Atenurix Adverse Reactions

The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience in gout patients are gout flares, liver function abnormalities, diarrhea, 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, and rare events of sudden cardiac death, have occurred in the post-marketing experience.
Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000) adverse reactions occurring in patients treated with Febuxostat are listed as follows. The frequencies are based on studies and post-marketing experience in gout patients. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Blood and lymphatic system disorders: Rare: Pancytopenia, thrombocytopenia, agranulocytosis*.
Immune system disorders: Rare: Anaphylactic reaction*, drug hypersensitivity*.
Endocrine disorders: Uncommon: Blood thyroid stimulating hormone increased.
Eye disorders: Rare: Blurred vision.
Metabolism and nutrition disorders: Common***: Gout flares.
Uncommon: Diabetes mellitus, hyperlipidemia, decreased appetite, weight increase.
Rare: Weight decrease, increased appetite, anorexia.
Psychiatric disorders: Uncommon: Libido decreased; insomnia.
Rare: Nervousness.
Nervous system disorders: Common: Headache.
Uncommon: Dizziness, paresthesia, hemiparesis, somnolence, altered taste, hypoesthesia, hyposmia.
Ear and labyrinth disorders: Rare: Tinnitus.
Cardiac disorders: Uncommon: Atrial fibrillation, palpitations, ECG abnormal.
Rare: Sudden cardiac death*.
Vascular disorders: Uncommon: Hypertension, flushing, hot flush.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnea, bronchitis, upper respiratory tract infection, cough.
Gastrointestinal disorders: Common: Diarrhea**, nausea.
Uncommon: Abdominal pain, abdominal distension, gastro-esophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort.
Rare: Pancreatitis, mouth ulceration.
Hepatobiliary disorders: Common: Liver function abnormalities**.
Uncommon: Cholelithiasis.
Rare: Hepatitis, jaundice*, liver injury*.
Skin and subcutaneous tissue disorders: Common: Rash (including various types of rash reported with lower frequencies, see as follows).
Uncommon: Dermatitis, urticaria, pruritus, skin discoloration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular.
Rare: Toxic epidermal necrolysis*, Stevens-Johnson Syndrome*, angioedema*, drug reaction with eosinophilia and systemic symptoms*, generalized rash (serious)*, erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic*, rash erythematous, rash morbilliform, alopecia, hyperhidrosis.
Musculoskeletal and connective tissue disorders: Uncommon: Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis.
Rare: Rhabdomyolysis*, joint stiffness, musculoskeletal stiffness.
Renal and urinary disorders: Uncommon: Renal failure, nephrolithiasis, hematuria, pollakiuria, proteinuria.
Rare: Tubulointerstitial nephritis*, micturition urgency.
Reproductive system and breast disorders: Uncommon: Erectile dysfunction.
General disorders and administration site conditions: Common: edema.
Uncommon: Fatigue, chest pain, chest discomfort.
Rare: Thirst.
Investigations: Uncommon: Blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, hemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, hematocrit decrease, blood lactate dehydrogenase increased, blood potassium increase.
Rare: Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase*.
* Adverse reactions coming from post-marketing experience.
** Treatment-emergent non-infective diarrhea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.