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Febuxostat Side Effects

For the Consumer

Applies to febuxostat: oral tablet

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
  • Abdominal or stomach fullness or pain
  • 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 tiredness and weakness
  • headache
  • heavier menstrual periods
  • inability to speak
  • increase in heart rate
  • increased thirst
  • itching
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • loss of appetite
  • loss of bladder control
  • muscle aching or cramping
  • nausea and vomiting
  • 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
  • rash
  • redness of the skin
  • right upper abdominal or stomach pain and fullness
  • runny nose
  • seizures
  • severe or sudden headache
  • shivering
  • shortness of breath
  • slow or fast heartbeat
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sunken eyes
  • sweating
  • swelling
  • temporary blindness
  • thirst
  • tightness in the chest
  • trouble sleeping
  • troubled breathing or swallowing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • 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
  • wheezing
  • wrinkled skin
  • yellow eyes and skin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • diarrhea
  • difficulty with swallowing
  • hives
  • 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

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
  • Acid or sour stomach
  • 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
  • depression
  • ear congestion
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • fruit-like breath odor
  • gum pain
  • hair loss or thinning of the hair
  • hearing loss
  • heartburn
  • hyperventilation
  • 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 appetite
  • loss of consciousness
  • loss of voice
  • muscle or bone pain or stiffness
  • muscle spasm, tightness, or weakness
  • muscle twitching
  • nasal congestion
  • 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, tiredness, weakness, or feeling of sluggishness
  • weight loss
Incidence not known
  • Aggressive thoughts
  • delusions
  • hallucinations

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, hyposmia, 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

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[Ref]

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]

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), 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 clinical trials, major adverse cardiac events occurred slightly more frequently in patients given 80 mg compared to 40 mg, allopurinol, or placebo. Further investigation did not show an increased frequency of events between patients given 80 mg and allopurinol over time, though patients that developed events had a history of atherosclerotic disease, myocardial infarction, or congestive heart failure. Gout has been associated with adverse cardiovascular events, and hyperuricemia was associated with a higher risk of cardiovascular morbidity and mortality.[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[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[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[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." O 0

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

3. Cerner Multum, Inc. "Australian Product Information." O 0

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

Some side effects of febuxostat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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