Uloric Side Effects

Generic Name: febuxostat

Please note - some side effects for Uloric 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 Uloric - for the Consumer

Uloric

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 Uloric:

Joint pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur when using Uloric:

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.

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Uloric Side Effects - for the Professional

Uloric

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 2757 subjects with hyperuricemia and gout were treated with Uloric 40 mg or 80 mg daily in clinical studies. For Uloric 40 mg, 559 patients were treated for ≥ 6 months. For Uloric 80 mg, 1377 subjects were treated for ≥ 6 months, 674 patients were treated for ≥ 1 year and 515 patients were treated for ≥ 2 years.

Most Common Adverse Reactions

In three randomized, controlled clinical studies (Studies 1, 2 and 3), which were 6 to 12 months in duration, the following adverse reactions were reported by the treating physician as related to study drug. Table 1 summarizes adverse reactions reported at a rate of at least 1% in Uloric treatment groups and at least 0.5% greater than placebo.

Table 1: Adverse Reactions Occurring in ≥ 1% of Uloric-Treated Patients and at Least 0.5% Greater than Seen in Patients Receiving Placebo in Controlled Studies
Adverse Reactions	Placebo	Uloric		allopurinol*
	(N=134)	40 mg daily (N=757)	80 mg daily (N=1279)	(N=1277)
* Of the subjects who received allopurinol, 10 received 100 mg, 145 received 200 mg, and 1122 received 300 mg, based on level of renal impairment.
Liver Function Abnormalities	0.7%	6.6%	4.6%	4.2%
Nausea	0.7%	1.1%	1.3%	0.8%
Arthralgia	0%	1.1%	0.7%	0.7%
Rash	0.7%	0.5%	1.6%	1.6%

The most common adverse reaction leading to discontinuation from therapy was liver function abnormalities in 1.8% of Uloric 40 mg, 1.2% of Uloric 80 mg, and in 0.9% of allopurinol-treated subjects.

In addition to the adverse reactions presented in Table 1, dizziness was reported in more than 1% of Uloric-treated subjects although not at a rate more than 0.5% greater than placebo.

Less Common Adverse Reactions

In Phase 2 and 3 clinical studies the following adverse reactions occurred in less than 1% of subjects and in more than one subject treated with doses ranging from 40 mg to 240 mg of Uloric. This list also includes adverse reactions (less than 1% of subjects) associated with organ systems from Warnings and Precautions.

Blood and Lymphatic System Disorders: anemia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia.

Cardiac Disorders: angina pectoris, atrial fibrillation/flutter, cardiac murmur, ECG abnormal, palpitations, sinus bradycardia, tachycardia.

Ear and Labyrinth Disorders: deafness, tinnitus, vertigo.

Eye Disorders: vision blurred.

Gastrointestinal Disorders: abdominal distention, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, frequent stools, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gingival pain, haematemesis, hyperchlorhydria, hematochezia, mouth ulceration, pancreatitis, peptic ulcer, vomiting.

General Disorders and Administration Site Conditions: asthenia, chest pain/discomfort, edema, fatigue, feeling abnormal, gait disturbance, influenza-like symptoms, mass, pain, thirst.

Hepatobiliary Disorders: cholelithiasis/cholecystitis, hepatic steatosis, hepatitis, hepatomegaly.

Immune System Disorder: hypersensitivity.

Infections and Infestations: herpes zoster.

Procedural Complications: contusion.

Metabolism and Nutrition Disorders: anorexia, appetite decreased/increased, dehydration, diabetes mellitus, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight decreased/increased.

Musculoskeletal and Connective Tissue Disorders: arthritis, joint stiffness, joint swelling, muscle spasms/twitching/tightness/weakness, musculoskeletal pain/stiffness, myalgia.

Nervous System Disorders: altered taste, balance disorder, cerebrovascular accident, Guillain-Barré syndrome, headache, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental impairment, migraine, paresthesia, somnolence, transient ischemic attack, tremor.

Psychiatric Disorders: agitation, anxiety, depression, insomnia, irritability, libido decreased, nervousness, panic attack, personality change.

Renal and Urinary Disorders: hematuria, nephrolithiasis, pollakiuria, proteinuria, renal failure, renal insufficiency, urgency, incontinence.

Reproductive System and Breast Changes: breast pain, erectile dysfunction, gynecomastia.

Respiratory, Thoracic and Mediastinal Disorders: bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory tract congestion, sneezing, throat irritation, upper respiratory tract infection.

Skin and Subcutaneous Tissue Disorders: alopecia, angio-edema, 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, urticaria.

Vascular Disorders: flushing, hot flush, hypertension, hypotension.

Laboratory Parameters: 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, MCV increased, RBC decreased, creatinine increased, blood urea increased, BUN/creatinine ratio increased, creatine phosphokinase (CPK) increased, alkaline phosphatase increased, LDH increased, PSA increased, urine output increased/decreased, lymphocyte count decreased, neutrophil count decreased, WBC increased/decreased, coagulation test abnormal, low density lipoprotein (LDL) increased, prothrombin time prolonged, urinary casts, urine positive for white blood cells and protein.

Cardiovascular Safety

Cardiovascular events and deaths were adjudicated to one of the pre-defined endpoints from the Anti-Platelet Trialists' Collaborations (APTC) (cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) in the randomized controlled and long-term extension studies. In the Phase 3 randomized controlled studies, the incidences of adjudicated APTC events per 100 patient-years of exposure were: Placebo 0 (95% CI 0.00-6.16), Uloric 40 mg 0 (95% CI 0.00-1.08), Uloric 80 mg 1.09 (95% CI 0.44-2.24), and allopurinol 0.60 (95% CI 0.16-1.53).

In the long-term extension studies, the incidences of adjudicated APTC events were: Uloric 80 mg 0.97 (95% CI 0.57-1.56), and allopurinol 0.58 (95% CI 0.02-3.24).

Overall, a higher rate of APTC events was observed in Uloric than in allopurinol-treated patients. A causal relationship with Uloric has not been established. Monitor for signs and symptoms of MI and stroke.

Postmarketing Experience

Adverse reactions have been identified during post approval use of Uloric. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship.

Immune System Disorders: anaphylaxis, anaphylactic reaction.
Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis.
Psychiatric Disorders: psychotic behavior including aggressive thoughts.
Renal and Urinary Disorders: tubulointerstitial nephritis.
Skin and Subcutaneous Tissue Disorders: generalized rash, Stevens Johnson Syndrome, hypersensitivity skin reactions.

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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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