Prescription medicine
Febuxostat Brand names: Uloric
Febuxostat (Uloric) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $0.191 per febuxostat 40 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the febuxostat FDA label on DailyMed (effective December 24, 2025, Takeda Pharmaceuticals America, Inc.); the NDA 21856 record on Drugs@FDA; every febuxostat label on DailyMed.
Highlights of the record
FDA label of December 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 [see Warnings and Precautions (5.1) ]. Consider the risks and benefits of ULORIC when deciding to prescribe or continue patients on ULORIC. ULORIC 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 ULORIC 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 ULORIC when deciding to prescribe or continue patients on ULORIC. ULORIC 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.
Used for
From the label: indications and usageULORIC 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.
Forms and strengths
- 40 mg
- 80 mg
Tablet; film-coated tablet; coated tablet; film.
On the market
- Earliest approval on file
- February 13, 2009 Uloric, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first July 1, 2019; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 23 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 8, 2031 Uloric tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.191 per tablet Febuxostat 40 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest March 4, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 16,668 through July 30, 2026
What is febuxostat used for?
From the label: indications and usageULORIC 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. 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. ( 1 ) Limitations of Use: ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. […]
Conditions named in the indications of febuxostat's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Xanthine Oxidase Inhibitor.
Source: FDA drug label (ULORIC), Takeda Pharmaceuticals America, Inc., effective December 24, 2025 (SPL set 54de10ef-fe5f-4930-b91d-6bbb04c664bd), via openFDA; the full label on DailyMed
What does the patient leaflet for febuxostat say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information that I should know about ULORIC?ULORIC may cause serious side effects, including: Heart-related deaths. Call your doctor or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: chest pain shortness of breath or trouble breathing dizziness, fainting or feeling lightheaded rapid or irregular heartbeat numbness or weakness on one side of your body slurring of speech sudden blurry vision or sudden severe headache
From the patient leaflet: How should I store ULORIC?Store ULORIC at room temperature. Keep ULORIC out of the light. Keep ULORIC and all medicines out of the reach of children.
Source: FDA drug label (ULORIC), Takeda Pharmaceuticals America, Inc., effective December 24, 2025 (SPL set 54de10ef-fe5f-4930-b91d-6bbb04c664bd), via openFDA; the full label on DailyMed
Is there a generic for febuxostat (Uloric)?
The FDA approved the first generic febuxostat on July 1, 2019. 15 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists febuxostat from 23 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Uloric tablets, the last expiring on September 8, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2019 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for febuxostat (Uloric)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.191 per Febuxostat 40 mg tablet, down 19% from $0.236 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Febuxostat 40 mg tablet (generic)
- Uloric 80 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Febuxostat 40 mg tablet | Generic | $0.191 per tablet | $5.73 | -19% |
| Febuxostat 80 mg tablet | Generic | $0.261 per tablet | $7.83 | -26% |
| Uloric 40 mg tablet | Brand | $10.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $316.32 | -0.3% |
| Uloric 80 mg tablet | Brand | $10.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $316.13 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has febuxostat been recalled?
The FDA's Enforcement Report lists 6 recalls naming febuxostat since 2013: 0 Class I (the most serious), 6 Class II, 0 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of febuxostat and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 4, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| January 25, 2024 | Class II | Amerisource Health Services LLC | CGMP Deviations |
| January 18, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 59746000103, Pedigree: AD21811_17, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the febuxostat label say about other medicines?
The febuxostat label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name febuxostat. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | boxed warning | ULORIC 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) ]. |
| Aspirin | warnings and precautions | Consider use of prophylactic low-dose aspirin therapy in patients with a history of CV disease. |
| Azathioprine | contraindications | CONTRAINDICATIONS ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7) ]. |
| Colchicine | drug interactions | 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) ]. |
| Desipramine | drug interactions | 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) ]. |
| Hydrochlorothiazide | drug interactions | 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) ]. |
| Indomethacin | drug interactions | 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) ]. |
| Mercaptopurine | contraindications | CONTRAINDICATIONS ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7) ]. |
| Naproxen | drug interactions | 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) ]. |
| Theophylline | drug interactions | 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) ]. |
| Warfarin | drug interactions | 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) ]. |
Other labels that name febuxostat
Source: FDA drug label (ULORIC), Takeda Pharmaceuticals America, Inc., effective December 24, 2025 (SPL set 54de10ef-fe5f-4930-b91d-6bbb04c664bd), via openFDA; the full label on DailyMed
What do FAERS reports show for febuxostat?
The FDA Adverse Event Reporting System holds 16,668 reports that list febuxostat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,179 are coded as a death and 7,176 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as febuxostat?
4 other medicines are given the same way (oral) and in the same FDA class as febuxostat or labeled mainly for the same use (gout), the same class first. Gout lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Allopurinol | Gout | 42 labelers | $0.0315 per tablet 100 mg tablet | A presentation being discontinued |
| Colchicine | Gout | 30 labelers | $0.122 per tablet 0.6 mg tablet | No current entry |
| Probenecid | Gout | 6 labelers | $0.636 per tablet 500 mg tablet | No current entry |
| Colchicine and probenecid | Gout | 4 labelers | $0.830 per tablet Probenecid-colchicine tablet | No current entry |
Every medicine labeled for the same conditions as febuxostat
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does febuxostat compare with medicines for the same use?
2 side-by-side pages set febuxostat beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to febuxostat
- 4 medicines for the same use
- Other xanthine oxidase inhibitors
- the pharmacologic class, with prices and generics
- Febuxostat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other