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Febuxostat Side Effects

In Summary

More frequently reported side effects include: abnormal hepatic function tests. See below for a comprehensive list of adverse effects.

For the Consumer

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.

Side effects requiring immediate medical attention

Along with its needed effects, febuxostat 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

  • Arm, back, or jaw pain
  • black, tarry stools
  • bloody nose
  • blurred vision
  • chest pain or discomfort
  • chills
  • cloudy urine
  • confusion
  • cough
  • dark urine
  • decreased frequency or amount of urine
  • diarrhea
  • difficult or labored breathing
  • difficulty with moving
  • dizziness
  • dry mouth
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of fullness
  • fever
  • gaseous abdominal or stomach pain
  • general feeling of tiredness and weakness
  • headache
  • heavier menstrual periods
  • inability to speak
  • increase in heart rate
  • increased thirst
  • itching, skin rash
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • lightheadedness
  • loss of appetite
  • loss of bladder control
  • muscle aching or cramping
  • nausea
  • nervousness
  • pain, swelling, or redness in the joints
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid breathing
  • redness of the skin
  • right upper abdominal or stomach pain and fullness
  • runny nose
  • seizures
  • severe or sudden headache
  • shivering
  • slow or fast heartbeat
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach fullness or pain
  • sunken eyes
  • sweating
  • swelling
  • temporary blindness
  • thirst
  • tightness in the chest
  • trouble sleeping
  • trouble swallowing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • weakness in the arm or leg on one side of the body, sudden and severe
  • weight gain
  • wrinkled skin
  • yellow eyes and skin

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • diarrhea
  • difficulty with swallowing
  • hives
  • hoarseness
  • lower back or side pain
  • muscle cramps or spasms
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes

Side effects not requiring immediate medical attention

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

  • Anxiety
  • bad, unusual, or unpleasant (after) taste
  • blistering, crusting, irritation, itching, or reddening of the skin
  • body aches or pain
  • breast pain
  • bruising
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • changes in hair color
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cough producing mucus
  • cracked, dry, or scaly skin
  • decrease in smell
  • decreased interest in sexual intercourse
  • deep or fast breathing with dizziness
  • depression
  • ear congestion
  • excess air or gas in the stomach or bowels
  • feeling of constant movement of self or surroundings
  • fruit-like breath odor
  • gum pain
  • hair loss or thinning of the hair
  • hearing loss
  • heartburn
  • inability to have or keep an erection
  • inability to move the arms and legs
  • increased or decreased appetite
  • increased sensitivity of the skin to sunlight
  • increased sweating
  • increased urination
  • irritability
  • large, flat, blue, or purplish patches in the skin
  • loss in sexual ability, desire, drive, or performance
  • loss of consciousness
  • loss of voice
  • muscle or bone pain or stiffness
  • muscle spasm, tightness, or weakness
  • muscle twitching
  • nasal congestion
  • numbness of the feet, hands, and around the mouth
  • painful blisters on the trunk of the body
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • sensation of spinning
  • severe or continuing stomach pain
  • severe sunburn
  • shakiness in the legs, arms, hands, or feet
  • skin rash, encrusted, scaly, and oozing
  • sleepiness or unusual drowsiness
  • small red or purple spots on the skin
  • sneezing
  • stomach discomfort, upset, or pain
  • sudden numbness and weakness in the arms and legs
  • sweating
  • swelling of the breasts or breast soreness in both females and males
  • throat irritation
  • trembling or shaking of the hands or feet
  • trouble sleeping
  • unexplained weight loss
  • unusual drowsiness, dullness, or feeling of sluggishness
  • weight loss

Incidence not known

  • Aggressive thoughts
  • false beliefs that cannot be changed by facts
  • seeing, hearing, or feeling things that are not there

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. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Uloric (febuxostat)." Takeda Pharmaceuticals America, Lincolnshire, IL.

4. Becker MA, Schumacher HR Jr, Wortmann RL, et al. "Febuxostat Compared with Allopurinol in Patients with Hyperuricemia and Gout." N Engl J Med 353 (2005): 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 59 (2008): 1540-1548

7. Edwards NL "Febuxostat: a new treatment for hyperuricaemia in gout." Rheumatology 48 (2009): 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.