Drug · FAERS side-effect profile with label screen
Axicabtagene Ciloleucel side effects: what 9,811 FDA adverse event reports show
Drug class
CD19-directed Chimeric Antigen Receptor, Genetically-modified Autologous T Cells
FDA label (Established Pharmacologic Class)
Brand names
Yescarta
openFDA label
Who reports
9,811 reports · 97% serious · 2,628 with death outcome · 39% female
openFDA FAERS counts, all years, deduplication not applied
Used for
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
FDA label, Indications and Usage
What it is
YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare YESCARTA, a patient's own T cells are harvested and genetically modified .
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 YESCARTA. Do not administer YESCARTA 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 40 strongest signals
Labeled — boxed warning 2Labeled adverse reaction 4Labeled (related wording) 9Likely indication confounding 10Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 10
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. 808 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Car t-cell-related encephalopathy syndrome | 115 | 26,937.2 13,672.4–53,071.4ROR 27,256.7 · χ² 222,872 / p <1e-300 | 1,472.1 EB05 1,259.8 · IC025 +7.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=113 · 97% clinician | no trial data cached |
| Cytokine increased | 76 | 2,861.0 2,027.0–4,038.2ROR 2,883.4 · χ² 90,973 / p <1e-300 | 928.1 EB05 765.8 · IC025 +6.7 3/3 methods agree | Labeled (related wording) related wording | serious n=76 · 99% clinician | no trial data cached |
| Lymphocyte adoptive therapy | 107 | 1,334.7 1,048.5–1,699.0ROR 1,349.4 · χ² 86,504 / p <1e-300 | 712.7 EB05 606.4 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious n=97 · 95% clinician | no trial data cached |
| Immune effector cell-associated neurotoxicity syndrome | 2,069 | 1,255.2 1,193.1–1,320.5ROR 1,590.3 · χ² 1,624,835 / p <1e-300 | 781.4 EB05 753.5 · IC025 +9.3 3/3 methods agree | Labeled (related wording) related wording | serious n=2,046 · 97% clinician | no trial data cached |
| Malignant genitourinary tract neoplasm | 19 | 976.9 567.3–1,682.5ROR 978.8 · χ² 12,000 / p <1e-300 | 398.8 EB05 269.9 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Immune effector cell-associated haematotoxicity | 41 | 971.2 671.2–1,405.2ROR 975.2 · χ² 26,543 / p <1e-300 | 507.0 EB05 389.6 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=41 · 98% clinician | no trial data cached |
| Myelodysplastic syndrome with multilineage dysplasia | 14 | 797.7 431.4–1,475.0ROR 798.8 · χ² 7,514 / p <1e-300 | 323.1 EB05 204.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Primary mediastinal large b-cell lymphoma | 28 | 663.2 433.9–1,013.7ROR 665.1 · χ² 13,584 / p <1e-300 | 375.1 EB05 272.3 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=28 · ♀ 59% (drug 39%) · 96% clinician | no trial data cached |
| Cytokine release syndrome | 4,499 | 663.0 645.3–681.2ROR 1,223.7 · χ² 2,263,948 / p <1e-300 | 503.5 EB05 491.3 · IC025 +8.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 300.4 · 97% clinician | no trial data cached |
| B-cell aplasia | 42 | 423.6 304.3–589.8ROR 425.5 · χ² 14,396 / p <1e-300 | 304.0 EB05 234.4 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=42 | no trial data cached |
| Immune effector cell-associated hlh-like syndrome | 18 | 403.7 243.9–668.2ROR 404.4 · χ² 5,735 / p <1e-300 | 249.4 EB05 166.9 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Human herpesvirus 6 encephalitis | 33 | 280.5 195.2–403.1ROR 281.5 · χ² 7,867 / p <1e-300 | 216.7 EB05 161.5 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=33 · 100% clinician | no trial data cached |
| High-grade b-cell lymphoma | 15 | 184.9 109.1–313.4ROR 185.2 · χ² 2,356 / p <1e-300 | 140.2 EB05 90.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Neurotoxicity | 1,375 | 183.8 174.6–193.5ROR 213.6 · χ² 229,928 / p <1e-300 | 168.7 EB05 161.4 · IC025 +7.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 98.9 · 95% clinician | no trial data cached |
| Refractory cancer | 17 | 181.9 110.9–298.5ROR 182.2 · χ² 2,652 / p <1e-300 | 141.3 EB05 93.4 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | no trial data cached |
