Safety and efficacy of cyproheptadine for treating dyspeptic symptoms in children

J Pediatr. 2013 Jul;163(1):261-7. doi: 10.1016/j.jpeds.2012.12.096. Epub 2013 Feb 16.


Objective: To present our experience using cyproheptadine, a potent serotonin antagonist used to stimulate appetite, to treat dyspeptic symptoms in children.

Study design: This was a retrospective open-label study conducted to evaluate the safety and efficacy of cyproheptadine in children with refractory upper gastrointestinal symptoms (eg, nausea, early satiety, vomiting, retching after fundoplication, abdominal pain). Response was graded as resolution if symptoms resolved and medication was discontinued, as significant improvement if symptoms resolved with no further interventions, and as failure with any other outcome.

Results: A total of 80 children (65% females) aged <12 years (mean age, 10 years) were included. Response to therapy was reported in 55% of patients. Multivariate analysis revealed better response in children and females (P = .04 and .03, respectively). No associations were found between response to therapy response and gastric emptying, antroduodenal manometry, functional dyspepsia, vomiting, and use of cyproheptadine as first therapy. Early vomiting (occurring within 1 hour after starting a meal) responded better than late vomiting (P = .03), and patients with retching after undergoing Nissen fundoplication had an 86% response rate. Twenty-four patients (30%) complained of side effects, all mild, including somnolence (16%), irritability and behavioral changes (6%), increased appetite and weight gain (5%), and abdominal pain (2.5%), but only 2 of these patients discontinued therapy. Multivariate analysis demonstrated an association between side effects and lack of response to therapy (P = .04), but no associations with age and sex.

Conclusion: Cyproheptadine is safe and effective for treating dyspeptic symptoms in children, particularly in young children and those with early vomiting and retching after fundoplication.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Cyproheptadine / adverse effects
  • Cyproheptadine / therapeutic use*
  • Dyspepsia / drug therapy*
  • Female
  • Humans
  • Infant
  • Male
  • Retrospective Studies
  • Serotonin Antagonists / adverse effects
  • Serotonin Antagonists / therapeutic use*
  • Young Adult


  • Serotonin Antagonists
  • Cyproheptadine