febuxostat
Brand names: Uloric
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.
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.
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.
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.
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.
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 7,173 FDA adverse event reports.
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
Death-Related Reports
2,099
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 |
| 5 | OFF LABEL USE | 715 |
| 6 | GOUT | 686 |
| 7 | DRUG INEFFECTIVE | 676 |
| 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 |
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.
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.
SUN PHARMACEUTICAL INDUSTRIES INC
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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 7,173 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.
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