| Cytokine storm | 46 | 154.9 114.9–208.8ROR 155.6 · χ² 6,410 / p <1e-300 | 136.3 EB05 106.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=46 | no trial data cached |
| Cardiorenal syndrome | 37 | 148.3 106.3–206.8ROR 148.8 · χ² 4,921 / p <1e-300 | 129.5 EB05 98.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=32 · 97% clinician | no trial data cached |
| Diffuse large b-cell lymphoma | 387 | 114.2 103.3–126.3ROR 118.8 · χ² 41,101 / p <1e-300 | 107.8 EB05 99.1 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 65.2 · 97% clinician | no trial data cached |
| B-cell lymphoma recurrent | 27 | 112.0 76.1–164.9ROR 112.4 · χ² 2,717 / p <1e-300 | 99.2 EB05 71.6 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=27 · 93% clinician | no trial data cached |
| Diffuse large b-cell lymphoma recurrent | 103 | 107.7 88.4–131.1ROR 108.8 · χ² 10,254 / p <1e-300 | 100.6 EB05 85.3 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=102 · 90% clinician | no trial data cached |
| Congenital aplasia | 11 | 84.3 46.2–154.0ROR 84.4 · χ² 793 / p 1e-174 | 71.5 EB05 42.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Diffuse large b-cell lymphoma stage iv | 12 | 82.4 46.3–146.6ROR 82.5 · χ² 852 / p 1e-187 | 70.8 EB05 43.1 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| American trypanosomiasis | 10 | 81.1 43.1–152.4ROR 81.2 · χ² 686 / p 1e-151 | 68.4 EB05 39.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Metastatic lymphoma | 14 | 78.7 46.2–134.1ROR 78.8 · χ² 962 / p 2e-211 | 69.1 EB05 43.7 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | no trial data cached |
| N-terminal prohormone brain natriuretic peptide increased | 47 | 74.1 55.4–99.1ROR 74.5 · χ² 3,205 / p <1e-300 | 69.7 EB05 54.5 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=47 · ♀ 61% (drug 39%) · 100% clinician | no trial data cached |
| Pseudomonal bacteraemia | 28 | 73.8 50.6–107.5ROR 74.0 · χ² 1,873 / p <1e-300 | 68.1 EB05 49.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=28 · 96% clinician | no trial data cached |
| Diffuse large b-cell lymphoma refractory | 28 | 66.3 45.6–96.6ROR 66.5 · χ² 1,684 / p <1e-300 | 61.8 EB05 44.8 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=28 · 100% clinician | no trial data cached |
| Encephalitis cytomegalovirus | 12 | 61.0 34.3–108.2ROR 61.0 · χ² 631 / p 2e-139 | 54.4 EB05 33.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hypofibrinogenaemia | 25 | 56.5 38.0–84.1ROR 56.7 · χ² 1,275 / p 2e-279 | 53.0 EB05 37.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial data cached |
| Hypogammaglobulinaemia | 161 | 55.0 47.1–64.3ROR 55.9 · χ² 8,274 / p <1e-300 | 53.3 EB05 46.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=161 · 98% clinician | no trial data cached |
| Blood immunoglobulin g decreased | 60 | 53.9 41.8–69.6ROR 54.3 · χ² 2,989 / p <1e-300 | 51.8 EB05 41.7 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=60 · 95% clinician | no trial data cached |
| T-cell lymphoma | 25 | 47.8 32.2–71.1ROR 47.9 · χ² 1,075 / p 4e-236 | 45.3 EB05 32.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=25 · 96% clinician | no trial data cached |
| Blood fibrinogen decreased | 24 | 46.8 31.2–70.0ROR 46.9 · χ² 1,007 / p 2e-221 | 44.3 EB05 31.3 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=24 · 96% clinician | no trial data cached |
| Follicular lymphoma | 18 | 46.1 28.9–73.4ROR 46.1 · χ² 733 / p 1e-161 | 43.2 EB05 28.9 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=18 | no trial data cached |
| Haemophagocytic lymphohistiocytosis | 142 | 42.8 36.3–50.5ROR 43.4 · χ² 5,647 / p <1e-300 | 41.8 EB05 36.3 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.0 · 96% clinician | no trial data cached |
| Myelodysplastic syndrome | 273 | 41.1 36.5–46.2ROR 42.2 · χ² 10,438 / p <1e-300 | 40.2 EB05 36.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 · 100% clinician | no trial data cached |
| Serum ferritin increased | 98 | 40.6 33.3–49.6ROR 41.0 · χ² 3,679 / p <1e-300 | 39.6 EB05 33.4 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=96 · 98% clinician | no trial data cached |
