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Uloric Side Effects

Generic name: febuxostat

Medically reviewed by Drugs.com. Last updated on May 23, 2023.

Note: This document contains side effect information about febuxostat. Some dosage forms listed on this page may not apply to the brand name Uloric.

Applies to febuxostat: oral tablet.

Warning

Oral route (Tablet)

Warning: Cardiovascular DeathGout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat. Febuxostat 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.

Serious side effects of Uloric

Along with its needed effects, febuxostat (the active ingredient contained in Uloric) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking febuxostat:

Rare

Incidence not known

Other side effects of Uloric

Some side effects of febuxostat may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Incidence not known

For Healthcare Professionals

Applies to febuxostat: oral tablet.

General

The more commonly reported side effects include gout flares, liver function abnormalities, diarrhea, nausea, rash, headache, and edema.[Ref]

Metabolic

Gout flares were commonly observed soon after the start of treatment and during the first months. Thereafter, the frequency of gout flares decreased in a time-dependent manner.[Ref]

Very common (10% or more): Gout flares (up to 43.1%)

Uncommon (0.1% to 1%): Blood cholesterol increase/hypercholesterolemia, blood lactate dehydrogenase increase, blood potassium increase, blood triglycerides increase/hypertriglyceridemia, decreased appetite, diabetes mellitus, hyperlipidemia, weight increase

Rare (0.01% to 0.1%): Anorexia, blood glucose increase/hyperglycemia, increased appetite, weight decrease

Frequency not reported: Bicarbonate decrease, dehydration, hypokalemia, low density lipoprotein (LDL) increase, sodium increase[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea

Uncommon (0.1% to 1%): Abdominal pain/distention, blood amylase increase, constipation, dry mouth, dyspepsia, flatulence, frequent stools, gastroesophageal reflux disease, gastrointestinal discomfort, vomiting

Rare (0.01% to 0.1%): Mouth ulceration, pancreatitis

Frequency not reported: Gastritis, gingival pain, hematemesis, hyperchlorhydria, hematochezia, peptic ulcer, treatment-emergent non-infective diarrhea[Ref]

Hepatic

Common (1% to 10%): ALT greater than/equal to 3 times upper limit of normal (3 x ULN), AST 3 x ULN, liver function abnormalities

Uncommon (0.1% to 1%): Alkaline phosphatase greater than/equal to 2 x ULN, cholelithiasis, total bilirubin greater than/equal to 2 mg/dL

Rare (0.01% to 0.1%): Blood alkaline phosphatase increase, hepatitis, jaundice, liver injury

Postmarketing reports: Cholecystitis, hepatic failure (some fatal), hepatic steatosis, hepatomegaly, liver disorder, serious cases of abnormal liver function tests[Ref]

Liver function abnormalities occurred more frequently when given with colchicine for gout flare prophylaxis; abnormalities also occurred more frequently at 40 mg doses (8.3%) compared to 80 mg and placebo (6.4% and 2.2%, respectively).

Alkaline phosphatase levels of at least 2 x the upper limit of normal (2 x ULN) most commonly occurred at 80 mg. ALT increases of at least 3 x ULN most frequently occurred in patients given this drug at any dose compared to allopurinol and placebo.[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Altered taste, dizziness, hemiparesis, hypoesthesia, hypoemia, paresthesia, somnolence

Frequency not reported: Balance disorder, cerebrovascular accident, EEG abnormal, gait disturbances, Guillain-Barre syndrome, lacunar infarction, lethargy, mental impairment, migraine, transient ischemic attack, tremor, vertigo[Ref]

Dermatologic

Serious skin and hypersensitivity reactions including Stevens-Johnson Syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms have been reported in the postmarketing period. In many cases, a previous similar skin reaction to allopurinol had occurred.

In clinical trials, no difference in side effects was observed between Asian patients and other ethnic groups; however, there have been postmarketing reports of serious skin/hypersensitivity reactions in some Asian patients.[Ref]

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Dermatitis, maculopapular rash, petechia, pruritus, rash macular, rash papular, skin discoloration/altered pigmentation, skin lesion, urticaria

Rare (0.01% to 0.1%): Alopecia, erythema, exfoliative rash, hyperhidrosis, pruritic rash,

rash erythematous, rash follicular, rash morbilliform, rash pustular, rash vesicular

Frequency not reported: Blisters, dermographism, ecchymosis, eczema, facial edema, generalized rash, hair color change, hair growth abnormal, herpes zoster, infiltrated maculopapular eruption, mucosal lesions, peeling skin, photosensitivity, progressive skin rashes, serious generalized rash, skin odor abnormal, Stevens-Johnson syndrome, toxic epidermal necrolysis

Postmarketing reports: Serious skin and hypersensitivity reactions including Stevens-Johnson Syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms[Ref]

Cardiovascular

Common (1% to 10%): Edema

Uncommon (0.1% to 1%): Atrial fibrillation, chest pain/discomfort, ECG abnormal, flushing, hemorrhage, hot flush, hypertension, left bundle branch block, palpitations, sinus tachycardia

Frequency not reported: Angina pectoris, atrial flutter, cardiac murmur, contusion, hypotension, major adverse cardiac events (cardiovascular death, non-fatal myocardial infarction/stroke), cardiovascular death, sinus bradycardia, tachycardia[Ref]

Edema occurred more frequently in patients given 80 mg (2.7%) than 40 mg (1.3%) or placebo (0.7%).

