Filgrastim side effects: what 37,395 FDA adverse event reports show

Filgrastim · Releuko · 1,270 reaction terms · 146,964 drug–reaction co-reports · data 2026-09-14

Drug class

Leukocyte Growth Factor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Releuko

openFDA label

Who reports

37,395 reports · 88% serious · 8,445 with death outcome · 52% female

openFDA FAERS counts, all years, deduplication not applied

Used for

RELEUKO 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-ayow, a leukocyte growth factor, is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim-ayow 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 40 strongest signals

Labeled adverse reaction 1Labeled (related wording) 2Likely indication confounding 5Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 30

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,230 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
Lymphoid tissue hypoplasia	145	40,045.7 9,920.5–161,650.9ROR 40,201.6 · calibrated p 4e-22 ✓	509.0 EB05 443.2 · IC025 +7.3 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=145 · ♀ 0% (drug 52%)	no trial arm names this drug
Thymus hypoplasia	143	2,925.4 1,939.2–4,413.2ROR 2,936.7 · calibrated p 1e-21 ✓	438.1 EB05 381.0 · IC025 +7.2 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=143 · ♀ 0% (drug 52%)	no trial arm names this drug
Human bocavirus infection	124	1,070.2 791.6–1,446.8ROR 1,073.7 · calibrated p 5e-17 ✓	345.5 EB05 297.4 · IC025 +6.9 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=124 · ♀ 100% (drug 52%)	no trial arm names this drug
Computerised tomogram thorax	39	1,025.8 603.5–1,743.5ROR 1,026.9 · calibrated p 2e-15 ✓	305.7 EB05 233.4 · IC025 +5.5 3/3 methods agree vs other Leukocyte Growth Factors: PRR 12.0 (7.7–18.8)	Not in label — unassessed	serious n=39 · ♀ 100% (drug 52%) · 100% clinician	no trial arm names this drug
Blood stem cell harvest failure	66	450.1 325.2–622.8ROR 450.9 · calibrated p 6e-13 ✓	231.8 EB05 188.6 · IC025 +6.0 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=52 · 100% clinician	no trial arm names this drug
Cystitis bacterial	110	268.8 214.1–337.6ROR 269.6 · calibrated p 4e-11 ✓	175.7 EB05 149.8 · IC025 +6.3 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=110 · ♀ 100% (drug 52%)	no trial arm names this drug
Norovirus test positive	94	229.7 180.7–292.2ROR 230.3 · calibrated p 2e-10 ✓	157.4 EB05 132.5 · IC025 +6.1 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Lab value / disease marker	serious n=94	no trial arm names this drug
Neuroblastoma recurrent	50	185.4 134.6–255.3ROR 185.6 · calibrated p 2e-9 ✓	132.1 EB05 104.1 · IC025 +5.4 3/3 methods agree vs other Leukocyte Growth Factors: PRR 26.2 (16.0–42.9)	Not in label — unassessed	serious n=50 · 100% clinician	no trial arm names this drug
Mycobacterium chelonae infection	165	162.2 136.4–192.8ROR 162.9 · calibrated p 3e-9 ✓	123.8 EB05 108.8 · IC025 +6.3 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=165	no trial arm names this drug
Disseminated aspergillosis	100	152.2 122.0–189.8ROR 152.6 · calibrated p 6e-9 ✓	116.9 EB05 98.9 · IC025 +5.9 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=100 · ♀ 0% (drug 52%)	no trial arm names this drug
Meningitis tuberculous	116	145.6 118.7–178.6ROR 146.1 · calibrated p 8e-9 ✓	113.3 EB05 97.1 · IC025 +6.0 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=116 · ♀ 0% (drug 52%)	no trial arm names this drug
Delayed engraftment	26	140.8 91.5–216.5ROR 140.9 · calibrated p 3e-8 ✓	104.0 EB05 74.6 · IC025 +4.5 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=26 · 100% clinician	no trial arm names this drug
Secondary immunodeficiency	233	136.0 117.9–157.0ROR 136.9 · calibrated p 1e-8 ✓	108.4 EB05 97.2 · IC025 +6.3 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Labeled (related wording) related wording	serious n=233 · ♀ 80% (drug 52%)	no trial arm names this drug
