Febuxostat Fahrenheit Adverse Reactions

The most commonly reported adverse reactions are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash, and oedema. These adverse reactions were mostly mild or moderate in severity. Rare serious hypersensitivity reactions to febuxostat, some of which were associated to systemic symptoms have occurred.
Blood and lymphatic system disorders: Pancytopenia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, splenomegaly, agranulocytosis, eosinophilia, anemia.
Immune system disorders: Anaphylactic reaction, drug hypersensitivity.
Endocrine system disorders: Blood thyroid stimulating hormone increased.
Eye disorders: Blurred vision.
Metabolism and nutrition disorders: Diabetes mellitus, hyperlipidemia, appetite decreased/increased, weight increased/decreased, anorexia.
Psychiatric disorders: Libido decreased, insomnia, nervousness, agitation, anxiety, depression, irritability, panic attack, personality change, psychotic behavior including aggressive thoughts.
Nervous system disorders: Headache, dizziness, paraesthesia, hemiparesis, somnolence, altered taste, hypoaesthesia, hyposmia, balance disorder, cerebrovascular accident, Guillain-Barré syndrome, lacunar infarction, lethargy, mental impairment, migraine, transient ischemic attack, tremor.
Ear and labyrinth disorders: Tinnitus, deafness and vertigo.
Cardiac disorders: Angina pectoris, atrial fibrillation/flutter, palpitations, ECG abnormal, cardiac murmur, sinus bradycardia, tachycardia.
Vascular disorders: Hypertension, flushing, hot flush, hypotension.
Respiratory, thoracic, and mediastinal disorder: Bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory tract congestion, sneezing, throat irritation, upper respiratory tract infection.
Gastrointestinal disorders: Nausea, abdominal pain, abdominal distension, gastro-oesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort, gastritis, pancreatitis, mouth ulceration, gingival pain, hematemesis, hyperchlorhydria, hematochezia, peptic ulcer.
Hepato-biliary disorders: Hepatic function abnormalities, cholelithiasis/cholecystitis, hepatic steatosis, hepatitis, hepatomegaly, hepatic failure (some fatal), jaundice, serious cases of abnormal hepatic function test results, hepatic disorder, liver injury.
Skin and subcutaneous tissue disorders: Rash (including various type of rash reported with lower frequencies), dermatitis, urticaria, pruritus, skin lesion, petechiae, rash macular, rash maculopapular, rash papular, Toxic epidermal necrolysis, Steven-Johnson Syndrome, angioedema, drug reaction with eosinophilia and systemic symptoms, generalized rash (serious), erythema, erythema multiforme, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic, rash erythematosus, rash morbilliform, alopecia, hyperhidrosis, dermographism, ecchymosis, eczema, hair color changes, hair growth abnormal, peeling skin, photosensitivity, purpura, skin discoloration/altered pigmentation, skin odor abnormal, hypersensitivity skin reactions.
Musculoskeletal and connective tissue disorders: Arthralgia, arthritis, myalgia, musculoskeletal pain/stiffness, muscle weakness, muscle spasm, muscle tightness, bursitis, rhabdomyolysis, joint stiffness, joint swelling.
Renal and urinary disorders: Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria, renal insufficiency, Tubulointerstitial nephritis, micturition urgency.
Reproductive system and breast disorders: Erectile dysfunction, breast pain, gynecomastia.
General disorders and administration site conditions: Oedema, fatigue, chest pain, chest discomfort, thirst, asthenia, feeling abnormal, gait disturbance, influenza-like symptoms, mass, pain.
Investigations: Blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, haemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, haematocrit decrease, blood lactate dehydrogenase increased, blood potassium increase. Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase.
Description of selected adverse reactions: Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred. Stevens-Johnson Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blister or mucosal lesions and eye irritation. Hypersensitivity reactions to febuxostat can be associated to the following symptoms: skin reactions characterised by infiltrated maculopapular eruption, generalised or exfoliative rashes, but also skin lesions, facial oedema, fever, haematologic abnormalities such as thrombocytopenia and eosinophilia, and single or multiple organ involvement (liver and kidney including tubulointerstitial nephritis).
Gout flares were commonly observed soon after the start of treatment and during the first months. Thereafter, the frequency of gout flares decreases in a time-dependent manner. Gout flare prophylaxis is recommended.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal products.