Drug · FAERS side-effect profile with label screen

Methoxy Polyethylene Glycol-Epoetin Beta side effects: what 10,973 FDA adverse event reports show

Methoxy Polyethylene Glycol-Epoetin Beta · Mircera · 980 reaction terms · 28,819 drug–reaction co-reports · data 2026-09-14

Drug class

Erythropoiesis-stimulating agent (esa)

FDA label, Indications wording

Brand names

Mircera

openFDA label

Who reports

10,973 reports · 72% serious · 2,904 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: • adult patients on dialysis and adult patients not on dialysis ( 1.1 ). • pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA ( 1.1 ).

FDA label, Indications and Usage

What it is

Methoxy polyethylene glycol-epoetin beta, is an ESA which differs from erythropoietin through formation of a chemical bond between either the N-terminal amino group or the ε-amino group of any.

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 2Reporting / coding artifact 1Lab value / disease marker 15Not in label — unassessed 19

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.
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.
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. 940 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
Transferrin decreased	43	509.7 364.1–713.5ROR 511.7 · χ² 16,787 / p <1e-300	340.5 EB05 263.4 · IC025 +5.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=43	no trial data cached
Ventricular hyperkinesia	13	322.4 179.1–580.4ROR 322.8 · χ² 3,288 / p <1e-300	196.4 EB05 122.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Agonal respiration	32	252.4 174.6–364.8ROR 253.1 · χ² 6,846 / p <1e-300	196.7 EB05 145.9 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=31	no trial data cached
Shunt stenosis	27	203.6 136.9–302.6ROR 204.1 · χ² 4,731 / p <1e-300	162.8 EB05 117.5 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=27 · 100% clinician	no trial data cached
Aplasia pure red cell	259	155.6 137.3–176.4ROR 159.4 · χ² 36,616 / p <1e-300	142.3 EB05 128.4 · IC025 +6.6 3/3 methods agree	Labeled (related wording) related wording	serious n=259 · 96% clinician	no trial data cached
Right atrial enlargement	13	137.7 78.4–241.7ROR 137.8 · χ² 1,519 / p <1e-300	108.4 EB05 67.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Hypochromasia	13	134.6 76.7–236.2ROR 134.8 · χ² 1,487 / p <1e-300	106.5 EB05 66.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Shunt occlusion	33	133.2 93.6–189.5ROR 133.6 · χ² 3,921 / p <1e-300	116.2 EB05 86.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=33 · 100% clinician	no trial data cached
Reticulocyte count decreased	26	121.0 81.4–179.8ROR 121.3 · χ² 2,796 / p <1e-300	105.2 EB05 75.4 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=24	no trial data cached
Anti-erythropoietin antibody positive	14	111.3 65.0–190.8ROR 111.5 · χ² 1,343 / p 2e-294	92.3 EB05 58.4 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=14	no trial data cached
Left ventricular enlargement	13	103.4 59.2–180.6ROR 103.5 · χ² 1,154 / p 3e-253	86.1 EB05 53.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Mitral valve thickening	13	93.9 53.8–163.8ROR 94.0 · χ² 1,051 / p 7e-231	79.4 EB05 49.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Transferrin saturation decreased	19	90.9 57.4–144.0ROR 91.0 · χ² 1,527 / p <1e-300	80.0 EB05 54.1 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=19	no trial data cached
Marasmus	56	73.9 56.6–96.4ROR 74.2 · χ² 3,804 / p <1e-300	69.5 EB05 55.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=56 · 100% clinician	no trial data cached
Transferrin saturation increased	11	62.4 34.3–113.8ROR 62.5 · χ² 586 / p 1e-129	55.0 EB05 32.8 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious n=7	no trial data cached
