Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Cabometyx

CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12

HOS-135837 · Präparat HOS-097776

Table 2: Adverse drug reactions (ADRs) reported in clinical trials or after post-marketing use in patients treated with cabozantinib in monotherapy Infections and infestations Common abscess, pneumonia Blood and lymphatic disorders Very common anaemia, thrombocytopenia Common neutropenia, lymphopenia Endocrine disorders Very common hypothyroidism* Metabolism and nutrition disorders decreased appetite, hypomagnesaemia, hypokalaemia, Very common hypoalbuminaemia, hypocalcaemia dehydration, hypophosphataemia, hyponatraemia, hyperkalaemia, Common hyperbilirubinemia, hyperglycaemia, hypoglycaemia Nervous system disorders Very common dysgeusia, headache, dizziness Common peripheral neuropathya convulsion, cerebrovascular accident, posterior reversible encephalopathy Uncommon syndrome Ear and labyrinth disorders Common tinnitus Cardiac disorders Uncommon acute myocardial infarction, cardiac failure Vascular disorders Very common hypertension, haemorrhageb* Common venous thrombosisc, hypotension, embolism Uncommon hypertensive crisis, arterial thrombosis, embolism arterial Not known aneurysms and artery dissections Respiratory, thoracic, and mediastinal disorders Very common dysphonia, dyspnoea, cough Common pulmonary embolism, rhinitis allergic Uncommon pneumothorax Gastrointestinal disorders diarrhoea*, nausea, vomiting, stomatitis, constipation, abdominal pain, Very common dyspepsia gastrointestinal perforation*g, pancreatitis, fistula*, gastroesophageal Common reflux disease, haemorrhoids, oral pain, dry mouth, dysphagia, flatulence Uncommon glossodynia Hepatobiliary disorders Common hepatic encephalopathy* Uncommon hepatitis cholestatic Skin and subcutaneous tissue disorders Very common palmar-plantar erythrodysaesthesia syndrome, rashf Common pruritus, alopecia, dry skin, hair colour change, hyperkeratosis, erythema Not known cutaneous vasculitis Musculoskeletal and connective tissue disorders Very common pain in extremity, arthralgia Common muscle spasms Uncommon osteonecrosis of the jaw Renal and urinary disorders

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