ONUREG® Safety

What are the possible side effects of ONUREG®?

ONUREG® can cause serious side effects, including:

New or worsening low white blood cell counts (also known as neutropenia)

New or worsening low white blood cell counts are common but can also be severe during treatment with ONUREG®. If your white blood cell counts become very low, you are at increased risk for infections. Your healthcare provider will check your white blood cell counts before and during treatment with ONUREG®. Your healthcare provider may prescribe a medicine to help increase your white blood cell count if needed.

Tell your healthcare provider right away if you get any of the following symptoms:

  • Fever or chills
  • Body aches
  • Feeling very tired or weak
  • Unusual headaches

New or worsening low platelet counts (also known as thrombocytopenia)

Low platelet counts are common but can also be severe during treatment with ONUREG®. Your healthcare provider will check your platelet counts before and during treatment with ONUREG®. Tell your healthcare provider right away if you have any unusual bruising or bleeding. Your healthcare provider may change your dose or tell you to stop taking ONUREG® if you have low blood cell counts.

Fertility problems

ONUREG® may cause fertility problems in males and females, which may affect your ability to have children. Talk with your healthcare provider if you have concerns about fertility.

The most common side effects of ONUREG® include:
  • Nausea and vomiting
  • Diarrhea
    • You may need to be treated with anti-diarrheal medicines
  • Tiredness or weakness
  • Constipation
  • Stomach area (abdominal) pain
  • Pneumonia
  • Joint pain
  • Decreased appetite
  • Pain in arms or legs
  • Dizziness
Side effects during cycles 1-2 of ONUREG®

In the clinical trial for ONUREG®, nausea, vomiting, and diarrhea were most common during the first 2 cycles of treatment. These side effects may improve over time and experiences may vary.

Talk to your healthcare provider about what to expect with ONUREG®. They will prescribe medication to help prevent nausea and vomiting during treatment, and may stop it after 2 cycles if you do not have these side effects. You may also be prescribed medication to help with diarrhea, if necessary.

These are not all of the possible side effects of ONUREG®. Call your healthcare provider for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

Taking ONUREG®