Prescription medication · Xanthine Oxidase Inhibitor
febuxostat
Also sold as Uloric. Febuxostat treats high uric acid levels in adults who have gout.
Data updated 2026-05-15
- 16,005
- FDA reportsModerately reported
- 9
- InteractionsFew interactions
- 97% less
- Generic vs brandHuge savings
- 1
- Recall record
What the data shows
febuxostat (Uloric) is a prescription Xanthine Oxidase Inhibitor, reported at a middle-of-the-pack volume (16,005 FDA reports), whose generic costs a fraction of the brand (about 97% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
febuxostat (Uloric) is a prescription Xanthine Oxidase Inhibitor. Febuxostat treats high uric acid levels in adults who have gout.
Febuxostat (Uloric) helps manage high uric acid levels in adults with gout. It is used when allopurinol doesn't work well, causes problems, or isn't a good option.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$10.57/unit
Generic Price
$0.33/unit
Generic Savings
97%
Generic Available
Yes (12 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Febuxostat treats high uric acid levels in adults who have gout.
Common side effects
Abnormal liver function tests, Nausea, Joint pain
Key warnings
Febuxostat may increase the risk of death from heart problems in people with existing heart disease.
The sections below are summarized in plain English from febuxostat's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Febuxostat lowers uric acid levels in your body. It does this by blocking an enzyme called xanthine oxidase. This enzyme helps make uric acid, so blocking it reduces uric acid production.
How to Take It
Take febuxostat once a day, either 40 mg or 80 mg. You can take it with or without food. If your uric acid level is not below 6 mg/dL after 2 weeks on 40 mg, your doctor may increase your dose to 80 mg. When you start taking febuxostat, your doctor may also prescribe another medicine like an NSAID or colchicine to prevent gout flares.
This is a plain-language summary of febuxostat's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if febuxostat can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if febuxostat passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking this medicine.
This is a plain-language summary of febuxostat's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of febuxostat's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store febuxostat at room temperature, between 68° to 77°F (20° to 25°C), and protect it from light.
Side Effects (from patient reports)
Based on 16,005 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for febuxostat, by number of reports
- Diarrhea
Diarrhea
849 reports
- Nausea
Nausea
841 reports
- Sudden kidney damage
Sudden kidney damage
837 reports
- Rash
Rash
783 reports
- Gout
Gout
686 reports
- Difficulty breathing
Difficulty breathing
620 reports
- Tiredness
Tiredness
598 reports
- Low red blood cell count
Low red blood cell count
568 reports
- Headache
Headache
567 reports
- Pneumonia
Pneumonia
532 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for febuxostat each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where febuxostat sits
febuxostat has more FDA adverse-event reports than 50% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is febuxostat; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 16,005 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2009–2025.
Total Reports
16,005
Reports Mentioning Death
2,099
13.1% of reports — not proof of cause
Hospitalization Reports
6,835
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DIARRHOEA | 849 |
| 2 | NAUSEA | 841 |
| 3 | ACUTE KIDNEY INJURY | 837 |
| 4 | RASH | 783 |
| 6 | GOUT | 686 |
| 8 | DYSPNOEA | 620 |
| 9 | FATIGUE | 598 |
| 10 | ANAEMIA | 568 |
| 11 | HEADACHE | 567 |
| 12 | PNEUMONIA | 532 |
| 13 | PYREXIA | 526 |
| 14 | DEATH | 515 |
| 15 | RENAL IMPAIRMENT | 494 |
| 16 | CHRONIC KIDNEY DISEASE | 467 |
| 17 | RENAL FAILURE | 457 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Febuxostat may increase the risk of death from heart problems in people with existing heart disease. Talk to your doctor about the risks and benefits of taking febuxostat. Febuxostat should only be used if allopurinol doesn't work well, causes problems, or isn't a good option for you.
Known Drug Interactions
Febuxostat Clinical Impact: Febuxostat increased rosuvastatin exposure more than 1.9-fold. Intervention: In patients taking febuxostat, do not exceed a dose of rosuvastatin 20 mg once daily.
Mechanism: Febuxostat slows down how your body gets rid of rosuvastatin, causing the medicine to build up in your blood. This increase can make side effects more likely.
What to do: If you are taking both medications, your doctor should limit your rosuvastatin dose to a maximum of 20 mg per day.
Febuxostat Clinical Impact: Febuxostat increased rosuvastatin exposure more than 1.9-fold. Intervention: In patients taking febuxostat, do not exceed a dose of rosuvastatin 20 mg once daily.
Mechanism: Febuxostat interferes with the way your body handles rosuvastatin, which can nearly double the amount of the drug in your bloodstream. This buildup increases the chance of experiencing harmful side effects.
What to do: When taking these two drugs together, ensure your rosuvastatin dose does not exceed 20 mg once daily.
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 febuxostat with theophylline.
Mechanism: Febuxostat interferes with how the body breaks down theophylline, which can change the amount of medicine in your body.
What to do: Use these drugs together with caution and talk to your doctor about any needed monitoring.
7.3 In Vivo Drug Interaction Studies Based on drug interaction studies in healthy patients, febuxostat does not have clinically significant interactions with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine [see Clinical Pharmacology (12.3) ].
Mechanism: These drugs do not have a meaningful effect on each other when taken at the same time.
What to do: No special precautions or dose changes are typically needed for this combination.
7.3 In Vivo Drug Interaction Studies Based on drug interaction studies in healthy patients, febuxostat does not have clinically significant interactions with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine [see Clinical Pharmacology (12.3) ].
Mechanism: Research shows that these two medications do not significantly change how the other works in the body.
What to do: You can take these together as prescribed without needing to change your routine.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take febuxostat if I'm taking azathioprine or mercaptopurine?
Will febuxostat cure my gout?
How long will I need to take febuxostat?
Can I drink alcohol while taking febuxostat?
What should I do if I get a gout flare while taking febuxostat?
Will febuxostat affect my liver?
Can febuxostat cause skin reactions?
Does febuxostat interact with other medicines?
Can I take febuxostat if I have kidney problems?
What are the symptoms of a serious heart problem?
What are the common side effects of febuxostat?
Does febuxostat interact with other medications?
What drug class is febuxostat?
Is there a generic version of febuxostat?
Is febuxostat safe during pregnancy?
Has febuxostat been recalled?
Active Recalls
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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What the FDA Data Shows for febuxostat
The FDA label for febuxostat (sold under brand names such as Uloric) classifies it as a prescription-only medication in the Xanthine Oxidase Inhibitor class. Febuxostat treats high uric acid levels in adults who have gout. Official labeling lists 4 commonly reported side effects, including Abnormal liver function tests, Nausea, Joint pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 16,005 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.33 versus $10.57 for the brand - a 97% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: May 8, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages