Xeloda: adverse event reports filed with FDA

32,279

reports as suspect product

0.2% of all reports · about 1,435 a year

280

reports, 12 months to June 2026

406 in the 12 months before

73%

marked serious by the reporter

92.2% across the class

22.6%

record death among outcomes, as reported

7,285 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 Xeloda reports recording the termmedian drug in nucleoside metabolic inhibitor

1. Diarrhoealoose or frequent stools16.1%5,204
2. Deaththe patient died; cause not stated by this term12.4%4,010
3. Nauseafeeling sick10.4%3,371
4. Palmar-plantar erythrodysaesthesia syndrome8.7%2,793
5. Fatiguetiredness8.1%2,607
6. Vomitingbeing sick7%2,254
7. Disease progressionthe disease advanced6.2%2,016
8. Off label useused for a purpose or in a way not on the label4.3%1,396
9. Decreased appetitereduced appetite3.8%1,232
10. Astheniaweakness or lack of energy3.6%1,165
11. Dehydrationdehydration3.2%1,041
12. Malignant neoplasm progression3%969
13. Rashskin rash3%958
14. Painpain, site not specified2.8%916
15. Stomatitissore mouth2.8%909
16. Weight decreasedweight loss2.8%899
17. Neuropathy peripheralnerve damage in hands or feet2.8%888
18. Dyspnoeashortness of breath2.6%847
19. Constipationconstipation2.6%824
20. Pyrexiafever2.5%811
21. Drug ineffectivethe medicine did not work as expected2.5%806
22. Abdominal painstomach or belly pain2.5%795
23. Pain in extremitypain in an arm or leg2.4%786
24. Erythemaskin redness2.1%693
25. Malaisegeneral feeling of being unwell2.1%688
26. Dry skindry skin2.1%682
27. Paraesthesiatingling or pins and needles2.1%680
28. Skin exfoliationpeeling skin2.1%669
29. Dizzinesslight-headedness or unsteadiness2%654
30. Headachehead pain1.9%623

Top 30 of 2,004 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 19 drugs in the nucleoside metabolic inhibitor 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 313,386 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. 54% 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 32,279 reports.

Drugs most often listed in the same reports

Other products listed in reports where Xeloda 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 nucleoside metabolic inhibitor 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 Xeloda as a suspect or interacting product; reports listing it only as a concomitant medication (4,692) 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.