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Pharmacologic class: Xanthine oxidase inhibitor

Therapeutic class: Antigout agent

Pregnancy risk category C


Decreases serum uric acid level


Tablets: 40 mg, 80 mg

Indications and dosages

Long-term management of hyperuricemia in patients with gout

Adults: Initially, 40 mg P.O. daily; for patients who don't achieve serum uric acid level of less than 6 mg/dl after 2 weeks with 40 mg, give 80 mg P.O. daily


• Concomitant use of azathioprine, mercaptopurine


Use cautiously in:
• severe hepatic or renal impairment
• patients with greatly increased rate of urate formation, such as in malignant disease and its treatment and Lesch-Nyhan syndrome (use not recommended)
• concurrent use of theophylline
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).


• Administer with or without food.

Adverse reactions

CNS: dizziness, nonfatal cerebrovascular accident (CVA)

CV: cardiovascular thromboembolic events (nonfatal myocardial infarction [MI], deaths)

GI: nausea

Hepatic: liver function abnormalities

Musculoskeletal: arthralgia

Skin: rash


Drug-drug.Drugs metabolized by xanthine oxidase (such as azathioprine, mercaptopurine): may increase plasma concentrations of these drugs, leading to severe toxicity

Theophylline: altered theophylline metabolism

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase: increased levels

Patient monitoring

Monitor patient for signs and symptoms of MI or CVA.
• Be aware that gout flares (caused by reduction in serum uric acid levels resulting in mobilization of urate from tissue deposits) may occur. To prevent such flares, provide concurrent prophylactic treatment with a non-steroidal anti-inflammatory drug or colchicine, as prescribed.
• Monitor liver function tests 2 months and 4 months after starting therapy and periodically thereafter.

Patient teaching

• Instruct patient to take drug with or without food.

Instruct patient to immediately report cardiovascular symptoms (such as shortness of breath or chest pain) or strokelike symptoms (such as headache or dizziness) to prescriber.
• Tell patient to inform prescriber of increased gout symptoms or rash.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


(fe-bux-o-stat) ,


(trade name)


Therapeutic: antigout agents
Pharmacologic: xanthine oxidase inhibitors
Pregnancy Category: C


Chronic management of hyperuricemia in patients with a history of gout.


Decreases production of uric acid by inhibiting xanthine oxidase.

Therapeutic effects

Lowering of serum uric acid levels with resultant decrease in gouty attacks.


Absorption: Well absorbed (49%) following oral administration.
Distribution: Unknown.
Protein Binding: 99.2%.
Metabolism and Excretion: Extensively metabolized by the liver; minimal renal excretion of unchanged drug, 45% eliminated in feces as unchanged drug, remainder is eliminated in urine and feces as inactive metabolites.
Half-life: 5–8 hr.

Time/action profile (blood levels)

POrapid1–1.5 hr*24 hr
*Maximum lowering of uric acid may take 2 wk


Contraindicated in: Concurrent azathioprine or mercaptopurine.
Use Cautiously in: Severe renal impairment (CCr <30 mL/min);Severe hepatic impairment; Obstetric: Use only when potential maternal benefit outweighs potential fetal risk; Lactation: Unknown if excreted into breast milk; use caution when breast feeding; Pediatric: Safety in children <18 yr not established.

Adverse Reactions/Side Effects


  • ↑ liver function tests
  • nausea


  • rash


  • gout flare
  • arthralgia


Drug-Drug interaction

Significantly ↑ levels of and risk of serious toxicity from azathioprine and mercaptopurine ; concurrent use is contraindicated.May ↑ levels of theophylline ; use cautiously together.


Oral (Adults) 40 mg once daily initially; if serum uric acid does not ↓ to <6 mg/dL, dose should be ↑ to 80 mg once daily.


