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Luspatercept Side Effects

Medically reviewed by Last updated on Dec 2, 2020.

For the Consumer

Applies to luspatercept: subcutaneous solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
  • High uric acid levels have happened with this drug. Call your doctor right away if you have joint pain, swelling, or stiffness.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at

For Healthcare Professionals

Applies to luspatercept: subcutaneous powder for injection


Very common (10% or more): Total bilirubin 2 or more times the upper limit of normal (ULN) (64%), alanine aminotransferase 3 or more times ULN (12%), aspartate aminotransferase 3 or more times ULN (11%)

Common (1% to 10%): Alkaline phosphatase 2 or more times ULN, direct bilirubin 2 or more times ULN[Ref]


Common (1% to 10%): Hypertension, deep vein thrombosis[Ref]

Nervous system

Very common (10% or more): Headache (26%), dizziness (11%)

Common (1% to 10%): Cerebrovascular accident[Ref]


Very common (10% or more): Bone pain (20%), arthralgia (19%)[Ref]


Very common (10% or more): Abdominal pain (14%), diarrhea (12%)

Common (1% to 10%): Nausea[Ref]


Common (1% to 10%): Hyperuricemia[Ref]


Very common (10% or more): Cough (14%)[Ref]


Common (1% to 10%): Influenza, viral upper respiratory infection[Ref]


Very common (10% or more): Fatigue (14%)

Frequency not reported: Death (due to unconfirmed acute myelogenous leukemia)[Ref]


1. "Product Information. Reblozyl (luspatercept)." Celgene Corporation, Summit, 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.