Bicalutamide
Androbloc, Bicalutamid +pharma, Bicalutamid Actavis, Bicalutamid Bluefish · ATC code L02BB03
Also known as: Bicalutamid, Bikalutamid · Brand names: Androbloc, Bicalutamid +pharma, Bicalutamid Actavis, Bicalutamid Bluefish, Bicalutamid G.L., Bicalutamid Genericon, Bicalutamid Ratiopharm, Bicalutamid Sandoz, Bicalutamid Stada, Casodex, Bicadex, Bicalut, Bicalutamide Teva, Bicalutin, Bicalexin …
- Key facts
- Active substance
- Bicalutamide
- ATC code
- L02BB03
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Key facts
Bicalutamide is, per the US prescribing information, an antiandrogen used in combination with an LHRH analog to treat Stage D₂ metastatic carcinoma of the prostate.
What it is used for
- Bicalutamide 50 mg daily in combination with an LHRH analog for Stage D₂ metastatic prostate carcinoma.
- Bicalutamide 150 mg daily is not approved for use alone or with other treatments.
Dosing
- One 50 mg tablet once daily (morning or evening), with or without food, preferably at the same time each day.
- Treatment should start at the same time as the LHRH analog.
- If a dose is missed, take the next dose at the scheduled time; do not take the missed dose or double the next one.
- No dose adjustment in renal impairment or in mild to moderate hepatic impairment; even in severe hepatic impairment no adjustment is necessary despite a longer half-life.
Contraindications
- Hypersensitivity to the drug or any tablet component (angioneurotic edema and urticaria have been reported).
- Women: no indication, should not be used.
- Pregnancy.
Important warnings
- Hepatitis: postmarketing cases of severe liver injury leading to death or hospitalization, usually within the first three to four months; measure transaminases before treatment, regularly during the first four months and periodically thereafter; stop immediately if jaundice occurs or ALT rises above two times the upper limit of normal.
- Hemorrhage with coumarin anticoagulants: excessive PT/INR prolongation with some serious bleeding; monitor PT/INR closely.
- Gynecomastia and breast pain (up to 38% and 39% with 150 mg as a single agent).
- Reduced glucose tolerance with LHRH agonists; consider monitoring blood glucose.
- Regular PSA assessments may help monitor the response.
Side effects
- Most frequent with an LHRH analog: hot flashes (53%).
- Other common: pain, back pain, asthenia, pelvic pain, constipation, infection, nausea, peripheral edema, dyspnea, diarrhea, nocturia, hematuria, anemia.
- Postmarketing: interstitial lung disease (some fatal), most often at doses greater than 50 mg; photosensitivity.
Interactions
- No interactions shown with the LHRH analogs goserelin or leuprolide.
- R-bicalutamide inhibits CYP 3A4: midazolam levels rose (Cmax 1.5-fold, AUC 1.9-fold); use caution with CYP 3A4 substrates.
- Coumarin anticoagulants may be displaced from protein binding; monitor PT/INR closely and adjust the anticoagulant dose if needed.
Pregnancy and breastfeeding
- Contraindicated in pregnancy because it can cause fetal harm; not indicated in females.
- Men with female partners of reproductive potential should use effective contraception during treatment and for 130 days after the final dose.
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.
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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
- AndroblocG.L. Pharma Gmbh · 1 register entry
- Bicalutamid +pharma+pharma Arzneimittel Gmbh · 1 register entry
- Bicalutamid ActavisActavis Group Ptc Ehf. · 1 register entry
- Bicalutamid BluefishBluefish Pharmaceuticals Ab · 1 register entry
- Bicalutamid G.L.G.L. Pharma Gmbh · 1 register entry
- Bicalutamid GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
- Bicalutamid RatiopharmTeva B.V · 1 register entry
- Bicalutamid SandozSandoz Gmbh · 1 register entry
- Bicalutamid StadaStada Arzneimittel Gmbh · 1 register entry
- CasodexLaboratoires Juvise Pharmaceuticals · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- BicadexTad Pharma Gmbh · 1 register entry
- BicalutGenthon Bv · 1 register entry
- BicalutamidMedac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel), 1 A Pharma Gmbh, Ratiopharm Gmbh, Tecnimede - Sociedade Técnico-Medicinal, Sa, Bluefish Pharmaceuticals Ab, Abanta Pharma Gmbh, Winthrop Arzneimittel Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Aristo Pharma Gmbh (Art 57), Biomo Pharma Gmbh, Eugia Pharma (Malta) Limited, Stadapharm Gmbh, Teva Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 18 register entries
