Prescription medicine
Bicalutamide Brand names: Casodex
Bicalutamide (Casodex) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.404 per bicalutamide 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the bicalutamide FDA label on DailyMed (effective April 23, 2026, Golden State Medical Supply, Inc.); the NDA 20498 record on Drugs@FDA; every bicalutamide label on DailyMed.
Highlights of the record
FDA label of April 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is 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.
Forms and strengths
- 50 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- October 4, 1995 Casodex, Ani Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first July 6, 2009; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 6 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.404 per tablet Bicalutamide 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 15,152 through July 30, 2026
What is bicalutamide used for?
From the label: indications and usageINDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is 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. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. Bicalutamide tablets 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 tablets 150 mg daily is not approved for use alone or with other treatments.
FDA pharmacologic class: Androgen Receptor Inhibitor.
Source: FDA drug label (Bicalutamide), NDA020498 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective April 23, 2026 (SPL set 26e30155-a50b-df14-e063-6394a90a9be4), via openFDA; the full label on DailyMed
What does the patient leaflet for bicalutamide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid during treatment with bicalutamide tablets?Do not drive, operate machinery, or do other dangerous activities until you know how bicalutamide tablets affects you. Bicalutamide tablets can make you sleepy. Avoid sunlight, sunlamps, and tanning beds, and consider using sunscreen during treatment with bicalutamide tablets. Some people have had skin sensitivity to sunlight during treatment with bicalutamide tablets.
From the patient leaflet: How should I store bicalutamide tablets?Store bicalutamide tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep bicalutamide tablets and all medicines out of the reach of children.
Source: FDA drug label (Bicalutamide), NDA020498 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective April 23, 2026 (SPL set 26e30155-a50b-df14-e063-6394a90a9be4), via openFDA; the full label on DailyMed
Is there a generic for bicalutamide (Casodex)?
The FDA approved the first generic bicalutamide on July 6, 2009. 13 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists bicalutamide from 6 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1995 earliest approval on file
- 2009 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bicalutamide (Casodex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.404 per Bicalutamide 50 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Bicalutamide 50 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bicalutamide 50 mg tablet | Generic | $0.404 per tablet | $12.13 | +0.7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the bicalutamide label say about other medicines?
The bicalutamide label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name bicalutamide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Goserelin | drug interactions | DRUG INTERACTIONS Clinical studies have not shown any drug interactions between bicalutamide and LHRH analogs (goserelin or leuprolide). |
| Leuprolide | drug interactions | DRUG INTERACTIONS Clinical studies have not shown any drug interactions between bicalutamide and LHRH analogs (goserelin or leuprolide). |
| Midazolam | drug interactions | Clinical studies have shown that with co-administration of bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5-fold (for C max ) and 1.9-fold (for AUC). |
Source: FDA drug label (Bicalutamide), NDA020498 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective April 23, 2026 (SPL set 26e30155-a50b-df14-e063-6394a90a9be4), via openFDA; the full label on DailyMed
What do FAERS reports show for bicalutamide?
The FDA Adverse Event Reporting System holds 15,152 reports that list bicalutamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,714 are coded as a death and 5,458 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other androgen receptor inhibitors
- the pharmacologic class, with prices and generics
- Bicalutamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other