Left atrial enlargement	13	47.8 27.6–82.8ROR 47.8 · χ² 536 / p 8e-119	43.8 EB05 27.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Mean platelet volume increased	14	46.0 27.1–78.1ROR 46.0 · χ² 558 / p 1e-123	42.5 EB05 26.9 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious n=14	no trial data cached
Haemoglobin increased	104	45.2 37.2–54.8ROR 45.6 · χ² 4,343 / p <1e-300	43.8 EB05 37.2 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=99	no trial data cached
Seizure like phenomena	34	39.5 28.1–55.5ROR 39.6 · χ² 1,213 / p 6e-266	38.0 EB05 28.4 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=34	no trial data cached
Pulse absent	96	39.2 32.1–48.0ROR 39.6 · χ² 3,466 / p <1e-300	38.2 EB05 32.2 · IC025 +4.7 3/3 methods agree	Lab value / disease marker	serious n=95	no trial data cached
Serum ferritin increased	94	34.8 28.4–42.7ROR 35.1 · χ² 2,999 / p <1e-300	34.0 EB05 28.6 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=85	no trial data cached
Blood phosphorus increased	44	31.3 23.3–42.2ROR 31.5 · χ² 1,242 / p 3e-272	30.5 EB05 23.6 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=40	no trial data cached
Sjs-ten overlap	10	29.9 16.0–55.9ROR 29.9 · χ² 247 / p 5e-56	28.0 EB05 16.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Drug hypersensitivity	2,981	29.8 28.9–30.7ROR 40.5 · χ² 82,354 / p <1e-300	29.3 EB05 28.5 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 23.2 · 99% clinician	no trial data cached
Carbon dioxide decreased	17	28.9 17.9–46.7ROR 29.0 · χ² 424 / p 1e-94	27.7 EB05 18.3 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious n=17	no trial data cached
Unresponsive to stimuli	340	25.6 23.0–28.4ROR 26.4 · χ² 7,910 / p <1e-300	25.2 EB05 23.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 20.5	no trial data cached
Blood bicarbonate decreased	25	25.3 17.1–37.6ROR 25.4 · χ² 553 / p 1e-122	24.6 EB05 17.5 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious n=25	no trial data cached
Blood parathyroid hormone increased	37	24.5 17.7–33.8ROR 24.6 · χ² 800 / p 3e-176	23.9 EB05 18.1 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious n=34	no trial data cached
Documented hypersensitivity to administered product	10	23.6 12.6–44.0ROR 23.6 · χ² 192 / p 6e-44	22.1 EB05 12.3 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Nephrogenic anaemia	48	19.8 14.9–26.3ROR 19.9 · χ² 830 / p 7e-183	19.5 EB05 15.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=47 · 97% clinician	no trial data cached
Blood chloride increased	16	17.9 10.9–29.3ROR 17.9 · χ² 236 / p 1e-53	17.1 EB05 10.7 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious n=16	no trial data cached
Blood iron decreased	83	13.5 10.9–16.8ROR 13.6 · χ² 945 / p 7e-208	13.3 EB05 11.0 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious PRR 14.5 · ♀ 28% (drug 49%)	no trial data cached
Hypertensive heart disease	13	13.3 7.7–22.9ROR 13.3 · χ² 135 / p 2e-31	11.8 EB05 6.6 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious n=13	no trial data cached
High density lipoprotein decreased	23	13.2 8.8–20.0ROR 13.3 · χ² 247 / p 7e-56	12.6 EB05 8.4 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious n=23 · ♀ 18% (drug 49%) · 91% clinician	no trial data cached
Azotaemia	27	12.9 8.9–18.9ROR 13.0 · χ² 284 / p 5e-64	12.4 EB05 8.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=27 · 91% clinician	no trial data cached
Red cell distribution width increased	27	12.5 8.6–18.2ROR 12.5 · χ² 272 / p 2e-61	11.9 EB05 8.2 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious n=27 · ♀ 27% (drug 49%)	no trial data cached
