Tbo-Filgrastim side effects: what 75 FDA adverse event reports show

Tbo-Filgrastim · 12 reaction terms · 171 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

75 reports · 96% serious · 8 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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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 9 strongest signals

Reporting / coding artifact 1Lab value / disease marker 2No label text to screen 6

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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
Cytokine release syndrome	27	34.5 23.8–50.0ROR 35.6 · χ² 844 / p 7e-186	33.7 EB05 24.3 · IC025 +3.8 3/3 methods agree	No label text to screen	–	no trial data cached
Leukaemia	8	20.6 10.3–41.1ROR 20.8 · χ² 130 / p 2e-30	18.8 EB05 8.8 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Full blood count decreased	11	13.3 7.4–23.9ROR 13.4 · χ² 113 / p 1e-26	11.6 EB05 6.0 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
White blood cell count decreased	52	11.6 9.0–15.2ROR 12.3 · χ² 498 / p 1e-110	11.4 EB05 8.9 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Laboratory test abnormal	13	10.7 6.2–18.4ROR 10.9 · χ² 105 / p 6e-25	9.1 EB05 5.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Febrile neutropenia	29	10.6 7.4–15.2ROR 11.0 · χ² 245 / p 2e-55	10.0 EB05 7.0 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Myelodysplastic syndrome	5	8.4 3.5–20.1ROR 8.4 · χ² 26 / p 2e-7	5.4 EB05 2.4 · IC025 +0.8 3/3 methods agree	No label text to screen	–	no trial data cached
Neurotoxicity	6	8.4 3.8–18.6ROR 8.4 · χ² 32 / p 8e-9	5.7 EB05 2.7 · IC025 +1.0 3/3 methods agree	No label text to screen	–	no trial data cached
Plasma cell myeloma	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	No label text to screen	–	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
White blood cell count decreased	52	11.6 9.0–15.2ROR 12.3 · χ² 498 / p 1e-110	11.4 EB05 8.9 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Febrile neutropenia	29	10.6 7.4–15.2ROR 11.0 · χ² 245 / p 2e-55	10.0 EB05 7.0 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Cytokine release syndrome	27	34.5 23.8–50.0ROR 35.6 · χ² 844 / p 7e-186	33.7 EB05 24.3 · IC025 +3.8 3/3 methods agree	No label text to screen	–	no trial data cached
Laboratory test abnormal	13	10.7 6.2–18.4ROR 10.9 · χ² 105 / p 6e-25	9.1 EB05 5.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Full blood count decreased	11	13.3 7.4–23.9ROR 13.4 · χ² 113 / p 1e-26	11.6 EB05 6.0 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Plasma cell myeloma	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	No label text to screen	–	no trial data cached
Leukaemia	8	20.6 10.3–41.1ROR 20.8 · χ² 130 / p 2e-30	18.8 EB05 8.8 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Neurotoxicity	6	8.4 3.8–18.6ROR 8.4 · χ² 32 / p 8e-9	5.7 EB05 2.7 · IC025 +1.0 3/3 methods agree	No label text to screen	–	no trial data cached
Myelodysplastic syndrome	5	8.4 3.5–20.1ROR 8.4 · χ² 26 / p 2e-7	5.4 EB05 2.4 · IC025 +0.8 3/3 methods agree	No label text to screen	–	no trial data cached
Acute myeloid leukaemia	4	6.2 2.3–16.6ROR 6.3 · χ² 13 / p 2e-4	4.0 EB05 1.7 · IC025 +0.2	No label text to screen	–	no trial data cached
Blood count abnormal	4	6.3 2.4–16.8ROR 6.3 · χ² 13 / p 2e-4	4.0 EB05 1.7 · IC025 +0.2	Lab value / disease marker	–	no trial data cached
Hair texture abnormal	3	5.4 1.7–16.7ROR 5.4 · χ² 7 / p 0.005	3.3 EB05 1.3 · IC025 -0.3 PRR-only: not supported by EBGM or IC	No label text to screen	–	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 Tbo-Filgrastim?

In FDA FAERS, the most frequently co-reported reaction terms for Tbo-Filgrastim are white blood cell count decreased, febrile neutropenia, cytokine release syndrome, full blood count decreased, plasma cell myeloma, leukaemia. 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 Tbo-Filgrastim have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Tbo-Filgrastim 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 12 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.