Brexucabtagene Autoleucel side effects: what 2,073 FDA adverse event reports show
Drug class
Cd19-directed genetically modified autologous t cell immunotherapy
Brand names
Tecartus
Who reports
2,073 reports · 96% serious · 581 with death outcome · 27% female
Used for
TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 1.1 Mantle Cell Lymphoma TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
What it is
TECARTUS (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare TECARTUS, a patient's own T cells are harvested and genetically modifie.
Boxed warning
CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS to patients with active infection or inflammatory disorders.
Causality screen of the 29 strongest signals
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. 20 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 917 | 511.7 486.5–538.2ROR 916.8 · χ² 444,512 / p <1e-300 | 481.9 EB05 456.3 · IC025 +8.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 291.7 · 97% clinician | no trial data cached |
| Neurotoxicity | 201 | 118.4 103.7–135.1ROR 131.0 · χ² 23,023 / p <1e-300 | 115.7 EB05 102.9 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 67.5 · 94% clinician | no trial data cached |
| Myelodysplastic syndrome | 60 | 42.1 32.8–54.1ROR 43.3 · χ² 2,358 / p <1e-300 | 41.4 EB05 33.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 · 100% clinician | no trial data cached |
| Basal cell carcinoma | 42 | 27.3 20.2–36.8ROR 27.8 · χ² 1,035 / p 2e-227 | 26.9 EB05 20.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · 100% clinician | no trial data cached |
| Cytopenia | 30 | 25.5 17.8–36.3ROR 25.8 · χ² 679 / p 5e-150 | 25.0 EB05 18.4 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.8 · 93% clinician | no trial data cached |
| Encephalopathy | 53 | 21.9 16.8–28.6ROR 22.5 · χ² 1,037 / p 9e-228 | 21.7 EB05 17.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 · 98% clinician | no trial data cached |
| Brain oedema | 21 | 16.8 11.0–25.8ROR 17.0 · χ² 297 / p 7e-67 | 16.4 EB05 11.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.2 · ♀ 52% (drug 27%) | no trial data cached |
| Aphasia (loss of speech) | 45 | 15.1 11.3–20.1ROR 15.4 · χ² 576 / p 1e-127 | 14.9 EB05 11.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 98% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 36 | 13.1 9.4–18.1ROR 13.3 · χ² 389 / p 6e-87 | 12.7 EB05 9.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 · 94% clinician | no trial data cached |
| Febrile neutropenia | 83 | 12.7 10.3–15.7ROR 13.2 · χ² 884 / p 1e-194 | 12.5 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 98% clinician | no trial data cached |
| Hypoxia (low oxygen) | 43 | 12.4 9.2–16.7ROR 12.7 · χ² 440 / p 5e-98 | 12.1 EB05 9.2 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Bacteraemia | 14 | 12.0 7.1–20.3ROR 12.1 · χ² 131 / p 1e-30 | 10.7 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Intestinal perforation | 13 | 11.7 6.8–20.1ROR 11.8 · χ² 117 / p 2e-27 | 10.2 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Hyperbilirubinaemia | 11 | 10.8 6.0–19.5ROR 10.9 · χ² 88 / p 3e-21 | 8.9 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Acute myeloid leukaemia | 16 | 10.4 6.4–17.0ROR 10.5 · χ² 127 / p 1e-29 | 9.1 EB05 5.6 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.9 | no trial data cached |
| Tachypnoea | 13 | 9.7 5.6–16.7ROR 9.8 · χ² 93 / p 3e-22 | 8.1 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 51 | 9.3 7.1–12.2ROR 9.5 · χ² 368 / p 2e-82 | 8.9 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.5 · 98% clinician | no trial data cached |
| Disease progression | 106 | 9.1 7.6–11.0ROR 9.5 · χ² 760 / p 2e-167 | 8.9 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 97% clinician | no trial data cached |
| Mental status changes | 22 | 8.0 5.3–12.1ROR 8.1 · χ² 128 / p 5e-30 | 7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 90% clinician | no trial data cached |
| Delirium | 27 | 7.9 5.4–11.5ROR 8.0 · χ² 156 / p 4e-36 | 7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 96% clinician | no trial data cached |
| Bone marrow failure | 12 | 5.9 3.4–10.4ROR 6.0 · χ² 44 / p 1e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Depressed level of consciousness | 23 | 5.9 3.9–8.9ROR 6.0 · χ² 89 / p 2e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 91% clinician | no trial data cached |
| Septic shock | 25 | 5.9 4.0–8.6ROR 5.9 · χ² 96 / p 6e-23 | 5.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 96% clinician | no trial data cached |
