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Epidyolex · 4.8 · Description of selected adverse reactions
Eintrag öffnenEpidyolex · 4.8 · Diarrhoea Cannabidiol can cause dose-related diarrhoea. In controlled trials in LGS and DS, the frequency of d
Eintrag öffnenEpidyolex · 4.8 · Dose ALT elevations greater than 3 times the ULN were reported in 15% of patients taking cannabidiol 20 or 25
Eintrag öffnenEpidyolex · 4.8 · Haematologic abnormalities Cannabidiol can cause decreases in haemoglobin and haematocrit. In LGS, DS and TSC
Eintrag öffnenEpidyolex · 4.8 · Hepatocellular injury Cannabidiol can cause dose-related elevations of ALT and AST (see section 4.4).
Eintrag öffnenEpidyolex · 4.8 · In controlled studies for LGS, DS (receiving 10 or 20 mg/kg/day) and for TSC (receiving 25 mg/kg/day), the inc
Eintrag öffnenEpidyolex · 4.8 · In the clinical trials, the first onset of diarrhoea was typically in the first 6 weeks of treatment with cann
Eintrag öffnenEpidyolex · 4.8 · Increases in creatinine Cannabidiol can cause elevations in serum creatinine. The mechanism has not yet been d
Eintrag öffnenEpidyolex · 4.8 · Less than 1% of cannabidiol-treated patients had ALT or AST levels greater than 20 times the ULN. There have b
Eintrag öffnenEpidyolex · 4.8 · Pneumonia Pneumonia events have been observed in controlled trials with cannabidiol in patients with LGS, DS,
Eintrag öffnenEpidyolex · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenEpidyolex · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenEpidyolex · 4.8 · Risk factors for hepatocellular injury Concomitant valproate and clobazam, dose of cannabidiol and baseline tr
Eintrag öffnenEpidyolex · 4.8 · Seizures In the controlled trial in TSC patients, an increased frequency of adverse events associated with sei
Eintrag öffnenEpidyolex · 4.8 · Somnolence and sedation Somnolence and sedation (including lethargy) events have been observed in controlled t
Eintrag öffnenEpidyolex · 4.8 · Summary of the safety profile
Eintrag öffnenEpidyolex · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenEpidyolex · 4.8 · The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000
Eintrag öffnenEpidyolex · 4.8 · The most common adverse reactions are somnolence (23%), decreased appetite (21%), diarrhoea (20%), pyrexia (16
Eintrag öffnenEpidyolex · 4.8 · The most frequent causes of discontinuation were transaminase elevation (2%), somnolence (2%) and decreased ap
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