A Review of the FAERS Data on 5-Alpha Reductase Inhibitors: Implications for Postfinasteride Syndrome
October 2018
in “
Urology
”
5-alpha reductase inhibitors finasteride adverse events diminished libido erectile dysfunction ejaculatory issues dermatologic complaints metabolic complaints psychological complaints neurologic complaints Propecia side effects sexual side effects skin issues metabolism issues mental health issues nerve issues
TLDR The review suggests younger men taking 1 mg finasteride report more side effects, including sexual, skin, metabolic, and psychological issues.
The review analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS) data from April 2011 to October 2014, focusing on 2,048 cases of monotherapy with 5-alpha reductase inhibitors, specifically finasteride. It found a significant increase in reported adverse events (AEs) for the 1 mg dose of finasteride following labeling changes, with 1,581 cases for the 1 mg dose, 240 for the 5 mg dose, and 226 with unreported doses. The reported AEs included sexual side effects like diminished libido, erectile dysfunction, and ejaculatory issues, as well as dermatologic, metabolic, and psychological/neurologic complaints. The data suggests that younger men taking the 1 mg dose reported more AEs compared to older men on the 5 mg dose, with the range of symptoms being broader than those identified in previous long-term controlled studies.
