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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
  • 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
  • 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)
Rare
  • Fever and sore throat
  • hives
  • itching
  • pale skin
  • skin rash
  • unusual tiredness or weakness

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
  • pain in the joints
  • runny nose
  • shivering
  • sneezing
  • trouble with sleeping

For Healthcare Professionals

Applies to darbepoetin alfa: injectable solution

General

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]

Gastrointestinal

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]

Other

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]

Cardiovascular

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]

Musculoskeletal

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]

Respiratory

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]

Genitourinary

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

Renal

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

Metabolic

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

Psychiatric

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

Dermatologic

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

Local

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

Hematologic

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

Oncologic

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

Immunologic

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

References

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.

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