Bicalutamide (Casodex) is an oral antiandrogen used in prostate-cancer care. NCI drug identity. It blocks androgen signalling.
Confidence is high for the documented identity and attributed licence/safety instructions. This review does not establish an independent comparative-benefit verdict: commercial trial outcomes are excluded, and public education does not clear the financial interests of its supporting research.
- Bicalutamide blocks androgen action; it is not a GnRH injection.
- UK 50 mg, UK 150 mg and US indications differ.
- Jaundice, abdominal pain or new serious breathlessness need immediate advice.
- After excess tablets, seek help straight away.
- Prescription items are not patients, benefit or worldwide popularity.
Table of contents
- Evidence summary
- Names and licences
- Androgen blockade and early flare
- Liver, glucose and PSA
- Symptoms, sunlight and supplements
- England prescribing and trial evidence
- Urgent symptoms
- Blood thinners and other interactions
- Reproductive precautions
- Taking and driving
- Preclinical findings and commercial roles
- Funding and source roles
- Frequently asked questions
- Sources and funding notes
Evidence summary
Clinical descriptions, care guidance and independently established treatment outcomes have different evidentiary roles. The table identifies what the reviewed sources can support and which financial or clinical questions remain unresolved.
| Question / approach | Evidence reviewed | Funding / conflicts | Interpretation / limits |
|---|---|---|---|
| Identity | NCI | Reviewer chain unclosed | Names/class only. |
| UK licences | 50 mg; 150 mg | Seller | Distinct indications; no conversion. |
| US scope | US label | Seller | US indication and safety only. |
| Patient precautions | 50 mg leaflet; 150 mg leaflet | Seller | Immediate warnings and handling. |
| Salvage-radiation trial | RTOG 9601 | NCI/AstraZeneca; author ties | Design only; efficacy excluded. |
| England items | PCA Table 7 | Agency route below | One dispensing setting; not benefit. |
Names and licences
The NCI dictionary lists Casodex, Cosudex and ICI 176,334 as bicalutamide names. Identity and aliases. These identify the medicine, not a guarantee that every brand is available locally.
UK 50 mg: advanced prostate cancer with an LHRH analogue or surgical castration. UK 50 mg scope.
UK 150 mg covers selected locally advanced, high-progression-risk disease, alone or alongside prostatectomy/radiotherapy; another licensed setting is locally advanced nonmetastatic disease when other medical intervention or castration is unsuitable or unacceptable. Separate UK scope.
US Casodex is licensed with an LHRH analogue for Stage D2 metastatic prostate cancer; its 150 mg use is not approved, alone or combined. US scope.
Confirm your prescribed product.
Androgen blockade and early flare
Androgens activate receptors in prostate cells. Bicalutamide blocks androgen action, whereas GnRH treatment reduces testosterone production. Antiandrogens are sometimes used at the start of an agonist to address its initial testosterone flare. Mechanism and treatment distinction.
Ask the specialist to coordinate the tablet and injection plan. No personal start/stop calendar is supplied.
Read the related prostate cancer guide and leuprorelin guide for their separate scope. This medicine is not interchangeable with every hormone-directed cancer drug.
Liver, glucose and PSA
US label: jaundice requires immediate discontinuation with close liver follow-up. Seek immediate advice. Arrange liver tests for potentially fatal injury. Liver warning.
With LHRH agonists, review glucose, especially diabetes. Rising PSA needs progression assessment. Monitoring precautions.
Ask who reviews results and whom to contact between appointments. No result threshold or withdrawal sequence is supplied.
Symptoms, sunlight and supplements
Breast swelling/tenderness, hot flushes, weakness, nausea, bowel symptoms, sexual changes and mood symptoms can occur. Persistent effects deserve support. Avoid excessive sunlight/UV exposure. Patient precautions.
Tell the cancer team about every herb, supplement and complementary practice. These should not replace or delay cancer care. Complementary-care safety. No independent bicalutamide-specific supplement benefit is established here.
Do not assume that a product sold as natural is compatible. Take the actual product/ingredient list to the pharmacist; an unlisted interaction is not a safety clearance.
England prescribing and trial evidence
The original FY2025/26 England Table 7 records 168,261 bicalutamide prescription items, BNF code 0803042A0. Original chemical-substance row 1028.
PCA describes community dispensing. Publication setting. Hospital-issued prescriptions fulfilled in the community are included; hospital dispensary supplies are excluded. Individual indications are not recorded. Actual coverage.
Items are not unique patients or treatment responses. This is one English dispensing measure, not worldwide popularity or a ranking of effectiveness.
