Darbepoetin Alfa Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 30, 2024.

Applies to darbepoetin alfa: injection solution.

Important warnings This medicine can cause some serious health issues

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 side effects

• 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 side effects

• 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 side effects

• fever
• hives, itching, skin rash
• pale skin
• sore throat

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

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 side effects

• 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.

General adverse events

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

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Further information

Darbepoetin alfa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer