Kymriah: adverse event reports filed with FDA

3,656

reports as suspect product

0% of all reports · about 330 a year

214

reports, 12 months to June 2026

313 in the 12 months before

92.9%

marked serious by the reporter

95.8% across the class

30.5%

record death among outcomes, as reported

1,114 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 Kymriah reports recording the termmedian drug in cd19-directed chimeric antigen receptor

1. Cytokine release syndrome39.8%1,454
2. Pyrexiafever26%951
3. Malignant neoplasm progression15.2%554
4. Hypotensionlow blood pressure10.7%392
5. Hypogammaglobulinaemia10.3%375
6. Platelet count decreasedlow platelet count10.2%374
7. Neurotoxicity10.2%373
8. Immune effector cell-associated neurotoxicity syndrome10%366
9. Haemoglobin decreasedlow haemoglobin9.9%362
10. White blood cell count decreasedlow white cell count9.8%358
11. Lymphocyte count decreased9.7%355
12. Acute lymphocytic leukaemia recurrent9.3%341
13. Neutrophil count decreased8.9%325
14. Diffuse large B-cell lymphoma7.6%277
15. Deaththe patient died; cause not stated by this term7.5%274
16. Haematocrit decreased7.3%268
17. Hypoxialow oxygen5.8%213
18. Cytopenia5.5%202
19. Diffuse large B-cell lymphoma recurrent4.9%178
20. Thrombocytopenialow platelets4.7%171
21. Headachehead pain4%148
22. Neutropenialow neutrophils, a type of white blood cell3.9%142
23. Drug ineffectivethe medicine did not work as expected3.9%141
24. Second primary malignancy3.8%139
25. Tachycardiafast heart rate3.6%133
26. Disease progressionthe disease advanced3.2%118
27. Fatiguetiredness3.1%113
28. Febrile neutropeniafever with low white blood cells2.9%107
29. Off label useused for a purpose or in a way not on the label2.8%104
30. Confusional stateconfusion2.8%102

Top 30 of 735 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. 59.4% 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 3,656 reports.

Drugs most often listed in the same reports

Other products listed in reports where Kymriah 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 Kymriah as a suspect or interacting product; reports listing it only as a concomitant medication (57) 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.