Safety Labeling Update for Capecitabine and Fluorouracil on Risks Associated With Dihydropyrimidine Dehydrogenase Deficiency

The FDA is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All health care providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.

For more information, read the FDA announcement.

Posted on 2/6/2026