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Darbepoetin alfa Side Effects

In Summary

Commonly reported side effects of darbepoetin alfa include: hypertension and peripheral edema. Other side effects include: congestive heart failure and hypervolemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to darbepoetin alfa: injection solution

In addition to its needed effects, some unwanted effects may be caused by darbepoetin alfa. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking darbepoetin alfa:

More common:
  • Abdominal or stomach pain
  • accumulation of pus
  • arm, back, or jaw pain
  • blurred vision
  • breathing problems (irregular, noisy, or trouble when resting)
  • chest pain, discomfort, tightness, or heaviness
  • chills
  • confusion
  • cough producing mucus
  • decrease in the amount of urine
  • diarrhea
  • dilated neck veins
  • dizziness, fainting, or lightheadedness
  • dry mouth
  • fast, slow, or irregular heartbeat
  • fatigue or tiredness (extreme or unusual)
  • fever
  • headache
  • nausea
  • pain, tenderness, swelling, or warmth over injection site
  • pounding in the ears
  • rapid breathing
  • rapid or pounding pulse
  • shortness of breath
  • skin discoloration at the injection site
  • sunken eyes
  • sweating
  • swelling of the ankles, face, fingers, feet, hands, or lower legs
  • thirst
  • trouble with breathing
  • unconsciousness
  • vomiting
  • weight gain
  • wheezing
  • wrinkled skin
Less common:
  • Anxiety
  • convulsions
  • difficulty with speaking (slow speech or unable to speak)
  • double vision
  • trouble with thinking
  • trouble with walking
  • unable to move the arms, legs, or face muscles (including numbness and tingling)
  • Fever and sore throat
  • hives
  • itching
  • pale skin
  • skin rash
  • unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with darbepoetin alfa may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Constipation
  • general feeling of discomfort or illness
  • lack or loss of strength
  • loss of appetite
  • muscle aches, pains, or stiffness
  • pain in the joints
  • runny nose
  • shivering
  • sneezing
  • trouble with sleeping

For Healthcare Professionals

Applies to darbepoetin alfa: injectable solution


The most common adverse reactions in patients with chronic kidney disease (CKD) were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. The most common adverse reactions in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.[Ref]


Very common (10% or more): Nausea (up to 38%), vomiting (up to 27%), diarrhea (up to 20%), constipation (up to 19%), abdominal pain (up to 16%)
Common (1% to 10%): Dyspepsia[Ref]


Very common (10% or more): Fatigue (up to 32%), fever (up to 19%), peripheral edema (up to 17%), asthenia (up to 16%), edema (up to 12.8%), procedural hypotension (10%), chest pain (up to 10%)
Common (1% to 10%): Death, influenza-like symptoms, fluid overload, fall, contusion, pain, arteriovenous graft thrombosis[Ref]


Very common (10% or more): Hypertension (up to 31%), hypotension (up to 22%)
Common (1% to 10%): Myocardial infarction, thrombotic events, angina pectoris
Frequency not reported: Arrhythmia, thromboembolism, thrombosis, thrombophlebitis[Ref]


Very common (10% or more): Myalgia (up to 20%), back pain (14%), arthralgia (up to 13%), limb pain (up to 11%)
Common (1% to 10%): Skeletal pain[Ref]


Very common (10% or more): Dyspnea (up to 20%), upper respiratory infection (up to 14%), cough (up to 12%), nasopharyngitis (11%)
Common (1% to 10%): Bronchitis, sinusitis, sore throat, pulmonary embolism
Frequency not reported: Epistaxis, allergic bronchospasm[Ref]

Nervous system

Very common (10% or more): Headache (up to 16%), dizziness (up to 14%)
Common (1% to 10%): Cerebrovascular accident/transient ischemic attack, convulsions, paresthesia, hypoesthesia, cerebrovascular disorders, stroke
Frequency not reported: Somnolence[Ref]


Very common (10% or more): Urinary tract infection (15%)[Ref]


Very common (10% or more): Chronic renal failure (15%)[Ref]


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


Very common (10% or more): Insomnia (11%)
Common (1% to 10%): Depression, anxiety[Ref]


Common (1% to 10%): Pruritus, cellulitis, rash, skin ulcer, alopecia
Frequency not reported: Angioedema, urticaria[Ref]


Common (1% to 10%): Injection site pain, access hemorrhage, access infection, vascular access thrombosis, vascular access complications[Ref]


Common (1% to 10%): Granulocytopenia
Frequency not reported: Anemia, pure red cell aplasia associated with neutralizing antibodies to erythropoietin[Ref]


Common (1% to 10%): Metastatic neoplasm[Ref]


Frequency not reported: Serious allergic reaction, hypersensitivity reaction, anaphylactic reaction[Ref]


1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Aranesp (darbepoetin alfa)." Amgen, Thousand Oaks, CA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for darbepoetin alfa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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