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Darbepoetin alfa Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 6, 2023.

Applies to darbepoetin alfa: injection solution.

Warning

Injection route (Solution)

Erythropoiesis-stimulating agents (ESAs) increase the risk for death, myocardial infarction, stroke, and other serious cardiovascular events. Patients with chronic kidney disease (CKD) were at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of greater than 11 g/dL in clinical studies. No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks. In CKD patients, use the lowest sufficient dose to reduce the need for RBC transfusions. In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and increased the risk of tumor progression or recurrence in clinical studies. In cancer patients, use the lowest dose needed to avoid RBC transfusions to reduce these risks and the risk of serious cardiovascular and thromboembolic reactions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Patients receiving myelosuppressive therapy when the anticipated outcome is cure should not be treated with ESAs.

Serious side effects of Darbepoetin alfa

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

Less common

Rare

Incidence not known

Other side effects of Darbepoetin alfa

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

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

Postmarketing reports: Severe cutaneous reaction[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]

Frequently asked questions

References

1. Product Information. Aranesp (darbepoetin alfa). Amgen. 2001.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

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.

Medical Disclaimer