| Peripheral t-cell lymphoma unspecified | 10 | 37.0 19.8–69.2ROR 37.1 · χ² 310 / p 1e-69 | 34.2 EB05 19.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Cytomegalovirus infection reactivation | 71 | 36.1 28.6–45.7ROR 36.4 · χ² 2,351 / p <1e-300 | 35.2 EB05 28.9 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=71 · 94% clinician | no trial data cached |
| Cytopenia | 193 | 35.1 30.5–40.4ROR 35.8 · χ² 6,254 / p <1e-300 | 34.4 EB05 30.5 · IC025 +4.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 20.5 · 97% 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 |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 4,499 | 663.0 645.3–681.2ROR 1,223.7 · χ² 2,263,948 / p <1e-300 | 503.5 EB05 491.3 · IC025 +8.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 300.4 · 97% clinician | no trial data cached |
| Immune effector cell-associated neurotoxicity syndrome | 2,069 | 1,255.2 1,193.1–1,320.5ROR 1,590.3 · χ² 1,624,835 / p <1e-300 | 781.4 EB05 753.5 · IC025 +9.3 3/3 methods agree | Labeled (related wording) related wording | serious n=2,046 · 97% clinician | no trial data cached |
| Neurotoxicity | 1,375 | 183.8 174.6–193.5ROR 213.6 · χ² 229,928 / p <1e-300 | 168.7 EB05 161.4 · IC025 +7.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 98.9 · 95% clinician | no trial data cached |
| Death | 994 | 2.5 2.3–2.6ROR 2.6 · χ² 903 / p 1e-198 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.5 | no trial data cached |
| Pyrexia (fever) | 900 | 5.6 5.2–5.9ROR 6.0 · χ² 3,416 / p <1e-300 | 5.5 EB05 5.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Disease progression | 804 | 14.7 13.7–15.7ROR 15.9 · χ² 10,211 / p <1e-300 | 14.6 EB05 13.7 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 · 92% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 502 | 7.9 7.3–8.7ROR 8.3 · χ² 3,049 / p <1e-300 | 7.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 97% clinician | no trial data cached |
| Hypotension (low blood pressure) | 396 | 4.2 3.8–4.7ROR 4.4 · χ² 982 / p 8e-216 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 96% clinician | no trial data cached |
| Diffuse large b-cell lymphoma | 387 | 114.2 103.3–126.3ROR 118.8 · χ² 41,101 / p <1e-300 | 107.8 EB05 99.1 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 65.2 · 97% clinician | no trial data cached |
| Confusional state (confusion) | 303 | 4.0 3.6–4.5ROR 4.1 · χ² 684 / p 4e-151 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · 93% clinician | no trial data cached |
| Febrile neutropenia | 303 | 9.8 8.8–11.0ROR 10.1 · χ² 2,388 / p <1e-300 | 9.7 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · 98% clinician | no trial data cached |
| Encephalopathy | 289 | 25.5 22.8–28.6ROR 26.3 · χ² 6,708 / p <1e-300 | 25.2 EB05 22.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 · 100% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 285 | 5.5 4.9–6.1ROR 5.6 · χ² 1,041 / p 1e-228 | 5.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · 99% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 281 | 0.5 0.4–0.5ROR 0.4 · χ² 194 / p 2e-44 | 0.5 EB05 0.4 · IC025 -1.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Myelodysplastic syndrome | 273 | 41.1 36.5–46.2ROR 42.2 · χ² 10,438 / p <1e-300 | 40.2 EB05 36.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 · 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.
- Cytokine storm — n=46, PRR 154.9
- Cardiorenal syndrome — n=37, PRR 148.3
- Pseudomonal bacteraemia — n=28, PRR 73.8
- Hypofibrinogenaemia — n=25, PRR 56.5
- Hypogammaglobulinaemia — n=161, PRR 55.0
- Myelodysplastic syndrome — n=273, PRR 41.1
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 Axicabtagene Ciloleucel?
In FDA FAERS, the most frequently co-reported reaction terms for Axicabtagene Ciloleucel are cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, neurotoxicity, pyrexia, neutropenia, hypotension. 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 Axicabtagene Ciloleucel 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 YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders.
Do FAERS signals prove that Axicabtagene Ciloleucel 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 9b70606e-b99c-4272-a0f1-b5523cce0c59, effective 20260806; matched on
openfda.generic_name.exact:"AXICABTAGENE CILOLEUCEL") - 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, 848 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.