Ondansetron

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