Dutasteride: What it is and how its sale is regulated

What is dutasteride and what is it used for?

Dutasteride is a prescription drug used primarily to treat benign prostatic hyperplasia (BPH), a common condition in older men. Its main function is to reduce levels of dihydrotestosterone (DHT), a hormone that contributes to prostate growth and hair loss. Although its use for androgenic alopecia (male pattern hair loss) has been investigated, the FDA in the United States has not approved this indication.

How is the sale of dutasteride regulated?

Dutasteride is a regulated drug in most countries and requires a prescription. In the United States, the FDA classifies it as a prescription drug due to its potential side effects and the need for medical supervision. Regulations are in place for several reasons: The US label lists impotence, decreased libido, ejaculation disorders and breast enlargement or tenderness. It states that these sexual side effects may persist after treatment discontinuation, and that the role of dutasteride in this persistence is unknown. It also lists depressed mood. In May 2026 the UK regulator (MHRA) added a warning about mood changes for dutasteride and advised patients who develop depression or suicidal thoughts to contact a doctor as soon as possible. If you have thoughts of harming yourself, seek emergency help right away.

Dutasteride is not indicated for women. Women who are pregnant or may be pregnant should not handle the capsules, because the drug can be absorbed through the skin and may harm a male fetus. Men taking it should not donate blood until at least 6 months after their last dose. In a label study, the drop in total sperm count had not reversed 24 weeks after stopping; the effect on fertility is not known. Dutasteride also lowers prostate-specific antigen (PSA), a marker used to detect prostate cancer, by about 50%, so any doctor reading a PSA test needs to know you take it.

Is dutasteride used to treat hair loss?

Although the FDA has not officially approved dutasteride to treat androgenic alopecia, some studies have investigated its effectiveness in this area. A 6-month placebo-controlled trial in 153 men reported a larger increase in hair count with dutasteride 0.5 mg than with placebo (Eun et al., 2010). A 2019 meta-analysis of three 24-week trials (576 men) reported larger hair-count gains with dutasteride than with finasteride, and no significant difference in sexual side effects (Zhou et al., 2019). These trials were short. Dutasteride is approved for male hair loss in South Korea and Japan. In Japan the regulator's review sets a usual dose of 0.1 mg once daily, which may be increased to 0.5 mg if needed (PMDA, 2015). In the US, the EU and the UK it is approved only for BPH, so its use for hair loss there is off-label and must be prescribed and supervised by a doctor.

What are the brand names of dutasteride?

The original brand is Avodart. Generic dutasteride is also sold under other names by different manufacturers, depending on the country.

Buying dutasteride online

While some online pharmacies offer dutasteride, it is important to ensure that they are authorized distributors. There are risks associated with purchasing medications from unverified sources, such as the possibility of receiving counterfeit or dubious quality products.

Before purchasing dutasteride online, it is recommended to consult with a doctor and verify that the pharmacy is licensed to sell prescription drugs. In addition, local regulations regarding the sale of prescription-only medicines should be followed.

Conclusion

Dutasteride is approved for treating BPH. It is also used for androgenetic alopecia, which is an approved use in South Korea and Japan but off-label in the US, the EU and the UK. Its sale and use are regulated because of its side effects and risks. It should be used under medical supervision and bought only from a licensed pharmacy with a prescription.

sources

Eun, H. C., et al. (2010). Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male patients with male pattern hair loss: a randomized, double-blind, placebo-controlled, phase III study. Journal of the American Academy of Dermatology, 63(2), 252-258. PMID 20605255. https://pubmed.ncbi.nlm.nih.gov/20605255/

Zhou, Z., et al. (2019). The efficacy and safety of dutasteride compared with finasteride in treating men with androgenetic alopecia: a systematic review and meta-analysis. Clinical Interventions in Aging, 14, 399-406. PMID 30863034. https://pubmed.ncbi.nlm.nih.gov/30863034/

Avodart (dutasteride) prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4

Medicines and Healthcare products Regulatory Agency. (2026, May 11). Finasteride and dutasteride: updated safety warnings for psychiatric side effects and sexual dysfunction. Drug Safety Update. https://www.gov.uk/drug-safety-update/finasteride-and-dutasteride-updated-safety-warnings-for-psychiatric-side-effects-and-sexual-dysfunction

Pharmaceuticals and Medical Devices Agency. (2015). Report on the deliberation results: Zagallo Capsules 0.1 mg / 0.5 mg (dutasteride). https://www.pmda.go.jp/files/000245812.pdf

U.S. Food and Drug Administration. (2011). Avodart (dutasteride) [Prescribing information]. GlaxoSmithKline. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf

U.S. Food and Drug Administration. (2008). Avodart (dutasteride) [Prescribing information]. GlaxoSmithKline. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf

U.S. Food and Drug Administration. (2010). Avodart (dutasteride) [Prescribing information]. GlaxoSmithKline. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022460s000lbl.pdf