Real World Safety Profile of Proton Pump Inhibitors in Infants: Tiny Tummies, Key Decisions

Background: Proton pump inhibitors (PPIs) are widely used for gastric acid suppression, yet their efficacy and safety in neonates and infants remain unclear. While esomeprazole is the only FDA-approved PPI for infants, other PPIs are also frequently prescribed. Objectives: This study utilizes FAERS data to evaluate potential adverse drug events (ADEs) of PPIs, providing crucial real-world insights into their safety in this vulnerable population. Methods: This observational cross-sectional study was conducted using an individual case safety report (ICSR) database. Only patients receiving omeprazole, pantoprazole, lanso-prazole, rabeprazole, or esomeprazole monotherapy were evaluated. The most frequently prescribed PPI, the most common indication, the most reported ADE, seriousness of ad-verse events and the countries reporting the highest ADE number were analyzed using 2D disproportionality analyses (e.g., reporting odds ratio (ROR)). Results: A total of 464 patients were included, 323 (69.6%) of them were stated as serious and 15 (3.2%) of them were stated as related to mortality. Most of the ADEs were reported for lansoprazole (45.9%). The most reported PPI associated ADE was vomiting (8.8%). According to the ROR analysis, vomiting associated with PPI monotherapy was more likely to occur (ROR: 2.88, 95% CI: 2.09 – 3.96), which is followed by diarrhea, hypertri-chosis, choking, and erythema. Additionally, medication errors were reported in 50 (10.8%) patients. Conclusion: ICSR databases are valuable pharmacovigilance tools. The absence of causal-ity assessment is a shortage since it limits its ability to confirm that whether the ADEs are truly caused by the suspected drug, mitigated using ROR analysis. Integrating neona-tal-specific algorithms could enhance drug safety evaluations, strengthen evidence-based decision-making, and improve risk-benefit assessments in neonates and infants.