Febuxostat: uses, dosing, side effects & brands

Febuxostat is a xanthine oxidase inhibitor sold in the U.S. under one brand, for gout. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Xanthine Oxidase Inhibitor
Treats: Gout
Available as: Tablet
Sold as: Uloric
Prescription?: Prescription only
Generic available?: Not in our catalog
What the pharmacy pays: about $6 for a 30-count supply — not your price
Boxed warning: Boxed warning

How febuxostat is dosed

From the FDA label for Uloric (application NDA021856). Other febuxostat products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

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. ( 2.1 ) Patients with severe renal impairment: Limit the dosage to 40 mg once daily. ( 2.2 , 8.6 ) Flare prophylaxis is recommended upon initiation of ULORIC. ( 2.4 ) Can be administered without regard to food or antacid use. ( 2.1 ) 2.1 Recommended Dosage The recommended ULORIC dosage is 40 mg or 80 mg once daily. The recommended starting dosage of ULORIC is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks, the recommended ULORIC dosage is 80 mg once daily. ULORIC can be taken without regard to food or antacid use [see Clinical Pharmacology (12.3) ]. Concurrent prophylactic treatment with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ]. 2.2 Dosage Recommendations in Patients with Renal Impairment and Hepatic Impairment The recommended dosage of ULORIC is limited to 40 mg once daily in patients with severe renal impairment. No dose modification is necessary when administering ULORIC in patients with mild or moderate renal impairment [see Use in Specific Populations (8.6) and Clinical…

Febuxostat side effects

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 ULORIC are liver function abnormalities, nausea, arthralgia, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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 2757 patients with hyperuricemia and gout were treated with ULORIC 40 mg or 80 mg daily. For ULORIC 40 mg, 559 patients were treated for ≥6 months. For ULORIC 80 mg, 1377 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 ULORIC 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…

Who shouldn’t take febuxostat

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

Febuxostat drug interactions

Concomitant administration of ULORIC 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 ULORIC is an XO inhibitor. Based on a drug interaction study in healthy patients, febuxostat altered the metabolism of theophylline (a substrate of XO) in humans [see Clinical Pharmacology (12.3) ]. Therefore, use with caution when coadministering ULORIC with theophylline. A drug interaction study of ULORIC 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 ULORIC with other drugs that are metabolized by XO (e.g., mercaptopurine) have not been conducted. ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine [see Contraindications (4) ]. 7.2 Cytotoxic Chemotherapy Drugs Drug interaction studies of ULORIC with cytotoxic chemotherapy have not been conducted. No data are available regarding the safety of ULORIC during cytotoxic chemotherapy. 7.3 In Vivo Drug Interaction Studies Based on drug interaction studies in healthy patients, ULORIC does not have clinically significant interactions with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine [see Clinical Pharmacology (12.3) ]. Therefore, ULORIC may be used concomitantly with these medications.

Every febuxostat product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Uloric.

What febuxostat pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Febuxostat pill imprints
Imprint	Strength	Colour	Shape	Maker
401	40 mg	white	oval	—
C32	80 mg	white	capsule	—
C33	40 mg	white	round	—
40;F	40 mg	green	round	—
80	80 mg	yellow	oval	—
TAP;40	40 mg	green	round	—
TAP;80	80 mg	green	tear	—
40;F	40 mg	green	round	—
80	80 mg	yellow	oval	—

Febuxostat recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long febuxostat keeps

No febuxostat label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does febuxostat expire? The in-use limits and storage rules from its labels

What people report to the FDA about febuxostat

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 10,321 reports naming febuxostat, and the FDA flagged 94% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

acute kidney injury604 reports
diarrhoea546 reports
anaemia511 reports
nausea500 reports
renal impairment451 reports
pyrexia435 reports
dyspnoea420 reports
rash410 reports

Read these as a signal, not a rate. A report does not mean febuxostat caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is febuxostat?

Uloric (Febuxostat) is a xanthine oxidase inhibitor used to treat Gout.

What kind of drug is febuxostat?

The FDA classifies febuxostat as a xanthine oxidase inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take febuxostat with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run febuxostat against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does febuxostat come in?

Across the brands we track, febuxostat is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic febuxostat?

We do not currently list a generic-labelled febuxostat product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Has febuxostat been recalled?

The FDA's Enforcement database lists at least 5 recall records whose product description mentions febuxostat. The most recent: Febuxostat Tablets 40mg (Mar 4, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Cite this page

APA: pharmaranks. (2026, July 24). Febuxostat: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/febuxostat
MLA: “Febuxostat: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/febuxostat.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for febuxostat on DailyMed (NIH) ↗ — including its boxed warning in full.