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A real-world pharmacovigilance case/non-case study of FDA adverse event reporting system events for mannitol

Zhi Jin1, Yu Liu2, Zongren Zhao2

  • 1Department of Neurology, Shanghai Fifth People's Hospital, Fudan University, Shanghai, China.

Expert Opinion on Drug Safety
|April 10, 2025
PubMed
Abstract

Insights

This pharmacovigilance study identified safety signals for mannitol, an osmotic diuretic. Key adverse events included hyperosmolar state, hyperchloremia, and hypernatremia, highlighting the need for careful mannitol monitoring.

Area of Science:

  • Pharmacovigilance
  • Clinical Pharmacology
  • Drug Safety

Background:

  • Mannitol is an osmotic diuretic commonly used for edema and intracranial hypertension.
  • Adverse events (AEs) associated with mannitol require ongoing safety surveillance.
  • This study aimed to identify potential safety signals for mannitol using real-world data.

Purpose of the Study:

  • To analyze mannitol-related adverse events (AEs) using the FDA adverse event reporting system (FAERS) database.
  • To identify and evaluate potential safety signals associated with mannitol use.
  • To assess the frequency, severity, and clinical relevance of reported mannitol AEs.

Main Methods:

  • A retrospective pharmacovigilance study design.
  • Utilized FAERS data from Q1 2013 to Q4 2023.
  • Employed signal detection algorithms such as Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR).

Main Results:

  • Analyzed 1,014 reports mentioning mannitol out of over 39 million total reports.
  • Identified 'hyperosmolar state' (ROR=665.98), 'hyperchloremia,' and 'hypernatremia' (ROR=25.18) as significant safety signals.
  • AEs frequently involved renal and urinary disorders (295 cases) and skin/subcutaneous tissue disorders (371 cases).

Conclusions:

  • Vigilant monitoring of mannitol use is crucial due to identified safety signals.
  • Further research is needed to elucidate mechanisms of unexpected AEs.
  • Establishing a comprehensive safety profile for mannitol remains an ongoing priority.
Keywords:
Adverse eventFAERS databasemannitolosmotic diureticpharmacovigilance

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