Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Xeloda

Xeloda 150 mg film-coated tablets. Xeloda 500 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 13–14

HOS-091444 · Präparat HOS-084311

13 Body System Very Common Uncommon Rare/Very Rare Common (Post-Marketing All grades Severe and/or Life- Experience) All grades threatening (grade 3-4) or considered medically relevant Ear and - - Vertigo, Ear pain labyrinth disorders Cardiac - - Angina unstable, Ventricular fibrillation disorders Angina pectoris, (rare), QT Myocardial prolongation (rare), ischaemia/infarction, Torsade de pointes Atrial fibrillation, (rare), Bradycardia Arrhythmia, (rare), Vasospasm Tachycardia, Sinus (rare) tachycardia, Palpitations Vascular - Thrombophlebitis Deep vein thrombosis, disorders Hypertension, Petechiae, Hypotension, Hot flush, Peripheral coldness Respiratory, - Dyspnoea, Pulmonary embolism, thoracic and Epistaxis, Cough, Pneumothorax, mediastinal Rhinorrhoea Haemoptysis, Asthma, disorders Dyspnoea exertional Gastrointestin Diarrhoea, Gastrointestinal Intestinal obstruction, al disorders Vomiting, haemorrhage, Ascites, Enteritis, Nausea, Constipation, Gastritis, Dysphagia, Stomatitis, Upper abdominal Abdominal pain lower, Abdominal pain, Dyspepsia, Oesophagitis, pain Flatulence, Abdominal Dry mouth discomfort, Gastrooesophageal reflux disease, Colitis, Blood in stool Hepatobiliary - Hyperbilirubinem Jaundice Hepatic failure (rare), disorders ia, Liver function Cholestatic hepatitis test abnormalities (rare) Skin and Palmar-plantar Rash, Alopecia, Blister, Skin ulcer, Cutaneous lupus subcutaneous erythro- Erythema, Dry Rash, Urticaria, erythematosus (rare), tissue dysaesthesia skin, Pruritus, Photosensitivity Severe skin reactions disorders syndrome** Skin hyper- reaction, Palmar such as Stevens- pigmentation, erythema, Swelling Johnson Syndrome Rash macular, face, Purpura, and toxic Epidermal Skin Radiation recall Necrolysis (very rare) desquamation, syndrome (see section 4.4.) Dermatitis, Pigmentation disorder, Nail disorder

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