Academic Journal
Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database.
| Τίτλος: | Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database. |
|---|---|
| Συγγραφείς: | Wang S; Department of Pharmacy, The first Affiliated Hospital of Army Medical University(Third Military Medical University), Chongqing, China., Cheng Y; Department of Pharmacy, The first Affiliated Hospital of Army Medical University(Third Military Medical University), Chongqing, China., Wang X; Department of Pharmacy, The first Affiliated Hospital of Army Medical University(Third Military Medical University), Chongqing, China., Wang Q; Department of Pharmacy, The first Affiliated Hospital of Army Medical University(Third Military Medical University), Chongqing, China. |
| Πηγή: | Expert opinion on drug safety [Expert Opin Drug Saf] 2026 Aug; Vol. 25 (8), pp. 1607-1614. Date of Electronic Publication: 2025 Mar 12. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Taylor & Francis Country of Publication: England NLM ID: 101163027 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1744-764X (Electronic) Linking ISSN: 14740338 NLM ISO Abbreviation: Expert Opin Drug Saf Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2015- : Abingdon, Oxford : Taylor & Francis Original Publication: London : Ashley Publications, c2002- |
| Ιατρικοί όροι (MeSH): | Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Amphotericin B*/adverse effects , Amphotericin B*/administration & dosage , Antifungal Agents*/adverse effects , Antifungal Agents*/administration & dosage, Invasive Fungal Infections/drug therapy ; Data Mining/methods ; Humans ; Female ; Databases, Factual ; Male ; United States ; Adult ; Adolescent ; United States Food and Drug Administration ; Bayes Theorem |
| Περίληψη: | 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. |
| Contributed Indexing: | Keywords: AmB; FAERS; adverse drug event; drug safety; signal detection |
| Substance Nomenclature: | 7XU7A7DROE (Amphotericin B) 0 (Antifungal Agents) |
| Entry Date(s): | Date Created: 20250312 Date Completed: 20260803 Latest Revision: 20260803 |
| Update Code: | 20260803 |
| DOI: | 10.1080/14740338.2025.2468856 |
| PMID: | 40070343 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1744-764X |
|---|---|
| DOI: | 10.1080/14740338.2025.2468856 |