Pharmacologic class (EPC) · 4 drug pages

CD19-directed chimeric antigen receptor: adverse event reports filed with FDA

14,019 reports list a drug in this class as a suspect or interacting product, 2015–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

14,019
reports across the class: 0.1% of all reports; 1,709
reports, 12 months to June 2026: 2,005 in the 12 months before; 95.8%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

CD19-directed chimeric antigen receptor is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 14,019 adverse event reports received by FDA, 0.1% of the database, from June 2015 to June 2026.

1,709 reports arrived in the 12 months to June 2026, down 15% from 2,005 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 95.8% of the class's reports are marked serious, 27.7% record death among the outcomes and 33.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are cytokine release syndrome (44.3%), immune effector cell-associated neurotoxicity syndrome (17.9%) and pyrexia (13.8%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
YescartaAxicabtagene ciloleucel	brand	6,930	1,005	95.7%	Cytokine release syndrome
KymriahTisagenlecleucel	brand	3,656	214	92.9%	Cytokine release syndrome
Axicabtagene ciloleucel	generic	2,709	430	99.1%	Cytokine release syndrome
Tisagenlecleucel	generic	724	60	98.3%	Cytokine release syndrome

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Cytokine release syndrome44.3%6,206
Immune effector cell-associated neurotoxicity syndrome17.9%2,513
Pyrexiafever13.8%1,930
Neurotoxicity12.8%1,794
Deaththe patient died; cause not stated by this term9.1%1,270
Disease progressionthe disease advanced6.9%966
Hypotensionlow blood pressure6%836
Diffuse large B-cell lymphoma5%695
Neutropenialow neutrophils, a type of white blood cell4.7%656
Malignant neoplasm progression4.6%643
Platelet count decreasedlow platelet count4.2%583
Neutrophil count decreased3.9%552
Hypogammaglobulinaemia3.9%540
White blood cell count decreasedlow white cell count3.9%540
Lymphocyte count decreased3.4%479
Thrombocytopenialow platelets3.4%471
Febrile neutropeniafever with low white blood cells3.2%455
Drug ineffectivethe medicine did not work as expected3.2%452
Hypoxialow oxygen3.2%445
Confusional stateconfusion2.9%412
Cytopenia2.9%406
Encephalopathy2.7%378
Haemoglobin decreasedlow haemoglobin2.7%372
Acute lymphocytic leukaemia recurrent2.6%371
Fatiguetiredness2.6%371

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death27.7%3,880

Life-threatening8.4%1,184

Hospitalisation (initial or prolonged)33.6%4,705

Disability1.6%225

Congenital anomaly0%2

Other serious77.9%10,919

Not serious4.2%594

Patient age

Under 20.4%55

2 to 113.3%465

12 to 172.7%378

18 to 4411.7%1,645

45 to 6425.9%3,636

65 to 7419%2,665

75 and over5.7%799

Age not given31.2%4,376

Who reported

Physician43.1%6,041

Pharmacist4.5%626

Other health professional42.1%5,902

Lawyer0%0

Consumer or non-health professional9.2%1,288

Not given1.2%162

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about CD19-directed chimeric antigen receptor reports

Which drugs are in the CD19-directed chimeric antigen receptor class on this site?

Yescarta, Kymriah, Axicabtagene ciloleucel and Tisagenlecleucel. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

14,019 reports through June 2026, 1,709 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

cytokine release syndrome (44.3%), immune effector cell-associated neurotoxicity syndrome (17.9%), pyrexia (13.8%), neurotoxicity (12.8%) and death (9.1%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.