Capecitabine 500mg: adverse event reports filed with FDA

652

reports as suspect product

0% of all reports · about 31 a year

0

reports, 12 months to June 2026

0 in the 12 months before

63.3%

marked serious by the reporter

92.2% across the class

21.2%

record death among outcomes, as reported

138 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

Reactions recorded in the reports

share of Capecitabine 500mg reports recording the termmedian drug in nucleoside metabolic inhibitor

1. Deaththe patient died; cause not stated by this term19.9%130
2. Diarrhoealoose or frequent stools11.5%75
3. Palmar-plantar erythrodysaesthesia syndrome6.1%40
4. Hospitalisationadmission to hospital4.6%30
5. Nauseafeeling sick4.4%29
6. Therapy cessation4.1%27
7. Skin exfoliationpeeling skin4%26
8. Fatiguetiredness3.8%25
9. Dehydrationdehydration3.5%23
10. Disease progressionthe disease advanced3.2%21
11. Vomitingbeing sick2.8%18
12. Pain in extremitypain in an arm or leg2.1%14
13. Paraesthesiatingling or pins and needles2.1%14
14. Neuropathy peripheralnerve damage in hands or feet2%13
15. Therapy interrupted1.8%12
16. Decreased appetitereduced appetite1.7%11
17. Dry skindry skin1.7%11
18. Pneumonialung infection1.7%11
19. Peripheral swellingswelling of the arms or legs1.5%10
20. Therapy change1.5%10
21. Weight decreasedweight loss1.5%10
22. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine1.4%9
23. Headachehead pain1.4%9
24. Rashskin rash1.4%9
25. Astheniaweakness or lack of energy1.2%8
26. Burning sensationa burning feeling1.2%8
27. Erythemaskin redness1.2%8
28. Painpain, site not specified1.2%8
29. Sepsisa severe body-wide response to infection1.2%8
30. Skin discolourationa change in skin colour1.2%8

Top 30 of 108 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. 99.5% 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 652 reports.

Drugs most often listed in the same reports

Other products listed in reports where Capecitabine 500mg 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 Capecitabine 500mg as a suspect or interacting product; reports listing it only as a concomitant medication (23) 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.