Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Pifeltro

Pifeltro 100 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14

HOS-141300 · Präparat HOS-098618

13 Frequency Adverse reactions Metabolism and nutrition disorders Uncommon hypophosphataemia Rare hypomagnesaemia Psychiatric disorders Common abnormal dreams, insomnia1 Uncommon nightmare, depression2, anxiety3, irritability, confusional state, suicidal ideation Rare aggression, hallucination, adjustment disorder, mood altered, somnambulism Nervous system disorders Common headache, dizziness, somnolence Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep Vascular disorders Uncommon hypertension Respiratory, thoracic and mediastinal disorders Rare dyspnoea, tonsillar hypertrophy Gastrointestinal disorders Common nausea, diarrhoea, flatulence, abdominal pain4, vomiting Uncommon constipation, abdominal discomfort5, abdominal distension, dyspepsia, faeces soft6, gastrointestinal motility disorder7 Rare rectal tenesmus Hepatobiliary disorders Not known hepatitis Skin and subcutaneous tissue disorders Common rash8 Uncommon pruritus Rare dermatitis allergic, rosacea Not known toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Uncommon myalgia, arthralgia Rare musculoskeletal pain Renal and urinary disorders Rare acute kidney injury, renal disorder, calculus urinary, nephrolithiasis General disorders and administration site conditions Common fatigue Uncommon asthenia, malaise Rare chest pain, chills, pain, thirst Investigations Common alanine aminotransferase increased9 Uncommon lipase increased, aspartate aminotransferase increased, amylase increased, haemoglobin decreased Rare blood creatine phosphokinase increased 1insomnia includes: insomnia, initial insomnia and sleep disorder 2depression includes: depression, depressed mood, major depression, and persistent depressive disorder 3anxiety includes: anxiety and generalised anxiety disorder 4 abdominal pain includes: abdominal pain, and abdominal pain upper 5abdominal discomfort includes: abdominal discomfort, and epigastric discomfort 6faeces soft includes: faeces soft and abnormal faeces

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