Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Imatinib Teva

Imatinib Teva 100 mg film-coated tablets Imatinib Teva 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14

HOS-218627 · Präparat HOS-216223

13 Not known Pericarditis*, cardiac tamponade* Vascular disorders4 Common Flushing, haemorrhage Uncommon Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud’s phenomenon Not known Thrombosis/embolism* Respiratory, thoracic and mediastinal disorders Common Dyspnoea, epistaxis, cough Uncommon Pleural effusion5, pharyngolaryngeal pain, pharyngitis Rare Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage Not known Acute respiratory failure11*, interstitial lung disease* Gastrointestinal disorders Very common Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6 Common Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis Uncommon Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis Rare Colitis, ileus, inflammatory bowel disease Not known Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)* Hepatobiliary disorders Common Increased hepatic enzymes Uncommon Hyperbilirubinaemia, hepatitis, jaundice Rare Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common Periorbital oedema, dermatitis/eczema/rash Common Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction Uncommon Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions, panniculitis12 Rare Acute febrile neutrophilic dermatosis (Sweet’s syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP), pemphigus* Not known Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10 Common Joint swelling Uncommon Joint and muscle stiffness, osteonecrosis* Rare Muscular weakness, arthritis, rhabdomyolysis/myopathy Not known Growth retardation in children* Renal and urinary disorders Uncommon Renal pain, haematuria, renal failure acute, urinary frequency increased Not known Renal failure chronic Reproductive system and breast disorders

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