FDA label
What is febuxostat used for?
The FDA-approved uses of febuxostat, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout 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.”
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Febuxostat, tablet
Indications and Usage, quoted from the label by Lannett Company, Inc. (ANDA213069). Cross-references to other label sections are left out.
Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout 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.
Limitations of Use:
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Source: DailyMed label, set id 73b07a94-c044-42dc-abe4-7d7c860c9638, version 6, effective January 16, 2024. NDC 0527-2244, one of 23 listings for this product.
Febuxostat, tablet, film coated
Indications and Usage, quoted from the label by Novadoz Pharmaceuticals LLC (ANDA210461). Cross-references to other label sections are left out.
Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout 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. Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Source: DailyMed label, set id d1969ea8-5178-42ee-97fc-feee8595e677, version 6, effective February 20, 2026. NDC 72205-028, one of 14 listings for this product.
Questions
What is febuxostat used for?
The FDA label says: “Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout 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.”
What drug class is febuxostat?
FDA lists febuxostat in the Xanthine Oxidase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.