From the FDA Drug Label
In patients with severe hepatic impairment, clearance is reduced and the apparent volume of distribution is increased, resulting in a significant increase in the half-life of ondansetron Therefore, do not exceed a total daily dose of 8 mg in patients with severe hepatic impairment (Child-Pugh score of 10 or greater)
- Dosage adjustment is needed in patients with severe hepatic impairment.
- The recommended total daily dose in patients with severe hepatic impairment is 8 mg.
- No dosage adjustment is needed in patients with mild or moderate hepatic impairment 1.
From the Research
Ondansetron can be used in patients with liver failure, but dose adjustment is recommended, with a maximum daily dose of 8 mg for patients with severe hepatic impairment (Child-Pugh score ≥10). This is because ondansetron is primarily metabolized in the liver, and hepatic dysfunction leads to decreased clearance and increased plasma concentrations of the drug, as shown in a study published in the Journal of Clinical Pharmacology 2. For patients with mild to moderate hepatic impairment, no initial dosage adjustment is necessary, but monitoring for side effects is advisable. The typical adult dosing for ondansetron is 4-8 mg orally or intravenously every 8-12 hours for nausea and vomiting.
Key Considerations
- Common side effects include headache, constipation, and dizziness
- QT interval prolongation is a serious potential adverse effect, so caution should be exercised in patients with congenital long QT syndrome, those taking other QT-prolonging medications, or those with electrolyte abnormalities, which are common in advanced liver disease
- Regular monitoring of liver function and electrocardiograms may be warranted in these patients
- A study published in the Lancet found that ondansetron can provide relief from profound fatigue associated with chronic liver disease 3
Dosing and Administration
- The maximum daily dose of ondansetron should be limited to 8 mg for patients with severe hepatic impairment (Child-Pugh score ≥10) 2
- For patients with mild to moderate hepatic impairment, no initial dosage adjustment is necessary, but monitoring for side effects is advisable
- The typical adult dosing for ondansetron is 4-8 mg orally or intravenously every 8-12 hours for nausea and vomiting
Safety and Efficacy
- Ondansetron has been shown to be effective in preventing postoperative nausea and vomiting, with a meta-analysis published in Anesthesia and Analgesia finding that ondansetron and droperidol were more effective than metoclopramide in reducing postoperative vomiting 4
- The safety of ondansetron has been reviewed, with a study published in the European Journal of Cancer and Clinical Oncology finding that ondansetron is well tolerated, with few adverse events 5