Cetuximab: adverse event reports filed with FDA

10,866

reports as suspect product

0.1% of all reports · about 483 a year

512

reports, 12 months to June 2026

444 in the 12 months before

97.5%

marked serious by the reporter

85.5% across the class

18%

record death among outcomes, as reported

1,956 reports · not verified by FDA

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 Cetuximab reports recording the termmedian drug in epidermal growth factor receptor antagonist

1. Diarrhoealoose or frequent stools9%980
2. Off label useused for a purpose or in a way not on the label7.3%792
3. Nauseafeeling sick7.1%770
4. Vomitingbeing sick6.3%684
5. Neutropenialow neutrophils, a type of white blood cell6.2%677
6. Dehydrationdehydration5.7%614
7. Fatiguetiredness5%548
8. Pyrexiafever4.7%516
9. Anaemialow red blood cells4.5%488
10. Decreased appetitereduced appetite4.4%474
11. Rashskin rash4.3%469
12. Malignant neoplasm progression4.2%455
13. Astheniaweakness or lack of energy4.1%446
14. Mucosal inflammation4.1%442
15. Dyspnoeashortness of breath4%440
16. Weight decreasedweight loss3.9%423
17. Thrombocytopenialow platelets3.6%390
18. Pneumonialung infection3.4%373
19. Disease progressionthe disease advanced3.4%367
20. Pulmonary embolisma blood clot in the lung3.3%354
21. Febrile neutropeniafever with low white blood cells3.2%346
22. Hypotensionlow blood pressure3.1%339
23. Deaththe patient died; cause not stated by this term2.8%302
24. Sepsisa severe body-wide response to infection2.7%298
25. Stomatitissore mouth2.7%292
26. Dermatitis acneiform2.7%291
27. Dysphagiadifficulty swallowing2.6%283
28. Abdominal painstomach or belly pain2.4%265
29. Hypomagnesaemialow blood magnesium2.4%259
30. General physical health deteriorationgeneral decline in health2.4%257

Top 30 of 1,169 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 30.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 10,866 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cetuximab 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

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

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.

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 Cetuximab as a suspect or interacting product; reports listing it only as a concomitant medication (1,692) 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.