Note: This document contains side effect information about febuxostat. Some of the dosage forms listed on this page may not apply to the brand name Uloric.
More frequent side effects include: abnormal hepatic function tests. See below for a comprehensive list of adverse effects.
Applies to febuxostat: oral tablet
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:
Incidence not known
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:
Incidence not known
Applies to febuxostat: oral tablet
The more commonly reported side effects include gout flares, liver function abnormalities, diarrhea, nausea, rash, headache, and edema.
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.
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
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
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
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.
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
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
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.
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
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.
In postmarketing reports, rhabdomyolysis occurred more frequently in patients given concomitant treatment with a statin and colchicine; some patients had preexisting renal impairment/failure.
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
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
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
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
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
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)
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
Uncommon (0.1% to 1%): Blood thyroid stimulating hormone (TSH) increased
Frequency not reported: Gynecomastia
Rare (0.01% to 0.1%): Blurred vision
Frequency not reported: Eye irritation
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
Rare (0.01% to 0.1%): Drug reaction with eosinophilia and systemic symptoms (DRESS)
Frequency not reported: Influenza-like symptoms
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Uloric