Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Sivextro

Sivextro 200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-130252 · Präparat HOS-096879

System organ class Frequency Adverse reactions Infections and infestations Uncommon: Vulvovaginal mycotic infection, fungal infection, vulvovaginal candidiasis, abscess, Clostridioides difficile colitis, dermatophytosis, oral candidiasis, respiratory tract infection Blood and lymphatic system Uncommon: Lymphadenopathy, anaemia disorders Not known*: Thrombocytopenia* Immune system disorders Uncommon: Drug hypersensitivity Metabolism and nutrition Uncommon: Dehydration, diabetes mellitus inadequate control, disorders hyperkalaemia Psychiatric disorders Uncommon: Insomnia, sleep disorder, anxiety, nightmare Nervous system disorders Common: Headache, dizziness Uncommon: Somnolence, dysgeusia, tremor, paraesthesia, hypoaesthesia Eye disorders Uncommon: Vision blurred, vitreous floaters Cardiac disorders Uncommon: Bradycardia Vascular disorders Uncommon: Flushing, hot flush Respiratory, thoracic and Uncommon: Cough, nasal dryness, pulmonary congestion mediastinal disorders Gastrointestinal disorders Common: Nausea, diarrhoea, vomiting Uncommon: Abdominal pain, constipation, abdominal discomfort, dry mouth, dyspepsia, abdominal pain upper, flatulence, gastro-oesophageal reflux disease, haematochezia, retching Skin and subcutaneous tissue Common: Pruritus generalised disorders Uncommon: Hyperhidrosis, pruritus, rash, urticaria, alopecia, rash erythematous, rash generalised, acne, pruritus allergic, rash maculo-papular, rash papular, rash pruritic Musculoskeletal and Uncommon: Arthralgia, muscle spasms, back pain, limb connective tissue disorders discomfort, neck pain Renal and urinary disorders Uncommon: Urine odour abnormal Reproductive system and Uncommon: Vulvovaginal pruritus breast disorders General disorders and Common: Fatigue administration site conditions Uncommon: Chills, irritability, pyrexia, peripheral oedema Investigations Uncommon: Grip strength decreased, transaminases increased, white blood cell count decreased * Based on post-marketing reports. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.

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