Drugs › Epidermal growth factor receptor antagonist
Brand name · Cetuximab
Erbitux: adverse event reports filed with FDA
18,121 reports list it as a suspect or interacting product, 2004–2026. Class: Epidermal growth factor receptor antagonist.
- 18,121
- reports as suspect product
- 0.1% of all reports · about 812 a year
- 831
- reports, 12 months to June 2026
- 728 in the 12 months before
- 77%
- marked serious by the reporter
- 85.5% across the class
- 10%
- record death among outcomes, as reported
- 1,804 reports · not verified by FDA
18,121 adverse event reports received by FDA list the brand name Erbitux (cetuximab) as a suspect or interacting product, from March 2004 to June 2026. A further 813 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, 831 reports listed it, up 14% from 728 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 812 reports a year and 0.1% of the 20,646,523 reports in the database, and 41.3% of the reports for the epidermal growth factor receptor antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded rash (9.5%), off label use (5.2%) and infusion related reaction (5.1%). A report can list several reactions, so shares add to more than 100%; 1,155 different terms appear across these reports. Rash is recorded in 9.5% of these reports, about the same share as in the median epidermal growth factor receptor antagonist drug (8.5%).
77% of the reports are marked serious by the reporter (85.5% across the class); 10% record death among the outcomes and 33.4% record hospitalisation, as reported. 53.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (30.1%). 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 Erbitux reports recording the termmedian drug in epidermal growth factor receptor antagonist
- Rashskin rash9.5%1,722
- Off label useused for a purpose or in a way not on the label5.2%935
- Infusion related reactiona reaction during or soon after an infusion5.1%933
- Diarrhoealoose or frequent stools4.8%863
- Dyspnoeashortness of breath4.8%861
- Nauseafeeling sick4.1%746
- Vomitingbeing sick3.5%630
- Myelosuppression3.1%563
- Hypotensionlow blood pressure3.1%554
- Deaththe patient died; cause not stated by this term3%543
- Dermatitis acneiform2.9%531
- White blood cell count decreasedlow white cell count2.9%530
- Pruritusitching2.9%528
- Pyrexiafever2.9%523
- Neutropenialow neutrophils, a type of white blood cell2.7%486
- Dehydrationdehydration2.5%452
- Hypersensitivityan allergic-type reaction2.4%437
- Erythemaskin redness2.4%426
- Neutrophil count decreased2.3%421
- Fatiguetiredness2.3%408
- Chillschills or shivering2.1%382
- Anaemialow red blood cells2%367
- Anaphylactic reactiona severe, sudden allergic reaction2%357
- Mucosal inflammation2%356
- Stomatitissore mouth2%356
- Hypomagnesaemialow blood magnesium1.9%341
- Astheniaweakness or lack of energy1.8%324
- Malaisegeneral feeling of being unwell1.7%316
- Decreased appetitereduced appetite1.7%305
Top 30 of 1,155 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 epidermal growth factor receptor antagonist 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 43,907 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. 47.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Colon cancer | 1,955 | 10.8% |
| Head and neck cancer | 1,314 | 7.3% |
| Colorectal cancer metastatic | 1,312 | 7.2% |
| Colorectal cancer | 889 | 4.9% |
| Colon cancer metastatic | 756 | 4.2% |
| Rectal cancer | 573 | 3.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 18,121 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Erbitux reports |
|---|---|---|
| Fluorouracil | 2,739 | 15.1% |
| Oxaliplatin | 1,546 | 8.5% |
| Cisplatin | 1,324 | 7.3% |
| Benadryl | 1,307 | 7.2% |
| Irinotecan | 1,235 | 6.8% |
| Carboplatin | 1,136 | 6.3% |
| Decadron | 673 | 3.7% |
| Paclitaxel | 625 | 3.4% |
| Irinotecan hcl | 590 | 3.3% |
| Leucovorin calcium | 547 | 3% |
Other products listed in reports where Erbitux 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 | Erbitux | Epidermal growth factor receptor antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 18,121 | 43,907 | 20,646,523 |
| Share of that pool | — | 41.3% | 0.1% |
| Reports, latest 12 months | 831 | — | 1,332,454 |
| Marked serious | 77% | 85.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 100 | 142 | 91 |
| Hospitalisation recorded, per 1,000 reports | 334 | 387 | 213 |
| Consumer-filed share | 53.3% | 33.6% | 45.8% |
| Top term, share of reports | Rash 9.5% | median 8.5% | 2.1% |
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 epidermal growth factor receptor antagonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Cetuximab | generic | 10,866 | 512 | 97.5% |
| Vectibix | brand | 9,256 | 1,079 | 80.4% |
| Panitumumab | generic | 5,664 | 220 | 98% |
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 Erbitux reports
How many adverse event reports has FDA received for Erbitux?
18,121 reports list Erbitux as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 831 of them arrived in the latest 12 months. Another 813 list it only as a concomitant medication.
What reactions are recorded in Erbitux reports?
rash (9.5%), off label use (5.2%), infusion related reaction (5.1%), diarrhoea (4.8%) and dyspnoea (4.8%). 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 Erbitux was responsible.
How serious are the reports?
77% are marked serious by the reporter. Among the outcomes recorded, 10% of reports include death and 33.4% 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?
consumer or non-health professional (53.3%), other health professional (21.1%) and physician (16.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Erbitux rising?
831 reports in the 12 months to June 2026, up 14% from 728 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 Erbitux 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 Erbitux?
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 Erbitux as a suspect or interacting product; reports listing it only as a concomitant medication (813) 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.