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ADDITIONAL TOLERABILITY DATA

Most men stayed on NUBEQA without stopping treatment because of side effects, in clinical studies

Your doctor may change your dose, temporarily stop, or completely stop your treatment with NUBEQA if you have certain side effects.

94% of men did not stop treatment

6% of 445 men permanently stopped treatment with NUBEQA, 14% of them paused treatment, and 3.6% of them took a lower dose of NUBEQA.

  • The most common side effects that resulted in permanently stopping NUBEQA each occurred in 0.4% of men and were an increase in liver function tests, brain injury, heart attack, and rash
  • The most common side effects that resulted in pausing treatment with NUBEQA each occurred in less than 2% of men and were an increase in liver function tests and rash
  • The most common side effects that resulted in men taking a lower dose of NUBEQA each occurred in less than 1% of men and were an increase in liver function tests, rash, and high blood pressure
86% of men did not stop treatment

14% of 652 men permanently stopped treatment with NUBEQA, 23% of them paused treatment, and 9% of them took a lower dose of NUBEQA.

  • The most common side effects that resulted in permanently stopping NUBEQA each occurred in ~1% of men and were rash, muscle/bone/joint pain, and an increase in liver function tests
  • The most common side effects that resulted in pausing treatment with NUBEQA each occurred in approximately 2%–3% of men and were an increase in liver function tests and fever with low levels of white blood cells
  • The most common side effects that resulted in men taking a lower dose of NUBEQA each occurred in less than 3% of men and were an increase in liver function tests
91% of men did not stop treatment

9% of 954 men permanently stopped treatment with NUBEQA, 13% of them paused treatment, and 6% of them took a lower dose of NUBEQA.

  • The most common side effects that resulted in permanently stopping NUBEQA each occurred in 0.4% of men and were heart failure and death
  • The most common side effects that resulted in pausing treatment with NUBEQA each occurred in less than 1% of men and were high blood pressure, diarrhea, and pneumonia
  • The most common side effects that resulted in men taking a lower dose of NUBEQA each occurred in less than 1% of men and were fatigue, high blood pressure, and nausea

Talk to your doctor

Remember that your doctor is there to help manage your treatment, including any side effects that may occur.

Doctor Discussion Guide
Side effects
Taking NUBEQA

Important Safety Information

Important Safety Information

Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you:

  • have heart problems, high blood pressure, diabetes, or high amounts of fat or cholesterol in your blood (dyslipidemia)
  • have a history of seizures, brain injury, stroke, or brain tumors
  • have kidney or liver problems
  • are pregnant or plan to become pregnant. NUBEQA can cause harm to your unborn baby and loss of pregnancy (miscarriage)
  • have a partner who may become pregnant. Males who have female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of NUBEQA. Talk with your healthcare provider about birth control methods
  • are breastfeeding or plan to breastfeed. It is not known if NUBEQA passes into breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUBEQA may affect the way other medicines work and other medicines may affect how NUBEQA works.

You should not start or stop any medicine before you talk with the healthcare provider that prescribed NUBEQA.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

NUBEQA may cause serious side effects, including:

  • Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA.
  • Seizure. Treatment with NUBEQA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure during treatment with NUBEQA.

The most common side effects of NUBEQA include:

  • increase in liver function tests
  • decreased white blood cells (neutropenia)
  • feeling more tired than usual

The most common side effects of NUBEQA in combination with docetaxel include:

  • constipation
  • rash
  • decreased appetite
  • bleeding
  • weight gain
  • high blood pressure
  • decreased red blood cells (anemia)
  • high blood sugar levels
  • decreased white blood cells
  • increase in liver function tests
  • low blood calcium levels

NUBEQA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of NUBEQA.

Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see the full Prescribing Information.

<span>WHAT IS NUBEQA<sup>®</sup>?</span>

WHAT IS NUBEQA®?

NUBEQA® (darolutamide) is a prescription medicine used to treat adults with prostate cancer:

  • that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone
  • that has spread to other parts of the body and responds to a medical or surgical treatment that lowers testosterone
  • that has spread to other parts of the body and responds to a medical or surgical treatment that lowers testosterone in combination with docetaxel.

It is not known if NUBEQA is safe and effective in females or children.

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Date of last update: 9/17/2026