Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database.

BACKGROUND

Invasive fungal infections (IFIs) have become an increasingly serious public health problem. Amphotericin B (AmB) remains the important component in the treatment of IFIs. But its clinical application is limited due to its adverse reactions.

RESEARCH DESIGN AND

METHODS

In this study we mined the adverse drug event signals of AmB based on the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2023, using the Reported Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network and Multi-item Gamma Poisson Shrinker methods to provide a reference for the safe clinical use.

RESULTS

A total of 3597 adverse event (AE) reports for the primary suspect drug AmB were obtained, involving 22 system organ classes (SOCs), 1355 AEs. Patients aged 18-60 (47.93%) and female patients (53.82%) were at a higher risk of AEs with AmB. High risk signals in the report include hypokalemia, pyrexia, chill, renal failure. Additional high risk signals not mentioned in the instructions conclude respiratory failure, tachycardia, deafness.

CONCLUSIONS

Mining the adverse reaction signal study of AmB based on the FAERS database provides support for the clinical monitoring and risk identification of this drug.