Erythropoietin side effects: what 20,432 FDA adverse event reports show

Erythropoietin · Procrit · 1,169 reaction terms · 74,789 drug–reaction co-reports · data 2026-09-14

Drug class

Erythropoiesis-stimulating agent (esa)

FDA label, Indications wording

Brand names

Procrit

openFDA label

Who reports

20,432 reports · 74% serious · 5,024 with death outcome · 54% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PROCRIT is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ).

FDA label, Indications and Usage

What it is

Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced.

FDA label, Description section

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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 3Likely indication confounding 5Lab value / disease marker 7Not in label — unassessed 25

What the badges mean

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.
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.
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. 1,129 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Anti-erythropoietin antibody positive	45	221.0 160.1–305.0ROR 221.5 · χ² 7,908 / p <1e-300	168.7 EB05 131.2 · IC025 +5.4 3/3 methods agree	Lab value / disease marker	serious n=44 · 100% clinician	no trial arm names this drug
Shunt stenosis	38	160.8 114.3–226.4ROR 161.1 · χ² 5,071 / p <1e-300	130.0 EB05 98.9 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=38 · 100% clinician	no trial arm names this drug
Myelodysplastic syndrome with excess blasts	13	127.7 71.7–227.3ROR 127.8 · χ² 1,340 / p 9e-294	97.6 EB05 60.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Athetosis	16	102.4 61.3–171.3ROR 102.5 · χ² 1,369 / p 6e-300	84.1 EB05 54.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Reticulocyte count decreased	39	100.6 72.4–139.8ROR 100.8 · χ² 3,409 / p <1e-300	87.8 EB05 67.0 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=31 · 100% clinician	no trial arm names this drug
Aplasia pure red cell	296	96.6 85.8–108.7ROR 98.0 · χ² 25,480 / p <1e-300	87.8 EB05 79.7 · IC025 +6.1 3/3 methods agree	Labeled (related wording) related wording	serious n=294 · 94% clinician	no trial arm names this drug
Drug specific antibody absent	15	79.4 47.0–134.4ROR 79.5 · χ² 1,006 / p 5e-221	67.7 EB05 43.5 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=15	no trial arm names this drug
Refractory anaemia	13	76.9 43.8–135.1ROR 77.0 · χ² 836 / p 4e-184	65.0 EB05 40.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Skin fibrosis	32	72.9 50.9–104.3ROR 73.0 · χ² 2,050 / p <1e-300	65.5 EB05 48.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=32	no trial arm names this drug
Iron overload	52	51.9 39.3–68.5ROR 52.0 · χ² 2,420 / p <1e-300	48.6 EB05 38.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=47 · ♀ 25% (drug 54%)	no trial arm names this drug
Nephrogenic systemic fibrosis	141	49.5 41.8–58.6ROR 49.9 · χ² 6,346 / p <1e-300	47.0 EB05 40.8 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=140	no trial arm names this drug
Shunt occlusion	23	48.8 32.1–74.1ROR 48.8 · χ² 982 / p 8e-216	45.0 EB05 31.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=23 · 100% clinician	no trial arm names this drug
Erythropoiesis abnormal	13	45.7 26.2–79.6ROR 45.7 · χ² 501 / p 2e-111	41.3 EB05 25.7 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=13	no trial arm names this drug
Blood product transfusion dependent	18	45.4 28.3–72.8ROR 45.5 · χ² 706 / p 6e-156	41.7 EB05 27.9 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious n=17	no trial arm names this drug
Neutralising antibodies positive	17	44.4 27.3–72.2ROR 44.5 · χ² 650 / p 9e-144	40.8 EB05 27.0 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious n=17	no trial arm names this drug
