# Ondansetron ```text DRUG INFORMATION ADULT - Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy ( 2.1 ): • Dilution of Ondansetron Injection in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients. Source: US FDA label for ondansetron (Ondansetron), section 'dosage and administration', retrieved 2026-08-29 - Dosage and Administration The recommended dosage for adult and pediatric patients 6 months of age and older for prevention of nausea and vomiting associated with emetogenic chemotherapy is 0.15 mg/kg per dose for 3 doses (maximum of 16 mg per dose). Source: US FDA label for ondansetron (Ondansetron), section 'dosage and administration', retrieved 2026-08-29 - Recommended Dose and Administration of Ondansetron Injection for Prevention of Postoperative Nausea and/or Vomiting Population Recommended Single-Dose Administration Instructions Timing of Administration Adults and pediatric patients older than 12 years of age 4 mg Few patients above 80 kg have been studied. Source: US FDA label for ondansetron (Ondansetron), section 'dosage and administration', retrieved 2026-08-29 CHILD - Little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month [see Clinical Studies (14.2) ] . Little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months [see Clinical Studies (14.1) , Dosage and Administration (2) ] . Source: US FDA label for ondansetron (Ondansetron), section 'pediatric use', retrieved 2026-08-29 - Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy ( 2.1 ): • Dilution of Ondansetron Injection in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients. Source: US FDA label for ondansetron (Ondansetron), section 'dosage and administration', retrieved 2026-08-29 - Dosage and Administration The recommended dosage for adult and pediatric patients 6 months of age and older for prevention of nausea and vomiting associated with emetogenic chemotherapy is 0.15 mg/kg per dose for 3 doses (maximum of 16 mg per dose). Source: US FDA label for ondansetron (Ondansetron), section 'dosage and administration', retrieved 2026-08-29 RENAL IMPAIRMENT - In such patients, a total daily dose of 8 mg should not be exceeded [see Dosage and Administration (2.3) ] . 8.7 Renal Impairment Although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min), no dosage adjustment is recommended [see Clinical Pharmacology (12.3) ] . Source: US FDA label for ondansetron (Ondansetron), section 'use in specific populations', retrieved 2026-08-29 HEPATIC IMPAIRMENT - Pediatric patients 1 month to 12 years and 40 kg or less 0.1 mg/kg Infuse intravenously over at least 30 seconds and preferably longer (over 2 to 5 minutes). 2.3 Dosage Adjustment for Patients With Hepatic Impairment In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. Source: US FDA label for ondansetron (Ondansetron), section 'dosage and administration', retrieved 2026-08-29 - Dosage adjustment is not needed in patients over the age of 65. 8.6 Hepatic Impairment In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see Clinical Pharmacology (12.3) ] . Source: US FDA label for ondansetron (Ondansetron), section 'use in specific populations', retrieved 2026-08-29 PREGNANCY - Risk Summary Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see Data ) . Source: US FDA label for ondansetron (Ondansetron), section 'pregnancy', retrieved 2026-08-29 - Available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. Source: US FDA label for ondansetron (Ondansetron), section 'pregnancy', retrieved 2026-08-29 - Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (BSA), respectively (see Data ) . Source: US FDA label for ondansetron (Ondansetron), section 'pregnancy', retrieved 2026-08-29 BREASTFEEDING - With the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated F1 generation. 8.2 Lactation Risk Summary Ondansetron is unlikely to result in clinically relevant exposures in breastfed infants when administered intravenously at doses up to 4 mg/day to women who are breastfeeding. Source: US FDA label for ondansetron (Ondansetron), section 'use in specific populations', retrieved 2026-08-29 - Available data from a lactation study involving pharmacokinetic samples from 80 lactating women and 20 infants indicate that ondansetron is present at low levels in human milk and in the plasma of breastfed infants. Source: US FDA label for ondansetron (Ondansetron), section 'use in specific populations', retrieved 2026-08-29 - In the same study, no adverse effects attributed to ondansetron were reported in infants exposed to ondansetron through breast milk. Source: US FDA label for ondansetron (Ondansetron), section 'use in specific populations', retrieved 2026-08-29 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)