Last reviewed 2026-04-20 · How we verify

Uloric (FEBUXOSTAT)

Uloric works by blocking the enzyme xanthine dehydrogenase/oxidase, which is involved in the production of uric acid.

Uloric (FEBUXOSTAT) is a small molecule xanthine oxidase inhibitor developed by Takeda Pharms USA, targeting xanthine dehydrogenase/oxidase to prevent gout and treat hyperuricemia. It was FDA approved in 2009 and is currently owned by Takeda Pharms USA. Uloric is available as a generic medication, with 15 generic manufacturers. Key safety considerations include potential liver damage and increased risk of serious skin reactions. Uloric is a commercial medication with a complex pharmacology.

At a glance

Mechanism of action

ULORIC, xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. ULORIC is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Approved indications

• Gout Prevention
• Hyperuricemia

Boxed warnings

• WARNING: CARDIOVASCULAR DEATH 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 [see Warnings and Precautions (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 [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 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 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. ( 1 )

Common side effects

• Enthesopathy
• Renal impairment
• Tenosynovitis
• Tongue disorder
• Cardiac failure
• Tendonitis
• Blood parathyroid hormone decreased
• Panniculitis
• Red blood cell sedimentation rate
• Acute kidney injury
• Granuloma skin
• Drug eruption

Key clinical trials

• Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia (PHASE2)
• Tigulixostat (IBI128) vs Febuxostat in Gout (PHASE3)
• Boosting Osimertinib Blood Brain Barrier Penetration (PHASE2)
• Time Required to Dissolve Urate Deposits
• The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia (PHASE2)
• Treat-to-target by Email During Urate-lowering Therapy in Gout (NA)
• HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness (PHASE4)
• Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration (PHASE3)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Uloric CI brief — competitive landscape report
• Uloric updates RSS · CI watch RSS
• Takeda portfolio CI