FDA: New Labeling For Finasteride

Labels for finasteride will soon include an expanded list of potential sexual adverse events, the FDA announced.  

The labeling change will affect both name brand and generic finasteride used for the treatment of benign prostatic hyperplasia and alopecia areata, 5 mg and 1mg respectively. 

The following information will be added to the labels in response to events reported to the FDA. 

• Finasteride 1 mg -- Libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug
• Finasteride 5 mg -- Decreased libido that continued after discontinuation of the drug
• Finasteride 1 mg and 5 mg -- Male infertility and/or poor semen quality that normalized or improved after drug discontinuation

 For more information, read the full FDA release.