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Darolutamide Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 2, 2021.

For the Consumer

Applies to darolutamide: oral tablet

Side effects requiring immediate medical attention

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:

Less common

  • Blood in the urine
  • painful or difficult urination

Rare

Side effects not requiring immediate medical attention

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

  • Pain in the arms or legs
  • unusual tiredness or weakness

Less common

  • Chest pain
  • cough
  • fever or chills
  • rash
  • sneezing
  • sore throat
  • troubled breathing
  • tightness in the chest

Rare

For Healthcare Professionals

Applies to darolutamide: oral tablet

Hematologic

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]

References

1. "Product Information. Nubeqa (darolutamide)." Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.