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

ABSTRACT:

Background

Low-dose oral minoxidil (LDOM) is used to treat hair loss, but the literature on its safety profile is relatively sparse.

Aims

Using the FDA Adverse Event Reporting System (FAERS) database, we determined signals for adverse events (AEs) with LDOM use.

Methods

Four sets of case/noncase study disproportionality analyses were conducted to determine reporting odds ratio (ROR) for 10 AEs including pericardial effusion (PE). The oral minoxidil dose ranges were: (i) ≤1.25 mg (i.e., 0-1.25 mg), (ii) ≤2.5 mg (i.e., 0-2.5 mg), (iii) ≤5 mg (i.e., 0-5 mg), and (iv) ≤10 mg (i.e., 0-10 mg).

Results

For ≤1.25 mg, we detected a signal for PE (ROR = 16.41, 95% CI: 2.29, 117.37, p < 0.05). For ≤2.5 mg, the analyses detected a signal for PE (ROR = 13.30, 95% CI: 5.96,

SUBMITTER: Gupta AK 

PROVIDER: S-EPMC11743066 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature