Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Votrient

Votrient 200 mg film-coated tablets Votrient 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15–16

HOS-122601 · Präparat HOS-095539

15  Very common Alanine 246 (21%) 84 (7%) 14 (1%) aminotransferase increased Aspartate 211 (18%) 51 (4%) 10 (<1%) aminotransferase increased Common Weight decreased 96 (8%) 7 (<1%) 0 Blood bilirubin 61 (5%) 6 (<1%) 1 (<1%) increased Blood creatinine 55 (5%) 3 (<1%) 0 increased Lipase increased 51 (4%) 21 (2%) 7 (<1%) White blood cell count 51 (4%) 3 (<1%) 0 decreasedd Blood thyroid 36 (3%) 0 0 stimulating hormone increased Amylase increased 35 (3%) 7 (<1%) 0 Gamma- 31 (3%) 9 (<1%) 4 (<1%) glutamyltransferase Investigations increased Blood pressure 15 (1%) 2 (<1%) 0 increased Blood urea increased 12 (1%) 1 (<1%) 0 Liver function test 12 (1%) 6 (<1%) 1 (<1%) abnormal Uncommon Hepatic enzyme 11 (<1%) 4 (<1%) 3 (<1%) increased Blood glucose 7 (<1%) 0 1 (<1%) decreased Electrocardiogram QT 7 (<1%) 2 (<1%) 0 prolonged Transaminase 7 (<1%) 1 (<1%) 0 increased Thyroid function test 3 (<1%) 0 0 abnormal Blood pressure 2 (<1%) 0 0 diastolic increased Blood pressure 1 (<1%) 0 0 systolic increased †Treatment-related adverse reaction reported during post-marketing period (spontaneous case reports and serious adverse reactions from all pazopanib clinical studies). *Treatment-related adverse reaction reported only during the post-marketing period. Frequency cannot be estimated from the available data. The following terms have been combined: a Abdominal pain, abdominal pain upper and abdominal pain lower b Oedema, oedema peripheral, eye oedema, localised oedema and face oedema c Dysgeusia, ageusia and hypogeusia d White cell count decreased, neutrophil count decreased and leukocyte count decreased e Decreased appetite and anorexia f Cardiac dysfunction, left ventricular dysfunction, cardiac failure and restrictive cardiomyopathy g Venous thromboembolic event, deep vein thrombosis, pulmonary embolism and thrombosis

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