Febuxostat is a xanthine oxidase 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, among other approved uses. MedsAcross supplies Febuxostat for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ULORIC 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: ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.
Source: US FDA prescribing information
ULORIC, a 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.
Source: US FDA prescribing information
Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. Patients with severe renal impairment: Limit the dosage to 40 mg once daily. Flare prophylaxis is recommended upon initiation of ULORIC. Can be administered without regard to food or antacid use.
Source: US FDA prescribing information
ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
Source: US FDA prescribing information
Boxed warning (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. Gout Flares: An increase in gout flares is frequently observed after initiation of ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug or colchicine) upon initiation of treatment may be beneficial for up to six months. Hepatic Effects: Cases of hepatic failure, some fatal, have been reported. If liver injury is detected, promptly interrupt ULORIC and treat cause, if possible, to resolution or stabilization.
Source: US FDA prescribing information
The following serious adverse reactions are described elsewhere in the prescribing information: Cardiovascular Death Hepatic Effects Serious Skin Reactions Adverse reactions in ≥ 1% of patients treated with ULORIC are liver function abnormalities, nausea, arthralgia, and rash.
Source: US FDA prescribing information
Concomitant administration of ULORIC with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
6 presentations of Febuxostat, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Febuxostat 40 mg tabletOralGeneric name | — | US FDA | Available on request |
| Febuxostat 80 mg tabletOralGeneric name | — | US FDA | Available on request |
| Uloric 40 mg tabletOral | Takeda Pharmaceuticals | US FDA | Available on request |
| Uloric 80 mg tabletOral | Takeda Pharmaceuticals | US FDA | Available on request |
| Febuxostat 40 mg oral filmOralGeneric name | — | US FDA | Available on request |
| Febuxostat 80 mg oral filmOralGeneric name | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Febuxostat in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 6 presentations of Febuxostat and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Febuxostat, including Uloric.
Yes. The US FDA first approved Febuxostat on 13 February 2009, according to Drugs@FDA.
Yes. Febuxostat has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Febuxostat is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Febuxostat is classified under ATC code M04AA03 (Febuxostat).
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