Drug-Induced Intracranial Pressure Increase: Disproportionality Analysis of the Public Version of the FDA Event Reporting System

Objective: This study is aimed at identifying the most common drugs associated with the risk of intracranial pressure increase (IPI) based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: OpenVigil 2.1 was used to query the FAERS database and data from the first quarter of 2004 to the third quarter of 2022 were retrieved. Pharmacovigilance tools were employed for the quantitative detection of signals, where a signal represents a drug-induced adverse event, including the reporting odds ratio (ROR>1 with 95% confidence interval, the reports number >= 2) and proportional reporting ratio (PRR>2, chi 2 >= 4). Results: Among the 12,060,031 adverse event reports, there were 3113 cases in which drugs were the primary suspect cause of IPI. Drug-induced intracranial pressure increase (DIPI) was more often observed in young females. The Top 5 drugs with the highest ROR and PRR were minocycline, doxycycline, acetazolamide, somatropin recombinant, and cytarabine. Conclusion: Potential risks of DIPI should be closely monitored in clinical practice. Our study is consistent with clinical observations, which call for further research to establish the basis of these drugs and IPI.