Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System

This pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System to compare adverse events associated with topical and oral finasteride and dutasteride. The study found that oral finasteride is linked to a higher number of sexual and neuropsychiatric adverse events, including 411 cases of erectile dysfunction and 250 cases of suicidal ideation, compared to topical finasteride, which had significantly fewer cases. No significant adverse events were reported for topical dutasteride. The findings suggest that topical administration may be a safer alternative due to reduced systemic exposure, though further research is needed. The study also notes that many reported adverse events may reflect background rates or confounding factors rather than being drug-specific effects.