MedeliX
Start asking

Testosterone undecanoate

Nebido, Testomed, Testosteron Orifarm, Testosteron Ratiopharm · ATC code G03BA03

Also known as: Testosteron undekanoat, Tlando · Brand names: Nebido, Testomed, Testosteron Orifarm, Testosteron Ratiopharm, Testosterone Undecanoate Ever Pharma, Testogalen, Testosteron Axiromed, Testosteron Basics, Testosteron Besins, Testosteron Biomo, Testosteron-Depot Eifelfango, Testosteron Libra-Pharm, Testosteronundecanoat Mibe, Sustanon, Testogel …

Key facts
Active substance
Testosterone undecanoate
Drug class
Androgen
ATC code
G03BA03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Testosterone undecanoate is an oral androgen (here the product TLANDO). Per the US prescribing information, it is used for testosterone replacement in adult men with primary or hypogonadotropic hypogonadism.

What it is used for

  • Testosterone replacement in adult males with deficiency or absence of endogenous testosterone due to primary hypogonadism (e.g. testicular failure) or hypogonadotropic hypogonadism (e.g. pituitary-hypothalamic injury)
  • Safety and efficacy are not established in males under 18 or in age-related hypogonadism

Dosing

  • Confirm hypogonadism first with morning serum testosterone below normal on at least two separate days
  • 225 mg (two 112.5 mg capsules) orally twice daily, morning and evening, with food
  • Check serum testosterone 8 to 9 hours after the morning dose, 3 to 4 weeks after starting and periodically: continue at 300 - 1080 ng/dL; discontinue if < 300 ng/dL or > 1080 ng/dL
  • Not substitutable with other oral testosterone undecanoate products

Contraindications

  • Carcinoma of the breast or known or suspected carcinoma of the prostate
  • Pregnant women (risk of virilization of a female fetus)
  • Known hypersensitivity to testosterone undecanoate or any ingredient

Important warnings

  • Polycythemia: check hematocrit before starting, about every 3 months in the first year and every 6 months thereafter; stop if elevated
  • Venous thromboembolism (deep vein thrombosis, pulmonary embolism)
  • Blood pressure increases, which can raise cardiovascular risk; monitor blood pressure
  • Worsening of benign prostatic hyperplasia and potential risk of prostate cancer
  • Abuse of testosterone; suppression of spermatogenesis; not for use in women
  • Also: hepatic effects, edema, sleep apnea, gynecomastia, lipid changes, hypercalcemia

Side effects

  • In a 4-month study: hypertension (5.1%), increased hematocrit (4.3%), upper respiratory tract infection (3.6%)
  • Serious: polycythemia, venous thromboembolism, blood pressure increases

Interactions

  • Insulin and antidiabetics: blood glucose and insulin requirements may decrease
  • Oral anticoagulants: changes in anticoagulant activity; monitor INR and prothrombin time
  • Corticosteroids: increased fluid retention
  • Other drugs that increase blood pressure: see the full text

Pregnancy and breastfeeding

  • Contraindicated in pregnancy and not indicated in females; testosterone is teratogenic and can virilize a female fetus

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

This product has no separate US patient information.

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

  • NebidoGrünenthal Österreich Gmbh · 1 register entry
  • TestomedDermapharm Gmbh · 1 register entry
  • Testosteron OrifarmOrifarm Healthcare A/S · 1 register entry
  • Testosteron RatiopharmTeva B.V · 1 register entry
  • Testosterone Undecanoate Ever PharmaEver Valinject Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • NebidoGrünenthal Pharmaceuticals Gmbh & Co. Kg · 1 register entry
  • TestogalenGalenpharma Gmbh · 1 register entry
  • TestomedMibe Gmbh Arzneimittel · 1 register entry
  • Testosteron AxiromedMedical Valley Invest Ab · 1 register entry
  • Testosteron BasicsBasics Gmbh · 1 register entry
  • Testosteron BesinsBesins Healthcare Germany Gmbh · 1 register entry
  • Testosteron BiomoBiomo Pharma Gmbh · 1 register entry
  • Testosteron-Depot EifelfangoEifelfango Chem. Pharm. Werk Gmbh & Co. Kg · 1 register entry
  • Testosteron Libra-PharmLibra-Pharm Gmbh · 1 register entry
  • Testosteron RatiopharmRatiopharm Gmbh · 1 register entry
  • Testosteronundecanoat MibeMibe Gmbh Arzneimittel · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • NebidoMENARİNİ SAĞLIK VE İLAÇ SAN. TİC. A.Ş. · 1 register entry
  • SustanonVLD DANIŞMANLIK TIBBİ ÜRÜNLER VE TANITIM HİZMETLERİ LTD. ŞTİ. · 1 register entry
  • TestogelER-KİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

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

USA

  • AveedEndo USA, Inc. · 1 register entry
  • TlandoVerity Pharmaceuticals Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 25 more European countries
Belgium
Nebido, Testosterone Besins
Bulgaria
Небидо, Тестостерон Тева
Croatia
Nebido
Cyprus
Nebido
Czechia
Nebido, Testosteron Undekanoát Besins, Testosteron Undekanoát Ever Pharma, Testosterone Undecanoate Ever Pharma
Denmark
Nebido, Testonur, Testosteron Medical Valley, Testosterone Teva, Tozaron
Finland
Nebido, Testonur, Testosteron Grünenthal, Testosterone Orifarm, Testosterone Ratiopharm, Testosterone Sun
France
Nebido, Testosterone Besins, Undecanoate De Testosterone Sun
Greece
Nebido
Hungary
Nebido, Testosterone Sun, Testosterone Undecanoate Ever Pharma
Iceland
Depotesto, Nebido, Testosteron Medical Valley, Testosterone Teva
Ireland
Nebido, Testosterone Besins, Testosterone Undecanoate Ever Pharma
Italy
Nebid, Testex, Testomed, Testosterone Undecanoato Besins, Testosterone Undecanoato Sun
Lithuania
Nebido, Testosterone Undecanoate Orifarm
Luxembourg
Nebido, Testosterone Besins
Malta
Nebido
Netherlands
Nebido, Testosteron Teva, Testosteron Undecanoaat Sit, Testosteron Undecanoaat Sun, Testosteron Undecanoat Galen, Testosteron Xiromed, Testosterone Undecanoaat Orifarm, Testosterone Undecanoate Ever Pharma
Norway
Nebido, Testonur, Testosterone Undecanoate Sun, Testosterone Undecanoate Teva, Testosteronundekanoat Medical Valley, Tozaron
Poland
Nebido, Testosterone Undecanoate Besins, Testosterone Undecanoate Ever Pharma
Portugal
Nebido, Testosterona Besins
Romania
Androject, Nebido, Testosteron Teva, Testosterone Undecanoate Ever Pharma
Slovakia
Androject, Nebido, Sterovid, Testosterone Undecanoate Ever Pharma, Testosterone Undecanoate Sun
Slovenia
Nebido
Spain
Reandron, Teneone, Testosterona Sit, Testosterona Sun
Sweden
Nebido, Testonur, Testosteron Medical Valley, Testosterone Besins, Testosterone Orifarm, Testosterone Sun, Testosterone Teva

EMA – Article 57 product data (EU/EEA), 2026-10-29

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

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Tlando (Verity Pharmaceuticals Inc.) – Prescribing Information, 2026-02-25. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4b0b92e9-6d3c-a0e5-e1c7-342999f72580
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. 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), 2026-10-29. 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
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC G03BA.

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.