Axicabtagene ciloleucel: adverse event reports filed with FDA

2,709

reports as suspect product

0% of all reports · about 335 a year

430

reports, 12 months to June 2026

486 in the 12 months before

99.1%

marked serious by the reporter

95.8% across the class

30.6%

record death among outcomes, as reported

829 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Axicabtagene ciloleucel reports recording the termmedian drug in cd19-directed chimeric antigen receptor

1. Cytokine release syndrome37.3%1,011
2. Immune effector cell-associated neurotoxicity syndrome16.9%458
3. Pyrexiafever10.6%288
4. Neurotoxicity8.3%226
5. Myelodysplastic syndrome7.7%209
6. Disease progressionthe disease advanced7%190
7. Deaththe patient died; cause not stated by this term6.6%178
8. Neutropenialow neutrophils, a type of white blood cell5.8%157
9. Neutrophil count decreased5.5%150
10. Diffuse large B-cell lymphoma5.3%143
11. Drug ineffectivethe medicine did not work as expected5.1%139
12. Anaemialow red blood cells5.1%138
13. Platelet count decreasedlow platelet count4.9%133
14. White blood cell count decreasedlow white cell count4.3%116
15. Hypotensionlow blood pressure3.9%106
16. Lymphocyte count decreased3.8%103
17. Squamous cell carcinoma of skin3.4%91
18. Thrombocytopenialow platelets3.3%89
19. C-reactive protein increased3.2%88
20. Pneumonialung infection3.2%88
21. Astheniaweakness or lack of energy3.2%86
22. Hypokalaemialow blood potassium3.2%86
23. Off label useused for a purpose or in a way not on the label3.1%85
24. Confusional stateconfusion2.9%78
25. Hypoxialow oxygen2.7%74
26. Cytokine increased2.7%73
27. Hypoalbuminaemia2.7%72
28. Covid-19COVID-19 infection2.6%70
29. Acute myeloid leukaemia2.5%67
30. Febrile neutropeniafever with low white blood cells2.4%66

Top 30 of 467 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the cd19-directed chimeric antigen receptor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 14,019 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 54.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,709 reports.

Drugs most often listed in the same reports

Other products listed in reports where Axicabtagene ciloleucel is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the cd19-directed chimeric antigen receptor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Axicabtagene ciloleucel as a suspect or interacting product; reports listing it only as a concomitant medication (157) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.