RTOG 9601 was a blinded placebo-controlled postoperative salvage-radiation trial in a selected recurrence population. NCI support coexisted with AstraZeneca funding/product supply and author commercial ties. Original methods and disclosures. Outcomes are excluded from the independent verdict; its regimen is not a current universal prescription.
Urgent symptoms
Tell a doctor straight away about jaundice, abdominal pain, blood in urine, or serious/newly worsening breathlessness with or without cough/fever. Lung inflammation is a labelled concern. Immediate patient warnings.
Call 999 or your local emergency number for sudden throat/tongue swelling, severe breathing difficulty or collapse suggesting anaphylaxis. Emergency allergy recognition.
After taking too much Casodex, contact a doctor or go to hospital straight away; do not wait for symptoms. Excess-tablet instructions.
For suspected harmful ingestion, seek emergency help. Do not induce vomiting, give food/drink or drive yourself to emergency care. Poisoning precautions.
New weakness, walking difficulty, numbness or bladder/bowel dysfunction with cancer can indicate cord compression. Seek immediate specialist or emergency assessment. Oncology-emergency recognition.
Blood thinners and other interactions
Warfarin/coumarin combinations can cause serious bleeding; the clinician monitors PT/INR. Check ciclosporin, calcium-channel blockers, cimetidine, ketoconazole and medicines affecting heart rhythm. Cisapride, terfenadine and astemizole are contraindicated. Interaction and QT precautions.
Report bleeding or unexplained bruising with anticoagulants. US warning.
Heart-rhythm disease and QT-prolonging medicines need individual risk review. Rhythm precautions.
Give the pharmacist your complete medicine/supplement list.
Reproductive precautions
UK Casodex must not be given to women, including during pregnancy/breastfeeding, or to children. Check ingredient allergy and sugar intolerance. Product exclusions.
Discuss male fertility and effective contraception if your partner could become pregnant. Long-term fertility effects are unstudied; absent human-milk data do not establish breastfeeding safety. Reproductive precautions.
This prostate-cancer guide supplies no off-label fertility, paediatric or gender-related regimen. An individual specialist pathway needs its own assessment and locally applicable product instructions.
Taking and driving
Swallow tablets whole as prescribed. Skip a missed dose; never double the next one. Sleepiness warrants driving/machinery caution. Patient instructions.
Keep the original container away from children; ask a pharmacist about disposal. Storage and disposal.
Routine changes need prescriber advice; urgent warnings still apply.
Preclinical findings and commercial roles
UK preclinical sections describe animal reproductive/testicular findings. They do not establish human benefit, individual fertility recovery or an independent treatment effect. Preclinical scope.
UK leaflets name AstraZeneca UK as holder and Macclesfield manufacturer. UK manufacturer identity.
ANI reports medicine sales, royalties/services and financing; its own filing also documents the AstraZeneca trademark licence. AstraZeneca’s own report documents the UK subsidiary and commercial revenue.
CordenPharma’s dated report identifies contract-manufacturing sales, Basel headquarters and Astorg ownership. Manufacturing-group route. Astorg’s own profile documents a private-equity business, not a complete investor chain.
These relationships explain the source roles. Regulated product warnings are useful safety instructions; a seller-funded trial still does not become independent because a public agency participates.
Funding and source roles
Research funding at a glance
30 disclosure entries. The counts below summarize independence tiers explicitly assigned in this article. They count disclosures, not studies, funding amounts or evidence quality.
Consult this article’s source and funding notes for named funders, countries, relationships and exceptions where available. Institutional backing, researcher interests and trial sponsorship are separate questions. Public funding alone does not establish independence; commercial ties alone do not prove a claim false. This overview is not a new financial audit.
The source-specific map separates documented institutional funding from disease-page payments and trial sponsorship. Unknown allocations remain unknown. A public agency, charity or academic address does not by itself establish independent treatment efficacy.
