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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

EPOETIN ALFA-EPBX: 1,341 Adverse Event Reports & Safety Profile

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1,341
Total FAERS Reports
343 (25.6%)
Deaths Reported
261
Hospitalizations
1,341
As Primary/Secondary Suspect
26
Life-Threatening
3
Disabilities
Prescription
Status

FDA Application: 125545 ·

First Report: 199911 · Latest Report: 20250910

What Are the Most Common EPOETIN ALFA-EPBX Side Effects?

#1 Most Reported
Death
329 reports (24.5%)
#2 Most Reported
Off label use
263 reports (19.6%)
#3 Most Reported
Haemoglobin decreased
112 reports (8.4%)

All EPOETIN ALFA-EPBX Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 329 24.5% 317 5
Off label use 263 19.6% 57 19
Haemoglobin decreased 112 8.4% 3 21
Hospitalisation 49 3.7% 0 44
Anaemia 42 3.1% 1 12
Asthenia 42 3.1% 2 6
Drug ineffective 41 3.1% 2 4
Product dose omission issue 39 2.9% 1 4
Fatigue 33 2.5% 0 5
Malaise 33 2.5% 0 4
Hypoacusis 30 2.2% 2 0
Dyspnoea 24 1.8% 2 14
Illness 24 1.8% 4 5
Haematocrit decreased 23 1.7% 0 4
Covid-19 21 1.6% 1 6
Red blood cell count decreased 21 1.6% 0 4
Full blood count decreased 20 1.5% 1 5
Renal failure 20 1.5% 3 5
Therapy interrupted 20 1.5% 0 11
Ischaemic stroke 19 1.4% 1 4

Who Reports EPOETIN ALFA-EPBX Side Effects? Age & Gender Data

Gender: 53.3% female, 46.7% male. Average age: 72.6 years. Most reports from: US. View detailed demographics →

Is EPOETIN ALFA-EPBX Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 7 0 4
2019 60 19 16
2020 111 39 34
2021 113 45 16
2022 97 47 25
2023 58 23 11
2024 24 7 9
2025 15 1 9

View full timeline →

What Is EPOETIN ALFA-EPBX Used For?

IndicationReports
Anaemia 267
Nephrogenic anaemia 169
Chronic kidney disease 136
Myelodysplastic syndrome 69
Product used for unknown indication 48
Haemoglobin decreased 26
Anaemia of chronic disease 24
End stage renal disease 22
Iron deficiency anaemia 18
Myelofibrosis 16

EPOETIN ALFA-EPBX vs Alternatives: Which Is Safer?

EPOETIN ALFA-EPBX vs EPOGEN EPOETIN ALFA-EPBX vs EPOPROSTENOL EPOETIN ALFA-EPBX vs EPTIFIBATIDE EPOETIN ALFA-EPBX vs EPTINEZUMAB-JJMR EPOETIN ALFA-EPBX vs EPTINEZUMAB\EPTINEZUMAB-JJMR EPOETIN ALFA-EPBX vs EQUINE THYMOCYTE IMMUNE GLOBULIN EPOETIN ALFA-EPBX vs ERAVACYCLINE EPOETIN ALFA-EPBX vs ERBITUX EPOETIN ALFA-EPBX vs ERDAFITINIB EPOETIN ALFA-EPBX vs ERENUMAB

Official FDA Label for EPOETIN ALFA-EPBX

Official prescribing information from the FDA-approved drug label.