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Note: This document contains side effect information about darbepoetin alfa. Some of the dosage forms listed on this page may not apply to the brand name Aranesp.
Common side effects of Aranesp include: hypertension and peripheral edema. Other side effects include: congestive heart failure and hypervolemia. See below for a comprehensive list of adverse effects.
Applies to darbepoetin alfa: injection solution
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.
Along with its needed effects, darbepoetin alfa (the active ingredient contained in Aranesp) 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:
Incidence not known
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:
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.
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
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
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
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
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
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
Very common (10% or more): Urinary tract infection (15%)
Very common (10% or more): Chronic renal failure (15%)
Very common (10% or more): Hypoglycemia (14%)
Very common (10% or more): Insomnia (11%)
Common (1% to 10%): Depression, anxiety
Common (1% to 10%): Pruritus, cellulitis, rash, skin ulcer, alopecia
Frequency not reported: Angioedema, urticaria
Postmarketing reports: Severe cutaneous reaction
Common (1% to 10%): Injection site pain, access hemorrhage, access infection, vascular access thrombosis, vascular access complications
Common (1% to 10%): Granulocytopenia
Frequency not reported: Anemia, pure red cell aplasia associated with neutralizing antibodies to erythropoietin
Common (1% to 10%): Metastatic neoplasm
Frequency not reported: Serious allergic reaction, hypersensitivity reaction, anaphylactic reaction