Transferrin saturation decreased	14	35.5 20.8–60.5ROR 35.5 · χ² 421 / p 9e-94	32.9 EB05 20.8 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Joint contracture	34	33.5 23.8–47.2ROR 33.6 · χ² 1,007 / p 2e-221	32.0 EB05 23.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=34	no trial arm names this drug
Renal ischaemia	16	31.1 18.9–51.2ROR 31.2 · χ² 424 / p 2e-94	29.3 EB05 19.1 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=16	no trial arm names this drug
Marrow hyperplasia	20	30.7 19.7–47.9ROR 30.7 · χ² 529 / p 2e-117	29.1 EB05 19.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Haemoglobin abnormal	184	30.4 26.2–35.1ROR 30.6 · χ² 5,045 / p <1e-300	29.4 EB05 26.0 · IC025 +4.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=93	no trial arm names this drug
Haematocrit abnormal	35	29.9 21.4–41.8ROR 29.9 · χ² 921 / p 1e-202	28.7 EB05 21.5 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious n=22	no trial arm names this drug
Diffuse large b-cell lymphoma refractory	25	28.3 19.0–42.1ROR 28.4 · χ² 615 / p 5e-136	27.1 EB05 19.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=25 · ♀ 100% (drug 54%)	no trial arm names this drug
Skin induration	55	28.1 21.5–36.7ROR 28.1 · χ² 1,370 / p 3e-300	27.1 EB05 21.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=55	no trial arm names this drug
Aortic calcification	15	26.7 16.0–44.6ROR 26.7 · χ² 337 / p 1e-75	25.3 EB05 16.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Extremity contracture	16	26.2 16.0–43.1ROR 26.3 · χ² 354 / p 2e-79	24.9 EB05 16.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Nephrogenic anaemia	110	24.7 20.5–29.8ROR 24.8 · χ² 2,420 / p <1e-300	24.1 EB05 20.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=110	no trial arm names this drug
Anaemia of chronic disease	21	24.4 15.8–37.6ROR 24.4 · χ² 437 / p 2e-97	23.4 EB05 16.1 · IC025 +3.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=20	no trial arm names this drug
Blood iron increased	43	24.0 17.7–32.4ROR 24.0 · χ² 903 / p 1e-198	23.2 EB05 18.0 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious n=28	no trial arm names this drug
Transfusion reaction	19	22.7 14.4–35.8ROR 22.8 · χ² 365 / p 1e-81	21.8 EB05 14.7 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=18	no trial arm names this drug
Hyperparathyroidism secondary	53	21.9 16.7–28.8ROR 22.0 · χ² 1,015 / p 4e-223	21.3 EB05 16.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=53	no trial arm names this drug
Serratia infection	14	19.8 11.6–33.5ROR 19.8 · χ² 226 / p 2e-51	18.7 EB05 11.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Excessive granulation tissue	15	19.4 11.6–32.3ROR 19.4 · χ² 239 / p 4e-54	18.4 EB05 11.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Diabetic foot	56	19.1 14.7–24.8ROR 19.1 · χ² 924 / p 3e-203	18.6 EB05 14.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=55 · 100% clinician	no trial arm names this drug
Bone marrow depression	18	19.0 11.9–30.3ROR 19.0 · χ² 284 / p 4e-64	18.2 EB05 11.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Primary sequestrum	16	18.2 11.1–29.8ROR 18.2 · χ² 239 / p 4e-54	17.3 EB05 10.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Intervertebral disc space narrowing	14	18.2 10.7–30.8ROR 18.2 · χ² 206 / p 4e-47	17.1 EB05 10.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Skin hypertrophy	48	17.9 13.4–23.8ROR 17.9 · χ² 735 / p 4e-162	17.4 EB05 13.6 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=48	no trial arm names this drug
Red blood cell count abnormal	24	17.1 11.4–25.6ROR 17.1 · χ² 342 / p 1e-76	16.5 EB05 11.4 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=12	no trial arm names this drug
Acquired haemophilia	16	16.9 10.3–27.7ROR 16.9 · χ² 220 / p 5e-50	16.0 EB05 9.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Osteolysis	33	16.8 11.9–23.6ROR 16.8 · χ² 466 / p 1e-103	16.3 EB05 12.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=33	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Erythropoietin only as a background or rescue medication (NCT00093015, NCT02876835); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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	2,605	3.1 3.0–3.2ROR 3.4 · χ² 3,876 / p <1e-300	3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 2.4	no trial arm names this drug
