Effectiveness and safety of proton pump inhibitors in infantile gastroesophageal reflux disease

Ann Pharmacother. 2010 Mar;44(3):572-6. doi: 10.1345/aph.1M519. Epub 2010 Feb 2.


Objective: To evaluate the efficacy and safety of proton pump inhibitors (PPIs) in the treatment of gastroesophageal reflux disease (GERD) in infants <1 year of age.

Data sources: A literature search was conducted through PubMed (up to December 2009), International Pharmaceutical Abstracts (1970-December 2009), and The Cochrane Library (up to December 2009) using combinations of the following key search terms: proton pump inhibitor, GERD, infant, children, pediatric, omeprazole, rabeprazole, lansoprazole, esomeprazole, and pantoprazole. Reference citations from identified articles were also reviewed.

Study selection and data extraction: All double-blind, placebo-controlled trials published in English that evaluated the safety and efficacy of PPIs in infants with GERD were included in this review. Trials involving children older than 12 months were not included.

Data synthesis: GERD is a source of pain and discomfort in adults; yet, in infants, symptoms that are thought to be indicative of painful stimuli have no clear cause-and-effect relationship with infant GERD. PPIs are beneficial in relieving symptoms of GERD in the adult population, but their usefulness in decreasing GERD-associated behaviors in infants is still questionable, despite a large increase in PPI prescribing for children <1 year of age. In all studies reviewed, infants treated with PPIs did not experience a significant decrease in behaviors perceived to be caused by GERD. The largest placebo-controlled trial to date found that rates of adverse events were increased in the PPI group compared with the placebo group, whereas the other trials reviewed reported no difference in adverse effects with the use of PPIs.

Conclusions: Clinical trials reveal that PPI therapy is not an effective treatment for common infant GERD-associated symptoms. Evidence supporting safety of PPI use in infants is conflicting, and more large-scale, randomized, placebo-controlled trials are necessary to better establish the role of PPIs in infant GERD.

Publication types

  • Review

MeSH terms

  • Age Factors
  • Gastroesophageal Reflux / drug therapy*
  • Gastroesophageal Reflux / physiopathology
  • Humans
  • Infant
  • Proton Pump Inhibitors / adverse effects
  • Proton Pump Inhibitors / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Treatment Outcome


  • Proton Pump Inhibitors