Evaluation of safety of pantoprazole in gastroenterology based on FAERS database
Liu Li-yang
Gao Chu-meng
Wang Xiao-ying
Dong Yan-wei
Cui Yu-hua
Liu Chang
Abstract：Objective To evaluate the safety of pantoprazole in the field of gastroenterology by analyzing the Adverse Event Reporting System (AERS) database of the US Food and Drug Administration (FDA),particularly its potential risks associated with adverse drug reactions (ADRs),to provide valuable safety information for clinical physicians using pantoprazole. Methods Raw FAERS data were collected from the first quarter of 2004 through the third quarter of 2023,covering pantoprazol-related adverse event (AE) reports. Statistical analysis was performed using SAS9.4 software. Systematic organ classification (SOC) and preferred term (PT) were determined by MedDRA standard query and signal detection was performed by ROR and PRR. Results FDA data screening showed a gastroenterologically related report of 28839 pantoprazole cases with an AE of 95951. The incidence was higher in women (50.10％) than in men (35.28％) and was more common in the 45-65 age group (25.18％). Compared with non-serious re-ports (13.59％),the proportion of serious reports was significantly higher (86.41％) and most of them required hospitalization (26.88％). The majority of AE events occurred within 30 days of medication,and about 50％ of adverse events occurred between day 1 and 48,with the median time for the first occurrence being day 8. Secondary screening with ROR and PRR detected 678 AE signals,involv-ing 27 SOCs,among which gastrointestinal diseases accounted for 14.9％. Gastroesophageal reflux disease was the most common (1093 cases),followed by nausea and diarrhea (1067 and 1035 cases). The most common AES in SMQ were hematochezia (168 cases),hematemesis (102 cases),and black stool (99 cases). Ulcerative colitis was the most common gastrointestinal ulcer (129 cases). Non-specific gastroesophageal reflux disease (1093 cases),dyspepsia (434 cases) and hyperelastic gastric acid secretion (187 cases) were also strongly associated. Conclusion Based on large-scale data analysis of the FAERS database,this study pro-vides important insights into the safety of pantoprazole in gastroenterology. The study highlights the importance of monitoring and managing potential adverse effects of pantoprazole in clinical practice.
Keywords：FAERS databaseSignal miningPantoprazoleGastrointestinal adverse eventMonitoring of adverse reaction
Publication Date：2024-12-25
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 846-851 )