Exakte Wirkstoffkennungen und zitierbare Passagen zu Wechselwirkungen, Gegenanzeigen und Nebenwirkungen.
Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Hepatotoxicity
Serious hepatic toxicity caused by ketoconazole treatment is rare (1/15000). Acute hepatocellular injury has
been primarily observed as has cholestatic injury or a mixed pattern of toxicity. Fatal cases have been reported
particularly when treatment is continued despite liver enzyme elevation. Increases in liver enzymes (≤ 5N and
> 5N) were observed in ~13.5 % and ~2.5% of patients respectively occurring mostly within the first 6 months
of treatment. Liver enzyme levels returned to normal within 2-12 weeks after a dose decrease or withdrawal
of ketoconazole. Hepatotoxicity does not appear to be dose dependent. All potential associated factors of
hepatotoxicity, and abnormal liver enzyme levels detected before ketoconazole initiation, should be taken into
account before considering ketoconazole treatment. Ketoconazole should not be administered when liver
enzymes are greater than 2 times the upper limit of normal or in association with other hepatotoxic medicinal
products. Liver enzyme monitoring should be performed once weekly during the first month of treatment and
then monthly for 6 months. In the case an increase of liver enzymes is detected which is less than 3 times the
upper limit of normal, closer monitoring of liver function should be performed and the daily dose should be
decreased by at least 200 mg. In the case of increase of liver enzymes levels above 3 times the upper limit of
normal, Ketoconazole should be stopped immediately and should not be reintroduced because of the risk of
serious hepatic toxicity.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Adrenal insufficiency
Adrenal insufficiency may occur in patients on ketoconazole without corticosteroid substitution (block-only
regimen) or if there is an insufficient glucocorticoid replacement therapy (for the patients treated with a block-
and-replace regimen). Monitor and instruct patients on the signs and symptoms associated with
hypocortisolism (e.g. weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyperkalemia,
hyponatraemia, hyperkalaemia or hypoglycaemia). Adrenal insufficiency may be detected by periodic clinical
assessment and monitoring of plasma/serum or salivary cortisol levels. In case of adrenal insufficiency,
Ketoconazole Esteve treatment should be temporarily discontinued or the dose reduced and, if needed, a
corticosteroid substitution therapy added.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Paediatric population
Frequency of hepatotoxicity could be higher in adolescents than in adults. In the literature, among 24 paediatric
patients treated with ketoconazole, two developed severe hepatoxicity. A 14 year-old girl who was treated for
Cushing’s disease with ketoconazole 200 mg twice daily presented one month later with jaundice, fever
anorexia, nausea and vomiting. Ketoconazole was stopped, but she deteriorated rapidly and died. A 17 years
old girl was treated on ketoconazole 1,200 mg/day for an adrenal carcinoma with liver metastasis and had
altered liver function tests at 22 days. After ketoconazole withdrawal, liver enzymes returned to normal levels
within 3 weeks (section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked
to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Version 2025-05-05T12:00:00Z · SHA-256 1463d2e081bcaa454cdfd6129ad3b8e03e3df9233f9d0704cfceba71c89c59b5 · Passage abc22b83570c331ebe9a37a7b4305c41c3bcb8c53c05f8737a30b225ed05b7c8 · Zeichen 7961–8316 im Abschnitt
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.