil, used off-label

In a 24-week randomised trial of oral minoxidil 5 mg versus topical minoxidil 5% (n=45 per arm): In a retrospective multicentre study of 1,404 patients treated for at least 3 months, the most frequent adverse effect was hypertrichosis (15.1%, causing withdrawal in 0.5%). Systemic effects were lightheadedness 1.7%, fluid retention 1.3%, tachycardia 0.9%, headache 0.4%, periorbital oedema 0.3% and insomnia 0.2%, leading to discontinuation in 1.2% of patients.
EU-authorised minoxidil tablets are indicated only for severe resistant high blood pressure, and their product information states they must never be used alone or as initial therapy — always alongside a beta-blocker and a diuretic. None of that licensed dosing framework applies to the low doses used off-label for hair loss, which is why the doctor monitors blood pressure.

Dutasteride

Dutasteride is authorised in the EU for an enlarged prostate, not for hair loss; using it for hair loss in Europe is off-label. The figures below come from placebo-controlled phase III prostate trials in older men taking 0.5 mg, not from hair-loss trials. The EU product information states that these sexual adverse events are associated with dutasteride treatment, that they may persist after treatment is stopped, and that the role of dutasteride in that persistence is not known. Depression is listed with frequency not known. Following the EU Article 31 review concluded in 2025, information about the mood changes seen with finasteride is being added to dutasteride product information as a precaution, because dutasteride works in the same way; a direct link between dutasteride and suicidal ideation was not established. Alopecia (mainly loss of body hair) and hypertrichosis are listed as uncommon.

Two medicines Hi-Doctor does not prescribe for hair

Authorised in EU countries for high blood pressure, some types of heart failure and excess aldosterone — not for hair loss anywhere in the EU. In a pooled analysis of five studies (413 patients), scalp itching or flaking was reported in 18.9% of women, menstrual changes in 11.9% and facial hair growth in 6.9%. Those five studies were mostly observational, used doses from 25 to 200 mg over six months to over a year, and none compared spironolactone against a placebo, so the figures cannot be separated from natural variation or from other treatments taken at the same time.
An antifungal. In the EU the shampoo, cream and gel are authorised for dandruff, seborrhoeic dermatitis and pityriasis versicolor. The Spanish product information for topical ketoconazole 20 mg/g lists a local burning sensation, itching, and contact dermatitis from irritation or allergy, and records oily or dry hair as rare along with rare discolouration of chemically damaged or grey hair. The oral form was suspended EU-wide — CHMP recommendation 25 July 2013, European Commission decision 11 October 2013 — because the risk of liver injury outweighed the benefit. Topical forms were not suspended.

Contact your doctor if

  • you have persistent side effects that concern you — sexual, mood changes, breast tenderness or enlargement
  • you notice a breast lump or nipple discharge, or severe low mood
  • a scalp reaction does not improve, or you have a severe scalp reaction, facial swelling or breathing difficulty
  • you have chest pain, a fast heartbeat, faintness, sudden weight gain, or swelling of hands or feet while on oral minoxidil
  • there is no visible improvement after 12 months of consistent use
Related: finasteride · minoxidil · dutasteride · what to expect in the first month · Safety

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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.