Fexoxan Adverse Reactions

Most Common Adverse Reactions: In three randomized, controlled clinical studies (Studies 1, 2 and 3), which were six to 12 months in duration, the following adverse reactions were reported by the treating physician as related to study drug. Adverse reactions reported at a rate of at least 1% in FEBUXOSTAT treatment groups and at least 0.5% greater than placebo.
The most common adverse reaction leading to discontinuation from therapy was liver function abnormalities in 1.8% of FEBUXOSTAT 40 mg, 1.2% of FEBUXOSTAT 80 mg, and in 0.9% of patients treated with allopurinol.
Less Common Adverse Reactions: In Phase 2 and 3 clinical studies the following adverse reactions occurred in less than 1% of patients and in more than one subject treated with doses ranging from 40 mg to 240 mg of FEBUXOSTAT. This list also includes adverse reactions (less than 1% of patients) associated with organ systems from 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: Blurred vision.
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, decreased/increased weight.
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-Barre syndrome, headache, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental impairment, migraine, paresthesia, somnolence, transient ischemic attack, and 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, haematocrit decreased, haemoglobin decreased, MCV increased, RBC decreased, creatinine increased, blood urea increased, BUN/creatine 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 studies, the incidences of adjudicated APTC events per 100 patient-years of exposure were: Placebo 0 (95% CI 0.00-6.16), FEBUXOSTAT 40 mg 0 (95% CI 0.00-1.08), Febuxostat 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: FEBUXOSTAT 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 FEBUXOSTAT than in patients treated with allopurinol. A causal relationship with FEBUXOSTAT has not been established. Monitor for signs and symptoms of Myocardial infarction and stroke.