Filgrastim-Aafi side effects: what 640 FDA adverse event reports show

Filgrastim-Aafi · Nivestym · 13 reaction terms · 97 drug–reaction co-reports · data 2026-09-14

Drug class

Leukocyte Growth Factor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Nivestym

openFDA label

Who reports

640 reports · 60% serious · 112 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

NIVESTYM is a leukocyte growth factor indicated to • Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

FDA label, Indications and Usage

What it is

Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. NIVESTYM is produced by Escherichia coli ( E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene.

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 8 strongest signals

Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 2

What the badges mean

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. 5 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 defective	12	24.3 13.9–42.5ROR 24.7 · χ² 245 / p 2e-55	23.3 EB05 14.0 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Device mechanical issue	8	20.3 10.2–40.4ROR 20.5 · χ² 128 / p 5e-30	18.5 EB05 8.6 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Needle issue	16	18.3 11.3–29.7ROR 18.8 · χ² 245 / p 2e-55	17.7 EB05 11.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Device leakage	13	10.0 5.9–17.2ROR 10.2 · χ² 97 / p 3e-23	8.4 EB05 4.9 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Full blood count decreased	6	9.7 4.4–21.6ROR 9.8 · χ² 39 / p 2e-10	6.6 EB05 3.0 · IC025 +1.1 3/3 methods agree	Lab value / disease marker	serious PRR 9.0	no trial data cached
Product prescribing error	7	9.7 4.6–20.2ROR 9.8 · χ² 46 / p 5e-12	6.9 EB05 3.3 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 5.6	no trial data cached
Device breakage	6	5.0 2.3–11.1ROR 5.0 · χ² 15 / p 4e-5	3.8 EB05 1.9 · IC025 +0.5	Reporting / coding artifact	–	no trial data cached
Drug dose omission by device	11	4.7 2.6–8.4ROR 4.8 · χ² 29 / p 5e-8	4.0 EB05 2.4 · IC025 +1.0 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
Needle issue	16	18.3 11.3–29.7ROR 18.8 · χ² 245 / p 2e-55	17.7 EB05 11.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Device leakage	13	10.0 5.9–17.2ROR 10.2 · χ² 97 / p 3e-23	8.4 EB05 4.9 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device defective	12	24.3 13.9–42.5ROR 24.7 · χ² 245 / p 2e-55	23.3 EB05 14.0 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Drug dose omission by device	11	4.7 2.6–8.4ROR 4.8 · χ² 29 / p 5e-8	4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Device mechanical issue	8	20.3 10.2–40.4ROR 20.5 · χ² 128 / p 5e-30	18.5 EB05 8.6 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product prescribing error	7	9.7 4.6–20.2ROR 9.8 · χ² 46 / p 5e-12	6.9 EB05 3.3 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 5.6	no trial data cached
Device breakage	6	5.0 2.3–11.1ROR 5.0 · χ² 15 / p 4e-5	3.8 EB05 1.9 · IC025 +0.5	Reporting / coding artifact	–	no trial data cached
Full blood count decreased	6	9.7 4.4–21.6ROR 9.8 · χ² 39 / p 2e-10	6.6 EB05 3.0 · IC025 +1.1 3/3 methods agree	Lab value / disease marker	serious PRR 9.0	no trial data cached
Syringe issue	4	7.5 2.8–19.8ROR 7.5 · χ² 16 / p 3e-5	4.5 EB05 1.9 · IC025 +0.4	Not in label — unassessed	–	no trial data cached
Device deployment issue	4	10.9 4.1–29.0ROR 11.0 · χ² 27 / p 1e-7	6.3 EB05 2.4 · IC025 +0.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Full blood count abnormal	4	12.4 4.7–33.0ROR 12.5 · χ² 31 / p 1e-8	7.3 EB05 2.6 · IC025 +0.7 3/3 methods agree	Lab value / disease marker	serious PRR 7.9	no trial data cached
Device difficult to use	3	1.5 0.5–4.6ROR 1.5 · χ² 0 / p 0.368	1.4 EB05 0.6 · IC025 -1.6 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Exposure via skin contact	3	4.3 1.4–13.4ROR 4.4 · χ² 5 / p 0.015	2.9 EB05 1.2 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious n=2	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 Filgrastim-Aafi?

In FDA FAERS, the most frequently co-reported reaction terms for Filgrastim-Aafi are needle issue, drug dose omission by device, full blood count decreased, syringe issue, full blood count abnormal. 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 Filgrastim-Aafi have an FDA boxed warning?

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

Do FAERS signals prove that Filgrastim-Aafi 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 d23ab39c-b6ec-41cf-a529-9dd2852c9d9a, effective 20250812; matched on openfda.generic_name.exact:"FILGRASTIM-AAFI")
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, 13 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.