Drug · FAERS side-effect profile with label screen
Granulocyte Colony Stimulating Factor side effects: what 2,180 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Guna-Gcsf
openFDA label
Who reports
2,180 reports · 98% serious · 687 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
IMMUNE SUPPORT
FDA label, Indications and Usage
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 40 strongest signals
Reporting / coding artifact 2Lab value / disease marker 3No label text to screen 35
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. 47 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Mucosal inflammation | 139 | 51.5 43.9–60.6ROR 55.0 · χ² 6,811 / p <1e-300 | 50.9 EB05 44.2 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.9 · 92% clinician | no trial data cached |
| Cytomegalovirus infection | 87 | 50.5 41.1–62.1ROR 52.6 · χ² 4,157 / p <1e-300 | 49.8 EB05 41.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.8 · 94% clinician | no trial data cached |
| Febrile neutropenia | 333 | 48.6 44.0–53.7ROR 57.2 · χ² 15,443 / p <1e-300 | 48.2 EB05 44.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.3 · 94% clinician | no trial data cached |
| Haematotoxicity | 35 | 36.4 26.2–50.6ROR 37.0 · χ² 1,167 / p 5e-256 | 35.7 EB05 26.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.2 · 100% clinician | no trial data cached |
| Bone marrow failure | 65 | 30.6 24.1–38.9ROR 31.5 · χ² 1,830 / p <1e-300 | 30.3 EB05 24.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.0 · 94% clinician | no trial data cached |
| Acute myeloid leukaemia | 33 | 20.4 14.5–28.7ROR 20.7 · χ² 589 / p 2e-130 | 20.2 EB05 15.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 · 97% clinician | no trial data cached |
| Bacteraemia | 23 | 18.8 12.5–28.3ROR 19.0 · χ² 370 / p 1e-82 | 18.4 EB05 12.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 | no trial data cached |
| Myelodysplastic syndrome | 28 | 18.6 12.9–26.9ROR 18.9 · χ² 449 / p 5e-100 | 18.3 EB05 13.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 · 100% clinician | no trial data cached |
| Neutrophil count increased | 18 | 16.9 10.6–26.7ROR 17.0 · χ² 253 / p 3e-57 | 16.3 EB05 10.5 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 10.8 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 16 | 15.4 9.5–25.1ROR 15.5 · χ² 201 / p 6e-46 | 14.6 EB05 8.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 216 | 15.4 13.5–17.4ROR 16.9 · χ² 2,898 / p <1e-300 | 15.3 EB05 13.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 · 94% clinician | no trial data cached |
| Thrombotic microangiopathy | 15 | 14.9 9.0–24.7ROR 15.0 · χ² 181 / p 2e-41 | 14.0 EB05 8.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 | no trial data cached |
| Lymphopenia | 20 | 13.7 8.8–21.2ROR 13.8 · χ² 222 / p 1e-50 | 13.0 EB05 8.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · 100% clinician | no trial data cached |
| Clostridium difficile colitis | 15 | 13.6 8.2–22.5ROR 13.7 · χ² 163 / p 2e-37 | 12.5 EB05 7.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 | no trial data cached |
| Septic shock | 57 | 12.7 9.8–16.4ROR 13.0 · χ² 603 / p 2e-133 | 12.5 EB05 9.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 94% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 143 | 12.3 10.5–14.5ROR 13.1 · χ² 1,485 / p <1e-300 | 12.3 EB05 10.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 96% clinician | no trial data cached |
| Disseminated intravascular coagulation | 18 | 12.3 7.7–19.4ROR 12.4 · χ² 175 / p 3e-40 | 11.3 EB05 7.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Sepsis (blood infection) | 140 | 12.1 10.3–14.2ROR 12.8 · χ² 1,417 / p <1e-300 | 12.0 EB05 10.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 · ♀ 22% (drug 43%) · 92% clinician | no trial data cached |
| Lung infection | 19 | 11.6 7.4–18.2ROR 11.7 · χ² 174 / p 6e-40 | 10.6 EB05 6.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Nephropathy toxic | 12 | 10.4 5.9–18.2ROR 10.4 · χ² 92 / p 4e-22 | 8.6 EB05 4.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Pancytopenia (all blood cells low) | 58 | 10.0 7.8–12.9ROR 10.3 · χ² 462 / p 7e-103 | 9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 29 | 10.0 7.0–14.4ROR 10.1 · χ² 226 / p 2e-51 | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 · 97% clinician | no trial data cached |
| Interstitial lung disease | 50 | 10.0 7.6–13.1ROR 10.2 · χ² 395 / p 4e-88 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Multi-organ failure | 18 | 9.9 6.2–15.6ROR 9.9 · χ² 135 / p 2e-31 | 8.7 EB05 5.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Respiratory failure | 71 | 9.4 7.4–11.8ROR 9.6 · χ² 523 / p 4e-116 | 9.1 EB05 7.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Candida infection (yeast infection) | 15 | 8.6 5.2–14.3ROR 8.7 · χ² 94 / p 2e-22 | 7.3 EB05 4.5 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Neutrophil count decreased | 36 | 8.6 6.2–11.8ROR 8.7 · χ² 233 / p 7e-53 | 8.0 EB05 5.9 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 · 91% clinician | no trial data cached |
| Generalised oedema | 10 | 7.8 4.2–14.5ROR 7.8 · χ² 53 / p 2e-13 | 6.1 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial data cached |