| Source | Funding / backers | Country / jurisdiction | Independence | Credibility / incentives / gaps |
|---|---|---|---|---|
| NCI: bicalutamide | Public/gift routes below; reviewer/trial receipts unclosed. | US; Bethesda. | Tier 2 education, provisional. | C — 10 September 2024; clinical accountability, not independent efficacy. |
| NCI: drug dictionary | Public/gift routes below; reviewer/trial receipts unclosed. | US; Bethesda. | Tier 2 education, provisional. | C — Date unexposed; clinical accountability, not independent efficacy. |
| NCI: prostate hormone therapy | Public/gift routes below; reviewer/trial receipts unclosed. | US; Bethesda. | Tier 2 education, provisional. | C — 4 October 2024; clinical accountability, not independent efficacy. |
| Casodex 50 mg UK SmPC | AstraZeneca UK; parent/hosting routes below. | UK; Cambridge holder. | Tier 4 seller. | D — 17 January 2024; regulated safety; efficacy excluded. |
| Casodex 150 mg UK SmPC | AstraZeneca UK; parent/hosting routes below. | UK; Cambridge holder. | Tier 4 seller. | D — 17 January 2024; regulated safety; efficacy excluded. |
| Casodex 50 mg UK leaflet | AstraZeneca UK; parent/hosting routes below. | UK; Cambridge holder; Macclesfield manufacturer. | Tier 4 seller. | D — October 2022; regulated safety; efficacy excluded. |
| Casodex 150 mg UK leaflet | AstraZeneca UK; parent/hosting routes below. | UK; Cambridge holder; Macclesfield manufacturer. | Tier 4 seller. | D — October 2022; regulated safety; efficacy excluded. |
| Casodex US label | ANI distributor; Corden manufacturer; routes below. | US; Baudette; German manufacture. | Tier 4 seller. | D — September 2025 text; February 2026 SPL. Efficacy excluded. |
| RTOG 9601 original paper | NCI grants and AstraZeneca support/drug-placebo supply; Lukka, Feng, Souhami and Sandler report commercial fees/grants; Shipley historical stock. | US/Canada collaboration. | Tier 4 industry-supported trial. | D — February 2017; methods/footer read. No outcomes adopted; individual disclosure forms unclosed. |
| ANI 2025 Form 10-K | Medicine sales, royalties/services, debt/equity; 2024 credit-facility agent JPMorgan; AstraZeneca trademark licence. | Delaware corporation; Baudette executive offices; Princeton commercial HQ. | Tier 4 commercial filing. | D — selected original sections read. Product receipts, investors and page allocation unclosed. |
| AstraZeneca 2025 annual-report exhibit | Product sales, alliance/collaboration income; AstraZeneca UK listed wholly owned. | UK parent; Cambridge. | Tier 4 commercial filing. | D — selected original financial/subsidiary sections. Beneficial investors and historical trial payments unclosed. |
| CordenPharma 2024 report | Contract development/manufacturing sales; Astorg ownership. | Group HQ Basel, Switzerland. | Tier 4 corporate report. | D — dated sustainability self-report; not current audited accounts or exact plant/lot receipts. |
| CordenPharma imprint | Commercial group; report above. | International GmbH: Plankstadt, Germany. | Tier 4 corporate identity. | D — legal issuer only; exact manufacturer-entity link/ownership unclosed. |
| Astorg: ownership profile | Partner-owned investment firm; full limited-partner/beneficial chain unclosed. | European firm; Paris office separately documented. | Tier 4 investor self-report. | D — ownership route, not independent manufacturing or treatment assessment. |
| Astorg: contact | Investment business above. | Paris office: 29b–31 Avenue Pierre 1er de Serbie, France. | Tier 4 self-report. | D — office identity, not an assertion of exclusive global headquarters. |
| eMC: publisher and funding | Datapharm; pharmaceutical subscriptions pay for publication. | Leatherhead registered office, England. | Tier 4 industry-paid publisher. | D — regulated company-origin texts, not independent outcomes. Full shareholder and product-fee chain unclosed. |
| NCCIH: complementary cancer care | Public/gift routes below; named NCI/NCCIH reviewer interests and trials unclosed. | US; Bethesda. | Tier 2 safety context, provisional. | C — October 2021; dated safety, no bicalutamide-adjunct efficacy verdict. |
| NHS: anaphylaxis | National-site policy below; page/reviewer receipts unclosed. | United Kingdom. | Tier 2 safety context, provisional. | C — June 2023; June 2026 review deadline passed. No drug-specific incidence inferred. |
| NHS: poisoning | National-site policy below; personal interests unclosed. | United Kingdom. | Tier 2 safety context, provisional. | B — June 2025; safety duties, not bicalutamide antidote guidance. |
| NICE NG234: cord-compression signs | Institutional route below; committee/trial interests unclosed. | UK; NICE Manchester/London. | Tier 2 guidance, provisional. | C — September 2023; actual indexed recognition read, direct access blocked. No algorithm adopted. |
| NCI: budget | Congressional appropriations through HHS/NIH. | United States. | Tier 3 fiscal self-report. | B — May 2026; enacted funding distinct from requests. Page/trial allocation unknown. |