In the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial, gout patients with established cardiovascular (CV) disease experienced a significant increase in CV deaths compared to allopurinol (134/3098 vs 100/3092). Sudden cardiac death was the most common cause of CV death (83 vs 56). For the primary endpoint, time to first occurrence of MACE (defined as the composite of CV death, nonfatal MI, nonfatal stroke, or unstable angina with urgent coronary revascularization), a significant difference in febuxostat and allopurinol treated patients was not found.[Ref]

Musculoskeletal

In postmarketing reports, rhabdomyolysis occurred more frequently in patients given concomitant treatment with a statin and colchicine; some patients had preexisting renal impairment/failure.[Ref]

Common (1% to 10%): Arthralgia

Uncommon (0.1% to 1%): Arthritis, blood creatine increase, bursitis, muscle spasm, muscle tightness, muscle weakness, musculoskeletal pain, myalgia

Rare (0.01% to 0.1%): Blood creatine phosphokinase (CPK) increase, joint stiffness, musculoskeletal stiffness, rhabdomyolysis

Frequency not reported: Joint swelling, muscle twitching, rhabdomyolysis[Ref]

Renal

Uncommon (0.1% to 1%): Blood creatinine increase, blood urea increase, nephrolithiasis, renal failure/insufficiency

Rare (0.01% to 0.1%): Tubulointerstitial nephritis

Frequency not reported: BUN/creatinine ratio increase

Postmarketing reports: Tubulointerstitial nephritis[Ref]

Hematologic

Uncommon (0.1% to 1%): Hematocrit decrease, hemoglobin decrease, hemorrhage, lymphocyte count decrease, platelet count decrease, WBC decrease

Rare (0.01% to 0.1%): Activated partial thromboplastin time prolonged, pancytopenia, red blood cell count decrease, thrombocytopenia

Frequency not reported: Anemia, coagulation test abnormal, eosinophilia, idiopathic thrombocytopenia purpura, leukocytosis, leukopenia, mean corpuscular volume increase, neutropenia, neutrophil count decrease, prothrombin time prolonged, splenomegaly, purpura, WBC increase

Postmarketing reports: Agranulocytosis, eosinophilia[Ref]

Genitourinary

Uncommon (0.1% to 1%): Erectile dysfunction, hematuria, pollakiuria, proteinuria

Rare (0.01% to 0.1%): Micturition urgency/urgency

Frequency not reported: Breast pain, incontinence, prostate-specific antigen (PSA) increase, urinary casts, urine output increase/decrease, urine positive for WBC and protein[Ref]

Respiratory

Uncommon (0.1% to 1%): Bronchitis, cough, dyspnea, upper respiratory tract infection

Frequency not reported: Epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory tract congestion, sneezing, throat irritation[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia, decreased libido

Rare (0.01% to 0.1%): Nervousness

Frequency not reported: Agitation, anxiety, depression, irritability, panic attack, personality change

Postmarketing reports: Confusion, psychotic behavior (including aggressive thoughts)[Ref]

Other

Uncommon (0.1% to 1%): Fatigue

Rare (0.01% to 0.1%): Thirst, tinnitus

Frequency not reported: Asthenia, deafness, feeling abnormal, fever, mass, pain, single/multiple organ involvement[Ref]

Endocrine

Uncommon (0.1% to 1%): Blood thyroid stimulating hormone (TSH) increased

Frequency not reported: Gynecomastia[Ref]

Ocular

Rare (0.01% to 0.1%): Blurred vision

Frequency not reported: Eye irritation[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reactions, angioedema, drug hypersensitivity

Frequency not reported: Hypersensitivity (including infiltrated maculopapular eruption, generalized/exfoliative rash, skin lesions, facial edema, fever, thrombocytopenia, eosinophilia, single/multiple organ involvement [e.g. tubulointerstitial nephritis])

Postmarketing reports: Anaphylactic shock, anaphylaxis, hypersensitivity skin reactions[Ref]

Immunologic

Rare (0.01% to 0.1%): Drug reaction with eosinophilia and systemic symptoms (DRESS)

Frequency not reported: Influenza-like symptoms[Ref]

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Uloric (febuxostat). Takeda Pharmaceuticals America. 2009.

4. Becker MA, Schumacher HR Jr, Wortmann RL, et al. Febuxostat Compared with Allopurinol in Patients with Hyperuricemia and Gout. N Engl J Med. 2005;353:2450-2461.

5. Sun YM, Wang LF, Li J, Li ZQ, Pan W. The 223A>G polymorphism of the leptin receptor gene and lipid-lowering efficacy of simvastatin in Chinese patients with coronary heart disease. Eur J Clin Pharmacol. 2008.

6. Schumacher HR Jr, Becker MA, Wortmann RL, et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008;59:1540-1548.

7. Edwards NL. Febuxostat: a new treatment for hyperuricaemia in gout. Rheumatology. 2009;48:ii15-ii19.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.