Why is loperamide (Loperamide) contraindicated in pediatric patients?

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From the Guidelines

Loperamide is contraindicated in children under 18 years of age with acute diarrhea due to the risk of serious adverse effects, including central nervous system depression, respiratory depression, and paralytic ileus. The primary concern is the risk of these adverse effects due to immature blood-brain barrier development in young children, which can allow loperamide to cross the barrier more easily than in adults, potentially causing serious neurological side effects or even death 1. Additionally, in acute diarrheal illnesses, especially those caused by invasive organisms, loperamide may worsen the condition by slowing intestinal motility and allowing pathogens to remain in the gut longer, potentially increasing toxin absorption and delaying pathogen clearance.

Key Considerations

  • The risk of central nervous system depression, respiratory depression, and paralytic ileus is higher in children due to their immature blood-brain barrier development 1.
  • Loperamide can worsen acute diarrheal illnesses by slowing intestinal motility and allowing pathogens to remain in the gut longer 1.
  • The preferred approach for children with diarrhea is oral rehydration therapy to prevent dehydration, along with appropriate nutrition and, if necessary, targeted antimicrobial therapy based on the cause.

Recommendations

  • Parents should seek medical attention for children with persistent diarrhea rather than using over-the-counter antidiarrheal medications like loperamide 1.
  • Loperamide may be given to immunocompetent adults with acute watery diarrhea, but should be avoided at any age in suspected or proven cases where toxic megacolon may result in inflammatory diarrhea or diarrhea with fever 1.

From the FDA Drug Label

Loperamide hydrochloride capsules are contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions Postmarketing cases of cardiac arrest, syncope, and respiratory depression have been reported in pediatric patients less than 2 years of age Pediatric patients may be more sensitive to CNS effects, such as altered mental status, somnolence, and respiratory depression, than adults.

Loperamide is contraindicated in children under 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions. These risks are supported by postmarketing cases of cardiac arrest, syncope, and respiratory depression in pediatric patients less than 2 years of age 2, 2, 2.

From the Research

Loperamide Contraindication in Children

  • Loperamide is contraindicated in children due to the risk of developing paralytic ileus, as reported in a case study of a 2-year-old girl who was prescribed loperamide for acute diarrhea 3.
  • The study suggests that in young children with acute diarrhea, there is usually no place for medicinal treatment, and certainly not with antimotility drugs such as loperamide 3.
  • While loperamide is effective in treating diarrhea in adults, its use in children is not recommended due to the potential for serious side effects, including ileus 3.
  • Other studies have reported the effectiveness and safety of loperamide in adults, but do not provide information on its use in children 4, 5, 6, 7.
  • The lack of information on the safety and efficacy of loperamide in children, combined with the reported risk of paralytic ileus, supports the contraindication of loperamide in this population.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

[Ileus after the use of loperamide in a child with acute diarrhea].

Nederlands tijdschrift voor geneeskunde, 2003

Research

Loperamide: a pharmacological review.

Reviews in gastroenterological disorders, 2007

Research

The role of loperamide in gastrointestinal disorders.

Reviews in gastroenterological disorders, 2008

Research

Loperamide, the "Poor Man's Methadone": Brief Review.

Journal of psychoactive drugs, 2017

Research

Oral rehydration therapy plus loperamide versus loperamide alone in the treatment of traveler's diarrhea.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 1999

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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