Anaemia (low red blood cells)	1,526	8.3 7.9–8.7ROR 8.9 · χ² 9,746 / p <1e-300	8.2 EB05 7.9 · IC025 +2.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.3	no trial arm names this drug
Fatigue (tiredness)	1,432	1.9 1.8–2.0ROR 2.0 · χ² 625 / p 4e-138	1.9 EB05 1.8 · IC025 +0.8	Likely indication confounding term in indications	serious PRR 2.0	no trial arm names this drug
Haemoglobin decreased	1,397	14.1 13.4–14.8ROR 15.1 · χ² 16,854 / p <1e-300	13.9 EB05 13.3 · IC025 +3.7 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 9.1	no trial arm names this drug
Asthenia (weakness)	1,037	2.8 2.7–3.0ROR 2.9 · χ² 1,249 / p 7e-274	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial arm names this drug
Diarrhoea (diarrhea)	1,024	1.6 1.5–1.7ROR 1.7 · χ² 259 / p 1e-58	1.6 EB05 1.6 · IC025 +0.6	Not in label — unassessed	serious PRR 1.7	no trial arm names this drug
Nausea	978	1.3 1.2–1.4ROR 1.3 · χ² 59 / p 8e-15	1.3 EB05 1.2 · IC025 +0.2	Labeled adverse reaction exact term	serious PRR 1.3	no trial arm names this drug
Off label use (used outside approved label)	895	1.1 1.0–1.1ROR 1.1 · χ² 3 / p 0.043	1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.1	no trial arm names this drug
Dyspnoea (shortness of breath)	861	1.6 1.5–1.7ROR 1.6 · χ² 179 / p 5e-41	1.6 EB05 1.5 · IC025 +0.5	Not in label — unassessed	serious PRR 1.4	no trial arm names this drug
Pneumonia (lung infection)	776	2.5 2.3–2.6ROR 2.5 · χ² 684 / p 4e-151	2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.0	no trial arm names this drug
Drug ineffective (drug did not work)	694	0.5 0.5–0.6ROR 0.5 · χ² 288 / p 6e-65	0.5 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.8	no trial arm names this drug
Pain	688	1.1 1.1–1.2ROR 1.2 · χ² 13 / p 1e-4	1.1 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	serious PRR 1.2	no trial arm names this drug
Vomiting	627	1.4 1.3–1.5ROR 1.4 · χ² 64 / p 5e-16	1.4 EB05 1.3 · IC025 +0.3	Labeled adverse reaction exact term	serious PRR 1.3	no trial arm names this drug
Pyrexia (fever)	612	1.8 1.7–2.0ROR 1.8 · χ² 227 / p 2e-51	1.8 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 1.6	no trial arm names this drug
Platelet count decreased	594	5.7 5.3–6.2ROR 5.9 · χ² 2,324 / p <1e-300	5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 4.6	no trial arm names this drug

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.

Shunt stenosis — n=38, PRR 160.8
Skin fibrosis — n=32, PRR 72.9
Iron overload — n=52, PRR 51.9
Nephrogenic systemic fibrosis — n=141, PRR 49.5
Shunt occlusion — n=23, PRR 48.8
Joint contracture — n=34, PRR 33.5
Marrow hyperplasia — n=20, PRR 30.7
Diffuse large b-cell lymphoma refractory — n=25, PRR 28.3
Skin induration — n=55, PRR 28.1
Nephrogenic anaemia — n=110, PRR 24.7

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 Erythropoietin?

In FDA FAERS, the most frequently co-reported reaction terms for Erythropoietin are anaemia, fatigue, haemoglobin decreased, asthenia, diarrhoea, nausea. 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 Erythropoietin 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 Erythropoietin 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 0c721ba4-ae19-417f-aae1-221ed1a0866a, effective 20250409; matched on openfda.generic_name.exact:"ERYTHROPOIETIN")
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, field patient.drug.openfda.generic_name.exact, 1,169 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
ClinicalTrials.gov API v2 (query ERYTHROPOIETIN, results-bearing studies sorted by enrollment)

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.