Tablets: 40 mg, 80 mg

Nursing implications

Nursing assessment

  • Assess for joint pain and swelling, especially during early therapy. Changing serum uric acid levels from mobilization of urate from tissue deposits may cause gout flares. Use prophylactic NSAID or colchicine therapy for up to 6 mo. If a gout flare occurs, continue febuxostat therapy and treat flare concurrently.
  • Monitor for signs and symptoms of MI and stroke.
  • Lab Test Considerations: Monitor serum uric acid levels prior to, 2 wk after intitiating, and periodically thereafter. If serum uric acid levels are ≥6 mg/dL after 2 wk of daily 40 mg therapy, increase dose to 80 mg daily.
    • Monitor liver function at 2 and 4 mo of therapy and periodically thereafter. May cause ↑ AST, ALT, CPK, LDH, alkaline phosphatase, and creatine.
    • May cause prolonged aPTT and PT, and ↓ hematocrit, hemoglobin, RBC, platelet count, and lymphocyte, neutrohpil counts. May cause ↑ or ↓ WBC.
    • May cause ↓ serum bicarbonate and ↑ serum sodium, glucose, potassium, and TSH levels.
    • May cause ↑ serum cholesterol, triglycerides, amylase, and LDL levels.
    • May cause ↑ BUN and serum creatinine and proteinuria.

Potential Nursing Diagnoses

Chronic pain (Indications)


  • Oral: May be taken with or without food and with antacids.

Patient/Family Teaching

  • Instruct patient to take febuxostat as directed. If a gout flare occurs, continue febuxostat and consult health care professional; medications to manage gout flare may be added.
  • Advise patient to notify health care professional if rash, chest pain, shortness of breath, or stroke symptoms (weakness, headache, confusion, slurred speech) occur or if side effects are persistent or bothersome.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
  • Emphasize the importance of follow-up lab tests to monitor therapy.

Evaluation/Desired Outcomes

  • Reduction in serum uric acid levels and resultant gout attacks.


A non-purine selective inhibitor of xanthine oxidase that has been tested as an alternative to allopurinol in patients with GOUT and HYPERURICAEMIA.
References in periodicals archive ?
com)-- Rheumatology Therapeutics Market to 2018 - Increasing Uptake of Benlysta, Uloric, Krystexxa, and the Launch of Oral Tofacitinib to Spur Growth
9 December 2011 - Metabolex Inc, a US-based company developing new treatments for metabolic diseases such as diabetes, unveiled on Thursday positive results from its clinical trial of arhalofenate in combination with febuxostat, which is sold under the name of Uloric by Takeda Pharmaceutical Company Limited (TYO:4502).
Title: Uloric Disease State Campaign Agency: GSW Worldwide Creative Director: Randall Montgomery Art Directors: Dennis Leahy, Andy Spitzer Copywriter: Randall Montgomery Client: TAP Pharmaceuticals
com/research/54cqrc/rheumatology) has announced the addition of the "Rheumatology Therapeutics Market to 2018 - Increasing Uptake of Benlysta, Uloric, Krystexxa, and the Launch of Oral Tofacitinib to Spur Growth" report to their offering.
FDA approves Uloric (febuxostat) for the chronic management of hyperuricemia in patients with gout [press release].
mln9708 (ixazomib) multiple myeloma TOP SELLING DRUGS DRUG INDICATION 2013 SALES (+/- %) Candesartan hypertension $1,507 -14% Leuprorelin prostatic cancer $1,206 8% Pioglitazone type 2 diabetes $1,196 37% Lansoproazole peptic ulcers $1,148 8% Pantoprazole GERD $1,050 25% Velcade multiple myeloma $924 73% Colcrys gout $506 18% Dexilant GERD $486 4% Nesina type 2 diabetes $389 5% Uloric high uric acid $263 92% Amitzia IBS $253 3% Calcium hypertension $185 15% Adcetris Hodgkin lymphoma $136 5%
The company added that the figure was boosted by overseas sales growth of multiple myeloma drug VELCADE, gastroesophageal reflux disease medicine DEXILANT and ULORIC, a drug for hyperuricemia for patients with chronic gout.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the launch of febuxostat (Takeda's Uloric, Ipsen/Menarini's Adenuric, Teijin's Feburic) in 2009 and anticipated launches of AstraZeneca's lesinurad and BioCryst's ulodesine for the treatment of gout are creating a depth of new clinical data and treatment options in what had been a dormant therapy area for decades.
from the gout drugs that came over with last year's URL Pharma purchase, Uloric and Colcrys.
In addition, two of the drugs from the TAP pipeline, Kapidex (GERD) and Uloric (hyperuricemia in gout) received FDA approval in 2009.
According to Treatment Algorithms in Gout, more than half of all drug switches to Takeda's Uloric came from patients previously taking allopurinol.