Dinutuximab side effects: what 832 FDA adverse event reports show

Dinutuximab · Unituxin · 44 reaction terms · 810 drug–reaction co-reports · data 2026-09-14

Drug class

Glycolipid Disialoganglioside-directed Antibody

FDA label (Established Pharmacologic Class)

Brand names

Unituxin

openFDA label

Who reports

832 reports · 88% serious · 168 with death outcome · 39% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy .

FDA label, Indications and Usage

What it is

Dinutuximab is a glycolipid disialoganglioside (GD2)-binding chimeric monoclonal antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG 1 and light chain kappa.

FDA label, Description section

Boxed warning

SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication.

FDA 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 30 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 5Labeled (related wording) 5Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 14

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
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. 14 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
Nerve compression	25	68.6 46.6–100.9ROR 70.7 · χ² 1,594 / p <1e-300	65.1 EB05 46.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 60.4 · ♀ 0% (drug 39%)	no trial data cached
Thrombotic microangiopathy	25	65.2 44.3–96.0ROR 67.2 · χ² 1,514 / p <1e-300	62.1 EB05 44.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 42.5 · 100% clinician	no trial data cached
Mydriasis	22	43.3 28.7–65.5ROR 44.5 · χ² 867 / p 8e-191	41.8 EB05 29.1 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.0	no trial data cached
Eyelid oedema	19	41.0 26.3–63.9ROR 41.9 · χ² 701 / p 1e-154	39.4 EB05 26.7 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 39.2	no trial data cached
Gamma-glutamyltransferase increased	36	41.0 29.8–56.4ROR 42.8 · χ² 1,363 / p 1e-298	40.1 EB05 30.3 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious PRR 27.9 · 97% clinician	no trial data cached
Posterior reversible encephalopathy syndrome	15	39.8 24.1–65.7ROR 40.5 · χ² 528 / p 3e-117	38.0 EB05 24.4 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 26.0	no trial data cached
Leukocytosis	27	37.7 26.0–54.6ROR 38.9 · χ² 927 / p 6e-204	36.7 EB05 26.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.2 · ♀ 8% (drug 39%)	no trial data cached
Hypoxia (low oxygen)	48	34.5 26.2–45.5ROR 36.6 · χ² 1,530 / p <1e-300	34.1 EB05 26.7 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.9 · 100% clinician	no trial data cached
Face oedema	23	34.3 22.9–51.3ROR 35.2 · χ² 709 / p 1e-156	33.4 EB05 23.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.0 · 100% clinician	no trial data cached
Metastases to liver	23	33.1 22.1–49.5ROR 34.0 · χ² 684 / p 5e-151	32.3 EB05 22.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 21.7 · ♀ 0% (drug 39%)	no trial data cached
Therapy partial responder	18	30.2 19.1–47.6ROR 30.8 · χ² 478 / p 2e-106	29.3 EB05 19.6 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 23.9	no trial data cached
Aspartate aminotransferase increased	63	29.9 23.6–38.0ROR 32.3 · χ² 1,736 / p <1e-300	29.7 EB05 24.0 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.7 · 98% clinician	no trial data cached
Device related infection	18	29.4 18.6–46.5ROR 30.1 · χ² 466 / p 1e-103	28.6 EB05 19.1 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 19.7	no trial data cached
Hyperbilirubinaemia	11	26.9 15.0–48.5ROR 27.3 · χ² 249 / p 2e-56	25.7 EB05 15.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.9	no trial data cached
Clostridium difficile colitis	11	26.1 14.5–47.0ROR 26.5 · χ² 241 / p 1e-54	25.0 EB05 14.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.4	no trial data cached
Alanine aminotransferase increased	61	25.0 19.7–31.9ROR 27.0 · χ² 1,387 / p <1e-300	24.9 EB05 20.0 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.2 · 98% clinician	no trial data cached
Urinary retention	30	22.7 16.0–32.3ROR 23.5 · χ² 602 / p 3e-133	22.4 EB05 16.4 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 15.6 · 97% clinician	no trial data cached
Myelodysplastic syndrome	12	20.9 11.9–36.7ROR 21.2 · χ² 208 / p 2e-47	20.0 EB05 11.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.8	no trial data cached
Respiratory depression	10	20.6 11.1–38.1ROR 20.8 · χ² 167 / p 2e-38	19.4 EB05 10.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.8	no trial data cached
Neoplasm progression	27	19.4 13.4–28.1ROR 20.0 · χ² 453 / p 7e-101	19.1 EB05 13.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.9 · ♀ 10% (drug 39%)	no trial data cached
Respiratory distress	21	19.2 12.6–29.3ROR 19.6 · χ² 344 / p 4e-77	18.8 EB05 12.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.7 · 100% clinician	no trial data cached
Neutrophil count decreased	30	18.7 13.1–26.5ROR 19.3 · χ² 485 / p 9e-108	18.4 EB05 13.4 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.7 · 97% clinician	no trial data cached
