Aranespdarbepoetin alfa
According to the FDA label: Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis ( 1.1 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.2 ). Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being ( 1.3 ).
53,034 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Aranesp in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Death 15,926 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Hospitalisation 6,117 reports
A report that the person was admitted to a hospital. This records that a hospital stay occurred, which is one way the seriousness of an event is tracked. Also spelled hospitalization in American English.
Full definition in the glossary →Off Label Use 2,527 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Anaemia 2,124 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Haemoglobin Decreased 1,636 reports
A blood test result showing a low level of haemoglobin, the protein in red blood cells that carries oxygen. This is closely related to anaemia. Also spelled hemoglobin in American English.
Full definition in the glossary →Product Storage Error 1,623 reports
A report that a medication was stored incorrectly, for example at the wrong temperature. This is a handling category, not a sign of a problem with the drug.
Full definition in the glossary →Pneumonia 1,464 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Fatigue 1,456 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 1,403 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 1,303 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 1,255 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fall 1,205 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Asthenia 1,130 reports
Physical weakness or lack of strength.
Full definition in the glossary →Vomiting 1,094 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →- Circumstance Or Information Capable Of Leading To Medication Error 1,052 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 25,688 |
| Female | 22,493 |
| Unknown | 139 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 563 |
| 18-34 | 960 |
| 35-49 | 2,206 |
| 50-64 | 6,125 |
| 65-74 | 7,011 |
| 75+ | 14,945 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Aranesp. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 28,121 |
| Hospitalization | 23,763 |
| Death | 19,589 |
| Non-Serious | 5,686 |
| Life-Threatening | 2,140 |
| Disability | 893 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Aranesp. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 499 |
| 2005 | 637 |
| 2006 | 935 |
| 2007 | 936 |
| 2008 | 860 |
| 2009 | 914 |
| 2010 | 933 |
| 2011 | 1,072 |
| 2012 | 1,681 |
| 2013 | 1,536 |
| 2014 | 5,752 |
| 2015 | 6,451 |
| 2016 | 6,847 |
| 2017 | 7,062 |
| 2018 | 4,412 |
| 2019 | 1,520 |
| 2020 | 1,680 |
| 2021 | 1,596 |
| 2022 | 1,610 |
| 2023 | 2,363 |
| 2024 | 1,993 |
| 2025 | 1,431 |
| 2026 (partial) | 314 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Aranesp
In FDA adverse event reports that mention Aranesp, these medications appeared most often in the same report.
- Furosemide (4,143 reports)
- Aspirin (2,314 reports)
- Acetaminophen (2,093 reports)
- Folic Acid (2,029 reports)
- Allopurinol (2,006 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026