Drugs › Bispecific CD20-directed CD3 T cell engager
Generic name
Glofitamab: adverse event reports filed with FDA
1,537 reports list it as a suspect or interacting product, 2018–2026. Class: Bispecific CD20-directed CD3 T cell engager.
- 1,537
- reports as suspect product
- 0% of all reports · about 201 a year
- 523
- reports, 12 months to June 2026
- 357 in the 12 months before
- 96.2%
- marked serious by the reporter
- 91.8% across the class
- 29.3%
- record death among outcomes, as reported
- 450 reports · not verified by FDA
Between November 2018 and June 2026, 1,537 adverse event reports received by FDA list glofitamab, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (84) are left out of every figure here.
In the 12 months to June 2026, 523 reports listed it, up 46% from 357 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 201 reports a year and 0% of the 20,646,523 reports in the database, and 43.2% of the reports for the bispecific CD20-directed CD3 T cell engager class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are cytokine release syndrome (37.1%), disease progression (20.2%) and off label use (11.3%). A report can list several reactions, so shares add to more than 100%; 269 different terms appear across these reports. Cytokine release syndrome is recorded in 37.1% of these reports, about the same share as in the median bispecific CD20-directed CD3 T cell engager drug (35.3%).
96.2% of the reports are marked serious by the reporter (91.8% across the class); 29.3% record death among the outcomes and 36.9% record hospitalisation, as reported. 72.3% of the reports came from physicians, and the largest patient age group is 45 to 64 (25.6%). 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 Glofitamab reports recording the termmedian drug in bispecific cd20-directed cd3 t cell engager
- Cytokine release syndrome37.1%570
- Disease progressionthe disease advanced20.2%310
- Off label useused for a purpose or in a way not on the label11.3%174
- Deaththe patient died; cause not stated by this term11.1%170
- Neutropenialow neutrophils, a type of white blood cell10.5%162
- Pyrexiafever8.1%125
- Covid-19COVID-19 infection6.4%98
- Febrile neutropeniafever with low white blood cells5.7%88
- Anaemialow red blood cells4.9%75
- Infectionan infection, type not specified4.2%64
- Thrombocytopenialow platelets4.2%64
- Pneumonialung infection4.1%63
- Drug ineffectivethe medicine did not work as expected3.9%60
- Alanine aminotransferase increasedraised liver enzyme (ALT)3.5%54
- Tumour flare2.9%45
- Aspartate aminotransferase increasedraised liver enzyme (AST)2.8%43
- Diffuse large B-cell lymphoma recurrent2.2%34
- Septic shockshock arising from infection2.1%33
- Sepsisa severe body-wide response to infection2%31
- Bacterial infectiona bacterial infection2%30
- COVID-19 pneumonia1.7%26
- Platelet count decreasedlow platelet count1.7%26
- Cytomegalovirus infection reactivation1.6%25
- Diarrhoealoose or frequent stools1.5%23
- Mantle cell lymphoma1.5%23
- Product use issuea problem in how the product was used1.5%23
- Back painback pain1.4%22
Top 30 of 269 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 3 drugs in the bispecific cd20-directed cd3 t cell engager 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 3,559 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. 6.4% 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 | 696 | 45.3% |
| B-cell lymphoma | 109 | 7.1% |
| Diffuse large b-cell lymphoma refractory | 102 | 6.6% |
| Mantle cell lymphoma | 73 | 4.7% |
| Non-hodgkin's lymphoma | 37 | 2.4% |
| Diffuse large b-cell lymphoma stage iv | 36 | 2.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,537 reports.
In context
| Measure | Glofitamab | Bispecific CD20-directed CD3 T cell engager | All reports |
|---|---|---|---|
| Reports as suspect product | 1,537 | 3,559 | 20,646,523 |
| Share of that pool | — | 43.2% | 0% |
| Reports, latest 12 months | 523 | — | 1,332,454 |
| Marked serious | 96.2% | 91.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 293 | 314 | 91 |
| Hospitalisation recorded, per 1,000 reports | 369 | 292 | 213 |
| Consumer-filed share | 7.7% | 12.4% | 45.8% |
| Top term, share of reports | Cytokine release syndrome 37.1% | median 35.3% | 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 bispecific cd20-directed cd3 t cell engager class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Epkinly | brand | 1,264 | 365 | 92.9% |
| Columvi | brand | 758 | 325 | 81.1% |
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 Glofitamab reports
How many adverse event reports has FDA received for Glofitamab?
1,537 reports list Glofitamab as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 523 of them arrived in the latest 12 months. Another 84 list it only as a concomitant medication.
What reactions are recorded in Glofitamab reports?
cytokine release syndrome (37.1%), disease progression (20.2%), off label use (11.3%), death (11.1%) and neutropenia (10.5%). 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 Glofitamab was responsible.
How serious are the reports?
96.2% are marked serious by the reporter. Among the outcomes recorded, 29.3% of reports include death and 36.9% 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?
physician (72.3%), other health professional (16.5%) and consumer or non-health professional (7.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Glofitamab rising?
523 reports in the 12 months to June 2026, up 46% from 357 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 Glofitamab 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 Glofitamab?
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 Glofitamab as a suspect or interacting product; reports listing it only as a concomitant medication (84) 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.