> ## Documentation Index
> Fetch the complete documentation index at: https://docs.hi-doctor.ai/llms.txt
> Use this file to discover all available pages before exploring further.
# Dutasteride 0.5mg
> Dutasteride is EU-authorised only for an enlarged prostate. Using it for hair loss is off-label everywhere in Europe, so Hi-Doctor proposes finasteride instead.
Dutasteride is a daily capsule that lowers DHT, the hormone involved in male pattern hair loss, by blocking both forms of the enzyme that makes it. In the EU it is authorised only for an enlarged prostate — using it for hair loss is off-label, and no doctor in the EU, including Hi-Doctor's, can prescribe it for that specific use.
## What it is
Active ingredient: **dutasteride** · Dosage: **0.5 mg / day**, one soft capsule swallowed whole, with or without food.
Dutasteride is a dual 5-alpha-reductase inhibitor. It has been approved specifically for male pattern hair loss in South Korea and Japan, but no European regulator has assessed it for that purpose — in the EU its marketing authorisation covers benign prostatic hyperplasia only.
## How it works
DHT (dihydrotestosterone) shrinks scalp hair follicles in male pattern hair loss. Testosterone is converted to DHT by two forms of the enzyme 5-alpha-reductase — type I and type II. Finasteride blocks only type II; dutasteride blocks both, so less DHT reaches the follicle. The DHT blockade is more complete, which can translate into a better response in some patients — a doctor weighs this case by case.
## What the studies reported
Every NCT identifier links to its ClinicalTrials.gov record. A readout is not the same as peer-reviewed publication.
The main hair-loss trial, [NCT01231607](https://clinicaltrials.gov/study/NCT01231607) (dutasteride vs placebo and finasteride in men with androgenetic alopecia), ran for 24 weeks entirely outside the EU and was never submitted to support an EU marketing authorisation for hair loss. No EU regulator has assessed dutasteride for this indication, and no long-term hair-loss outcome data exist.
## What has been reported
The figures below come from the placebo-controlled phase III programme in **prostate** trials in older men taking dutasteride 0.5 mg — not from hair-loss trials — because that is the only controlled safety dataset for the medicine.
| Reported effect | Year 1 | Year 2 |
| ------------------------------------------------------ | -------------- | -------------- |
| Impotence (reduced erections) | 6.0% (n=2,167) | 1.7% (n=1,744) |
| Decreased libido | 3.7% | 0.6% |
| Ejaculation disorders (including reduced semen volume) | 1.8% | 0.5% |
| Breast disorders (tenderness and enlargement) | 1.3% | 1.3% |
The EU product information states these sexual adverse events are associated with dutasteride, 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's product information as a precaution, because dutasteride works 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 in the EU product information.
## Can I get it here?
Dutasteride has no EU marketing authorisation for hair loss. It is an approved medicine for something else (an enlarged prostate) and approved in another country for this use (South Korea, Japan) — but not something a doctor here can prescribe for hair loss. What can you take instead? Finasteride is approved in the EU, has published peer-reviewed trial results, and can be prescribed today if a doctor decides it suits you.
## Common questions
No. Dutasteride has no EU marketing authorisation for hair loss. No doctor in the EU can prescribe it for that use. It is authorised only for an enlarged prostate in the EU and is approved for hair loss in South Korea and Japan.
Finasteride is EU-authorised for hair loss, has published peer-reviewed trial results, and can be prescribed if a doctor decides it suits you. See [the finasteride page](/library/medicines/finasteride).
The main hair-loss trial ran for 24 weeks entirely outside the EU and was never submitted to support an EU marketing authorisation. No EU regulator has assessed dutasteride for this indication.
Yes. The EU product information states that sexual adverse events are associated with dutasteride, that they may persist after stopping, 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 mood changes seen with finasteride is being added as a precaution because dutasteride works the same way. A direct link between dutasteride and suicidal ideation was not established.
Dutasteride blocks both types of 5-alpha-reductase whereas finasteride blocks only type II, so the DHT blockade is more complete. Whether this translates into a better response varies by patient — a doctor weighs this case by case.
## How Hi-Doctor handles it
A licensed doctor decides case by case and never prescribes without evaluation. Hi-Doctor's doctors review your hair growth questionnaire and propose an EU-authorised alternative, such as [minoxidil](/library/medicines/minoxidil) or a personalised compounded formulation. See [how a consultation works](/essentials/how-it-works), the [treatment areas](/essentials/treatments) Hi-Doctor covers, and how eligibility is decided in [safety](/essentials/safety).
## Sources
* AEMPS CIMA — Dutasterida 0,5 mg cápsulas blandas EFG, ficha técnica (Spain, registration 80595) — indication is benign prostatic hyperplasia only
* ClinicalTrials.gov — [NCT01231607](https://clinicaltrials.gov/study/NCT01231607) (dutasteride vs placebo and finasteride in men with androgenetic alopecia, posted results)
* ClinicalTrials.gov — NCT00441116
* Gubelin Harcha et al., *J Am Acad Dermatol* 2014 (PMID 24411083)
* Eun et al., *J Am Acad Dermatol* 2010;63(2):252-258 (PMID 20605255)
* Ding Y, Wang C, Bi L, et al. Dutasteride for the treatment of androgenetic alopecia: an updated review. *Dermatology*. 2024;240(5-6):833-843 (PMID 39278205) — states that only South Korea and Japan have approved dutasteride for male AGA
* EMA — Article 31 referral: finasteride- and dutasteride-containing medicinal products
## Start a consultation
Answer the hair-growth questionnaire and a registered doctor reviews it.
They decide whether treatment is appropriate, which one, and at what dose —
and declining is a normal outcome. See [what it costs](/essentials/pricing)
and [how the review works](/essentials/how-it-works).
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.