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

Background: Mannitol, an osmotic diuretic, is widely used to treat edema, intracranial hypertension, and cerebral edema. This study analyzed mannitol-related adverse events (AEs) using the FDA adverse event reporting system (FAERS) data to identify potential safety signals.

Research design and methods: A retrospective pharmacovigilance study was conducted using FAERS data from Q1 2013 to Q4 2023. Signal detection algorithms, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to identify and evaluate mannitol-related AEs. The analysis focused on the frequency, severity, and clinical relevance of reported AEs.

Results: Among 39,061,894 reports, 1,014 mentioned mannitol. Common AEs included increased intracranial pressure, hyperosmolar state, hyperchloremia, and hypernatremia. 80% of AEs fell under 'renal and urinary disorders' (295 cases), 'skin and subcutaneous tissue disorders' (371 cases). Specific preferred terms (PTs) linked with mannitol included 'hyperosmolar state', (ROR = 665.98 (95% CI: 272.28-1628.95), PRR = 664.53 (95% CI: 269.75-1637.1)), 'hyperchloremia,' 'hypernatremia' (ROR = 25.18 (95% CI: 17.66-35.9), PRR = 24.85 (95% CI: 17.46-35.36)).

Conclusions: This study underscores the need for vigilant monitoring of mannitol use. Further research is required to understand the mechanisms behind unexpected AEs and establish a comprehensive safety profile.