What is the recommended dose for racecadotril?

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Last updated: November 19, 2025View editorial policy

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Racecadotril Dosing

Racecadotril is dosed at 1.5 mg/kg orally every 8 hours (three times daily) in children, and 100 mg orally three times daily in adults, used as adjunctive therapy to oral rehydration for acute diarrhea.

Adult Dosing

  • Standard dose: 100 mg orally three times daily 1, 2
  • Used as adjunctive therapy alongside oral rehydration solution 1
  • Indicated for Grade 1 immunotherapy-induced diarrhea in cancer patients as symptomatic treatment 1

Pediatric Dosing

  • Standard dose: 1.5 mg/kg orally every 8 hours (three times daily) 3, 4
  • Studied in children aged 3 months to 5 years 3, 5, 4
  • Maximum treatment duration studied was typically 3-5 days 3, 4
  • Always administered as adjunct to oral rehydration therapy, never as monotherapy 3, 5, 4

Clinical Context and Limitations

The evidence for racecadotril shows mixed results. While it demonstrates antisecretory effects and reduces stool output in the first 48 hours by approximately 46-50% in children 3, 4, a 2019 Cochrane review concluded that current evidence does not support routine use of racecadotril in management of acute diarrhea in children under five outside of placebo-controlled trials 5. The drug appears safe with adverse events similar to placebo 3, 5, 4, 2, but clinical benefits beyond stool output reduction remain uncertain 5.

Important caveat: Racecadotril is not available in North America 1, limiting its practical utility in the United States and Canada. In regions where it is available (Europe, Latin America, parts of Asia), it may be considered for symptomatic treatment of acute watery diarrhea when combined with appropriate rehydration therapy 1.

Special Populations

  • Cancer patients with immunotherapy-induced diarrhea: Racecadotril is specifically mentioned as an option for Grade 1 diarrhea alongside loperamide, combined with oral rehydration 1
  • Prophylactic use: A randomized trial of prophylactic racecadotril (100 mg three times daily for 15 days) during chemotherapy failed to demonstrate benefit in preventing diarrhea 1

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Racecadotril versus placebo in the treatment of acute diarrhoea in adults.

Alimentary pharmacology & therapeutics, 1999

Research

Racecadotril in the treatment of acute watery diarrhea in children.

The New England journal of medicine, 2000

Research

Racecadotril for acute diarrhoea in children.

The Cochrane database of systematic reviews, 2019

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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