Drugs › CD19-directed chimeric antigen receptor
Brand name · Axicabtagene ciloleucel
Yescarta: adverse event reports filed with FDA
6,930 reports list it as a suspect or interacting product, 2017–2026. Class: CD19-directed chimeric antigen receptor.
- 6,930
- reports as suspect product
- 0% of all reports · about 808 a year
- 1,005
- reports, 12 months to June 2026
- 1,127 in the 12 months before
- 95.7%
- marked serious by the reporter
- 95.8% across the class
- 25.4%
- record death among outcomes, as reported
- 1,763 reports · not verified by FDA
Between December 2017 and June 2026, 6,930 adverse event reports received by FDA list the brand name Yescarta (axicabtagene ciloleucel) as a suspect or interacting product. Reports that mention it only as a concomitant medication (25) are left out of every figure here.
In the 12 months to June 2026, 1,005 reports listed it, down 11% from 1,127 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 808 reports a year and 0% of the 20,646,523 reports in the database, and 49.4% of the reports for the CD19-directed chimeric antigen receptor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded cytokine release syndrome (50%), immune effector cell-associated neurotoxicity syndrome (23.1%) and neurotoxicity (16.6%). A report can list several reactions, so shares add to more than 100%; 599 different terms appear across these reports. Cytokine release syndrome is recorded in 50% of these reports, a larger share than in the median CD19-directed chimeric antigen receptor drug (38.8%).
95.7% of the reports are marked serious by the reporter (95.8% across the class); 25.4% record death among the outcomes and 38% record hospitalisation, as reported. 50% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (29.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Yescarta reports recording the termmedian drug in cd19-directed chimeric antigen receptor
- Cytokine release syndrome50%3,468
- Neurotoxicity16.6%1,147
- Deaththe patient died; cause not stated by this term11.7%808
- Pyrexiafever8.8%609
- Disease progressionthe disease advanced8.6%593
- Neutropenialow neutrophils, a type of white blood cell4.8%331
- Hypotensionlow blood pressure4.1%287
- Encephalopathy3.5%243
- Febrile neutropeniafever with low white blood cells3.3%230
- Confusional stateconfusion3.2%225
- Fatiguetiredness3%210
- Pancytopenialow counts of all blood cells3%205
- Thrombocytopenialow platelets2.7%187
- Tremorshaking2.7%187
- Aphasiadifficulty with language2.6%181
- Tachycardiafast heart rate2.2%149
- Cytopenia2.1%147
- Headachehead pain2.1%143
- Hypoxialow oxygen2%136
- Somnolencedrowsiness1.7%119
- Hypogammaglobulinaemia1.6%108
- Infectionan infection, type not specified1.6%108
- Septic shockshock arising from infection1.4%100
- Pneumonialung infection1.3%93
- Drug ineffectivethe medicine did not work as expected1.3%90
- Malaisegeneral feeling of being unwell1.3%90
- Sepsisa severe body-wide response to infection1.3%90
Top 30 of 599 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 54.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Diffuse large b-cell lymphoma | 3,024 | 43.6% |
| B-cell lymphoma | 328 | 4.7% |
| Follicular lymphoma | 238 | 3.4% |
| Diffuse large b-cell lymphoma refractory | 227 | 3.3% |
| Non-hodgkin's lymphoma | 171 | 2.5% |
| Primary mediastinal large b-cell lymphoma | 138 | 2% |
The indication field is filled in by the reporter and is often blank; shares are of all 6,930 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Yescarta reports |
|---|---|---|
| Cyclophosphamide | 925 | 13.3% |
| Fludarabine | 584 | 8.4% |
| Dexamethasone | 323 | 4.7% |
| Rituximab | 286 | 4.1% |
| Allopurinol | 243 | 3.5% |
| Fludarabine phosphate | 226 | 3.3% |
| Pantoprazole | 219 | 3.2% |
| Acyclovir | 209 | 3% |
| Acetaminophen | 192 | 2.8% |
| Ondansetron | 184 | 2.7% |
Other products listed in reports where Yescarta 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
| Measure | Yescarta | CD19-directed chimeric antigen receptor | All reports |
|---|---|---|---|
| Reports as suspect product | 6,930 | 14,019 | 20,646,523 |
| Share of that pool | — | 49.4% | 0% |
| Reports, latest 12 months | 1,005 | — | 1,332,454 |
| Marked serious | 95.7% | 95.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 254 | 277 | 91 |
| Hospitalisation recorded, per 1,000 reports | 380 | 336 | 213 |
| Consumer-filed share | 7.8% | 9.2% | 45.8% |
| Top term, share of reports | Cytokine release syndrome 50% | median 38.8% | 0.1% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Kymriah | brand | 3,656 | 214 | 92.9% |
| Axicabtagene ciloleucel | generic | 2,709 | 430 | 99.1% |
| Tisagenlecleucel | generic | 724 | 60 | 98.3% |
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.
Questions about Yescarta reports
How many adverse event reports has FDA received for Yescarta?
6,930 reports list Yescarta as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,005 of them arrived in the latest 12 months. Another 25 list it only as a concomitant medication.
What reactions are recorded in Yescarta reports?
cytokine release syndrome (50%), immune effector cell-associated neurotoxicity syndrome (23.1%), neurotoxicity (16.6%), death (11.7%) and pyrexia (8.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Yescarta was responsible.
How serious are the reports?
95.7% are marked serious by the reporter. Among the outcomes recorded, 25.4% of reports include death and 38% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (50%), physician (33.8%) and consumer or non-health professional (7.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Yescarta rising?
1,005 reports in the 12 months to June 2026, down 11% from 1,127 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Yescarta was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Yescarta?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Yescarta as a suspect or interacting product; reports listing it only as a concomitant medication (25) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.