What is the pediatric dose of Ondansetron (Zofran)?

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Last updated: April 5, 2025View editorial policy

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From the Guidelines

The recommended dose of Zofran (ondansetron) for pediatric patients is 0.15 mg/kg, which is a commonly used dose in clinical practice 1. When determining the dose, it's essential to consider the patient's weight and age.

  • For weight-based dosing, children can receive 0.1-0.15 mg/kg per dose, with a maximum single dose of 8 mg.
  • The dose can be administered orally or intravenously, with the intravenous dose typically being 0.1 mg/kg for children weighing less than 40 kg, with a maximum single dose of 4 mg. Ondansetron works by blocking serotonin receptors in the brain and gut that trigger nausea and vomiting.
  • It's crucial to use ondansetron cautiously in children with cardiac conditions or electrolyte abnormalities due to potential QT interval prolongation. The medication typically starts working within 30 minutes and can last 4-8 hours.
  • Always check for the most current dosing guidelines and consult with a healthcare provider before administering any medication to children, as the optimal dose and scheduling of 5-HT3 receptor antagonists, such as ondansetron, may vary depending on the specific clinical context 1.

From the FDA Drug Label

Pediatric Trials Three open-label, single-arm, non-US trials have been performed with 182 pediatric patients aged 4 to 18 years with cancer who were given a variety of cisplatin or non cisplatin regimens. The initial dose of ondansetron tablets injection ranged from 0. 04 to 0.87 mg per kg (total dose of 2. 16 mg to 12 mg) followed by the administration of oral doses of ondansetron tablets ranging from 4 to 24 mg daily for 3 days. The pediatric dose of ondansetron is based on the patient's weight, with an initial dose ranging from 0.04 to 0.87 mg per kg. The oral dose can range from 4 to 24 mg daily for 3 days. In patients younger than 12 years, 4 mg three times a day was similar to 8 mg three times daily in patients 12 to 18 years 2.

From the Research

Zofran Pediatric Dose

  • The optimal dose of ondansetron for pediatric patients is not well established, but several studies have investigated its use in children 3, 4, 5, 6.
  • A study published in 2010 found that ondansetron doses ranging from 0.13 to 0.26 mg/kg were effective in reducing emesis in children with acute gastroenteritis, with no significant difference in efficacy or side effects between higher and lower doses within this range 3.
  • Another study from 1999 compared the antiemetic efficacy of single high-dose ondansetron (0.6 mg/kg, maximum dose 32 mg) with multiple standard-dose ondansetron (0.15 mg/kg, maximum dose 8 mg, every 4 hours for four doses) in pediatric oncology patients, and found that the single high-dose regimen was as efficacious as the multiple standard-dose regimen 4.
  • A 1997 study evaluated the safety and efficacy of ondansetron (0.1 mg/kg to 4 mg intravenously) in preventing postoperative vomiting in pediatric outpatients, and found that ondansetron was effective in reducing postoperative emesis 5.
  • The pharmacokinetics of ondansetron have been studied in healthy volunteers, with a terminal plasma half-life of 3.0-3.5 hours and plasma clearance of approximately 600 ml/min 7.
  • A 2008 study evaluated the safety of ondansetron loading doses in children with cancer, and found that doses of 16 mg/m(2) (top, 24 mg) i.v. were safe, with mild to moderate adverse events reported in 26% of cases 6.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Safety of ondansetron loading doses in children with cancer.

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2008

Research

The clinical pharmacology of ondansetron.

European journal of cancer & clinical oncology, 1989

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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