Prescription medicine
Radium ra 223 dichloride Brand names: Xofigo
Radium ra 223 dichloride (Xofigo) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the radium ra 223 dichloride FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 203971 record on Drugs@FDA; every radium ra 223 dichloride label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Forms and strengths
Injection.
On the market
- Earliest approval on file
- May 15, 2013 Xofigo, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,023 through July 30, 2026
What is radium ra 223 dichloride used for?
From the label: indications and usageXofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Conditions named in the indications of radium ra 223 dichloride's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Radioactive alpha-Particle Emitting Therapeutic Agent.
Source: FDA drug label (Xofigo), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set a398400e-bd31-41a9-9696-4f7c06569ede), via openFDA; the full label on DailyMed
Is there a generic for radium ra 223 dichloride (Xofigo)?
No generic radium ra 223 dichloride is approved (Drugs@FDA, October 8, 2026).
- 2013 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the radium ra 223 dichloride label say about other medicines?
The radium ra 223 dichloride label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name radium ra 223 dichloride. 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 |
|---|---|---|
| Abiraterone | warnings and precautions | Increased Fractures and Mortality in Combination with Abiraterone plus Prednisone/Prednisolone: |
| Prednisolone | warnings and precautions | Increased Fractures and Mortality in Combination with Abiraterone plus Prednisone/Prednisolone: |
| Prednisone | warnings and precautions | Increased Fractures and Mortality in Combination with Abiraterone plus Prednisone/Prednisolone: |
Source: FDA drug label (Xofigo), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set a398400e-bd31-41a9-9696-4f7c06569ede), via openFDA; the full label on DailyMed
What do FAERS reports show for radium ra 223 dichloride?
The FDA Adverse Event Reporting System holds 5,023 reports that list radium ra 223 dichloride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,027 are coded as a death and 1,165 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 else is labeled for the same conditions as radium ra 223 dichloride?
1 other medicine is given the same way (intravenous) and in the same FDA class as radium ra 223 dichloride or labeled mainly for the same use (prostate cancer), the same class first. Prostate cancer lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lutetium lu 177 vipivotide tetraxetan | Prostate cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Radium ra 223 dichloride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other