Last updated on RxList: 3/15/2019
Aranesp Side Effects Center

Last reviewed on RxList 3/15/2019

Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating agent, or ESA, used to treat anemia (a lack of red blood cells in the body) in people with long-term serious kidney disease (chronic renal failure) and people receiving chemotherapy for some types of cancer. Common side effects of Aranesp include:

  • headache,
  • body aches,
  • stomach pain,
  • cough,
  • skin rash or redness,
  • diarrhea, and
  • injection site reactions (pain, bruising, swelling, warmth, redness, oozing, or bleeding).

Aranesp may rarely cause very serious side effects, including blood clots, which can be fatal. Aranesp may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. Rarely, Aranesp may suddenly stop working well after a period of time because your body may make antibodies that make it work less well, and serious anemia can result. Tell your doctor if symptoms of anemia return (such as increased tiredness, low energy, pale skin color, or shortness of breath).

The dosage is based on your medical condition, weight, and response to treatment. Aransep is given as an injection under the skin or into a vein, usually once a week or as directed by your doctor. There may be other drugs that can interact with Aransep. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. During pregnancy, Aransep should be used only when prescribed. In some women of child-bearing age, menstrual periods have resumed during treatment with a similar drug (epoetin alfa). If this occurs with Aransep treatment, it may be possible to get pregnant while using this medication. Discuss the need for birth control with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Aranesp Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Aranesp Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, wheezing, difficult breathing, severe dizziness or fainting, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Darbepoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use darbepoetin alfa. Seek emergency medical help if you have:

  • heart attack symptoms--chest pain or pressure, shortness of breath, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), confusion, sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg; or
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • unusual weakness or tiredness;
  • a seizure (convulsions); or
  • shortness of breath (even with mild exertion), swelling, rapid weight gain.

Common side effects may include:

  • low blood pressure during dialysis;
  • cough, trouble breathing;
  • stomach pain; or
  • swelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aranesp (Darbepoetin Alfa)


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Aranesp Professional Information


The following clinically significant adverse reactions are discussed in greater detail in other sections of the label:

  • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see WARNINGS AND PRECAUTIONS]
  • Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Pure Red Cell Aplasia [see WARNINGS AND PRECAUTIONS]
  • Serious allergic reactions [see WARNINGS AND PRECAUTIONS]
  • Severe Cutaneous Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.

Patients With Chronic Kidney Disease

Adult Patients

Adverse reactions were determined based on pooled data from 5 randomized, active-controlled studies of Aranesp with a total of 1357 patients (Aranesp 766, epoetin alfa 591). The median duration of exposure for patients receiving Aranesp was 340 days, with 580 patients exposed for greater than 6 months and 360 patients exposed for greater than 1 year. The median (25th, 75th percentiles) weight-adjusted dose of Aranesp was 0.50 mcg/kg (0.32, 0.81). The median (range) age for patients administered Aranesp was 62 years (18 to 88). In the Aranesp group, 55% were male, 72% were white, 83% were receiving dialysis, and 17% were not receiving dialysis.

Table 5 lists adverse reactions occurring in ≥ 5% of patients treated with Aranesp.

Table 5. Adverse Reactions Occurring in ≥ 5% of Patients with CKD

Adverse Reaction Patients Treated with Aranesp (n = 766)
Hypertension 31%
Dyspnea 17%
Peripheral edema 17%
Cough 12%
Procedural hypotension 10%
Angina pectoris 8%
Vascular access complications 8%
Fluid overload 7%
Rash/Erythema 5%
Arteriovenous graft thrombosis 5%

Rates of adverse reactions with Aranesp therapy were similar to those observed with other recombinant erythropoietins in these studies.

Pediatric Patients

Adverse reactions were determined based on pooled data from 2 randomized, controlled trials [see Clinical Studies]. In one study, Aranesp was administered to 81 pediatric patients with CKD who had stable hemoglobin concentrations while previously receiving epoetin alfa. In a second study, Aranesp was administered to 114 anemic pediatric patients with CKD receiving or not receiving dialysis for initial treatment of anemia. In these studies, the most frequently reported serious adverse reactions with Aranesp were hypertension and convulsions. The most commonly reported adverse reactions were hypertension, injection site pain, rash, and convulsions. Aranesp administration was discontinued because of injection site pain in 2 patients and hypertension in 3 patients.