Abscess bacterial	68	131.8 101.2–171.7ROR 132.0 · calibrated p 2e-8 ✓	103.6 EB05 84.5 · IC025 +5.5 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=68	no trial arm names this drug
Colony stimulating factor therapy	32	102.2 70.1–149.0ROR 102.3 · calibrated p 2e-7 ✓	82.3 EB05 61.0 · IC025 +4.6 3/3 methods agree vs other Leukocyte Growth Factors: PRR 5.3 (3.5–8.0)	Reporting / coding artifact	serious n=32 · 100% clinician	no trial arm names this drug
Engraft failure	44	102.1 74.0–140.8ROR 102.2 · calibrated p 2e-7 ✓	83.3 EB05 64.6 · IC025 +5.0 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=44 · 100% clinician	no trial arm names this drug
Corona virus infection	59	87.8 66.8–115.6ROR 88.0 · calibrated p 5e-7 ✓	74.2 EB05 59.6 · IC025 +5.1 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=59	no trial arm names this drug
Pseudomonal sepsis	231	84.6 73.7–97.1ROR 85.1 · calibrated p 4e-7 ✓	73.1 EB05 65.5 · IC025 +5.8 3/3 methods agree vs other Leukocyte Growth Factors: PRR 53.5 (39.6–72.2)	Not in label — unassessed	serious n=231	no trial arm names this drug
Computerised tomogram thorax abnormal	75	67.6 53.2–85.9ROR 67.7 · calibrated p 3e-6 ✓	59.5 EB05 49.0 · IC025 +5.1 3/3 methods agree vs other Leukocyte Growth Factors: PRR 12.2 (8.8–16.8)	Not in label — unassessed	serious n=75 · ♀ 100% (drug 52%) · 95% clinician	no trial arm names this drug
Blood stem cell transplant failure	23	66.9 43.4–103.1ROR 66.9 · calibrated p 5e-6 ✓	57.1 EB05 40.1 · IC025 +4.0 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Likely indication confounding shares a disease stem with the indications wording	serious n=23 · 100% clinician	no trial arm names this drug
Parainfluenzae virus infection	162	65.5 55.7–77.1ROR 65.8 · calibrated p 3e-6 ✓	58.3 EB05 51.1 · IC025 +5.4 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=161	no trial arm names this drug
Cystitis viral	36	58.5 41.5–82.4ROR 58.5 · calibrated p 9e-6 ✓	51.6 EB05 39.0 · IC025 +4.4 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=35	no trial arm names this drug
Aortitis	62	56.0 43.2–72.8ROR 56.1 · calibrated p 9e-6 ✓	50.2 EB05 40.6 · IC025 +4.8 3/3 methods agree vs other Leukocyte Growth Factors: PRR 5.6 (4.1–7.5)	Labeled adverse reaction exact term	serious n=62 · 100% clinician	no trial arm names this drug
Enterobacter infection	148	54.2 45.8–64.1ROR 54.4 · calibrated p 9e-6 ✓	49.1 EB05 42.8 · IC025 +5.1 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=148 · ♀ 76% (drug 52%)	no trial arm names this drug
Human herpesvirus 6 infection	166	53.5 45.6–62.7ROR 53.7 · calibrated p 1e-5 ✓	48.6 EB05 42.7 · IC025 +5.2 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=166 · ♀ 100% (drug 52%)	no trial arm names this drug
Acute myeloid leukaemia recurrent	185	53.3 45.8–61.9ROR 53.5 · calibrated p 1e-5 ✓	48.5 EB05 42.9 · IC025 +5.2 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Labeled (related wording) related wording	serious n=185 · ♀ 27% (drug 52%) · 92% clinician	no trial arm names this drug
Engraftment syndrome	46	47.6 35.2–64.3ROR 47.6 · calibrated p 3e-5 ✓	43.2 EB05 33.7 · IC025 +4.4 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=46 · 100% clinician	no trial arm names this drug
Viraemia	106	46.2 37.9–56.3ROR 46.3 · calibrated p 3e-5 ✓	42.4 EB05 36.0 · IC025 +4.8 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=106	no trial arm names this drug
Neutropenic infection	73	45.8 36.1–58.1ROR 45.9 · calibrated p 3e-5 ✓	41.9 EB05 34.4 · IC025 +4.7 3/3 methods agree vs other Leukocyte Growth Factors: PRR 15.7 (11.1–22.2)	Likely indication confounding shares a disease stem with the indications wording	serious n=73 · ♀ 29% (drug 52%) · 100% clinician	no trial arm names this drug
Nail bed inflammation	22	41.6 27.0–64.2ROR 41.6 · calibrated p 9e-5 ✓	37.6 EB05 26.2 · IC025 +3.7 3/3 methods agree vs other Leukocyte Growth Factors: PRR 11.5 (6.4–20.6)	Not in label — unassessed	serious n=21	no trial arm names this drug
