Cardiovascular Safety Signals of Oral Versus Topical Minoxidil in FAERS: A Disproportionality Analysis (Analytic Cohort 2012–2025)

The study analyzed cardiovascular safety signals of oral versus topical minoxidil using FAERS data from 2012 to 2025. It found that oral minoxidil had a higher disproportionate reporting of cardiovascular adverse events compared to topical minoxidil, with significant signals for conditions like pericardial effusion, hypertensive crisis, pulmonary hypertension, and pulmonary edema. In an alopecia-restricted cohort, cardiovascular events such as tachycardia and pericardial effusion were still disproportionately reported for oral minoxidil. However, due to limitations of the FAERS system, including lack of exposed-patient denominators and potential biases, these findings are considered hypothesis-generating rather than conclusive evidence of risk.