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Febuxostat

Cardiovascular Death

  • Gout patients with established cardiovascular (CV) disease treated with ULORIC had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.
  • Consider the risks and benefits of ULORIC when deciding to prescribe or continue patients on ULORIC. ULORIC should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

FDA and Industry Communications

Index to FDA Safety Information

Patient Counseling Information

Medication Guides

Patient Medication Guide - Uloric

Package Inserts

Febuxostat

Updated March 2019