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# FDA Updates Safety Labeling for Envarsus XR
- URL: https://www.fdaweb.com/fda-updates-safety-labeling-for-envarsus-xr/
- Published: 2024-04-12T12:00:00.000Z
- Updated: 2026-09-14T14:28:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156769

FDA has approved [new safety labeling](https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=136&ref=fdaweb.com) for Veloxis Pharmaceuticals’ Envarsus XR (tacrolimus), indicated for use with other medicines to help prevent organ rejection in people who have had a kidney transplant.

The labeling now reflects an updated contraindication in patients with known hypersensitivity to tacrolimus or to any of the ingredients in Envarsus XR.

It also revises a warning about the drug’s potential to cause acute or chronic nephrotoxicity in transplant patients “due to its vasoconstrictive effect on renal vasculature, toxic tubulopathy and tubular-interstitial effects.”