Vectibix: adverse event reports filed with FDA

9,256

reports as suspect product

0% of all reports · about 473 a year

1,079

reports, 12 months to June 2026

747 in the 12 months before

80.4%

marked serious by the reporter

85.5% across the class

14.1%

record death among outcomes, as reported

1,308 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 Vectibix reports recording the termmedian drug in epidermal growth factor receptor antagonist

1. Rashskin rash15.4%1,429
2. Diarrhoealoose or frequent stools8.1%748
3. Skin toxicity6.4%592
4. Deaththe patient died; cause not stated by this term6.1%564
5. Dermatitis acneiform6%556
6. Hypomagnesaemialow blood magnesium5.2%482
7. Dry skindry skin4.9%451
8. Disease progressionthe disease advanced4.7%432
9. Colorectal cancer metastatic4.6%424
10. Neuropathy peripheralnerve damage in hands or feet4.5%413
11. Nauseafeeling sick4.3%401
12. Neutropenialow neutrophils, a type of white blood cell4.3%400
13. Off label useused for a purpose or in a way not on the label4.3%399
14. Fatiguetiredness3.9%361
15. Pruritusitching3.8%351
16. Erythemaskin redness3.7%346
17. Astheniaweakness or lack of energy3.7%341
18. Vomitingbeing sick3.4%316
19. Acneacne3.3%308
20. Paronychia3%282
21. Pyrexiafever2.8%255
22. Thrombocytopenialow platelets2.7%254
23. Therapy partial responder2.7%252
24. Skin fissures2.7%248
25. Skin disorder2.6%245
26. Stomatitissore mouth2.6%244
27. Metastases to liver2.5%234
28. Decreased appetitereduced appetite2.5%231
29. Interstitial lung diseasescarring or inflammation of lung tissue2.5%229
30. Rash pustular2.4%225

Top 30 of 1,006 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. 25.3% 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 9,256 reports.

Drugs most often listed in the same reports

Other products listed in reports where Vectibix 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 Vectibix as a suspect or interacting product; reports listing it only as a concomitant medication (306) 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.