- Bicalutamide TevaTeva Gmbh · 1 register entry
- BicalutinDr. Pfleger Arzneimittel Gmbh · 1 register entry
- CasodexLaboratoires Juvise Pharmaceuticals · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- BicalexinRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- CaluxDEVA HOLDİNG A.Ş. · 2 register entries
- CasodexEİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 2 register entries
- CasomidONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- ProcalutKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- CasodexANI Pharmaceuticals, Inc. · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29
Brand names in 27 more European countries
- Belgium
- Bicalutamide Eg, Bicalutamide Sandoz, Bicalutamide Teva, Casodex
- Bulgaria
- Бикагратис, Бикалутамид Акорд, Бикалутамид Алуфарма, Йонистиб, Казодекс
- Croatia
- Bicaprox, Bikalis, Bikalutamid Jgl, Bixalan, Casodex, Kalufar
- Cyprus
- Bicalutamide Rafarm, Bikalen, Casodex
- Czechia
- Bicaluplex, Bicalutanorm, Bikalard, Binabic, Lanbica
- Denmark
- Bicalustad, Bicalutamid Bluefish, Bicalutamid Fair-Med, Bicalutamid Orion, Bicalutamid Sandoz, Bicalutamide Accord, Bicalutamide Teva, Casodex
- Estonia
- Bicalutamide Accord, Bicalutamide Teva, Casodex
- Finland
- Bicalutamid Orion, Bicalutamide Accord, Bicavan, Casodex
- France
- Bicalutamide Accord, Bicalutamide Almus, Bicalutamide Arrow, Bicalutamide Biogaran, Bicalutamide Cristers Pharma, Bicalutamide Eg, Bicalutamide Evolugen, Bicalutamide Sandoz, Bicalutamide Teva, Bicalutamide Viatris, Bicalutamide Zentiva, Bicalutamide Zydus, Casodex
- Greece
- Bicalut, Bicalutamide Rafarm, Bicamide, Bikalen, Biludex, Bilumide, Casodex, Encalor, Lutrak, Zarmol
- Hungary
- Bicalutamide Pharmacenter, Bilutamid, Capro
- Iceland
- Bicalutamid Medical, Bicalutamide Accord, Bicalutamide Alvogen
- Ireland
- Bicalutamide Accord, Bicalutamide Fair-Med, Bicalutamide Teva, Biluta, Casodex
- Italy
- Bicalutamide Accord, Bicalutamide Ahcl, Bicalutamide Aurobindo, Bicalutamide Doc Generici, Bicalutamide Eg, Bicalutamide Ibigen, Bicalutamide Ratiopharm, Bicalutamide Sun, Bicalutamide Tecnigen, Bicalutamide Teva, Bikader, Casodex, Midelut
- Latvia
- Bicalutamide Accord, Bicalutamide Teva, Sapro
- Lithuania
- Bicalutamide Accord, Bicalutamide Teva
- Luxembourg
- Bicalutamide Eg, Bicalutamide Teva, Casodex
- Malta
- Bicalutamide Pharmacare
- Netherlands
- Bicalutamide Accord, Bicalutamide Aurobindo, Bicalutamide Eugia, Bicalutamide Pch, Bicalutamide Sandoz B.V., Bilumide, Biluron, Casodex-50
- Norway
- Bicalutamide Accord, Bicalutamide Bluefish, Bicalutamide Teva, Casodex
- Poland
- Bicalutamide Accord, Binabic
- Portugal
- Bicalutamida Accord, Bicalutamida Aurovitas, Bicalutamida Fair-Med, Bicalutamida Farmoz, Bicalutamida Generis, Bicalutamida Pharmacare, Bicalutamida Sandoz, Bicalutamida Stada, Bicalutamida Tecnimede, Bicalutamida Teva, Bicalutamide Teva, Bicastad
- Romania
- Bicalutamida Accord, Bicalutamidă Accord, Bicalutamidă Labormed, Casodex, Yonistib
- Slovakia
- Bicagelan, Bicalutamid Teva, Bicalutamide Pharmevid, Binabic, Caprodez
- Slovenia
- Bikalutamid Accord, Bikalutamid Lek, Bikalutamid Synthon, Bikalutamid Teva, Casodex
- Spain
- Bicalutamida Accord, Bicalutamida Almus, Bicalutamida Aurovitas, Bicalutamida Cinfa, Bicalutamida Combix, Bicalutamida Kern Pharma, Bicalutamida Mabo, Bicalutamida Normogen, Bicalutamida Pensa, Bicalutamida Sandoz, Bicalutamida Stada, Bicalutamida Teva, Biobica, Casodex, Eftoran, Pencial, Probic, Saveprost, Wibical
- Sweden
- Bicalustad, Bicalutamid Sandoz, Bicalutamide Accord, Bicalutamide Bluefish, Bicalutamide Orion, Bicalutamide Teva, Casodex
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Sources
- U.S. Food and Drug Administration. Bicalutamide (ANI Pharmaceuticals, Inc.) – Prescribing Information, 2026-02-27. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7a08d88b-051a-4c16-9560-12685c500c58
- 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
- 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
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
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.