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# Safety Labeling Changes for Fluorouracil Injection
- URL: https://www.fdaweb.com/safety-labeling-changes-for-fluorouracil-injection/
- Published: 2024-03-21T12:00:00.000Z
- Updated: 2026-09-14T14:26:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156607

FDA has approved safety labeling changes for fluorouracil injection drug products. An online [post](https://downloads.regulations.gov/FDA-2024-P-1378-0001/attachment%5F2.pdf?ref=fdaweb.com) says the Office of Generic Drugs and Oncology Center of Excellence collaborated on the revisions.

Fluorouracil injection was first approved in 1962, the post says. FDA became aware of additional safety information on the risk of serious adverse reactions related to fluorouracil use in patients with dihydropyrimidine dehydrogenase deficiency, it says.

Revisions have been made to the Highlights of Prescribing Information, Warnings and Precautions, and Patient Counseling Information of the labeling to provide information about the risks, the post says. In addition, a Pharmacogenomics section has been added to the Clinical Pharmacology section of the labeling.