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Darbepoetin alfa Side Effects

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.

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.

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

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


Cardiovascular side effects have included hypertension (up to 23%), hypotension (up to 22%), cardiac arrhythmias/cardiac arrest (up to 10%), angina pectoris/cardiac chest pain (8%), congestive heart failure (up to 6%), thrombosis vascular access (6%), acute myocardial infarction (2%), and transient ischemic attack (1%).[Ref]


Hematologic side effects including an increased incidence of thrombotic events have been observed in patients treated with erythropoietic agents. In patients with cancer who received darbepoetin alfa, pulmonary emboli, thrombophlebitis, and thrombosis occurred more frequently than in placebo controls.[Ref]


Gastrointestinal side effects have included diarrhea (up to 22%), constipation (up to 18%), vomiting (up to 15%), nausea (up to 14%), abdominal pain (up to 12%), and constipation (5%).[Ref]


Musculoskeletal side effects have included myalgia (up to 21%), muscle spasm (17%), arthralgia (up to 13%), limb pain (up to 10%), and back pain (up to 8%).[Ref]

Nervous system

Nervous system side effects have included headache (up to 16%), dizziness (up to 8%), stroke (up to 2%), and seizure (1%).[Ref]


General side effects reported have included fatigue (33%), edema (up to 21%), fever (up to 19%), peripheral edema (up to 11%), access hemorrhage (7%), death (up to 7%), fluid overload (6%), access infection (6%), influenza-like symptoms (6%), asthenia (5%), and dehydration (5%).

In general, some of the adverse effects reported are typically associated with chronic renal failure, or recognized complications of dialysis, and may not necessarily be the result of darbepoetin alfa therapy.[Ref]


Dermatologic side effects have included pruritus (up to 8%) and rash (7%).[Ref]


Respiratory side effects have included upper respiratory infection (up to 27%), dyspnea (up to 12%), cough (up to 10%), and bronchitis (up to 6%).[Ref]


Local adverse effects have included pain at injection site (up to 7%).[Ref]


Immunologic side effects including neutralizing antibodies to erythropoietin, in association with pure red cell aplasia (PRCA) or severe anemia (with or without cytopenias) have been reported. Infection (24%) has been reported.[Ref]


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

2. Macdougall IC "Darbepoetin alfa: A new therapeutic agent for renal anemia." Kidney Int 61 Suppl 80 (2002): 55-61

3. Nissenson AR, Swan SK, Lindberg JS, et al. "Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients." Am J Kidney Dis 40 (2002): 110-8

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