Darbepoetin alfa Side Effects

Brand Names: Aranesp

Please note - some side effects for 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.

Side Effects of Darbepoetin alfa - for the Consumer

Darbepoetin Alfa (Albumin)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Darbepoetin Alfa (Albumin):

Constipation; cough; diarrhea; dizziness; headache; muscle, joint, back, or stomach pain; nausea or vomiting; pain, swelling, irritation, redness, or bruising at the injection site; unusual tiredness or weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; chest pain; confusion; fainting; fast or irregular heartbeat; flu-like symptoms (chills, fever, sore throat); one-sided weakness; redness, tenderness, or swelling of the calf; seizures; severe diarrhea, dizziness, headache, stomach pain, or vomiting; severe or persistent tiredness or weakness; slurred speech; sudden pain or numbness of an arm or leg; sudden shortness of breath; swelling of the arms or legs.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Darbepoetin Alfa (Polysorbate 80)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Darbepoetin Alfa (Polysorbate 80):

Cough; mild pain at the injection site; mild stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest, jaw, or left arm pain; confusion; coughing up blood; fainting; fast or irregular heartbeat; new or worsening pale skin color, or tiredness or weakness; numbness of an arm or leg; one-sided weakness; redness, pain, tenderness, or swelling of the calf or leg; seizures; severe or persistent pain or irritation at the injection site; severe or persistent stomach pain; shortness of breath; sudden, severe headache, dizziness, or vomiting; sudden trouble walking or loss of balance or coordination; swelling of the arms or legs; vision or speech problems; weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

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%).

Hematologic

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.

Gastrointestinal

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%).

Musculoskeletal

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%).

Nervous system

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

General

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.

Dermatologic

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

Respiratory

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

Local

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

Immunologic

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.

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