Sargramostim side effects: what 1,703 FDA adverse event reports show
Brand names
Leukine
Who reports
1,703 reports · 73% serious · 250 with death outcome · 44% female
Used for
LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
What it is
Sargramostim is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast ( S. cerevisiae ) expression system.
Boxed warning
None in the current label
Causality screen of the 31 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.
- 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. 36 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 |
|---|---|---|---|---|---|---|
| Device related infection | 26 | 20.8 14.2–30.4ROR 21.1 · χ² 469 / p 2e-104 | 20.4 EB05 14.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 16.8 · 100% clinician | no trial data cached |
| Small intestinal obstruction | 15 | 15.1 9.1–24.9ROR 15.2 · χ² 183 / p 5e-42 | 14.2 EB05 8.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Adrenal insufficiency | 14 | 14.4 8.6–24.3ROR 14.5 · χ² 162 / p 3e-37 | 13.3 EB05 7.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Prostatic specific antigen increased | 16 | 14.2 8.7–23.2ROR 14.4 · χ² 184 / p 4e-42 | 13.3 EB05 8.1 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 12.6 | no trial data cached |
| Device occlusion | 12 | 10.6 6.0–18.7ROR 10.7 · χ² 95 / p 8e-23 | 8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Hypoxia (low oxygen) | 30 | 10.5 7.4–15.0ROR 10.7 · χ² 250 / p 1e-56 | 9.9 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · 92% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 12 | 10.3 5.9–18.2ROR 10.4 · χ² 92 / p 4e-22 | 8.6 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Metastases to bone | 13 | 9.8 5.7–16.8ROR 9.9 · χ² 94 / p 2e-22 | 8.2 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Myelodysplastic syndrome | 11 | 9.4 5.2–16.9ROR 9.4 · χ² 74 / p 4e-18 | 7.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Febrile neutropenia | 45 | 8.4 6.3–11.2ROR 8.6 · χ² 285 / p 2e-64 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.3 · 98% clinician | no trial data cached |
| Bone pain | 39 | 8.2 6.0–11.2ROR 8.4 · χ² 240 / p 2e-54 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| White blood cell count increased | 25 | 8.0 5.4–11.8ROR 8.1 · χ² 146 / p 5e-34 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 · 92% clinician | no trial data cached |
| Mental status changes | 16 | 7.1 4.4–11.5ROR 7.1 · χ² 78 / p 6e-19 | 6.0 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Hypotension (low blood pressure) | 112 | 6.9 5.8–8.2ROR 7.3 · χ² 563 / p 9e-125 | 6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Injection site reaction | 38 | 6.8 5.0–9.3ROR 7.0 · χ² 184 / p 4e-42 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Toothache | 10 | 6.8 3.7–12.6ROR 6.8 · χ² 44 / p 2e-11 | 5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Osteomyelitis | 10 | 6.8 3.7–12.6ROR 6.8 · χ² 44 / p 2e-11 | 5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Syncope (fainting) | 55 | 6.8 5.2–8.8ROR 7.0 · χ² 266 / p 5e-60 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Colitis | 20 | 6.5 4.2–10.1ROR 6.6 · χ² 89 / p 3e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Hypocalcaemia (low calcium) | 10 | 6.5 3.5–12.1ROR 6.6 · χ² 41 / p 6e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Chills | 57 | 6.0 4.6–7.7ROR 6.2 · χ² 233 / p 8e-53 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Oral pain | 10 | 5.5 3.0–10.2ROR 5.5 · χ² 32 / p 7e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 10 | 4.9 2.7–9.2ROR 5.0 · χ² 28 / p 7e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Mucosal inflammation | 10 | 4.7 2.5–8.8ROR 4.7 · χ² 26 / p 2e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 44 | 4.0 3.0–5.4ROR 4.1 · χ² 97 / p 4e-23 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.0 | no trial data cached |
| Osteonecrosis (bone death) | 10 | 3.7 2.0–6.9ROR 3.7 · χ² 17 / p 2e-5 | 3.3 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Convulsion (seizure) | 15 | 3.2 1.9–5.3ROR 3.2 · χ² 20 / p 3e-6 | 3.0 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Malignant neoplasm progression | 24 | 2.9 2.0–4.3ROR 2.9 · χ² 28 / p 6e-8 | 2.8 EB05 2.0 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Injection site erythema (redness where injected) | 29 | 2.9 2.0–4.2ROR 2.9 · χ² 34 / p 2e-9 | 2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Injection site pruritus | 15 | 2.8 1.7–4.6ROR 2.8 · χ² 15 / p 4e-5 | 2.6 EB05 1.7 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 2.1 | no trial data cached |
| Injection site swelling | 16 | 2.6 1.6–4.2ROR 2.6 · χ² 14 / p 8e-5 | 2.5 EB05 1.6 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 1.7 | 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 |
|---|---|---|---|---|---|---|
| Hypotension (low blood pressure) | 112 | 6.9 5.8–8.2ROR 7.3 · χ² 563 / p 9e-125 | 6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Chills | 57 | 6.0 4.6–7.7ROR 6.2 · χ² 233 / p 8e-53 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Syncope (fainting) | 55 | 6.8 5.2–8.8ROR 7.0 · χ² 266 / p 5e-60 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Febrile neutropenia | 45 | 8.4 6.3–11.2ROR 8.6 · χ² 285 / p 2e-64 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.3 · 98% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 44 | 4.0 3.0–5.4ROR 4.1 · χ² 97 / p 4e-23 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.0 | no trial data cached |
| Bone pain | 39 | 8.2 6.0–11.2ROR 8.4 · χ² 240 / p 2e-54 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Injection site reaction | 38 | 6.8 5.0–9.3ROR 7.0 · χ² 184 / p 4e-42 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Hypoxia (low oxygen) | 30 | 10.5 7.4–15.0ROR 10.7 · χ² 250 / p 1e-56 | 9.9 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · 92% clinician | no trial data cached |
| Injection site erythema (redness where injected) | 29 | 2.9 2.0–4.2ROR 2.9 · χ² 34 / p 2e-9 | 2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Device related infection | 26 | 20.8 14.2–30.4ROR 21.1 · χ² 469 / p 2e-104 | 20.4 EB05 14.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 16.8 · 100% clinician | no trial data cached |
| White blood cell count increased | 25 | 8.0 5.4–11.8ROR 8.1 · χ² 146 / p 5e-34 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 · 92% clinician | no trial data cached |
| Malignant neoplasm progression | 24 | 2.9 2.0–4.3ROR 2.9 · χ² 28 / p 6e-8 | 2.8 EB05 2.0 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Colitis | 20 | 6.5 4.2–10.1ROR 6.6 · χ² 89 / p 3e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Injection site swelling | 16 | 2.6 1.6–4.2ROR 2.6 · χ² 14 / p 8e-5 | 2.5 EB05 1.6 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 1.7 | no trial data cached |
| Mental status changes | 16 | 7.1 4.4–11.5ROR 7.1 · χ² 78 / p 6e-19 | 6.0 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | 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.
- Colitis — n=20, PRR 6.5
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 Sargramostim?
In FDA FAERS, the most frequently co-reported reaction terms for Sargramostim are hypotension, chills, syncope, febrile neutropenia, neutropenia, bone pain. 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 Sargramostim have an FDA boxed warning?
No. The FDA label retrieved for Sargramostim has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sargramostim 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 bb9a3820-f31a-4dd9-bef4-97094c01a398, effective 20241206; matched on
openfda.generic_name.exact:"SARGRAMOSTIM") - 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, 67 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.