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Updated: Aug 20, 2025
Simultaneous Laryngopharyngeal and Conventional Esophageal pH Monitoring
Published on: December 14, 2020
Spontaneous reporting of adverse reactions related to proton pump inhibitors
Valeria Dipasquale1, Giuseppe Cicala2, Francesca Laganà1
1Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", "G. Martino" University Hospital, Messina, Italy.
Background:
Proton pump inhibitors (PPIs) are widely prescribed in all age groups, and their use is increasing. However, their safety profile has been frequently questioned.
Aims:
The aim of this study was to analyze the characteristics of PPI-related adverse drug reactions (ADRs) reported to the Italian spontaneous reporting system (SRS) database and relative to an Italian region (Sicily).
Methods:
A 20-year observational, retrospective study was conducted, evaluating PPI-related ADR reports from Sicily between January 1st, 2001, and June 30th, 2021. The factors associated with ADR seriousness were investigated.
Results:
A total of 148 spontaneous reports of ADRs related to PPIs were analyzed. Lansoprazole was the drug with the highest number of associated reports (30.87%). The most frequently reported ADRs were cutaneous (24.56%) and/or gastrointestinal manifestations (18.10%), the latter especially in the case of lansoprazole-related ADRs (p<0.006). The great majority of ADR reports were relative to on-label prescriptions. Serious ADRs were 39 (26.35%). Serious ADRs were more common in reports including omeprazole than in reports containing other PPIs (p<0.008) and in reports presenting PPIs combined with other drugs than in reports with PPI single therapies (p<0.001).
Conclusion:
Most PPI-related ADRs are non-serious. Omeprazole and combination therapy seem to be associated with ADR seriousness.
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