Diffuse alveolar damage	79	41.2 32.8–51.7ROR 41.3 · calibrated p 5e-5 ✓	38.1 EB05 31.5 · IC025 +4.6 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=79	no trial arm names this drug
Febrile neutropenia	4,490	40.7 39.6–41.9ROR 46.2 · calibrated p 2e-5 ✓	38.0 EB05 37.1 · IC025 +5.2 3/3 methods agree vs other Leukocyte Growth Factors: PRR 14.0 (13.4–14.6)	Likely indication confounding term in indications; also in warnings	serious PRR 24.9 · 95% clinician	no trial arm names this drug
Viral haemorrhagic cystitis	44	37.2 27.4–50.5ROR 37.3 · calibrated p 1e-4 ✓	34.5 EB05 26.7 · IC025 +4.2 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=44 · 100% clinician	no trial arm names this drug
Cytomegalovirus viraemia	257	34.9 30.8–39.6ROR 35.2 · calibrated p 1e-4 ✓	32.9 EB05 29.6 · IC025 +4.7 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=256 · ♀ 28% (drug 52%)	no trial arm names this drug
Cytomegalovirus chorioretinitis	110	33.9 27.9–41.0ROR 34.0 · calibrated p 2e-4 ✓	31.8 EB05 27.1 · IC025 +4.5 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=110	no trial arm names this drug
Neutropenic sepsis	403	33.4 30.2–36.9ROR 33.8 · calibrated p 1e-4 ✓	31.5 EB05 29.0 · IC025 +4.8 3/3 methods agree vs other Leukocyte Growth Factors: PRR 18.8 (16.1–22.0)	Likely indication confounding shares a disease stem with the indications wording	serious PRR 20.6 · 93% clinician	no trial arm names this drug
Alpha haemolytic streptococcal infection	52	33.2 25.1–43.9ROR 33.2 · calibrated p 2e-4 ✓	31.0 EB05 24.6 · IC025 +4.1 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=52 · 100% clinician	no trial arm names this drug
Neutropenic colitis	114	32.8 27.2–39.6ROR 32.9 · calibrated p 2e-4 ✓	30.9 EB05 26.4 · IC025 +4.5 3/3 methods agree vs other Leukocyte Growth Factors: PRR 17.6 (13.2–23.4)	Likely indication confounding shares a disease stem with the indications wording	serious n=114 · ♀ 31% (drug 52%) · 100% clinician	no trial arm names this drug
Diffuse large b-cell lymphoma refractory	50	31.8 23.9–42.3ROR 31.9 · calibrated p 2e-4 ✓	29.8 EB05 23.5 · IC025 +4.1 3/3 methods agree vs other Leukocyte Growth Factors: only this drug	Not in label — unassessed	serious n=50 · ♀ 74% (drug 52%)	no trial arm names this drug
Staphylococcal bacteraemia	232	31.7 27.8–36.1ROR 31.9 · calibrated p 2e-4 ✓	29.9 EB05 26.8 · IC025 +4.6 3/3 methods agree vs other Leukocyte Growth Factors: PRR 22.0 (17.7–27.3)	Not in label — unassessed	serious n=230 · ♀ 73% (drug 52%)	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Filgrastim only as a background or rescue medication (NCT00070564, NCT00014222); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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	4,490	40.7 39.6–41.9ROR 46.2 · calibrated p 2e-5 ✓	38.0 EB05 37.1 · IC025 +5.2 3/3 methods agree vs other Leukocyte Growth Factors: PRR 14.0 (13.4–14.6)	Likely indication confounding term in indications; also in warnings	serious PRR 24.9 · 95% clinician	no trial arm names this drug
Neutropenia (low neutrophils (infection-fighting cells))	3,519	14.9 14.5–15.4ROR 16.4 · calibrated p 0.005 ✓	14.6 EB05 14.2 · IC025 +3.8 3/3 methods agree vs other Leukocyte Growth Factors: PRR 14.9 (14.2–15.6)	Likely indication confounding term in indications; also in warnings	serious PRR 9.8 · 92% clinician	no trial arm names this drug
Off label use (used outside approved label)	3,149	2.0 2.0–2.1ROR 2.1 · calibrated p 0.985	2.0 EB05 2.0 · IC025 +1.0 vs other Leukocyte Growth Factors: PRR 10.0 (9.6–10.5)	Reporting / coding artifact	serious PRR 2.0 · 90% clinician	no trial arm names this drug
Pyrexia (fever)	2,902	4.7 4.6–4.9ROR 5.0 · calibrated p 0.230	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Leukocyte Growth Factors: PRR 13.9 (13.2–14.7)	Labeled adverse reaction exact term	serious PRR 3.7	no trial arm names this drug
Death	2,283	1.5 1.4–1.5ROR 1.5 · calibrated p 0.654	1.5 EB05 1.4 · IC025 +0.5 vs other Leukocyte Growth Factors: PRR 8.0 (7.6–8.5)	Outcome field, not a reaction	serious PRR 1.0	no trial arm names this drug
