Epoetin Alfa-Epbx side effects: what 2,185 FDA adverse event reports show
Drug class
Erythropoiesis-stimulating agent (esa)
Brand names
Retacrit
Who reports
2,185 reports · 68% serious · 488 with death outcome · 50% female
Used for
RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ).
What it is
Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line.
Boxed warning
ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTIO.
Causality screen of the 25 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 26 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Full blood count abnormal | 21 | 19.1 12.5–29.3ROR 19.3 · χ² 343 / p 8e-77 | 18.7 EB05 12.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.2 | no trial data cached |
| Haemoglobin decreased | 165 | 15.4 13.3–17.8ROR 16.6 · χ² 2,216 / p <1e-300 | 15.4 EB05 13.5 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.7 | no trial data cached |
| Dialysis | 21 | 14.2 9.3–21.7ROR 14.3 · χ² 244 / p 2e-55 | 13.6 EB05 8.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.5 | no trial data cached |
| Transfusion | 15 | 13.7 8.3–22.7ROR 13.8 · χ² 164 / p 7e-38 | 12.7 EB05 7.4 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.4 | no trial data cached |
| Haematocrit decreased | 28 | 13.5 9.3–19.5ROR 13.6 · χ² 311 / p 7e-70 | 13.0 EB05 9.2 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.4 | no trial data cached |
| Full blood count decreased | 26 | 12.4 8.5–18.2ROR 12.5 · χ² 261 / p 6e-59 | 11.8 EB05 8.1 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Hospice care | 12 | 11.7 6.7–20.6ROR 11.8 · χ² 107 / p 2e-25 | 10.0 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Ischaemic stroke | 20 | 10.7 6.9–16.6ROR 10.8 · χ² 167 / p 2e-38 | 9.7 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 · 100% clinician | no trial data cached |
| Red blood cell count decreased | 30 | 10.1 7.1–14.4ROR 10.2 · χ² 236 / p 1e-53 | 9.4 EB05 6.7 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.4 | no trial data cached |
| Product prescribing error | 24 | 9.7 6.5–14.5ROR 9.8 · χ² 180 / p 3e-41 | 8.9 EB05 6.0 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 | no trial data cached |
| Blood iron decreased | 11 | 9.0 5.0–16.2ROR 9.0 · χ² 70 / p 3e-17 | 7.2 EB05 4.1 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
| Syringe issue | 14 | 7.7 4.5–12.9ROR 7.7 · χ² 75 / p 3e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Blood count abnormal | 12 | 7.5 4.3–13.2ROR 7.5 · χ² 61 / p 3e-15 | 6.1 EB05 3.6 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 | no trial data cached |
| Hypoacusis | 33 | 7.4 5.3–10.4ROR 7.5 · χ² 176 / p 2e-40 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 11 | 5.7 3.2–10.3ROR 5.7 · χ² 38 / p 3e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Bone marrow failure | 12 | 5.6 3.2–9.9ROR 5.7 · χ² 41 / p 7e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Anaemia (low red blood cells) | 105 | 5.3 4.4–6.4ROR 5.5 · χ² 363 / p 3e-81 | 5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.9 | no trial data cached |
| Product dispensing error | 11 | 4.9 2.7–8.8ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Needle issue | 14 | 4.7 2.8–7.9ROR 4.7 · χ² 37 / p 5e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Death | 412 | 4.6 4.2–5.0ROR 5.4 · χ² 1,203 / p 6e-264 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 3.7 | no trial data cached |
| Hospitalisation | 70 | 4.4 3.5–5.6ROR 4.5 · χ² 182 / p 7e-42 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Therapy interrupted | 31 | 4.3 3.0–6.1ROR 4.4 · χ² 76 / p 2e-18 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 91% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 11 | 4.1 2.3–7.5ROR 4.1 · χ² 23 / p 8e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Febrile neutropenia | 26 | 3.8 2.6–5.5ROR 3.8 · χ² 50 / p 7e-13 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Intentional dose omission | 10 | 3.5 1.9–6.5ROR 3.5 · χ² 16 / p 4e-5 | 3.1 EB05 1.8 · IC025 +0.6 | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 412 | 4.6 4.2–5.0ROR 5.4 · χ² 1,203 / p 6e-264 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 3.7 | no trial data cached |
| Haemoglobin decreased | 165 | 15.4 13.3–17.8ROR 16.6 · χ² 2,216 / p <1e-300 | 15.4 EB05 13.5 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.7 | no trial data cached |
| Anaemia (low red blood cells) | 105 | 5.3 4.4–6.4ROR 5.5 · χ² 363 / p 3e-81 | 5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.9 | no trial data cached |
| Hospitalisation | 70 | 4.4 3.5–5.6ROR 4.5 · χ² 182 / p 7e-42 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Hypoacusis | 33 | 7.4 5.3–10.4ROR 7.5 · χ² 176 / p 2e-40 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Therapy interrupted | 31 | 4.3 3.0–6.1ROR 4.4 · χ² 76 / p 2e-18 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 91% clinician | no trial data cached |
| Red blood cell count decreased | 30 | 10.1 7.1–14.4ROR 10.2 · χ² 236 / p 1e-53 | 9.4 EB05 6.7 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.4 | no trial data cached |
| Haematocrit decreased | 28 | 13.5 9.3–19.5ROR 13.6 · χ² 311 / p 7e-70 | 13.0 EB05 9.2 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.4 | no trial data cached |
| Febrile neutropenia | 26 | 3.8 2.6–5.5ROR 3.8 · χ² 50 / p 7e-13 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Full blood count decreased | 26 | 12.4 8.5–18.2ROR 12.5 · χ² 261 / p 6e-59 | 11.8 EB05 8.1 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Product prescribing error | 24 | 9.7 6.5–14.5ROR 9.8 · χ² 180 / p 3e-41 | 8.9 EB05 6.0 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 | no trial data cached |
| Dialysis | 21 | 14.2 9.3–21.7ROR 14.3 · χ² 244 / p 2e-55 | 13.6 EB05 8.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.5 | no trial data cached |
| Full blood count abnormal | 21 | 19.1 12.5–29.3ROR 19.3 · χ² 343 / p 8e-77 | 18.7 EB05 12.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.2 | no trial data cached |
| Ischaemic stroke | 20 | 10.7 6.9–16.6ROR 10.8 · χ² 167 / p 2e-38 | 9.7 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 · 100% clinician | no trial data cached |
| Device issue | 16 | 1.8 1.1–2.9ROR 1.8 · χ² 5 / p 0.017 | 1.7 EB05 1.1 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hypoacusis — n=33, PRR 7.4
- Febrile neutropenia — n=26, PRR 3.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Erythropoiesis-stimulating agents (darbepoetin alfa) ↔ Mortality / cardiovascular risk.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Epoetin Alfa-Epbx?
In FDA FAERS, the most frequently co-reported reaction terms for Epoetin Alfa-Epbx are haemoglobin decreased, anaemia, hypoacusis, red blood cell count decreased, haematocrit decreased, febrile neutropenia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Epoetin Alfa-Epbx have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTIO.
Do FAERS signals prove that Epoetin Alfa-Epbx causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 3af26b0d-8ad0-44e1-a538-8bdb5ab39374, effective 20250622; matched on
openfda.generic_name.exact:"EPOETIN ALFA-EPBX") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 51 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.