Lisocabtagene Maraleucel side effects: what 846 FDA adverse event reports show

Lisocabtagene Maraleucel · Breyanzi · 17 reaction terms · 652 drug–reaction co-reports · data 2026-09-14

Drug class

Cd19-directed genetically modified autologous t cell immunotherapy

FDA label, Indications wording

Brand names

Breyanzi

openFDA label

Who reports

846 reports · 89% serious · 151 with death outcome · 38% female

openFDA FAERS counts, all years, deduplication not applied

Used for

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: • adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBC.

FDA label, Indications and Usage

What it is

BREYANZI (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous T cell immunotherapy administered as a defined composition of CAR-positive viable T cells (consisting of CD8 and CD4 components).

FDA label, Description section

Boxed warning

CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders.

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 15 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 6Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 3

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.
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. 2 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
Cytokine release syndrome	352	466.6 430.2–506.0ROR 798.3 · χ² 160,161 / p <1e-300	446.7 EB05 408.9 · IC025 +7.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 279.9 · 94% clinician	no trial data cached
Neurotoxicity	104	149.2 124.6–178.8ROR 170.0 · χ² 15,086 / p <1e-300	144.5 EB05 122.6 · IC025 +6.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 88.5	no trial data cached
Encephalopathy	21	21.3 13.9–32.4ROR 21.8 · χ² 386 / p 4e-86	20.9 EB05 14.3 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.5	no trial data cached
Myelodysplastic syndrome	12	20.6 11.7–36.1ROR 20.8 · χ² 204 / p 1e-46	19.7 EB05 11.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Aphasia (loss of speech)	25	20.5 13.9–30.1ROR 21.1 · χ² 444 / p 7e-99	20.1 EB05 14.3 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.2 · ♀ 58% (drug 38%)	no trial data cached
Lymphocyte count decreased	14	19.6 11.7–33.0ROR 19.9 · χ² 229 / p 4e-52	18.9 EB05 11.6 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.5	no trial data cached
Covid-19 pneumonia	8	16.7 8.4–33.3ROR 16.8 · χ² 103 / p 2e-24	14.5 EB05 6.4 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.9	no trial data cached
Full blood count decreased	13	16.0 9.3–27.4ROR 16.2 · χ² 168 / p 1e-38	15.0 EB05 8.5 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 14.9	no trial data cached
Cytopenia	7	14.5 6.9–30.4ROR 14.6 · χ² 75 / p 2e-18	11.6 EB05 4.8 · IC025 +1.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 9.7	no trial data cached
Incontinence	6	14.0 6.3–31.2ROR 14.1 · χ² 60 / p 4e-15	10.4 EB05 4.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Acute myeloid leukaemia	8	12.7 6.4–25.4ROR 12.9 · χ² 75 / p 2e-18	10.1 EB05 4.6 · IC025 +1.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 8.3	no trial data cached
Neutrophil count decreased	17	10.4 6.5–16.7ROR 10.6 · χ² 135 / p 1e-31	9.2 EB05 5.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.8	no trial data cached
Febrile neutropenia	26	9.7 6.7–14.2ROR 10.0 · χ² 196 / p 9e-45	8.9 EB05 6.2 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.3 · 92% clinician	no trial data cached
Cytomegalovirus infection	6	8.9 4.0–19.9ROR 9.0 · χ² 35 / p 2e-9	6.1 EB05 2.8 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Malignant neoplasm progression	24	5.8 3.9–8.7ROR 6.0 · χ² 92 / p 4e-22	5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8	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
Cytokine release syndrome	352	466.6 430.2–506.0ROR 798.3 · χ² 160,161 / p <1e-300	446.7 EB05 408.9 · IC025 +7.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 279.9 · 94% clinician	no trial data cached
Neurotoxicity	104	149.2 124.6–178.8ROR 170.0 · χ² 15,086 / p <1e-300	144.5 EB05 122.6 · IC025 +6.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 88.5	no trial data cached
Febrile neutropenia	26	9.7 6.7–14.2ROR 10.0 · χ² 196 / p 9e-45	8.9 EB05 6.2 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.3 · 92% clinician	no trial data cached
Aphasia (loss of speech)	25	20.5 13.9–30.1ROR 21.1 · χ² 444 / p 7e-99	20.1 EB05 14.3 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.2 · ♀ 58% (drug 38%)	no trial data cached
Malignant neoplasm progression	24	5.8 3.9–8.7ROR 6.0 · χ² 92 / p 4e-22	5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8	no trial data cached
Encephalopathy	21	21.3 13.9–32.4ROR 21.8 · χ² 386 / p 4e-86	20.9 EB05 14.3 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.5	no trial data cached
Neutrophil count decreased	17	10.4 6.5–16.7ROR 10.6 · χ² 135 / p 1e-31	9.2 EB05 5.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.8	no trial data cached
Lymphocyte count decreased	14	19.6 11.7–33.0ROR 19.9 · χ² 229 / p 4e-52	18.9 EB05 11.6 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.5	no trial data cached
Full blood count decreased	13	16.0 9.3–27.4ROR 16.2 · χ² 168 / p 1e-38	15.0 EB05 8.5 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 14.9	no trial data cached
Myelodysplastic syndrome	12	20.6 11.7–36.1ROR 20.8 · χ² 204 / p 1e-46	19.7 EB05 11.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Acute myeloid leukaemia	8	12.7 6.4–25.4ROR 12.9 · χ² 75 / p 2e-18	10.1 EB05 4.6 · IC025 +1.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 8.3	no trial data cached
Covid-19 pneumonia	8	16.7 8.4–33.3ROR 16.8 · χ² 103 / p 2e-24	14.5 EB05 6.4 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.9	no trial data cached
Cytopenia	7	14.5 6.9–30.4ROR 14.6 · χ² 75 / p 2e-18	11.6 EB05 4.8 · IC025 +1.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 9.7	no trial data cached
Prostate cancer	6	1.8 0.8–4.1ROR 1.8 · χ² 2 / p 0.109	1.7 EB05 0.9 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.2	no trial data cached
Cytomegalovirus infection	6	8.9 4.0–19.9ROR 9.0 · χ² 35 / p 2e-9	6.1 EB05 2.8 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	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 Lisocabtagene Maraleucel?

In FDA FAERS, the most frequently co-reported reaction terms for Lisocabtagene Maraleucel are cytokine release syndrome, neurotoxicity, febrile neutropenia, aphasia, encephalopathy, 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 Lisocabtagene Maraleucel have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders.

Do FAERS signals prove that Lisocabtagene Maraleucel 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 594bb413-af3b-4b97-afb3-bfe2b174f2ed, effective 20260220; matched on openfda.generic_name.exact:"LISOCABTAGENE MARALEUCEL")
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, 17 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.