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.
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
- Diarrhoea
Diarrhoea
849 reports
- Nausea
Nausea
841 reports
- Acute Kidney Injury
Acute Kidney Injury
837 reports
- Rash
Rash
783 reports
- Gout
Gout
686 reports
- Dyspnoea
Dyspnoea
620 reports
- Fatigue
Fatigue
598 reports
- Anaemia
Anaemia
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for febuxostat?
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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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for febuxostat: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 16,005.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 13.11%.
- cyclosporine Δ 0.00 pts · 106,440 reports · Calcineurin Inhibitor (Immunosuppressant) 13.12%death share
- zoledronic acid Δ 0.03 pts · 38,197 reports · Bisphosphonate (IV) 13.09%death share
- paroxetine Δ 0.03 pts · 32,666 reports · Selective Serotonin Reuptake Inhibitor (SSRI) 13.09%death share
- calcitriol Δ 0.03 pts · 20,452 reports · Active Vitamin D (1,25-dihydroxy) 13.14%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: May 8, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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