Tagraxofusp side effects: what 520 FDA adverse event reports show

Tagraxofusp · Elzonris · 4 reaction terms · 63 drug–reaction co-reports · data 2026-09-14

Drug class

CD123 Interaction, Cytotoxin

FDA label (Established Pharmacologic Class)

Brand names

Elzonris

openFDA label

Who reports

520 reports · 85% serious · 156 with death outcome · 22% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 )

FDA label, Indications and Usage

What it is

Tagraxofusp-erzs, a CD123-directed cytotoxin, is a fusion protein comprised of a recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT). Tagraxofusp-erzs has an approximate molecular weight of 57,695 Daltons.

FDA label, Description section

Boxed warning

CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning.

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 4 strongest signals

Labeled — boxed warning 1Labeled (related wording) 2Not in label — unassessed 1

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 (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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. 0 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
Transaminases increased	22	40.0 26.5–60.2ROR 41.7 · χ² 797 / p 1e-175	38.7 EB05 26.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 27.6 · 95% clinician	no trial data cached
Liver function test increased	19	36.0 23.1–55.9ROR 37.3 · χ² 611 / p 3e-135	34.8 EB05 23.5 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.1	no trial data cached
Hepatotoxicity (liver damage)	14	25.5 15.2–42.7ROR 26.2 · χ² 305 / p 1e-68	24.7 EB05 15.5 · IC025 +2.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.7	no trial data cached
Neoplasm progression	8	9.2 4.6–18.3ROR 9.3 · χ² 51 / p 6e-13	6.8 EB05 3.5 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	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
Transaminases increased	22	40.0 26.5–60.2ROR 41.7 · χ² 797 / p 1e-175	38.7 EB05 26.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 27.6 · 95% clinician	no trial data cached
Liver function test increased	19	36.0 23.1–55.9ROR 37.3 · χ² 611 / p 3e-135	34.8 EB05 23.5 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.1	no trial data cached
Hepatotoxicity (liver damage)	14	25.5 15.2–42.7ROR 26.2 · χ² 305 / p 1e-68	24.7 EB05 15.5 · IC025 +2.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.7	no trial data cached
Neoplasm progression	8	9.2 4.6–18.3ROR 9.3 · χ² 51 / p 6e-13	6.8 EB05 3.5 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	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 Tagraxofusp?

In FDA FAERS, the most frequently co-reported reaction terms for Tagraxofusp are transaminases increased, liver function test increased, hepatotoxicity, neoplasm progression. 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 Tagraxofusp have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning.

Do FAERS signals prove that Tagraxofusp 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 80eb1080-fe20-4af0-b2a5-a67999923fa8, effective 20241209; matched on openfda.generic_name.exact:"TAGRAXOFUSP")
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, 4 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.