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Dutasteride

Avodart, Dutaglandin, Dutasterid Accord, Dutasterid Genericon · ATC code G04CB02

Also known as: Dutasterid · Brand names: Avodart, Dutaglandin, Dutasterid Accord, Dutasterid Genericon, Dutascar, Dutasterid Aristo, Dutasterid Axiromed, Dutasterid Olpha, Adutax, Bepros, Dutapros, Restad, Urovelis

Key facts
Active substance
Dutasteride
ATC code
G04CB02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Dutasteride is a 5 alpha-reductase inhibitor. Per the US prescribing information, it treats symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, alone or with tamsulosin.

What it is used for

  • Symptomatic BPH with an enlarged prostate: improve symptoms
  • Reduce the risk of acute urinary retention and of BPH-related surgery
  • In combination with the alpha-blocker tamsulosin for symptomatic BPH
  • Not approved for the prevention of prostate cancer

Dosing

  • Monotherapy: 1 capsule (0.5 mg) once daily.
  • Combination: 0.5 mg dutasteride once daily plus tamsulosin 0.4 mg once daily.
  • Swallow capsules whole, not chewed or opened (contents may irritate the oropharyngeal mucosa); with or without food.

Contraindications

  • Pregnancy (may harm a male fetus)
  • Clinically significant hypersensitivity to dutasteride or other 5 alpha-reductase inhibitors (e.g. serious skin reactions, angioedema)

Important warnings

  • Reduces serum PSA by approximately 50% within 3 to 6 months; establish a new PSA baseline at least 3 months after starting
  • Any confirmed PSA increase from the lowest value on treatment should be evaluated
  • Double isolated PSA values after 3 months or more for comparison with normal values
  • Capsules should not be handled by women who are or may be pregnant (absorption through the skin)

Side effects

  • Most common: impotence, decreased libido, breast disorders (enlargement, tenderness), ejaculation disorders
  • With tamsulosin also dizziness; ejaculation disorders in 11%
  • Trial withdrawal due to adverse reactions in 4% (placebo 3%)

Interactions

  • Potent, chronic CYP3A4 inhibitors (e.g. ritonavir): use caution, as dutasteride is metabolised by CYP3A4
  • Tamsulosin or terazosin: no effect on their pharmacokinetics

