Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Votrient

Votrient 200 mg film-coated tablets Votrient 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17

HOS-122604 · Präparat HOS-095539

System Organ Frequency Adverse reactions All grades Grade 3 Grade 4 Class (all grades) n (%) n (%) n (%) Infections and Common Gingival infection 4 (1%) 0 0 infestations Neoplasms Very common Tumour pain 121 (32%) 32 (8%) 0 benign, malignant and unspecified (incl cysts and polyps) Very common Leukopenia 106 (44%) 3 (1%) 0 Thrombocytopenia 86 (36% 7 (3%) 2 (<1%) Neutropenia 79 (33%) 10 (4%) 0 Blood and Uncommon Thrombotic 1 (<1%) 1 (<1%) 0 lymphatic system microangiopathy disordersf (including thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome) Endocrine Common Hypothyroidism 18 (5%) 0 0 disorders Very common Decreased appetite 108 (28%) 12 (3%) 0 Hypoalbuminemiaf 81 (34%) 2 (<1%) 0 Metabolism and Common Dehydration 4 (1%) 2 (1%) 0 nutrition Uncommon Hypomagnesaemia 1 (<1%) 0 0 disorders Not known Tumour lysis not known not known not syndrome* known Psychiatric Common Insomnia 5 (1%) 1 (<1%) 0 disorders Very common Dysgeusiac 79 (21%) 0 0 Headache 54 (14%) 2 (<1%) 0 Common Peripheral sensory 30 (8%) 1 (<1%) 0 Nervous system neuropathy disorders Dizziness 15 (4%) 0 0 Uncommon Somnolence 3 (<1%) 0 0 Paresthesia 1 (<1%) 0 0 Cerebral infarction 1 (<1%) 0 1 (<1%) Eye disorders Common Vision blurred 15 (4%) 0 0 Cardiac dysfunctiong 21 (5%) 3 (<1%) 1 (<1%) Left ventricular 13 (3%) 3 (<1%) 0 Cardiac disorders dysfunction Bradycardia 4 (1%) 0 0 Uncommon Myocardial infarction 1 (<1%) 0 0 Very common Hypertension 152 (40%) 26 (7%) 0 Common Venous 13 (3%) 4 (1%) 5 (1%) thromboembolic eventd Vascular Hot flush 12 (3%) 0 0 disorders Flushing 4 (1%) 0 0 Uncommon Haemorrhage 2 (<1%) 1 (<1%) 0 Rare Aneurysms and artery not known not known not dissections known

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.