Low-Dose Oral Minoxidil and Associated Adverse Events: Analyses of the FDA Adverse Event Reporting System With a Focus on Pericardial Effusions

This study analyzed the FDA Adverse Event Reporting System (FAERS) data from 2016 to 2023 to investigate adverse events (AEs) associated with low-dose oral minoxidil (LDOM) used for hair loss, with a focus on pericardial effusions. Significant associations were found between LDOM and several AEs, including pericardial effusion, tachycardia, peripheral edema, hypertrichosis, fluid retention, and headache. Notably, pericardial effusion had a high reporting odds ratio (ROR) of 19.570, indicating a significant association, especially in individuals with cardiac impairment. The study suggests using LDOM at the lowest effective dose, ideally not exceeding 5 mg/day, and highlights the importance of cautious interpretation of these signals due to the nature of spontaneously reported data.