Gilteritinib side effects: what 1,340 FDA adverse event reports show

Gilteritinib · 120 reaction terms · 6,378 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

1,340 reports · 97% serious · 348 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

—

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 8No label text to screen 30

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. 80 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
Acute myeloid leukaemia	341	119.3 107.7–132.2ROR 130.5 · χ² 39,033 / p <1e-300	115.9 EB05 106.0 · IC025 +6.5 3/3 methods agree	No label text to screen	–	no trial data cached
Cytopenia	162	73.2 62.9–85.2ROR 76.3 · χ² 11,317 / p <1e-300	71.6 EB05 62.9 · IC025 +5.6 3/3 methods agree	No label text to screen	–	no trial data cached
Myelosuppression	295	46.6 41.7–52.0ROR 50.3 · χ² 13,025 / p <1e-300	46.1 EB05 41.8 · IC025 +5.2 3/3 methods agree	No label text to screen	–	no trial data cached
Bacteraemia	56	25.5 19.6–33.1ROR 25.8 · χ² 1,287 / p 5e-282	25.2 EB05 20.1 · IC025 +3.9 3/3 methods agree	No label text to screen	–	no trial data cached
Febrile neutropenia	243	19.6 17.4–22.2ROR 20.8 · χ² 4,274 / p <1e-300	19.5 EB05 17.6 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Blood lactate dehydrogenase increased	54	18.1 13.9–23.6ROR 18.3 · χ² 853 / p 7e-188	17.9 EB05 14.2 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Hepatic function abnormal	125	18.0 15.2–21.4ROR 18.6 · χ² 1,990 / p <1e-300	17.9 EB05 15.4 · IC025 +3.8 3/3 methods agree	No label text to screen	–	no trial data cached
Neutrophil count decreased	134	17.7 15.0–20.9ROR 18.3 · χ² 2,089 / p <1e-300	17.6 EB05 15.2 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Electrocardiogram qt prolonged	108	16.0 13.3–19.3ROR 16.5 · χ² 1,506 / p <1e-300	15.9 EB05 13.6 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Platelet count decreased	286	14.3 12.8–16.0ROR 15.4 · χ² 3,545 / p <1e-300	14.3 EB05 12.9 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Full blood count decreased	52	13.8 10.5–18.1ROR 13.9 · χ² 602 / p 3e-133	13.6 EB05 10.6 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Pancytopenia (all blood cells low)	122	11.7 9.8–13.9ROR 12.0 · χ² 1,182 / p 2e-259	11.6 EB05 9.9 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Blood creatine phosphokinase increased	61	11.1 8.7–14.3ROR 11.3 · χ² 552 / p 2e-122	10.8 EB05 8.6 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Hepatotoxicity (liver damage)	46	11.1 8.3–14.8ROR 11.2 · χ² 411 / p 9e-92	10.7 EB05 8.2 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Hepatic cytolysis	24	10.5 7.0–15.6ROR 10.5 · χ² 196 / p 7e-45	9.6 EB05 6.5 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Bone marrow failure	39	10.2 7.4–13.9ROR 10.3 · χ² 313 / p 2e-70	9.7 EB05 7.2 · IC025 +2.7 3/3 methods agree	No label text to screen	–	no trial data cached
Septic shock	77	9.5 7.6–11.9ROR 9.7 · χ² 578 / p 5e-128	9.2 EB05 7.6 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Haematotoxicity	16	9.2 5.6–15.0ROR 9.2 · χ² 109 / p 9e-26	7.9 EB05 4.9 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Multiple organ dysfunction syndrome	48	9.2 6.9–12.2ROR 9.3 · χ² 342 / p 1e-76	8.7 EB05 6.8 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Thrombotic microangiopathy	16	8.8 5.4–14.4ROR 8.8 · χ² 103 / p 2e-24	7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Disseminated intravascular coagulation	23	8.7 5.8–13.1ROR 8.7 · χ² 149 / p 2e-34	7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Liver disorder	69	8.3 6.6–10.5ROR 8.4 · χ² 437 / p 3e-97	8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Underdose	106	7.7 6.4–9.3ROR 7.9 · χ² 617 / p 2e-136	7.5 EB05 6.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Pneumocystis jirovecii pneumonia	14	7.5 4.4–12.6ROR 7.5 · χ² 72 / p 1e-17	6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Transaminases increased	31	7.4 5.2–10.6ROR 7.5 · χ² 167 / p 2e-38	6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Subdural haematoma	20	7.4 4.8–11.5ROR 7.5 · χ² 105 / p 7e-25	6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Thrombocytopenia (low platelets)	150	7.2 6.1–8.4ROR 7.4 · χ² 794 / p 4e-175	7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Bacterial infection	24	6.9 4.6–10.3ROR 6.9 · χ² 115 / p 4e-27	6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Product use issue	231	6.6 5.8–7.5ROR 6.9 · χ² 1,098 / p 4e-241	6.5 EB05 5.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Ejection fraction decreased	19	6.5 4.2–10.2ROR 6.5 · χ² 83 / p 4e-20	5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	–	no trial data cached