Foaming at mouth	13	12.4 7.2–21.4ROR 12.4 · χ² 124 / p 4e-29	10.9 EB05 6.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Polycythaemia	13	12.2 7.1–21.1ROR 12.3 · χ² 122 / p 9e-29	10.7 EB05 6.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Normochromic normocytic anaemia	19	12.2 7.8–19.1ROR 12.2 · χ² 183 / p 7e-42	11.2 EB05 7.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Electrocardiogram t wave inversion	13	11.2 6.5–19.4ROR 11.2 · χ² 110 / p 4e-26	9.6 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Drug hypersensitivity	2,981	29.8 28.9–30.7ROR 40.5 · χ² 82,354 / p <1e-300	29.3 EB05 28.5 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 23.2 · 99% clinician	no trial data cached
Death	1,577	3.5 3.3–3.7ROR 3.9 · χ² 2,934 / p <1e-300	3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 2.8	no trial data cached
Dyspnoea (shortness of breath)	1,123	3.8 3.6–4.0ROR 4.1 · χ² 2,373 / p <1e-300	3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 2.9 · 94% clinician	no trial data cached
Nausea	823	2.0 1.9–2.1ROR 2.1 · χ² 423 / p 3e-94	2.0 EB05 1.9 · IC025 +0.9	Not in label — unassessed	serious PRR 1.2 · 96% clinician	no trial data cached
Pruritus (itching)	783	4.0 3.7–4.2ROR 4.2 · χ² 1,762 / p <1e-300	4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.9 · 96% clinician	no trial data cached
Vomiting	682	2.8 2.6–3.0ROR 2.9 · χ² 794 / p 7e-175	2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.1 · 96% clinician	no trial data cached
Haemoglobin decreased	583	10.9 10.1–11.8ROR 11.4 · χ² 5,218 / p <1e-300	10.8 EB05 10.1 · IC025 +3.3 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 9.5	no trial data cached
Flushing	513	9.6 8.9–10.5ROR 10.1 · χ² 3,965 / p <1e-300	9.6 EB05 8.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.5 · 98% clinician	no trial data cached
Anaemia (low red blood cells)	347	3.5 3.1–3.9ROR 3.6 · χ² 615 / p 5e-136	3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 3.0	no trial data cached
Feeling hot	340	10.6 9.6–11.8ROR 10.9 · χ² 2,952 / p <1e-300	10.5 EB05 9.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.1 · 95% clinician	no trial data cached
Unresponsive to stimuli	340	25.6 23.0–28.4ROR 26.4 · χ² 7,910 / p <1e-300	25.2 EB05 23.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 20.5	no trial data cached
No adverse event	316	3.4 3.1–3.8ROR 3.5 · χ² 539 / p 1e-119	3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 2.0 · 95% clinician	no trial data cached
Dizziness	296	1.1 1.0–1.3ROR 1.1 · χ² 5 / p 0.014	1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.2	no trial data cached
Hypotension (low blood pressure)	281	2.7 2.4–3.0ROR 2.7 · χ² 298 / p 6e-67	2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.6 · 96% clinician	no trial data cached
Rash	276	1.2 1.1–1.4ROR 1.2 · χ² 11 / p 6e-4	1.2 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	serious PRR 0.6 · 95% clinician	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.

Agonal respiration — n=32, PRR 252.4
Shunt stenosis — n=27, PRR 203.6
Shunt occlusion — n=33, PRR 133.2
Marasmus — n=56, PRR 73.9
Seizure like phenomena — n=34, PRR 39.5
Unresponsive to stimuli — n=340, PRR 25.6
Nephrogenic anaemia — n=48, PRR 19.8
Azotaemia — n=27, PRR 12.9

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 Methoxy Polyethylene Glycol-Epoetin Beta?

In FDA FAERS, the most frequently co-reported reaction terms for Methoxy Polyethylene Glycol-Epoetin Beta are drug hypersensitivity, dyspnoea, nausea, pruritus, vomiting, haemoglobin decreased. 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 Methoxy Polyethylene Glycol-Epoetin Beta 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 Methoxy Polyethylene Glycol-Epoetin Beta 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 22c56f2a-f73c-60e7-e054-00144ff88e88, effective 20260814; matched on openfda.generic_name.exact:"METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA")
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, 980 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.