Labetalol adverse event signal mining based on FAERS database
ZHANG Qing
SU Chang-hai
ZHU Lei
TIAN Yi-xuan
TANG Hai-lang
DONG Li-sen
Abstract：Objective:To mine the labetalol-related adverse drug events(ADE)from the FDA Adverse Event Reporting System(FAERS)database to provide reference for clinical medication monitoring.Methods:The ADE reports in FAERS database from 2004 to the first quarter of 2022 were collected.The OpenVigil 2.1 data platform was used to preprocess the ADE of all patients using labetalol.The report odds ratio(ROR)method and the proportional report odds ratio(PRR)method were further used to analyze the ADE.The top 10 ADE in frequency and signal intensity were obtained and the combined medication in them was analyzed.Results:A total of 658 ADEs were reported and 136 of them belonged to adverse drug reactions(ADR).Among 658 ADEs,588 were caused by drug exposure during pregnancy(PRR=17.99,χ2=7 591.23;ROR=19.43,95%CI=17.69-1.34),and others by premature infants,liver damage,excessive tension,acute kidney injury,low blood pressure and renal failure,etc.The signal intensity analysis showed that scrotal transposition(PRR=2 578.43,χ2=2146.19;ROR=2 579.69,95%CI=430.96-15 441.72)was the highest signal intensity ADE event,which was followed by zoonotic bacterial infection,gastric intestinal obstruction,neonatal neutropenia,medullary cone syndrome,systemic vascular resistance increase and eye nevus,etc.In the patients with combined medication,the signal intensity from high to low was nifedipine,hydralazine,amlodipine,aspirin,methyldopa,betamethasone,aspirin,magnesium sulfate and levothyroxine sodium.Conclusion:During use of labetalol,its adverse reactions should be carefully detected,and combined medication should also be paid close attention to.
Keywords：LabetalolFAERS databaseAdverse drug eventCombined medicationSignal mining
Publication Date：2023-12-25
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 448-451 )