| NCI: Gift Fund | Gifts and research designations permitted; no named receipt inferred. | US; Bethesda. | Tier 3 self-report. | B — August 2025; donor/reviewer/page receipts unclosed. |
| NCCIH: appropriations | Congressional appropriations; displayed table ends FY2024. | US; Bethesda. | Tier 3 fiscal self-report. | B — actual table read; no FY2026 total/page funding inferred. |
| NCCIH: gifts | Voluntary conditional/unconditional donations and bequests. | US; Bethesda. | Tier 3 self-report. | B — authority, not named donor or disease-page receipt. |
| NHS: content policy | DHSC funds website; policy rejects advertising/corporate sponsorship. | United Kingdom. | Tier 3 self-report. | B — October 2022; October 2025 deadline passed. Not provider-trust or trial financing. |
| NICE 2025/26 accounts | DHSC grant; NHS England support; appraisal/advice and research income. | United Kingdom; Manchester/London. | Tier 3 financial report. | B — selected original pages 30–31 reread. NG234 allocation, committee and trial chain unclosed. |
| NHSBSA: PCA 2025/26 | Agency finance below; administrative compilation. | England community dispensing. | Tier 2 official statistics, provisional. | B — 4 June 2026; prescription volumes, not benefit. |
| PCA original Table 7 | NHSBSA data; agency route below. | England. | Tier 2 administrative data. | B — FY2025/26 row 1028; no patients, diagnoses or global-use ranking. |
| PCA original methods | NHSBSA compilation; finance below. | England. | Tier 2 statistics context. | B — June 2026, actual sections 1.1/1.2.3 read; not clinical outcomes. |
| NHSBSA 2025/26 accounts | DHSC parliamentary funding; external service charges/public repayment work. | UK; Newcastle upon Tyne. | Tier 3 financial report. | B — saved original PDF pages 132–133/143 reread. PCA allocation and trial money unclosed. |
Frequently asked questions
Is bicalutamide chemotherapy? It is an antiandrogen, blocking androgen action. Drug class. The treatment team explains how it fits the complete cancer plan.
Can I replace a hormone injection with Casodex? Do not make that substitution yourself. Receptor blockade and reduction of testosterone production have different roles. Treatment distinction.
Does a lower PSA prove cure? No. PSA is part of disease monitoring; clinical assessment is still needed. Monitoring scope.
Can I change products? Only the prescriber can choose or switch products; this guide supplies no conversion.
Sources and funding notes
Current product-text dates are distinguished from hosting dates in the funding rows.
RTOG methods and full funding/COI were read in a legitimate primary-paper replica; publisher-direct access failed. Separate individual disclosure forms were not retrieved.
Selected financial sections were read, not every ledger or beneficial-investor chain. NICE recognition was indexed; direct access was blocked. No numerical efficacy, personal dose/conversion, start/stop calendar or fertility regimen is supplied.
- NCI: bicalutamide — Identity only.
- NCI: drug dictionary — Names and class.
- NCI: prostate hormone therapy — Mechanism and flare context.
- Casodex 50 mg UK SmPC — Licence, liver and interactions.
- Casodex 150 mg UK SmPC — Separate licence and preclinical findings.
- Casodex 50 mg UK leaflet — Urgent symptoms and tablet instructions.
- Casodex 150 mg UK leaflet — Symptoms, exclusions and manufacture.
- Casodex US label — US scope, monitoring and reproductive precautions.
- RTOG 9601 original paper — Design and financial provenance only.
- ANI 2025 Form 10-K — US distributor revenue, financing and identity.
- AstraZeneca 2025 annual-report exhibit — UK parent control and revenue.
- CordenPharma 2024 report — Manufacturing-group revenue and owner.
- CordenPharma imprint — Separate legal issuer identity.
- Astorg: ownership profile — Private-equity backer identity.
- Astorg: contact — Office location.
- eMC: publisher and funding — Hosting route.
- NCCIH: complementary cancer care — Product-disclosure safety.
- NHS: anaphylaxis — Emergency recognition.
- NHS: poisoning — Harmful-ingestion precautions.
- NICE NG234: cord-compression signs — Oncology emergency recognition.
- NCI: budget — Appropriation route.
- NCI: Gift Fund — Separate voluntary funding authority.
- NCCIH: appropriations — Historical public funding.
- NCCIH: gifts — Separate gift authority.
- NHS: content policy — National-site money/editorial route.
- NICE 2025/26 accounts — Institutional money and identity.
- NHSBSA: PCA 2025/26 — Publication setting.
- PCA original Table 7 — Exact chemical-substance row.
- PCA original methods — Coverage limitations.
- NHSBSA 2025/26 accounts — Agency funding and address.
Educational research reviewed 5 October 2026. Diagnosis and treatment require a qualified clinician; this article does not provide an individual prescription or replace urgent assessment.
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