Brand names: Febuxostat
Xanthine Oxidase Inhibitor · Xanthine Oxidase Inhibitors
FDA Black Box Warning
BOXED WARNING WARNING : CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [ see Warnings and Precautions ( 5.1 )]. Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat. Febuxostat 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 [ see Indications and Usage ( 1 )]. WARNING: CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. • Gout patients with established cardiovascular (CV) disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study. (5.1) • Consider the risks and benefits of febuxostat tablets when deciding to prescribe or continue patients on febuxostat tablets. Febuxostat tablets 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. (1)
1 interaction on record
7.3 In Vivo Drug Interaction Studies Based on drug interaction studies in healthy patients, febuxostat does not have clinically significant interactions with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine [see Clinical Pharmacology ( 12.3 )].
Source: FDA drug label - febuxostat tablets 40 mg