| Bacterial infection | 15 | 7.8 4.7–12.9ROR 7.8 · χ² 82 / p 7e-20 | 6.5 EB05 4.1 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Product use in unapproved indication | 191 | 7.5 6.6–8.6ROR 8.1 · χ² 1,085 / p 2e-238 | 7.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · 97% clinician | no trial data cached |
| Blood bilirubin increased | 20 | 7.1 4.6–11.0ROR 7.2 · χ² 99 / p 1e-23 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 · 90% clinician | no trial data cached |
| Hypomagnesaemia | 10 | 6.9 3.7–12.9ROR 7.0 · χ² 45 / p 1e-11 | 5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Neoplasm progression | 25 | 6.9 4.6–10.1ROR 6.9 · χ² 119 / p 5e-28 | 6.2 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · 96% clinician | no trial data cached |
| Pneumonitis | 19 | 6.8 4.3–10.6ROR 6.8 · χ² 88 / p 4e-21 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Leukopenia (low white blood cells) | 35 | 6.7 4.9–9.4ROR 6.8 · χ² 166 / p 3e-38 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 · 94% clinician | no trial data cached |
| Ascites | 20 | 6.5 4.2–10.1ROR 6.6 · χ² 88 / p 3e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Disease progression | 80 | 6.5 5.3–8.1ROR 6.7 · χ² 371 / p 7e-83 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 100% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 12 | 6.2 3.6–11.0ROR 6.3 · χ² 48 / p 2e-12 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Infection | 92 | 6.1 5.0–7.5ROR 6.4 · χ² 393 / p 9e-88 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 · 99% clinician | no trial data cached |
| Respiratory disorder | 19 | 6.1 3.9–9.5ROR 6.1 · χ² 76 / p 1e-18 | 5.4 EB05 3.6 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 333 | 48.6 44.0–53.7ROR 57.2 · χ² 15,443 / p <1e-300 | 48.2 EB05 44.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.3 · 94% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 216 | 15.4 13.5–17.4ROR 16.9 · χ² 2,898 / p <1e-300 | 15.3 EB05 13.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 · 94% clinician | no trial data cached |
| Product use in unapproved indication | 191 | 7.5 6.6–8.6ROR 8.1 · χ² 1,085 / p 2e-238 | 7.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · 97% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 143 | 12.3 10.5–14.5ROR 13.1 · χ² 1,485 / p <1e-300 | 12.3 EB05 10.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 140 | 12.1 10.3–14.2ROR 12.8 · χ² 1,417 / p <1e-300 | 12.0 EB05 10.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 · ♀ 22% (drug 43%) · 92% clinician | no trial data cached |
| Mucosal inflammation | 139 | 51.5 43.9–60.6ROR 55.0 · χ² 6,811 / p <1e-300 | 50.9 EB05 44.2 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.9 · 92% clinician | no trial data cached |
| Infection | 92 | 6.1 5.0–7.5ROR 6.4 · χ² 393 / p 9e-88 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 · 99% clinician | no trial data cached |
| Cytomegalovirus infection | 87 | 50.5 41.1–62.1ROR 52.6 · χ² 4,157 / p <1e-300 | 49.8 EB05 41.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.8 · 94% clinician | no trial data cached |
| Disease progression | 80 | 6.5 5.3–8.1ROR 6.7 · χ² 371 / p 7e-83 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 100% clinician | no trial data cached |
| Respiratory failure | 71 | 9.4 7.4–11.8ROR 9.6 · χ² 523 / p 4e-116 | 9.1 EB05 7.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Bone marrow failure | 65 | 30.6 24.1–38.9ROR 31.5 · χ² 1,830 / p <1e-300 | 30.3 EB05 24.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.0 · 94% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 58 | 10.0 7.8–12.9ROR 10.3 · χ² 462 / p 7e-103 | 9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · 96% clinician | no trial data cached |
| Septic shock | 57 | 12.7 9.8–16.4ROR 13.0 · χ² 603 / p 2e-133 | 12.5 EB05 9.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 94% clinician | no trial data cached |
| Platelet count decreased | 56 | 5.1 3.9–6.5ROR 5.2 · χ² 179 / p 4e-41 | 4.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 · 93% clinician | no trial data cached |
| Interstitial lung disease | 50 | 10.0 7.6–13.1ROR 10.2 · χ² 395 / p 4e-88 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | 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 Granulocyte Colony Stimulating Factor?
In FDA FAERS, the most frequently co-reported reaction terms for Granulocyte Colony Stimulating Factor are febrile neutropenia, neutropenia, thrombocytopenia, sepsis, mucosal inflammation, infection. 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 Granulocyte Colony Stimulating Factor have an FDA boxed warning?
No. The FDA label retrieved for Granulocyte Colony Stimulating Factor has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Granulocyte Colony Stimulating Factor 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 7b996f4c-0d9a-48e3-8d9b-41e4aa9f1142, effective 20181221; matched on
openfda.generic_name.exact:"GRANULOCYTE COLONY STIMULATING FACTOR") - 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, 87 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.