Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 12/15/2025

Management of Increased Reflux in Infants on Lansoprazole

Critical Evidence Against PPI Use in Infants

  • The American Academy of Pediatrics guidelines emphasize that lansoprazole is not effective for reducing irritability or GERD symptoms in infants aged 1-12 months, with a 54% response rate in both lansoprazole and placebo groups 1
  • Serious adverse events, particularly lower respiratory tract infections, occurred significantly more frequently with lansoprazole compared to placebo (10 vs 2 patients, p=0.032) 1
  • The American Academy of Pediatrics guidelines recommend discontinuing lansoprazole immediately in infants under 1 year of age due to lack of efficacy and increased infection risk 1
  • The American Academy of Pediatrics guidelines emphasize that overuse or misuse of PPIs in infants with reflux is a matter for great concern 2, 1

Alternative Pharmacologic Options (If Truly Indicated)

  • The American Academy of Pediatrics guidelines state that there is insufficient evidence to support routine use of any prokinetic agent (including metoclopramide) for treatment of GERD in infants, and these carry significant adverse effects including extrapyramidal reactions 2, 1
  • H2-receptor antagonists should only be considered in cases of documented erosive esophagitis, as they carry risks of tachyphylaxis within 6 weeks and increased infection risk 1, 3