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; not indicated for use in women.
  • Blocking DHT formation can cause genital abnormalities in male fetuses.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • AvodartGlaxosmithkline Pharma Gmbh. · 1 register entry
  • DutaglandinG.L. Pharma Gmbh · 1 register entry
  • Dutasterid AccordAccord Healthcare B.V. · 1 register entry
  • Dutasterid GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • AvodartFd Pharma Gmbh, Glaxosmithkline Gmbh & Co. Kg · 2 register entries
  • DutascarTad Pharma Gmbh · 1 register entry
  • Dutasterid AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Dutasterid AxiromedMedical Valley Invest Ab · 1 register entry
  • Dutasterid OlphaOlpha As · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AdutaxDR. SERTUS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • AvodartGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 1 register entry
  • BeprosNOBİS SCİENTİFİC İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • DutaprosKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • RestadWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • UrovelisWORLD MEDICINE OPHTHALMICS İLAÇLARI LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 27 more European countries
Belgium
Avodart, Dutasteride Ab, Dutasteride Krka, Dutasteride Sandoz
Bulgaria
Дутастерид Акорд, Дутрис
Croatia
Avodart, Dupro, Duster, Dutasterid Accord, Dutasterid Genericon, Dutasteridum Stada, Dutrys
Cyprus
Avodart, Rafuster
Czechia
Adadut, Avodart, Dustar, Dutalan, Dutamon, Dutasterid Aristo, Dutasteride Olpha
Denmark
Deridust, Dutasterid "alkaloid", Dutasterid "hexal", Dutasterid "liconsa", Dutasterid Laboratorios Liconsa, Dutasterid Mylan, Dutasterid Universal Farma, Dutasteride Krka, Dutasteride Medical Valley, Dutasteride Teva, Lanadut
Estonia
Avodart, Dutasteride Elvim, Dutasteride Inteli, Dutasteride Ratiopharm, Dutasteride Teva
Finland
Avodart, Dutasteride Krka, Dutasteride Medical Valley, Dutasteride Ratiopharm, Dutasteride Viatris, Dutester
France
Avodart, Dutasteride Accord, Dutasteride Arrow Lab, Dutasteride Bgr, Dutasteride Biogaran, Dutasteride Cristers, Dutasteride Eg, Dutasteride Evolugen, Dutasteride Fairmed, Dutasteride Krka, Dutasteride Olpha, Dutasteride Sandoz, Dutasteride Teva, Dutasteride Viatris, Dutasteride Zentiva Lab
Greece
Avodart, Dastidem, Duaride, Dustezor, Rafuster
Hungary
Avodart
Iceland
Dutasteride Alvogen, Dutasteride Medical Valley
Ireland
Avodart, Dutasteride Krka, Dutasteride Rowa, Dutasteride Teva
Italy
Avodart, Decuster, Duagen, Durital, Dutas, Dutasteride Accord, Dutasteride Alter, Dutasteride Aristo, Dutasteride Aurobindo, Dutasteride Doc Generici, Dutasteride Eg, Dutasteride Krka, Dutasteride Mylan, Dutasteride Olpha, Dutasteride Pensa, Dutasteride Sandoz Gmbh, Dutasteride Tecnigen, Dutasteride Teva, Dutasteride Zentiva, Prodirexan, Produtal, Produxen, Vivister
Latvia
Avodart, Dutasteride Elvim, Dutasteride Inteli, Dutasteride Teva
Lithuania
Dortilla, Dutasteride Elvim, Dutasteride Inteli, Dutasteride Teva
Luxembourg
Avodart
Malta
Avodart, Dutalan, Dutasteride Aurobindo, Dutasteride Doc Generici, Dutasteride Galenicum, Dutasteride Gemax Pharma, Dutasteride Medreg, Dutasteride Mylan, Dutasteride Olpha, Dutrapro Mylan
Netherlands
Avodart, Dutasteride Aurobindo, Dutasteride Sandoz, Dutasteride Strides, Dutasteride Teva, Dutasteride Xiromed
Norway
Dutasteride Medical Valley
Poland
Adadut, Avodart, Davoster, Dutafin, Dutasteride Medreg, Dutasteride Olpha, Dutazyr, Dutrys, Findarts, Geroladut
Portugal
Aripsa, Avodart, Duagen, Dutasterida Aurovitas, Dutasterida Bluepharma, Dutasterida Bluesar, Dutasterida Bradex, Dutasterida Ciclum, Dutasterida Farmoz, Dutasterida Krka, Dutasterida Mylan, Dutasterida Pentafarma, Dutasterida Pharmakern, Dutasterida Rafarm, Dutasterida Ratiopharm, Dutasterida Sandoz, Dutasterida Teva, Dutasterida Tolife, Dutasterida Zentiva
Romania
Asium, Avodart, Deridust, Dutasterida Gemax Pharma, Dutasteridă Zentiva, Dutrys, Maxtrid
Slovakia
Adadut, Dutalan, Dutamed, Dutamon, Dutasterid Accord, Dutasteride Medreg, Dutasteride Olpha, Dutrys
Slovenia
Amdut, Avodart, Dortilla, Dutasterid Accordpharma, Lestedon
Spain
Avidart, Dutacap, Dutaqur, Dutasterida Aristo, Dutasterida Aurovitas, Dutasterida Cinfa, Dutasterida Combix, Dutasterida Kern Pharma, Dutasterida Krka, Dutasterida Olpha, Dutasterida Pensa, Dutasterida Ratiopharm, Dutasterida Stada, Dutasterida Tarbis, Dutasterida Teva-Ratiopharm, Dutasterida Viatris, Dutasterida Vir, Dutasteride Fairmed, Evidutix
Sweden
Avodart, Duagen, Dutasteride Medical Valley

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Dutasteride (Strides Pharma Science Limited) – Prescribing Information, 2026-08-27. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c78d18cf-05df-4154-b2f9-39cc374ca9e3
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.