Safety analysis of adverse events associated with mannitol based on the FAERS database
DENG Yunliang
Abstract：Objective To explore adverse events(AEs)associated with the use of mannitol,assess the safety of its clinical application,and provide evidence for safe drug use.Methods Data from the FAERS database from the first quarter of 2004 to the third quarter of 2023 were searched for AEs where mannitol was the primary suspect.Positive signal AEs were screened using the reporting odds ratio(ROR),proportional reporting ratio(PRR),and empirical Bayesian geometric mean(EBGM)methods.The screening criteria were an ROR 95%lower confidence interval(CI)limit>1 and ROR≥3;PRR>2 and χ²>4;and EBGM05>2.Results A total of 1 101 patients were identified,with the majority aged 51～60 years and a slightly higher propor-tion of males.The primary AEs related to mannitol affected the following System Organ Classes:skin and subcutaneous tissue disorders(23.05%),renal and urinary disorders(21.32%),and general disorders and administration site conditions(14.81%).Fre-quent mannitol-associated AEs included renal impairment(9.18%),pruritus(7.08%),and acute kidney injury(7.01%).Co-medica-tion analysis identified 2,078 cases.The top ten concomitant drugs were sodium chloride(6.69%),dexamethasone(4.76%),cispla-tin(2.94%),furosemide(1.88%),ondansetron(1.20%),epoprostenol(1.06%),propofol(0.91%),nitrous oxide(0.87%),fentanyl(0.82%),and lidocaine(0.77%).Common combinations for synergistic reduction of intracranial pressure included mannitol with dexamethasone or furosemide.84 death-related events were retrieved.Through matching preferred terms and full information,complete death details were obtained for 6 cases,including 4 deaths related to renal impairment.Analysis of death-related causes indicated the need to pay attention to drug incompatibilities,renal impairment,and electrolyte metabolism disorders in patients.Monitoring is also advised when using mannitol in patients with multiple chronic diseases.Most mannitol AEs occurred within 1 month of administration(98.18%).Conclusion Mannitol AEs frequently involve the skin and renal systems.Some adverse reactions are not listed in pharmacopeias.Therefore,close monitoring of liver and kidney function is still necessary during man-nitol use.For patients with worsening renal function,reducing mannitol use is recommended.Additionally,mannitol can be used sequentially with dexamethasone/furosemide to synergistically reduce intracranial pressure and improve patient prognosis.
Keywords：mannitol adverse eventsFAERS databasesafety analysis
Publication Date：2025-11-25
Online Publishing Date：2026-01-12(First online date of this platform, not the publication date of the document)
Pages：7( 672-678 )