Last reviewed 2026-04-20 · How we verify

Febuxostat Tablets

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• 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)

Common side effects

• Liver Function Abnormalities
• Liver Function Abnormalities
• Liver Function Abnormalities
• Nausea
• Nausea
• Arthralgia
• Rash
• Rash

Key clinical trials

• Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia (PHASE2)
• Tigulixostat (IBI128) vs Febuxostat in Gout (PHASE3)
• The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia (PHASE2)
• HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness (PHASE4)
• Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia (PHASE2)
• Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults (PHASE3)
• Drug-Drug Interaction of JMKX003142 With Amiodarone and Febuxostat in Healthy Subjects (PHASE1)
• A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease (PHASE1)

Primary sources

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