Febuxostat — $0 on Listed Strengths

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• Allopurinol
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About Febuxostat

Febuxostat is a crucial medication for managing chronic gout, a painful form of arthritis caused by high uric acid levels. If you're living with gout, understanding your treatment options is vital. TheDrugClub is dedicated to making essential medications like febuxostat more accessible and affordable, helping you save significantly on your prescription costs.

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Febuxostat is approved for (FDA label)

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. ( 1 ) Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) 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.

Source: Read the full FDA label on DailyMed. Label effective date: April 27, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Febuxostat (FDA label)

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 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 )

Source: FDA prescribing information (DailyMed). Set ID: f2c338dc-5bab-49f4-a4ac-d8dea8afeea5. SPL document ID: 50715053-7e60-460b-e063-6394a90a877c. Label effective date: April 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Febuxostat (FDA label)

Tablet: 40 mg, 80 mg. ( 3 ) 40 mg tablets, white to off-white, beveled-edge, oval-shaped tablets debossed with "401" on one side and plain on the other side.

Source: FDA prescribing information (DailyMed). Set ID: f2c338dc-5bab-49f4-a4ac-d8dea8afeea5. SPL document ID: 50715053-7e60-460b-e063-6394a90a877c. Label effective date: April 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Febuxostat (FDA label)

The following serious adverse reactions are described elsewhere in the prescribing information: Cardiovascular Death [see Warnings and Precautions ( 5.1 )] Hepatic Effects [see Warnings and Precautions ( 5.3 )] Serious Skin Reactions [see Warnings and Precautions ( 5.4 )] Adverse reactions in ≥ 1% of patients treated with febuxostat are liver function abnormalities, nausea, arthralgia, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phase 2 and 3 clinical studies, a total of 2,757 patients with hyperuricemia and gout were treated with febuxostat 40 mg or 80 mg daily. For febuxostat 40 mg, 559 patients were treated for ≥ 6 months. For febuxostat 80 mg, 1,377 patients were treated for ≥ 6 months, 674 patients were treated for ≥ 1 year and 515 patients were treated for ≥ 2 years. In the CARES study, a total of 3098 patients were treated with febuxostat 40 mg or 80 mg daily; of these, 2155 patients were treated for ≥ 1 year and 1539 were treated for ≥ 2 years [see Clinical Studies ( 14.2 )] . Most Common Adverse Reactions In three randomized, controlled clinical studies (Studies 1, 2 and 3), which were 6 to 12 months in duration, the following adverse reactions were reported by the treating physician as related to study drug.

Source: FDA prescribing information (DailyMed). Set ID: f2c338dc-5bab-49f4-a4ac-d8dea8afeea5. SPL document ID: 50715053-7e60-460b-e063-6394a90a877c. Label effective date: April 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Febuxostat (FDA label)

Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine. ( 4 ) Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions ( 7 )] .

Source: FDA prescribing information (DailyMed). Set ID: f2c338dc-5bab-49f4-a4ac-d8dea8afeea5. SPL document ID: 50715053-7e60-460b-e063-6394a90a877c. Label effective date: April 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Febuxostat (FDA label)

Gout Flares: An increase in gout flares is frequently observed after initiation of febuxostat. If a gout flare occurs during treatment, febuxostat 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. ( 2.4 , 5.2 ) Hepatic Effects: Cases of hepatic failure, some fatal, have been reported. If liver injury is detected, promptly interrupt febuxostat and treat cause, if possible, to resolution or stabilization. Permanently discontinue febuxostat if liver injury is confirmed, and no alternate etiology can be found. ( 5.3 ) Serious Skin Reactions: Serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms and toxic epidermal necrolysis have been reported in patients taking febuxostat.

Source: FDA prescribing information (DailyMed). Set ID: f2c338dc-5bab-49f4-a4ac-d8dea8afeea5. SPL document ID: 50715053-7e60-460b-e063-6394a90a877c. Label effective date: April 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Febuxostat (FDA label)

Concomitant administration of febuxostat with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity. ( 7 ) 7.1 Xanthine Oxidase Substrate Drugs Febuxostat is an XO inhibitor. A drug interaction study of febuxostat and azathioprine, also metabolized by XO, showed an increase in exposure of 6-mercaptopurine which may lead to toxicity [see Clinical Pharmacology ( 12.3 )] . Drug interaction studies of febuxostat with other drugs that are metabolized by XO (e.g., mercaptopurine) have not been conducted. Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Contraindications ( 4 )]. 7.2 Cytotoxic Chemotherapy Drugs Drug interaction studies of febuxostat with cytotoxic chemotherapy have not been conducted.

Source: FDA prescribing information (DailyMed). Set ID: f2c338dc-5bab-49f4-a4ac-d8dea8afeea5. SPL document ID: 50715053-7e60-460b-e063-6394a90a877c. Label effective date: April 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.