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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

Along with its needed effects, darbepoetin alfa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking darbepoetin alfa:

More common
  • 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 the injection site
  • pounding in the ears
  • rapid breathing
  • rapid or pounding pulse
  • skin discoloration at the injection site
  • stomach pain
  • sunken eyes
  • sweating
  • swelling of the ankles, face, fingers, feet, hands, or lower legs
  • thirst
  • trouble with breathing
  • unconsciousness
  • vomiting
  • weight gain
  • wrinkled skin
Less common
  • Anxiety
  • difficulty with speaking (slow speech or unable to speak)
  • double vision
  • seizures
  • trouble with thinking
  • trouble with walking
  • unable to move the arms, legs, or face muscles (including numbness and tingling)
Rare Incidence not known
  • Blistering, peeling, or loosening of the skin
  • cough
  • joint or muscle pain
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots in mouth or on the lips

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

More common
  • Constipation
  • general feeling of discomfort or illness
  • lack or loss of strength
  • loss of appetite
  • muscle aches, pains, or stiffness
  • 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
Postmarketing reports: Severe cutaneous reaction[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

Some side effects of darbepoetin alfa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.