Product name as reported
Epcoritamab: adverse event reports filed with FDA
2,262 reports list it as a suspect or interacting product, 2021–2026.
- 2,262
- reports as suspect product
- 0% of all reports · about 424 a year
- 297
- reports, 12 months to June 2026
- 511 in the 12 months before
- 99.2%
- marked serious by the reporter
- 57.4% across all reports
- 22.4%
- record death among outcomes, as reported
- 506 reports · not verified by FDA
2,262 adverse event reports received by FDA list the product name "Epcoritamab" as reporters wrote it as a suspect or interacting product, from March 2021 to June 2026. A further 105 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 297 reports listed it, down 42% from 511 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 424 reports a year and 0% of the 20,646,523 reports in the database. 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 (26.6%), pyrexia (11.9%) and off label use (10.7%). A report can list several reactions, so shares add to more than 100%; 389 different terms appear across these reports. Cytokine release syndrome is recorded in 26.6% of these reports, against 0.1% of all reports in the database.
99.2% of the reports are marked serious by the reporter; 22.4% record death among the outcomes and 77.1% record hospitalisation, as reported. 62.2% of the reports came from physicians, and the largest patient age group is 65 to 74 (31.7%). 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 Epcoritamab reports recording the termall reports in the database
- Cytokine release syndrome26.6%602
- Pyrexiafever11.9%270
- Off label useused for a purpose or in a way not on the label10.7%243
- Febrile neutropeniafever with low white blood cells10%226
- Pneumonialung infection7.2%162
- Covid-19COVID-19 infection5.8%132
- Sepsisa severe body-wide response to infection5.2%118
- Hypotensionlow blood pressure4.6%103
- Neutropenialow neutrophils, a type of white blood cell4.4%99
- Diarrhoealoose or frequent stools3.8%85
- Disease progressionthe disease advanced3.5%79
- Deaththe patient died; cause not stated by this term3.4%76
- Thrombocytopenialow platelets3.2%73
- Acute kidney injurysudden loss of kidney function3%68
- Septic shockshock arising from infection3%68
- Dyspnoeashortness of breath2.3%53
- Fatiguetiredness2.3%52
- Hypoxialow oxygen2.3%52
- Anaemialow red blood cells2.3%51
- Constipationconstipation2.3%51
- Respiratory failurethe lungs could not supply enough oxygen2.2%50
- Abdominal painstomach or belly pain2.1%47
- Astheniaweakness or lack of energy2.1%47
- Blood creatinine increasedraised creatinine, a kidney test2%46
- Hypokalaemialow blood potassium1.8%40
- Dehydrationdehydration1.5%35
Top 30 of 389 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 share of all reports in the database; 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 20,646,523 reports. 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. 10.9% 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 | 703 | 31.1% |
| Follicular lymphoma | 335 | 14.8% |
| Diffuse large b-cell lymphoma stage iv | 292 | 12.9% |
| Diffuse large b-cell lymphoma stage iii | 128 | 5.7% |
| Follicular lymphoma stage iv | 78 | 3.4% |
| Diffuse large b-cell lymphoma stage ii | 67 | 3% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,262 reports.
In context
| Measure | Epcoritamab | All reports |
|---|---|---|
| Reports as suspect product | 2,262 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 297 | 1,332,454 |
| Marked serious | 99.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 224 | 91 |
| Hospitalisation recorded, per 1,000 reports | 771 | 213 |
| Consumer-filed share | 3% | 45.8% |
| Top term, share of reports | Cytokine release syndrome 26.6% | 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."
Questions about Epcoritamab reports
How many adverse event reports has FDA received for Epcoritamab?
2,262 reports list Epcoritamab as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 297 of them arrived in the latest 12 months. Another 105 list it only as a concomitant medication.
What reactions are recorded in Epcoritamab reports?
cytokine release syndrome (26.6%), pyrexia (11.9%), off label use (10.7%), febrile neutropenia (10%) and pneumonia (7.2%). 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 Epcoritamab was responsible.
How serious are the reports?
99.2% are marked serious by the reporter. Among the outcomes recorded, 22.4% of reports include death and 77.1% 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 (62.2%), other health professional (33.4%) and consumer or non-health professional (3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Epcoritamab rising?
297 reports in the 12 months to June 2026, down 42% from 511 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 Epcoritamab 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 Epcoritamab?
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 Epcoritamab as a suspect or interacting product; reports listing it only as a concomitant medication (105) 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.