White blood cell count increased	45	6.2 4.7–8.3ROR 6.3 · χ² 193 / p 4e-44	5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Leukaemia	11	6.2 3.4–11.2ROR 6.2 · χ² 43 / p 3e-11	5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Leukocytosis	21	6.2 4.0–9.5ROR 6.2 · χ² 86 / p 8e-21	5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Posterior reversible encephalopathy syndrome	11	6.2 3.4–11.1ROR 6.2 · χ² 43 / p 3e-11	5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Sepsis (blood infection)	128	6.1 5.2–7.3ROR 6.3 · χ² 545 / p 7e-121	6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Melaena (black stool)	24	5.8 3.9–8.6ROR 5.8 · χ² 91 / p 9e-22	5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Infection	156	5.8 4.9–6.7ROR 6.0 · χ² 614 / p 7e-136	5.7 EB05 5.0 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Liver function test increased	23	5.8 3.8–8.6ROR 5.8 · χ² 86 / p 1e-20	5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
White blood cell count decreased	115	5.7 4.7–6.8ROR 5.8 · χ² 438 / p 2e-97	5.5 EB05 4.7 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	138	5.4 4.6–6.4ROR 5.6 · χ² 497 / p 2e-110	5.3 EB05 4.6 · IC025 +2.1 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
Off label use (used outside approved label)	487	3.0 2.8–3.3ROR 3.3 · χ² 671 / p 3e-148	3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Acute myeloid leukaemia	341	119.3 107.7–132.2ROR 130.5 · χ² 39,033 / p <1e-300	115.9 EB05 106.0 · IC025 +6.5 3/3 methods agree	No label text to screen	–	no trial data cached
Myelosuppression	295	46.6 41.7–52.0ROR 50.3 · χ² 13,025 / p <1e-300	46.1 EB05 41.8 · IC025 +5.2 3/3 methods agree	No label text to screen	–	no trial data cached
Platelet count decreased	286	14.3 12.8–16.0ROR 15.4 · χ² 3,545 / p <1e-300	14.3 EB05 12.9 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Pneumonia (lung infection)	272	4.5 4.0–5.0ROR 4.7 · χ² 745 / p 3e-164	4.5 EB05 4.0 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Death	268	1.7 1.5–1.9ROR 1.7 · χ² 72 / p 9e-18	1.7 EB05 1.5 · IC025 +0.5	Outcome field, not a reaction	–	no trial data cached
Pyrexia (fever)	257	4.0 3.5–4.5ROR 4.2 · χ² 574 / p 3e-127	3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Febrile neutropenia	243	19.6 17.4–22.2ROR 20.8 · χ² 4,274 / p <1e-300	19.5 EB05 17.6 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Product use issue	231	6.6 5.8–7.5ROR 6.9 · χ² 1,098 / p 4e-241	6.5 EB05 5.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Cytopenia	162	73.2 62.9–85.2ROR 76.3 · χ² 11,317 / p <1e-300	71.6 EB05 62.9 · IC025 +5.6 3/3 methods agree	No label text to screen	–	no trial data cached
Infection	156	5.8 4.9–6.7ROR 6.0 · χ² 614 / p 7e-136	5.7 EB05 5.0 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Thrombocytopenia (low platelets)	150	7.2 6.1–8.4ROR 7.4 · χ² 794 / p 4e-175	7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	138	5.4 4.6–6.4ROR 5.6 · χ² 497 / p 2e-110	5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Neutrophil count decreased	134	17.7 15.0–20.9ROR 18.3 · χ² 2,089 / p <1e-300	17.6 EB05 15.2 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Sepsis (blood infection)	128	6.1 5.2–7.3ROR 6.3 · χ² 545 / p 7e-121	6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree	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 Gilteritinib?

In FDA FAERS, the most frequently co-reported reaction terms for Gilteritinib are acute myeloid leukaemia, myelosuppression, platelet count decreased, pneumonia, pyrexia, febrile neutropenia. 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 Gilteritinib 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 Gilteritinib 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, 120 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.