Diarrhoea (diarrhea)	2,277	2.0 1.9–2.1ROR 2.1 · calibrated p 0.973	2.0 EB05 1.9 · IC025 +0.9 vs other Leukocyte Growth Factors: PRR 13.8 (13.0–14.6)	Labeled adverse reaction exact term	serious PRR 2.1	no trial arm names this drug
Nausea	2,053	1.5 1.4–1.5ROR 1.5 · calibrated p 0.633	1.5 EB05 1.4 · IC025 +0.5 vs other Leukocyte Growth Factors: PRR 10.0 (9.4–10.5)	Labeled adverse reaction exact term	serious PRR 1.7	no trial arm names this drug
Thrombocytopenia (low platelets)	1,998	10.2 9.8–10.7ROR 10.7 · calibrated p 0.025 ✓	10.0 EB05 9.7 · IC025 +3.3 3/3 methods agree vs other Leukocyte Growth Factors: PRR 21.2 (19.7–22.8)	Labeled adverse reaction exact term	serious PRR 6.7 · 93% clinician	no trial arm names this drug
Pneumonia (lung infection)	1,902	3.3 3.2–3.5ROR 3.4 · calibrated p 0.500	3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree vs other Leukocyte Growth Factors: PRR 20.9 (19.4–22.5)	Labeled (related wording) related wording	serious PRR 2.2	no trial arm names this drug
Fatigue (tiredness)	1,845	1.3 1.3–1.4ROR 1.3 · calibrated p 0.542	1.3 EB05 1.3 · IC025 +0.3 vs other Leukocyte Growth Factors: PRR 8.4 (7.9–8.9)	Labeled adverse reaction exact term	serious PRR 1.4	no trial arm names this drug
Anaemia (low red blood cells)	1,811	5.4 5.1–5.6ROR 5.6 · calibrated p 0.180	5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other Leukocyte Growth Factors: PRR 15.2 (14.2–16.3)	Labeled adverse reaction exact term	serious PRR 3.7	no trial arm names this drug
Sepsis (blood infection)	1,508	7.7 7.3–8.1ROR 7.9 · calibrated p 0.068	7.6 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Leukocyte Growth Factors: PRR 23.9 (21.9–26.1)	Labeled adverse reaction exact term	serious PRR 5.0 · 90% clinician	no trial arm names this drug
Vomiting	1,477	1.8 1.7–1.9ROR 1.8 · calibrated p 0.830	1.8 EB05 1.7 · IC025 +0.7 vs other Leukocyte Growth Factors: PRR 12.4 (11.6–13.3)	Labeled adverse reaction exact term	serious PRR 1.6	no trial arm names this drug
White blood cell count decreased	1,434	7.5 7.1–7.9ROR 7.8 · calibrated p 0.073	7.4 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other Leukocyte Growth Factors: PRR 12.0 (11.1–12.8)	Labeled (related wording) related wording	serious PRR 5.8	no trial arm names this drug
Pancytopenia (all blood cells low)	1,344	13.8 13.1–14.6ROR 14.3 · calibrated p 0.008 ✓	13.5 EB05 12.9 · IC025 +3.7 3/3 methods agree vs other Leukocyte Growth Factors: PRR 28.7 (26.1–31.7)	Labeled (related wording) related wording	serious PRR 8.9 · 91% clinician	no trial arm names this drug

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.

Lymphoid tissue hypoplasia — n=145, PRR 40,045.7
Thymus hypoplasia — n=143, PRR 2,925.4
Human bocavirus infection — n=124, PRR 1,070.2
Computerised tomogram thorax — n=39, PRR 1,025.8
Blood stem cell harvest failure — n=66, PRR 450.1
Cystitis bacterial — n=110, PRR 268.8
Neuroblastoma recurrent — n=50, PRR 185.4
Mycobacterium chelonae infection — n=165, PRR 162.2
Disseminated aspergillosis — n=100, PRR 152.2
Meningitis tuberculous — n=116, PRR 145.6

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?

In FDA FAERS, the most frequently co-reported reaction terms for Filgrastim are febrile neutropenia, neutropenia, pyrexia, diarrhoea, nausea, thrombocytopenia. 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 have an FDA boxed warning?

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

Do FAERS signals prove that 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

FDA label via openFDA (set ID 74e1ec6e-1630-4654-895c-2bd355f939e7, effective 20250424; matched on openfda.generic_name.exact:"FILGRASTIM")
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, 1,270 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
ClinicalTrials.gov API v2 (query FILGRASTIM, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.