ArticleFundamental & clinical pharmacology2025
Safety of Proton Pump Inhibitor in Paediatrics: A Study Based on EudraVigilance Data.
Article in Fundamental & clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Safety of Proton Pump Inhibitor in Paediatrics: A Study Based on EudraVigilance Data.Fundamental & clinical pharmacology · 2025Article
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Authors and funding
4 authors.
Funding
Abstract
BACKGROUND AND
objectivesDespite limited paediatric approvals, the use of proton pump inhibitors (PPIs) among children has increased in recent years, and concerns have arisen about their safety, including the risk of allergies. To provide additional evidence on the paediatric safety of PPIs, we performed a study on suspected adverse drug reactions (ADRs) in clinical practice.
methodsWe retrieved from EudraVigilance reports of suspected ADRs for PPIs in the age class 0-11 years in the period 2003-2022. Most reported ADRs and allergic conditions were evaluated by descriptive analysis. A case-non-case analysis was performed using reporting odds ratio (ROR) with a 95% confidence interval (CI). Chi-square or Fisher's exact tests were used to detect differences in reporting rates.
resultsA total of 1389 reports and 4157 suspected ADRs were analysed. Most reports involved omeprazole (46.9%) and esomeprazole (27.3%), and 75.8% concerned serious outcomes. Gastrointestinal disorders were among the most common suspected ADRs, with vomiting being the most frequently reported (2.3%). Among allergic conditions, there were six cases of toxic epidermal necrolysis, five of Stevens-Johnson syndrome and four of drug reaction with eosinophilia and systemic symptoms. Statistically significant reactions for omeprazole were choking (ROR 5.54; 95% CI, 1.04-29.56) and pneumonia (3.61; 1.41-9.20), while for esomeprazole gastrointestinal disorder (7.57; 1.18-48.60) and constipation (4.74; 2.25-9.98).
conclusionsMost common suspected ADRs reported with paediatric PPI use in Europe were gastrointestinal disorders, consistent with the safety profile in the product license. However, a high proportion of serious ADRs and few cases of severe cutaneous adverse reactions were reported.
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