Febuxostat Side Effects

Brand Names: Uloric

Please note - some side effects for Febuxostat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Febuxostat - for the Consumer

Febuxostat

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Febuxostat:

Joint pain; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain or discomfort; confusion; dark urine; decrease in the amount of urine produced; fainting; fast, slow, or irregular heartbeat; fever or chills; mental or mood changes; numbness of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; severe muscle pain; shortness of breath; signs of high or low blood pressure (eg, headache, dizziness, tiredness, weakness); slurred speech; stomach pain; unusual bruising or bleeding; vision problems (eg, blurred vision); yellowing of the skin or eyes.

Side Effects by Body System - for Healthcare Professionals

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.

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.

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