Pegfilgrastim-Cbqv side effects: what 1,328 FDA adverse event reports show

Pegfilgrastim-Cbqv · Udenyca · 21 reaction terms · 1,842 drug–reaction co-reports · data 2026-09-14

Drug class

Leukocyte Growth Factor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Udenyca

openFDA label

Who reports

1,328 reports · 21% serious · 127 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

UDENYCA 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-cbqv 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 (kDa).

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 18 strongest signals

Labeled (related wording) 1Reporting / coding artifact 14Not in label — unassessed 3

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.
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.
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. 3 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
Device malfunction	822	195.4 187.2–204.0ROR 510.6 · χ² 157,334 / p <1e-300	192.1 EB05 181.4 · IC025 +7.3 3/3 methods agree	Reporting / coding artifact	serious PRR 32.1 · 93% clinician	no trial data cached
No adverse event	636	56.8 53.7–60.1ROR 108.0 · χ² 34,965 / p <1e-300	56.5 EB05 52.9 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	94% clinician	no trial data cached
Device failure	31	32.3 22.8–45.8ROR 33.1 · χ² 908 / p 9e-200	31.7 EB05 23.4 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.5 · 100% clinician	no trial data cached
Syringe issue	13	11.7 6.8–20.1ROR 11.8 · χ² 117 / p 2e-27	10.2 EB05 5.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Neutrophil count decreased	28	10.9 7.6–15.7ROR 11.1 · χ² 243 / p 5e-55	10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.9	no trial data cached
Device leakage	24	8.9 6.0–13.3ROR 9.1 · χ² 162 / p 2e-37	8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product dose omission issue	150	8.3 7.2–9.7ROR 9.2 · χ² 971 / p 2e-213	8.2 EB05 7.1 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 10.8	no trial data cached
Needle issue	14	7.7 4.6–13.0ROR 7.8 · χ² 75 / p 2e-18	6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Device adhesion issue	7	7.3 3.5–15.2ROR 7.3 · χ² 32 / p 8e-9	5.2 EB05 2.7 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injury associated with device	8	6.3 3.1–12.5ROR 6.3 · χ² 30 / p 2e-8	4.8 EB05 2.6 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Accidental exposure to product	39	6.2 4.5–8.4ROR 6.3 · χ² 164 / p 7e-38	5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Incorrect dose administered by device	9	5.6 2.9–10.7ROR 5.6 · χ² 30 / p 3e-8	4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device use error	9	4.2 2.2–8.0ROR 4.2 · χ² 19 / p 8e-6	3.5 EB05 2.0 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Exposure via skin contact	5	3.5 1.5–8.4ROR 3.5 · χ² 7 / p 0.005	2.8 EB05 1.4 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Device delivery system issue	5	3.0 1.3–7.2ROR 3.0 · χ² 5 / p 0.014	2.5 EB05 1.2 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Device issue	16	2.9 1.8–4.7ROR 2.9 · χ² 18 / p 1e-5	2.7 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	–	no trial data cached
Wrong technique in device usage process	8	2.8 1.4–5.5ROR 2.8 · χ² 7 / p 0.003	2.5 EB05 1.4 · IC025 +0.1	Reporting / coding artifact	–	no trial data cached
Device dislocation	7	2.5 1.2–5.3ROR 2.6 · χ² 5 / p 0.012	2.3 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	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
Device malfunction	822	195.4 187.2–204.0ROR 510.6 · χ² 157,334 / p <1e-300	192.1 EB05 181.4 · IC025 +7.3 3/3 methods agree	Reporting / coding artifact	serious PRR 32.1 · 93% clinician	no trial data cached
No adverse event	636	56.8 53.7–60.1ROR 108.0 · χ² 34,965 / p <1e-300	56.5 EB05 52.9 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	94% clinician	no trial data cached
Product dose omission issue	150	8.3 7.2–9.7ROR 9.2 · χ² 971 / p 2e-213	8.2 EB05 7.1 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 10.8	no trial data cached
Accidental exposure to product	39	6.2 4.5–8.4ROR 6.3 · χ² 164 / p 7e-38	5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device failure	31	32.3 22.8–45.8ROR 33.1 · χ² 908 / p 9e-200	31.7 EB05 23.4 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.5 · 100% clinician	no trial data cached
Neutrophil count decreased	28	10.9 7.6–15.7ROR 11.1 · χ² 243 / p 5e-55	10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.9	no trial data cached
Device leakage	24	8.9 6.0–13.3ROR 9.1 · χ² 162 / p 2e-37	8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device issue	16	2.9 1.8–4.7ROR 2.9 · χ² 18 / p 1e-5	2.7 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	–	no trial data cached
Needle issue	14	7.7 4.6–13.0ROR 7.8 · χ² 75 / p 2e-18	6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Syringe issue	13	11.7 6.8–20.1ROR 11.8 · χ² 117 / p 2e-27	10.2 EB05 5.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Device use error	9	4.2 2.2–8.0ROR 4.2 · χ² 19 / p 8e-6	3.5 EB05 2.0 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Incorrect dose administered by device	9	5.6 2.9–10.7ROR 5.6 · χ² 30 / p 3e-8	4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Wrong technique in device usage process	8	2.8 1.4–5.5ROR 2.8 · χ² 7 / p 0.003	2.5 EB05 1.4 · IC025 +0.1	Reporting / coding artifact	–	no trial data cached
Injury associated with device	8	6.3 3.1–12.5ROR 6.3 · χ² 30 / p 2e-8	4.8 EB05 2.6 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Device dislocation	7	2.5 1.2–5.3ROR 2.6 · χ² 5 / p 0.012	2.3 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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-Cbqv?

In FDA FAERS, the most frequently co-reported reaction terms for Pegfilgrastim-Cbqv are neutrophil count decreased, needle issue, syringe issue, injury associated with device. 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-Cbqv have an FDA boxed warning?

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

Do FAERS signals prove that Pegfilgrastim-Cbqv 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 a8c290ee-b699-4395-a596-1453d4a4b4eb, effective 20250814; matched on openfda.generic_name.exact:"PEGFILGRASTIM-CBQV")
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, 21 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.