Patients With Cancer Receiving Chemotherapy

Adverse reactions were based on data from a randomized, double-blind, placebo-controlled study of Aranesp in 597 patients (Aranesp 301, placebo 296) with extensive stage small cell lung cancer (SCLC) receiving platinum-based chemotherapy. All patients were white, 64% were male, and the median age was 61 years (range: 28 to 82 years); 25% of the study population were from North America, Western Europe, and Australia. Patients received Aranesp at a dose of 300 mcg or placebo weekly for 4 weeks then every 3 weeks for a total of 24 weeks, and the median duration of exposure was 19 weeks (range: 1 to 26 weeks).

Adverse reactions were also based on data from 7 randomized, double-blind, placebo-controlled studies, including the SCLC study described above, that enrolled 2112 patients (Aranesp 1203, placebo 909) with non-myeloid malignancies. Most patients were white (95%), male (52%), and the median age was 63 years (range: 18 to 91 years); 73% of the study population were from North America, Western Europe, and Australia. Dosing and schedules varied by study from once weekly to once every 4 weeks, and the median duration of exposure was 12 weeks (range: 1 to 27 weeks).

Table 6. Thrombovascular Adverse Reactions in Patients Receiving Chemotherapy

Adverse Reaction SCLC Study All Placebo-controlled
(n = 301)
(n = 296)
(n = 2888)
(n = 1742)
Thromboembolic Adverse Reactions, n (%) 25 (8.3%) 13 (4.4%) 147 (5.1%) 64 (3.7%)
  Arterial 9 (3%) 3 (1 %) 33 (1.1%) 11 (0.6%)
    Myocardial infarction 5 (1.7%) 0 18 (0.6%) 5 (0.3%)
  Venous 16 (5.3%) 10 (3.4%) 118 (4.1%) 55 (3.2%)
    Pulmonary embolism 5 (1.7%) 3 (1%) 43 (1.5%) 14 (0.8%)
  Cerebrovascular disorders* 14 (4.7%) 9 (3%) 38 (1.3%) 23 (1.3%)
* “Cerebrovascular disorders” encompasses CNS hemorrhages and cerebrovascular accidents (ischemic and hemorrhagic). Events in this category may also be included under “thromboembolic adverse reactions.”

In addition to the thrombovascular adverse reactions, abdominal pain and edema occurred at a higher incidence in patients taking Aranesp compared to patients on placebo. Among all placebo-controlled studies, abdominal pain (13.2% vs. 9.4%) and edema (12.8% vs. 9.7%) were reported more frequently in patients receiving Aranesp compared to the placebo group. In the SCLC study the incidence of abdominal pain (10.3% vs. 3.4%) and edema (5.6% vs. 5.1%) in the Aranesp-treated patients compared to those receiving placebo.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of Aranesp.

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.


As with all therapeutic proteins, there is a potential for immunogenicity.

In clinical studies, the percentage of patients with antibodies to Aranesp was examined using the Biacore® assay. Sera from 1501 patients with CKD and 1159 patients with cancer were tested. At baseline, prior to Aranesp treatment, binding antibodies were detected in 59 patients (4%) with CKD and 36 patients with cancer (3%). During Aranesp therapy (range: 22 to 177 weeks), a follow-up sample was taken. One additional patient with CKD and 8 additional patients with cancer developed antibodies capable of binding Aranesp. In two studies of pediatric patients with CKD aged 2-16, 20 of 111 patients with CKD (18%) receiving dialysis and 6 of 69 patients (9%) not receiving dialysis had anti-ESA antibodies at baseline. During therapy, 4 additional patients receiving dialysis and 4 additional patients not receiving dialysis developed antibodies capable of binding Aranesp.

None of the patients had antibodies capable of neutralizing the activity of Aranesp or endogenous erythropoietin at baseline or at end of study. No clinical sequelae consistent with PRCA were associated with the presence of these antibodies.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Aranesp with the incidence of antibodies to other products may be misleading.

Neutralizing antibodies to darbepoetin alfa that cross-react with endogenous erythropoietin and other ESAs can result in PRCA or severe anemia (with or without other cytopenias) [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Aranesp (Darbepoetin Alfa)

© Aranesp Patient Information is supplied by Cerner Multum, Inc. and Aranesp Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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