Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-132891 · Präparat HOS-097310

System organ class Frequency Adverse reaction Blood and lymphatic Uncommon Thrombocytopenia system disorders Immune system Uncommon Allergic conditions including anaphylactic disorders shock, anaphylactoid reaction and anaphylactic reaction and angioedema Endocrine disorders Common Adrenal insufficiency Metabolism and Not known Alcohol intolerance, anorexia, increased nutrition disorders appetite Psychiatric Not Known Insomnia, nervousness disorders Nervous system Uncommon Headache, dizziness, somnolence disorders Not known Intracranial pressure increased (papilloedema, fontanelle bulging), paraesthesia Eye disorders Not known Photophobia Respiratory, Not known Epistaxis thoracic and mediastinal disorders Gastrointestinal Common Nausea, abdominal pain, vomiting, disorders diarrhoea Not known Dyspepsia, flatulence, tongue discoloration, dry mouth, dysgeusia Hepatobiliary Very common Liver function tests abnormal disorders Rare Serious hepatotoxicity, including jaundice, hepatitis, hepatic necrosis, hepatic cirrhosis, hepatic failure including cases necessitating transplantation or resulting in death. Skin and Common Pruritus, rash subcutaneous tissue disorders Uncommon Urticaria, alopecia Not known Photosensitivity, erythema multiforme, dermatitis, erythema, , xeroderma Musculoskeletal and Not known Myalgia, arthralgia connective tissue disorder Reproductive system Not known Menstrual disorder, azoospermia, erectile and breast disorders dysfunction, gynaecomastia

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