Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Adenuric

ADENURIC 120 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 23

HOS-117850 · Präparat HOS-094697

Table 1: Adverse reactions in combined phase 3, long-term extension studies, post-authorisation safety studies and post-marketing experience in gout patients Blood and lymphatic system Rare disorders Pancytopenia, thrombocytopenia, agranulocytosis*, anaemia# Immune system disorders Rare Anaphylactic reaction*, drug hypersensitivity* Endocrine disorders Uncommon Blood thyroid stimulating hormone increased, hypothyroidism# Eye disorders Uncommon Blurred vision Rare Retinal artery occlusion# Metabolism and nutrition Common*** disorders Gout flares Uncommon Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase Rare Weight decrease, increase appetite, anorexia Psychiatric disorders Uncommon Libido decreased, insomnia Rare Nervousness, depressed mood#, sleep disorder# Nervous system disorders Common Headache, dizziness Uncommon Paraesthesia, hemiparesis, somnolence, lethargy# altered taste, hypoaesthesia, hyposmia Rare Ageusia#, burning sensation# Ear and labyrinth disorders Uncommon Tinnitus Rare Vertigo# Cardiac disorders Uncommon Atrial fibrillation, palpitations, ECG abnormal, left bundle branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome), arrhythmia# Rare Sudden cardiac death* Vascular disorders Uncommon Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome) Rare Circulatory collapse# Respiratory system disorders Common

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