| Lymphocyte count decreased | 10 | 5.7 3.1–10.6ROR 5.7 · χ² 34 / p 2e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 | no trial data cached |
| Hypotension (low blood pressure) | 109 | 5.5 4.6–6.6ROR 5.8 · χ² 401 / p 1e-89 | 5.4 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 95% clinician | no trial data cached |
| Unresponsive to stimuli | 13 | 5.1 3.0–8.8ROR 5.1 · χ² 39 / p 2e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Shock | 11 | 4.9 2.7–8.8ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 53 | 4.0 3.0–5.2ROR 4.0 · χ² 115 / p 4e-27 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 100% clinician | no trial data cached |
| Nervous system disorder | 11 | 3.6 2.0–6.4ROR 3.6 · χ² 18 / p 1e-5 | 3.2 EB05 1.9 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 917 | 511.7 486.5–538.2ROR 916.8 · χ² 444,512 / p <1e-300 | 481.9 EB05 456.3 · IC025 +8.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 291.7 · 97% clinician | no trial data cached |
| Neurotoxicity | 201 | 118.4 103.7–135.1ROR 131.0 · χ² 23,023 / p <1e-300 | 115.7 EB05 102.9 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 67.5 · 94% clinician | no trial data cached |
| Hypotension (low blood pressure) | 109 | 5.5 4.6–6.6ROR 5.8 · χ² 401 / p 1e-89 | 5.4 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 95% clinician | no trial data cached |
| Disease progression | 106 | 9.1 7.6–11.0ROR 9.5 · χ² 760 / p 2e-167 | 8.9 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 97% clinician | no trial data cached |
| Febrile neutropenia | 83 | 12.7 10.3–15.7ROR 13.2 · χ² 884 / p 1e-194 | 12.5 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 98% clinician | no trial data cached |
| Myelodysplastic syndrome | 60 | 42.1 32.8–54.1ROR 43.3 · χ² 2,358 / p <1e-300 | 41.4 EB05 33.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 · 100% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 53 | 4.0 3.0–5.2ROR 4.0 · χ² 115 / p 4e-27 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 100% clinician | no trial data cached |
| Encephalopathy | 53 | 21.9 16.8–28.6ROR 22.5 · χ² 1,037 / p 9e-228 | 21.7 EB05 17.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 · 98% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 51 | 9.3 7.1–12.2ROR 9.5 · χ² 368 / p 2e-82 | 8.9 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.5 · 98% clinician | no trial data cached |
| Aphasia (loss of speech) | 45 | 15.1 11.3–20.1ROR 15.4 · χ² 576 / p 1e-127 | 14.9 EB05 11.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 98% clinician | no trial data cached |
| Hypoxia (low oxygen) | 43 | 12.4 9.2–16.7ROR 12.7 · χ² 440 / p 5e-98 | 12.1 EB05 9.2 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Basal cell carcinoma | 42 | 27.3 20.2–36.8ROR 27.8 · χ² 1,035 / p 2e-227 | 26.9 EB05 20.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · 100% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 36 | 13.1 9.4–18.1ROR 13.3 · χ² 389 / p 6e-87 | 12.7 EB05 9.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 · 94% clinician | no trial data cached |
| Cytopenia | 30 | 25.5 17.8–36.3ROR 25.8 · χ² 679 / p 5e-150 | 25.0 EB05 18.4 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.8 · 93% clinician | no trial data cached |
| Delirium | 27 | 7.9 5.4–11.5ROR 8.0 · χ² 156 / p 4e-36 | 7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 96% 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.
- Myelodysplastic syndrome — n=60, PRR 42.1
- Basal cell carcinoma — n=42, PRR 27.3
- Septic shock — n=25, PRR 5.9
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 Brexucabtagene Autoleucel?
In FDA FAERS, the most frequently co-reported reaction terms for Brexucabtagene Autoleucel are cytokine release syndrome, neurotoxicity, hypotension, febrile neutropenia, myelodysplastic syndrome, 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 Brexucabtagene Autoleucel 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 life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS to patients with active infection or inflammatory disorders.
Do FAERS signals prove that Brexucabtagene Autoleucel 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 a16108c2-7ca7-45af-965e-54bda4713022, effective 20260616; matched on
openfda.generic_name.exact:"BREXUCABTAGENE AUTOLEUCEL") - 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, fieldpatient.drug.openfda.generic_name.exact, 49 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.