Darolutamide Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 30, 2024.

Applies to darolutamide: oral tablet.

Serious side effects of darolutamide

Along with its needed effects, darolutamide 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 immediately if any of the following side effects occur while taking darolutamide:

More common side effects

• black, tarry stools
• bleeding gums
• blood in the urine
• bloody nose
• blurred vision
• coughing or spitting up blood
• difficulty in breathing or swallowing
• dizziness
• frequent urination
• headache
• increased menstrual flow or vaginal bleeding
• lower abdominal or stomach cramping
• nausea and vomiting
• nervousness
• nosebleeds
• painful urination
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or dark brown urine
• red or black, tarry stools
• slow, fast, or irregular heartbeat
• vomiting of blood or material that looks like coffee grounds
• unusual bleeding or bruising

Less common side effects

• blood in the urine
• chest pain or discomfort
• pain in the shoulders, arms, jaw, or neck
• painful or difficult urination
• seizures
• sweating
• trouble breathing

Other side effects of darolutamide

Some side effects of darolutamide 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 side effects

• constipation
• decreased appetite
• increased weight
• pain in the arms or legs
• rash
• unusual tiredness or weakness

Less common side effects

• chest pain or tightness
• cough
• fever or chills
• muscle or bone pain
• sneezing
• sore throat

Rare side effects

• diarrhea

For healthcare professionals

Applies to darolutamide: oral tablet.

Hematologic adverse events

• Very common (10% or more): Neutrophil count decreased (20%), bilirubin increased (16%)^[Ref]

Musculoskeletal

• Very common (10% or more): Pain in extremity^[Ref]

Genitourinary

• Common (1% to 10%): Urinary retention, hematuria^[Ref]

Hepatic

• Very common (10% or more): AST increased (23%)^[Ref]

Respiratory

• Common (1% to 10%): Pneumonia
• Uncommon (0.1% to 1%): Pulmonary embolism^[Ref]

Other

• Very common (10% or more): Fatigue (16%)
• Uncommon (0.1% to 1%): General physical health deterioration, death^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Cardiac failure, cardiac arrest, hypertension^[Ref]

Dermatologic

• Common (1% to 10%): Rash^[Ref]

Gastrointestinal

• Uncommon (0.1% to 1%): Diarrhea, nausea^[Ref]

Further information

Darolutamide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer