Pegfilgrastim-Bmez side effects: what 598 FDA adverse event reports show

Pegfilgrastim-Bmez · Ziextenzo · 16 reaction terms · 298 drug–reaction co-reports · data 2026-09-14

Drug class

Leukocyte Growth Factor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Ziextenzo

openFDA label

Who reports

598 reports · 83% serious · 183 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ZIEXTENZO is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

FDA label, Indications and Usage

What it is

Pegfilgrastim-bmez is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD).

FDA label, Description section

Boxed warning

None in the current 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 15 strongest signals

Labeled (related wording) 2Likely indication confounding 1Lab value / disease marker 1Not in label — unassessed 11

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 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
Brain oedema	27	75.1 51.9–108.7ROR 78.6 · χ² 1,898 / p <1e-300	71.3 EB05 51.5 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 52.3 · ♀ 100% (drug 61%) · 93% clinician	no trial data cached
Metastases to central nervous system	23	63.1 42.2–94.2ROR 65.6 · χ² 1,342 / p 4e-294	60.0 EB05 42.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 44.0 · ♀ 100% (drug 61%) · 91% clinician	no trial data cached
Candida infection (yeast infection)	29	61.0 42.8–87.1ROR 64.1 · χ² 1,652 / p <1e-300	58.7 EB05 42.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 54.2 · ♀ 100% (drug 61%) · 97% clinician	no trial data cached
Skin fissures	25	46.5 31.7–68.2ROR 48.5 · χ² 1,067 / p 2e-234	44.9 EB05 32.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=25 · ♀ 100% (drug 61%) · 92% clinician	no trial data cached
C-reactive protein increased	30	28.9 20.4–41.0ROR 30.4 · χ² 782 / p 2e-172	28.5 EB05 20.9 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious PRR 18.7 · ♀ 100% (drug 61%) · 97% clinician	no trial data cached
Restlessness	29	27.8 19.5–39.6ROR 29.1 · χ² 722 / p 2e-159	27.3 EB05 19.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 24.7 · ♀ 100% (drug 61%) · 97% clinician	no trial data cached
Breast cancer metastatic	7	22.9 11.0–47.8ROR 23.2 · χ² 125 / p 2e-29	20.7 EB05 9.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.1	no trial data cached
Eczema	25	17.4 11.9–25.6ROR 18.2 · χ² 372 / p 4e-83	17.1 EB05 12.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 35.3 · ♀ 100% (drug 61%) · 92% clinician	no trial data cached
Hyperthyroidism	6	14.5 6.6–32.3ROR 14.7 · χ² 63 / p 1e-15	10.9 EB05 4.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Cytokine release syndrome	7	12.9 6.2–26.9ROR 13.0 · χ² 65 / p 3e-16	9.8 EB05 4.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	48	12.4 9.5–16.3ROR 13.4 · χ² 496 / p 3e-110	12.2 EB05 9.4 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 8.9 · 94% clinician	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	9	12.4 6.5–23.6ROR 12.5 · χ² 83 / p 4e-20	10.1 EB05 4.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Skin haemorrhage	5	12.2 5.1–29.1ROR 12.2 · χ² 41 / p 9e-11	8.0 EB05 3.1 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Neoplasm malignant	18	9.5 6.0–14.9ROR 9.7 · χ² 128 / p 5e-30	8.3 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Needle issue	7	8.6 4.1–17.9ROR 8.7 · χ² 40 / p 2e-10	6.1 EB05 3.0 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious n=1	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
Neutropenia (low neutrophils (infection-fighting cells))	48	12.4 9.5–16.3ROR 13.4 · χ² 496 / p 3e-110	12.2 EB05 9.4 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 8.9 · 94% clinician	no trial data cached
C-reactive protein increased	30	28.9 20.4–41.0ROR 30.4 · χ² 782 / p 2e-172	28.5 EB05 20.9 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious PRR 18.7 · ♀ 100% (drug 61%) · 97% clinician	no trial data cached
Restlessness	29	27.8 19.5–39.6ROR 29.1 · χ² 722 / p 2e-159	27.3 EB05 19.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 24.7 · ♀ 100% (drug 61%) · 97% clinician	no trial data cached
Candida infection (yeast infection)	29	61.0 42.8–87.1ROR 64.1 · χ² 1,652 / p <1e-300	58.7 EB05 42.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 54.2 · ♀ 100% (drug 61%) · 97% clinician	no trial data cached
Brain oedema	27	75.1 51.9–108.7ROR 78.6 · χ² 1,898 / p <1e-300	71.3 EB05 51.5 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 52.3 · ♀ 100% (drug 61%) · 93% clinician	no trial data cached
Eczema	25	17.4 11.9–25.6ROR 18.2 · χ² 372 / p 4e-83	17.1 EB05 12.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 35.3 · ♀ 100% (drug 61%) · 92% clinician	no trial data cached
Skin fissures	25	46.5 31.7–68.2ROR 48.5 · χ² 1,067 / p 2e-234	44.9 EB05 32.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=25 · ♀ 100% (drug 61%) · 92% clinician	no trial data cached
Metastases to central nervous system	23	63.1 42.2–94.2ROR 65.6 · χ² 1,342 / p 4e-294	60.0 EB05 42.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 44.0 · ♀ 100% (drug 61%) · 91% clinician	no trial data cached
Neoplasm malignant	18	9.5 6.0–14.9ROR 9.7 · χ² 128 / p 5e-30	8.3 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	9	12.4 6.5–23.6ROR 12.5 · χ² 83 / p 4e-20	10.1 EB05 4.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Needle issue	7	8.6 4.1–17.9ROR 8.7 · χ² 40 / p 2e-10	6.1 EB05 3.0 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Cytokine release syndrome	7	12.9 6.2–26.9ROR 13.0 · χ² 65 / p 3e-16	9.8 EB05 4.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Breast cancer metastatic	7	22.9 11.0–47.8ROR 23.2 · χ² 125 / p 2e-29	20.7 EB05 9.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.1	no trial data cached
Hyperthyroidism	6	14.5 6.6–32.3ROR 14.7 · χ² 63 / p 1e-15	10.9 EB05 4.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Skin haemorrhage	5	12.2 5.1–29.1ROR 12.2 · χ² 41 / p 9e-11	8.0 EB05 3.1 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious n=5	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.

Brain oedema — n=27, PRR 75.1
Metastases to central nervous system — n=23, PRR 63.1
Candida infection — n=29, PRR 61.0
Skin fissures — n=25, PRR 46.5
Restlessness — n=29, PRR 27.8
Eczema — n=25, PRR 17.4

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 Pegfilgrastim-Bmez?

In FDA FAERS, the most frequently co-reported reaction terms for Pegfilgrastim-Bmez are neutropenia, c-reactive protein increased, restlessness, candida infection, brain oedema, eczema. 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 Pegfilgrastim-Bmez have an FDA boxed warning?

No. The FDA label retrieved for Pegfilgrastim-Bmez has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Pegfilgrastim-Bmez 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 7dada041-6528-4acf-809c-62d271538c9a, effective 20260514; matched on openfda.generic_name.exact:"PEGFILGRASTIM-BMEZ")
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, 16 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.