Bicalutamide
Anti-Androgens
- Drug class
- Anti-Androgens
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 34
- FDA reports (12 mo)
- 495
Overview
Bicalutamide is an active pharmaceutical ingredient in the Anti-Androgens group (L02BB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 24 | May 22, 2026 |
| CA Canada | Health Canada | 9 | May 25, 2026 |
| US United States | FDA | 1 | March 1, 2024 |
GBUnited Kingdom· MHRA
24 products
Uses
Treatment of advanced prostate cancer in combination with luteinizing-hormone releasing hormone (LHRH) analogue therapy or surgical castration.
How to take
CACanada· Health Canada
9 products
Uses
AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS .................................................................................
4 ADVERSE REACTIONS ................................................................................................... 8 DRUG INTERACTIONS ..................................................................................................
12 DOSAGE AND ADMINISTRATION .............................................................................. 13 OVERDOSAGE ................................................................................................................
13 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 13 STORAGE AND STABILITY.......................................................................................... 14 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate.
2)]. • Bicalutamide tablet 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate.
(1) • Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments. (1)
How to take
Drug interactions
Known interactions involving Bicalutamide. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 369. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL366870262 · revised July 18, 2025
- [2]Health Canada (DPD) · 02270226 · revised March 22, 2025
- [3]FDA DailyMed · 10e21544-f181-4c… · revised March 1, 2024 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.