Darolutamide Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 8, 2024.

Applies to darolutamide: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Women and children should not use this medicine. Darolutamide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. You must use an effective method of birth control during treatment with this medicine and for 1 week after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

This medicine may cause ischemic heart disease. Check with your doctor right away if you have chest pain or discomfort, irregular heartbeat, nausea or vomiting, pain in the shoulders, arms, jaw, or neck, sweating, or trouble breathing.

Seizures can occur while you are using this medicine. Tell your doctor right away if you have loss of consciousness.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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