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Drug Information:
The U.S. Food and Drug Administration (FDA) has approved Xofigo (radium 223 dichloride) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal Phase III ALSYMPCA trial. Learn more

Xofigo Side Effects

Xofigo Side Effects

Note: This document contains side effect information about radium 223 dichloride. Some of the dosage forms listed on this page may not apply to the brand name Xofigo.

For the Consumer

Applies to radium 223 dichloride: intravenous solution

Along with its needed effects, radium 223 dichloride (the active ingredient contained in Xofigo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking radium 223 dichloride:

More common

  • Black, tarry stools
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • chest pain
  • chills
  • cough
  • fever
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid weight gain
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tingling of the hands or feet
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less common

  • Confusion
  • decreased frequency or amount of urine
  • dizziness
  • dry mouth
  • fainting
  • high fever
  • hoarseness
  • increase in heart rate
  • increased blood pressure
  • increased thirst
  • lightheadedness
  • loss of appetite
  • nausea
  • rapid breathing
  • sunken eyes
  • thirst
  • vomiting
  • weight gain
  • wrinkled skin

Some side effects of radium 223 dichloride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Diarrhea

Less common

  • Redness, pain, and swelling at the injection site

For Healthcare Professionals

Applies to radium 223 dichloride: intravenous solution


The most common side effects (incidence of 10% or greater) were nausea, diarrhea, vomiting, and peripheral edema.

The most common hematologic laboratory abnormalities (incidence of 10% or greater) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.


Very common (10% or more): Anemia (93%), lymphocytopenia (72%), leukopenia (35%), thrombocytopenia (31%), neutropenia (18%)

Common (1% to 10%): Pancytopenia (2%)


Very common (10% or more): Nausea (36%), diarrhea (25%), vomiting (19%)


Common (1% to 10%): Erythema, pain, and edema at the injection site


Very common (10% or more): Peripheral edema (13%)

Common (1% to 10%): Dehydration (3%)


Common (1% to 10%): Renal failure and impairment (3%)

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Xofigo