Safety assessment of esomeprazole: real-world adverse event signal mining and analysis based on FAERS database

Esomeprazole holds a significant position in the treatment of acid-related diseases. However, as with all drugs, it may also carry some potential risk of adverse effects. This study aims to further evaluate the safety of esomeprazole for clinical use.

The data of esomeprazole-related adverse events was extracted from the FAERS database from the first quarter of 2004 to the first quarter of 2024 and used Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean(EBGM) for data mining.

A total of 67,712 esomeprazole-related adverse events were extracted from the FAERS database, involving 27 system organ class. The frequency of renal and urinary occurrence was the highest, and the signal was the strongest. Additionally, we detected 324 preferred terms: rebound acid hypersecretion, nephrogenic anemia, and hyperparathyroidism secondary showed significant high signal strength. In the elderly, adverse events were concentrated in the gastrointestinal disorders system, and the most common adverse events were dyspepsia and hyponatremia. Unexpected adverse events, such as vomiting, acute kidney injury, and anaphylactic reaction occurred in children.

We discovered some new and special esomeprazole-related adverse events, raising awareness of the safety of esomeprazole and further helping to mitigate associated risks.