Filgrastim-Sndz side effects: what 3,286 FDA adverse event reports show
Brand names
Zarxio
Who reports
3,286 reports · 57% serious · 740 with death outcome · 57% female
Used for
ZARXIO 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 .
What it is
Filgrastim-sndz is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim-sndz is produced by Escherichia coli ( E coli ) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene.
Boxed warning
None in the current label
Causality screen of the 30 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 42 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Full blood count decreased | 53 | 16.8 12.9–22.0ROR 17.1 · χ² 771 / p 6e-170 | 16.6 EB05 13.2 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 13.8 | no trial data cached |
| Full blood count abnormal | 17 | 10.3 6.4–16.5ROR 10.3 · χ² 133 / p 4e-31 | 9.1 EB05 5.7 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.3 | no trial data cached |
| White blood cell count decreased | 168 | 9.9 8.5–11.5ROR 10.4 · χ² 1,338 / p 3e-293 | 9.8 EB05 8.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Hospice care | 13 | 8.4 4.9–14.5ROR 8.5 · χ² 78 / p 6e-19 | 6.9 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Bone pain | 74 | 8.1 6.4–10.1ROR 8.2 · χ² 451 / p 2e-100 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Neutrophil count decreased | 51 | 8.0 6.1–10.6ROR 8.1 · χ² 307 / p 4e-69 | 7.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.5 | no trial data cached |
| Leukaemia | 10 | 6.8 3.6–12.6ROR 6.8 · χ² 44 / p 2e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.9 | no trial data cached |
| Neoplasm malignant | 68 | 6.5 5.1–8.2ROR 6.6 · χ² 312 / p 4e-70 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 76% consumer | no trial data cached |
| Laboratory test abnormal | 28 | 6.1 4.2–8.8ROR 6.1 · χ² 113 / p 9e-27 | 5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| Cytokine release syndrome | 18 | 6.0 3.8–9.6ROR 6.1 · χ² 71 / p 2e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Immune system disorder | 12 | 5.8 3.3–10.2ROR 5.8 · χ² 43 / p 2e-11 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Seasonal allergy | 12 | 5.4 3.1–9.5ROR 5.4 · χ² 39 / p 2e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Syringe issue | 14 | 5.1 3.0–8.6ROR 5.1 · χ² 42 / p 4e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Blood count abnormal | 12 | 5.0 2.8–8.8ROR 5.0 · χ² 34 / p 2e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.3 | no trial data cached |
| Plasma cell myeloma | 30 | 4.9 3.4–7.0ROR 4.9 · χ² 89 / p 2e-21 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Tooth disorder | 17 | 4.9 3.0–7.8ROR 4.9 · χ² 48 / p 2e-12 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| White blood cell count increased | 29 | 4.8 3.3–6.9ROR 4.8 · χ² 84 / p 3e-20 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 · ♀ 80% (drug 57%) | no trial data cached |
| Needle issue | 21 | 4.7 3.1–7.2ROR 4.7 · χ² 57 / p 2e-14 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Death | 628 | 4.7 4.3–5.0ROR 5.5 · χ² 1,873 / p <1e-300 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.7 | no trial data cached |
| Platelet count decreased | 74 | 4.4 3.5–5.6ROR 4.5 · χ² 194 / p 2e-44 | 4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | no trial data cached |
| Red blood cell count decreased | 19 | 4.2 2.7–6.6ROR 4.3 · χ² 44 / p 2e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.7 | no trial data cached |
| Product dispensing error | 14 | 4.1 2.4–6.9ROR 4.1 · χ² 30 / p 2e-8 | 3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 86 | 4.1 3.3–5.0ROR 4.1 · χ² 196 / p 9e-45 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.2 | no trial data cached |
| Hospitalisation | 92 | 3.9 3.1–4.7ROR 3.9 · χ² 193 / p 4e-44 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Febrile neutropenia | 35 | 3.4 2.4–4.7ROR 3.4 · χ² 56 / p 3e-14 | 3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.4 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 47 | 3.2 2.4–4.2ROR 3.2 · χ² 68 / p 8e-17 | 3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Illness | 48 | 3.0 2.3–4.0ROR 3.1 · χ² 64 / p 5e-16 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Thrombosis | 38 | 3.0 2.2–4.1ROR 3.0 · χ² 49 / p 1e-12 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Therapy cessation | 23 | 2.9 1.9–4.3ROR 2.9 · χ² 26 / p 1e-7 | 2.8 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Product dose omission | 25 | 2.4 1.6–3.6ROR 2.4 · χ² 19 / p 6e-6 | 2.3 EB05 1.7 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.2 · 96% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 628 | 4.7 4.3–5.0ROR 5.5 · χ² 1,873 / p <1e-300 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.7 | no trial data cached |
| White blood cell count decreased | 168 | 9.9 8.5–11.5ROR 10.4 · χ² 1,338 / p 3e-293 | 9.8 EB05 8.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Hospitalisation | 92 | 3.9 3.1–4.7ROR 3.9 · χ² 193 / p 4e-44 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 86 | 4.1 3.3–5.0ROR 4.1 · χ² 196 / p 9e-45 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.2 | no trial data cached |
| Platelet count decreased | 74 | 4.4 3.5–5.6ROR 4.5 · χ² 194 / p 2e-44 | 4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | no trial data cached |
| Bone pain | 74 | 8.1 6.4–10.1ROR 8.2 · χ² 451 / p 2e-100 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Neoplasm malignant | 68 | 6.5 5.1–8.2ROR 6.6 · χ² 312 / p 4e-70 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 76% consumer | no trial data cached |
| Full blood count decreased | 53 | 16.8 12.9–22.0ROR 17.1 · χ² 771 / p 6e-170 | 16.6 EB05 13.2 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 13.8 | no trial data cached |
| Neutrophil count decreased | 51 | 8.0 6.1–10.6ROR 8.1 · χ² 307 / p 4e-69 | 7.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.5 | no trial data cached |
| Illness | 48 | 3.0 2.3–4.0ROR 3.1 · χ² 64 / p 5e-16 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 47 | 3.2 2.4–4.2ROR 3.2 · χ² 68 / p 8e-17 | 3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Thrombosis | 38 | 3.0 2.2–4.1ROR 3.0 · χ² 49 / p 1e-12 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Febrile neutropenia | 35 | 3.4 2.4–4.7ROR 3.4 · χ² 56 / p 3e-14 | 3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.4 | no trial data cached |
| Plasma cell myeloma | 30 | 4.9 3.4–7.0ROR 4.9 · χ² 89 / p 2e-21 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| White blood cell count increased | 29 | 4.8 3.3–6.9ROR 4.8 · χ² 84 / p 3e-20 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 · ♀ 80% (drug 57%) | 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.
- Neoplasm malignant — n=68, PRR 6.5
- Plasma cell myeloma — n=30, PRR 4.9
- Needle issue — n=21, PRR 4.7
- Neuropathy peripheral — n=47, PRR 3.2
- Thrombosis — n=38, PRR 3.0
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-Sndz?
In FDA FAERS, the most frequently co-reported reaction terms for Filgrastim-Sndz are white blood cell count decreased, neutropenia, platelet count decreased, bone pain, neoplasm malignant, full blood count 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 Filgrastim-Sndz have an FDA boxed warning?
No. The FDA label retrieved for Filgrastim-Sndz has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Filgrastim-Sndz 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 c0d1c22b-566b-4776-bdbf-00f96dad0cae, effective 20250829; matched on
openfda.generic_name.exact:"FILGRASTIM-SNDZ") - 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, fieldpatient.drug.openfda.generic_name.exact, 72 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.