C-reactive protein increased	25	17.3 11.8–25.5ROR 17.8 · χ² 369 / p 2e-82	17.0 EB05 11.9 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 11.8 · 100% clinician	no trial data cached
Bone marrow failure	14	17.3 10.3–29.0ROR 17.5 · χ² 199 / p 2e-45	16.5 EB05 9.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Pallor	18	16.6 10.5–26.3ROR 17.0 · χ² 249 / p 2e-56	16.1 EB05 10.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.2	no trial data cached
Pancytopenia (all blood cells low)	33	14.9 10.7–20.9ROR 15.5 · χ² 416 / p 9e-93	14.7 EB05 10.7 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.8 · 100% clinician	no trial data cached
Mental status changes	16	14.5 8.9–23.6ROR 14.8 · χ² 188 / p 4e-43	13.7 EB05 8.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Proteinuria	10	13.4 7.2–24.8ROR 13.5 · χ² 102 / p 2e-24	11.5 EB05 5.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.8	no trial data cached
Pulmonary hypertension	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	Labeled (related wording) related wording	serious PRR 8.8	no trial data cached
Oxygen saturation decreased	28	12.7 8.8–18.2ROR 13.1 · χ² 290 / p 3e-65	12.1 EB05 8.5 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.8 · 100% clinician	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
Aspartate aminotransferase increased	63	29.9 23.6–38.0ROR 32.3 · χ² 1,736 / p <1e-300	29.7 EB05 24.0 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.7 · 98% clinician	no trial data cached
Alanine aminotransferase increased	61	25.0 19.7–31.9ROR 27.0 · χ² 1,387 / p <1e-300	24.9 EB05 20.0 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.2 · 98% clinician	no trial data cached
Hypoxia (low oxygen)	48	34.5 26.2–45.5ROR 36.6 · χ² 1,530 / p <1e-300	34.1 EB05 26.7 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.9 · 100% clinician	no trial data cached
Gamma-glutamyltransferase increased	36	41.0 29.8–56.4ROR 42.8 · χ² 1,363 / p 1e-298	40.1 EB05 30.3 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious PRR 27.9 · 97% clinician	no trial data cached
Pancytopenia (all blood cells low)	33	14.9 10.7–20.9ROR 15.5 · χ² 416 / p 9e-93	14.7 EB05 10.7 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.8 · 100% clinician	no trial data cached
Neutrophil count decreased	30	18.7 13.1–26.5ROR 19.3 · χ² 485 / p 9e-108	18.4 EB05 13.4 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.7 · 97% clinician	no trial data cached
Urinary retention	30	22.7 16.0–32.3ROR 23.5 · χ² 602 / p 3e-133	22.4 EB05 16.4 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 15.6 · 97% clinician	no trial data cached
Oxygen saturation decreased	28	12.7 8.8–18.2ROR 13.1 · χ² 290 / p 3e-65	12.1 EB05 8.5 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.8 · 100% clinician	no trial data cached
Neoplasm progression	27	19.4 13.4–28.1ROR 20.0 · χ² 453 / p 7e-101	19.1 EB05 13.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.9 · ♀ 10% (drug 39%)	no trial data cached
Leukocytosis	27	37.7 26.0–54.6ROR 38.9 · χ² 927 / p 6e-204	36.7 EB05 26.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.2 · ♀ 8% (drug 39%)	no trial data cached
C-reactive protein increased	25	17.3 11.8–25.5ROR 17.8 · χ² 369 / p 2e-82	17.0 EB05 11.9 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 11.8 · 100% clinician	no trial data cached
Thrombotic microangiopathy	25	65.2 44.3–96.0ROR 67.2 · χ² 1,514 / p <1e-300	62.1 EB05 44.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 42.5 · 100% clinician	no trial data cached
Nerve compression	25	68.6 46.6–100.9ROR 70.7 · χ² 1,594 / p <1e-300	65.1 EB05 46.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 60.4 · ♀ 0% (drug 39%)	no trial data cached
Metastases to liver	23	33.1 22.1–49.5ROR 34.0 · χ² 684 / p 5e-151	32.3 EB05 22.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 21.7 · ♀ 0% (drug 39%)	no trial data cached
Face oedema	23	34.3 22.9–51.3ROR 35.2 · χ² 709 / p 1e-156	33.4 EB05 23.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.0 · 100% clinician	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.

Nerve compression — n=25, PRR 68.6
Thrombotic microangiopathy — n=25, PRR 65.2
Leukocytosis — n=27, PRR 37.7
Face oedema — n=23, PRR 34.3
Metastases to liver — n=23, PRR 33.1
Neoplasm progression — n=27, PRR 19.4
Respiratory distress — n=21, PRR 19.2

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 Dinutuximab?

In FDA FAERS, the most frequently co-reported reaction terms for Dinutuximab are aspartate aminotransferase increased, alanine aminotransferase increased, hypoxia, gamma-glutamyltransferase increased, pancytopenia, neutrophil count decreased. 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 Dinutuximab have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication.

Do FAERS signals prove that Dinutuximab 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 d66bdf0d-9d65-45de-ae5b-a58617c27492, effective 20260706; matched on openfda.generic_name.exact:"DINUTUXIMAB")
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, 44 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.