85/100 · Critical
Manufactured by Amgen, Inc
High Serious Event Rate for Darbepoetin Alfa
81,618 FDA adverse event reports analyzed
Last updated: 2026-05-12
DARBEPOETIN ALFA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. Based on analysis of 81,618 FDA adverse event reports, DARBEPOETIN ALFA has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DARBEPOETIN ALFA include DEATH, HOSPITALISATION, OFF LABEL USE, ANAEMIA, HAEMOGLOBIN DECREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DARBEPOETIN ALFA.
Darbepoetin Alfa has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 81,618 adverse event reports for this medication, which is primarily manufactured by Amgen, Inc.
The most commonly reported adverse events include Death, Hospitalisation, Off Label Use. Of classified reports, 89.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A high percentage of reports (89.3%) involve serious adverse events.
The most common reactions include death, hospitalization, and severe infections. The majority of reports come from older patients, with a significant number of serious outcomes. There is a notable increase in cardiovascular and renal complications.
Patients taking Darbepoetin Alfa should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Darbepoetin Alfa is associated with a range of serious adverse events, including death, hospitalization, and severe infections. Warnings should be issued for potential drug interactions, particularly with medications affecting renal function and card This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Darbepoetin Alfa received a safety concern score of 85/100 (high concern). This is based on a 89.3% serious event ratio across 52,694 classified reports. The score accounts for 81,618 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 25,531, Female: 22,381, Unknown: 139. The most frequently reported age groups are age 80 (1,153 reports), age 76 (960 reports), age 85 (939 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 52,694 classified reports for DARBEPOETIN ALFA:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Darbepoetin Alfa is associated with a range of serious adverse events, including death, hospitalization, and severe infections. Warnings should be issued for potential drug interactions, particularly with medications affecting renal function and card
If you are taking Darbepoetin Alfa, here are important things to know. The most commonly reported side effects include death, hospitalisation, off label use, anaemia, haemoglobin decreased. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring of renal and cardiovascular function is recommended, especially in older patients. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA should closely monitor the safety profile of Darbepoetin Alfa, especially in elderly patients. Healthcare providers should be vigilant about potential serious adverse events and consider alternative treatments if necessary.
The FDA has received approximately 81,618 adverse event reports associated with Darbepoetin Alfa. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Darbepoetin Alfa include Death, Hospitalisation, Off Label Use, Anaemia, Haemoglobin Decreased. By volume, the top reported reactions are: Death (15,863 reports), Hospitalisation (6,091 reports), Off Label Use (2,479 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Darbepoetin Alfa.
Out of 52,694 classified reports, 47,038 (89.3%) were classified as serious and 5,656 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Darbepoetin Alfa break down by patient sex as follows: Male: 25,531, Female: 22,381, Unknown: 139. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Darbepoetin Alfa adverse events are: age 80: 1,153 reports, age 76: 960 reports, age 85: 939 reports, age 81: 917 reports, age 82: 917 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Darbepoetin Alfa adverse event reports is Amgen, Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Darbepoetin Alfa include: Product Storage Error, Pneumonia, Fatigue, Dyspnoea, Diarrhoea. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Darbepoetin Alfa to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Darbepoetin Alfa has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. A high percentage of reports (89.3%) involve serious adverse events.
Key safety signals identified in Darbepoetin Alfa's adverse event data include: Death and hospitalization are the most frequent serious outcomes.. Severe infections and cardiovascular events are key safety signals.. Renal failure and impairment are also significant concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Darbepoetin Alfa is associated with a range of serious adverse events, including death, hospitalization, and severe infections. Warnings should be issued for potential drug interactions, particularly with medications affecting renal function and card Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Darbepoetin Alfa.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring of renal and cardiovascular function is recommended, especially in older patients.
Darbepoetin Alfa has 81,618 adverse event reports on file with the FDA. The most common reactions include death, hospitalization, and severe infections. The volume of reports for Darbepoetin Alfa reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should closely monitor the safety profile of Darbepoetin Alfa, especially in elderly patients. Healthcare providers should be vigilant about potential serious adverse events and consider alternative treatments if necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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