What is Febuxostat used for?

Febuxostat is evaluated for the following indications with varying evidence strength: Gout prevention (urate-lowering therapy) (evidence tier A), Asymptomatic hyperuricemia (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Febuxostat?

Common side effects of Febuxostat (≥ 1 in 100): Gout flare in the first months, Elevated liver enzymes, Nausea, diarrhea, Headache, Rash. See the Safety section for uncommon and serious reactions.

Who should not take Febuxostat?

Febuxostat is contraindicated in: Febuxostat hypersensitivity; Concurrent azathioprine, mercaptopurine (risk of severe myelosuppression); Severe hepatic impairment. Full list in the Safety section.

Second-line agent in gout after allopurinol per 2016 and 2020. Used with allopurinol intolerance, inadequate response on maximum tolerated allopurinol dose, or in HLA-B*5801 positive status (raised risk of allopurinol hypersensitivity). Standard dose 80 mg once daily; up-titrate to 120 mg if target urate is not reached. Goal: serum urate under 6 mg/dL (under 5 mg/dL in severe tophaceous gout). The CARES trial (2018) showed higher cardiovascular mortality versus allopurinol – indications have since been narrowed.

Asymptomatic hyperuricemia

Not recommended

Febuxostat is actively prescribed to patients with asymptomatic hyperuricemia without gout or nephrolithiasis for anti-aging uric acid reduction. 2020 and 2023 recommend against treating asymptomatic hyperuricemia in patients without gout flares or urate nephropathy. CARES 2018 (White) in gout patients with cardiovascular disease showed increased cardiovascular mortality versus allopurinol, prompting an boxed warning 2019 on increased mortality. Use in asymptomatic patients is unjustified.

Sources

Timing and administration

Take once daily, with or without food. Start therapy between flares – a rapid urate drop in the first weeks can trigger a gout flare. For flare prophylaxis in the first 6 months, give concurrent colchicine 0.5 mg 1–2 times daily or an NSAID. Before starting febuxostat in patients with cardiovascular disease, assess cardiovascular risk – per the 2019 warning, allopurinol is preferred in patients with CVD.

Contraindications

Febuxostat hypersensitivity
Concurrent azathioprine, mercaptopurine (risk of severe myelosuppression)
Severe hepatic impairment

Serious adverse effects

Higher cardiovascular mortality in CVD patients (CARES trial)
Severe cutaneous reactions (Stevens–Johnson syndrome, DRESS)
Hepatotoxicity
Anaphylaxis
Acute kidney injury

Common adverse effects

Gout flare in the first months
Elevated liver enzymes
Nausea, diarrhea
Headache
Rash

PregnancyFDA C

Limited data. Urate-lowering therapy is generally not indicated in pregnancy – acute flares are treated with glucocorticoids or NSAIDs after T1. Febuxostat is not used.

Breastfeeding

No data on milk excretion. Not used during lactation.

Calculate RID Full profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Febuxostat

Mechanism of action

Indications

Gout prevention (urate-lowering therapy)

Marketing claims without evidence base

Asymptomatic hyperuricemia

Practical notes

Timing and administration

Check interaction with another drug

Official sources

Safety