Febuxostat Side Effects

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.

For the Consumer

Applies to febuxostat: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking febuxostat: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of febuxostat may include:

• nausea;

• joint pain, swelling, or stiffness;

• mild skin rash; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to febuxostat: oral tablet

Hepatic

Hepatic side effects have included liver function abnormalities (4.6% to 6.6%). Hepatic side effects occurring in less than 1% of patients have included cholelithiasis/cholecystitis, hepatic steatosis, hepatitis, and hepatomegaly.
Postmarketing side effects have included hepatic failure (some fatal), jaundice, serious cases of abnormal liver function test results, and liver disorder.

Liver function abnormality in 1.2% to 1.8% of patients was the most common adverse reaction leading to discontinuation of febuxostat therapy. Liver function tests (e.g., AST, ALT) should be performed at 2 and 4 months following initiation of therapy and periodically thereafter.

Gastrointestinal

Gastrointestinal side effects have included nausea (1.1% to 1.3%). Other gastrointestinal side effects occurring in less than 1% of patients have included abdominal distention, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, frequent stools, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gingival pain, hematemesis, hyperchlorhydria, hematochezia, mouth ulceration, pancreatitis, peptic ulcer, and vomiting.

Dermatologic

Dermatologic side effects have included rash (0.5% to 1.6%). Dermatologic side effects occurring in less than 1% of patients have included alopecia, angioedema, dermatitis, dermographism, ecchymosis, eczema, hair color changes, hair growth abnormal, hyperhidrosis, peeling skin, petechiae, photosensitivity, pruritus, purpura, skin discoloration/altered pigmentation, skin lesion, skin odor abnormal, and urticaria. Generalized rash, Stevens Johnson Syndrome, and hypersensitivity skin reactions have been reported postmarketing.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (0.7% to 1.1%). Musculoskeletal side effects occurring in less than 1% of patients have included arthritis, joint stiffness, joint swelling, muscle spasms/twitching/tightness/weakness, musculoskeletal pain/stiffness, and myalgia. Rhabdomyolysis has been reported postmarketing.

Hematologic

Hematologic side effects occurring in less than 1% of patients have included anemia, idiopathic thrombocytopenic purpura, leukocytosis/leucopenia, neutropenia, pancytopenia, splenomegaly, and thrombocytopenia.

Cardiovascular

Cardiovascular side effects occurring in less than 1% of patients have included angina pectoris, atrial fibrillation/flutter, cardiac murmur, ECG abnormal, palpitations, sinus bradycardia, tachycardia, chest pain/discomfort, hypertension, and hypotension.

Immunologic

Immunologic side effects occurring in less than 1% of patients have included herpes zoster.

Metabolic

Metabolic side effects occurring in less than 1% of patients have included anorexia, appetite decreased/increased, dehydration, diabetes mellitus, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, and weight increased/decreased.

Ocular

Ocular side effects have included blurred vision.

Nervous system

Nervous system side effects occurring in less than 1% of patients have included altered taste, balance disorder, cerebrovascular accident, Guillain-Barre syndrome, headache, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental impairment, migraine, paresthesia, somnolence, transient ischemic attack, and tremor.

Psychiatric

Psychiatric side effects occurring in less than 1% of patients have included agitation, anxiety, depression, insomnia, irritability, decreased libido, nervousness, panic attack, and personality change. Psychotic behavior including aggressive thoughts has been reported postmarketing.

Renal

Renal side effects occurring in less than 1% of patients have included hematuria, tubulointerstitial nephrolithiasis, pollakiuria, proteinuria, renal failure, renal insufficiency, urgency, and incontinence.

Respiratory

Respiratory side effects occurring in less than 1% of patients have included bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory tract congestion, sneezing, throat irritation, and upper respiratory tract infection.

Genitourinary

Genitourinary side effects occurring in less than 1% of patients have included erectile dysfunction.

Endocrine

Endocrine side effects occurring in less than 1% of patients have included flushing and hot flushes.

Other

Other side effects occurring in less than 1% of patients have included deafness, tinnitus, thirst, asthenia, edema, fatigue, feeling abnormal, gait disturbance, influenza-like symptoms, pain, breast pain, and gynecomastia. Altered laboratory parameters occurring in less than 1% of patients have included activated partial thromboplastin time prolonged, creatine increased, bicarbonate decreased, sodium increased, EEG abnormal, glucose increased, cholesterol increased, triglycerides increased, amylase increased, potassium increased, TSH increased, platelet count decreased, hematocrit decreased, hemoglobin decreased, mean corpuscular volume (MCV) increased, red blood cells (RBCs) decreased, creatinine increased, blood urea increased, blood urea nitrogen (BUN)/creatinine ratio increased, creatine phosphokinase (CPK) increased, alkaline phosphatase increased, lactate dehydrogenase (LDH) increased, prostate specific antigen (PSA) increased, urine output increased/decreased, lymphocyte count decreased, neutrophil count decreased, white blood cells (WBCs) increased/decreased, coagulation test abnormal, low density lipoprotein (LDL) increased, prothrombin time prolonged, urinary casts, and urine positive for white blood cells and protein.

Hypersensitivity

Postmarketing side effects have included anaphylaxis and anaphylactic reaction.

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