AXICABTAGENE CILOLEUCEL

N/A

Manufactured by Kite Pharma, Inc.

21,373 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AXICABTAGENE CILOLEUCEL

AXICABTAGENE CILOLEUCEL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kite Pharma, Inc.. The most commonly reported adverse reactions for AXICABTAGENE CILOLEUCEL include CYTOKINE RELEASE SYNDROME, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME, NEUROTOXICITY, PYREXIA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AXICABTAGENE CILOLEUCEL.

Top Adverse Reactions

CYTOKINE RELEASE SYNDROME4,226 reports
IMMUNE EFFECTOR CELL ASSOCIATED NEUROTOXICITY SYNDROME1,898 reports
NEUROTOXICITY1,340 reports
PYREXIA850 reports
DEATH814 reports
DISEASE PROGRESSION781 reports
NEUTROPENIA431 reports
HYPOTENSION381 reports
DIFFUSE LARGE B CELL LYMPHOMA317 reports
CONFUSIONAL STATE299 reports
FEBRILE NEUTROPENIA292 reports
ENCEPHALOPATHY280 reports
DRUG INEFFECTIVE261 reports
MYELODYSPLASTIC SYNDROME258 reports
FATIGUE256 reports
PANCYTOPENIA251 reports
APHASIA234 reports
TREMOR223 reports
THROMBOCYTOPENIA221 reports
ANAEMIA204 reports
HYPOXIA204 reports
HEADACHE189 reports
PNEUMONIA179 reports
OFF LABEL USE178 reports
TACHYCARDIA178 reports
CYTOPENIA175 reports
NEUTROPHIL COUNT DECREASED169 reports
PLATELET COUNT DECREASED168 reports
ASTHENIA159 reports
SOMNOLENCE157 reports
INFECTION148 reports
WHITE BLOOD CELL COUNT DECREASED143 reports
C REACTIVE PROTEIN INCREASED140 reports
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS136 reports
SEPTIC SHOCK136 reports
COVID 19135 reports
SEPSIS134 reports
HYPOGAMMAGLOBULINAEMIA131 reports
DIARRHOEA117 reports
LYMPHOCYTE COUNT DECREASED116 reports
CAR T CELL RELATED ENCEPHALOPATHY SYNDROME115 reports
DECREASED APPETITE115 reports
ASPARTATE AMINOTRANSFERASE INCREASED113 reports
HYPOALBUMINAEMIA113 reports
NAUSEA113 reports
ATRIAL FIBRILLATION111 reports
ACUTE MYELOID LEUKAEMIA109 reports
MALAISE109 reports
LYMPHOCYTE ADOPTIVE THERAPY107 reports
ACUTE KIDNEY INJURY106 reports
MEMORY IMPAIRMENT105 reports
SEIZURE101 reports
HYPOKALAEMIA98 reports
SERUM FERRITIN INCREASED98 reports
DISORIENTATION92 reports
PLEURAL EFFUSION89 reports
SQUAMOUS CELL CARCINOMA OF SKIN88 reports
RESPIRATORY FAILURE87 reports
MENTAL STATUS CHANGES85 reports
VOMITING84 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME83 reports
DIFFUSE LARGE B CELL LYMPHOMA RECURRENT81 reports
DYSGRAPHIA81 reports
BRAIN OEDEMA80 reports
AGITATION77 reports
BONE MARROW FAILURE77 reports
CYTOKINE INCREASED75 reports
DYSPNOEA74 reports
CHILLS73 reports
DEPRESSED LEVEL OF CONSCIOUSNESS70 reports
DISEASE RECURRENCE70 reports
HYPONATRAEMIA69 reports
HYPOPHOSPHATAEMIA65 reports
LYMPHOMA65 reports
ALANINE AMINOTRANSFERASE INCREASED64 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION63 reports
BLOOD IMMUNOGLOBULIN G DECREASED59 reports
COUGH59 reports
HYPOCALCAEMIA59 reports
INFUSION RELATED REACTION59 reports
PAIN58 reports
NERVOUS SYSTEM DISORDER57 reports
CHEST DISCOMFORT56 reports
BLOOD LACTATE DEHYDROGENASE INCREASED55 reports
MYALGIA55 reports
ABDOMINAL PAIN54 reports
CARDIAC ARREST54 reports
DELIRIUM54 reports
HYPOMAGNESAEMIA54 reports
CEREBROVASCULAR ACCIDENT53 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED52 reports
BACTERAEMIA51 reports
MYELOSUPPRESSION51 reports
COGNITIVE DISORDER47 reports
N TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED47 reports
CYTOKINE STORM46 reports
DYSPHAGIA46 reports
THERAPY NON RESPONDER45 reports
BASAL CELL CARCINOMA44 reports
TUMOUR LYSIS SYNDROME44 reports

Report Outcomes

Out of 9,017 classified reports for AXICABTAGENE CILOLEUCEL:

Serious 96.5%Non-Serious 3.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male4,452 (61.3%)
Female2,803 (38.6%)
Unknown8 (0.1%)

Reports by Age

Age 64284 reports
Age 68268 reports
Age 66240 reports
Age 67220 reports
Age 65213 reports
Age 69213 reports
Age 56205 reports
Age 58197 reports
Age 59196 reports
Age 63196 reports
Age 62195 reports
Age 70191 reports
Age 61190 reports
Age 71171 reports
Age 60168 reports
Age 57154 reports
Age 55149 reports
Age 73147 reports
Age 72143 reports
Age 74135 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with AXICABTAGENE CILOLEUCEL?

This profile reflects 21,373 FDA FAERS reports that mention AXICABTAGENE CILOLEUCEL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AXICABTAGENE CILOLEUCEL?

Frequently reported terms in FAERS include CYTOKINE RELEASE SYNDROME, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME, NEUROTOXICITY, PYREXIA, DEATH, DISEASE PROGRESSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AXICABTAGENE CILOLEUCEL?

Labeling and FAERS entries often list Kite Pharma, Inc. in connection with AXICABTAGENE CILOLEUCEL. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.