Bovazil was approved by the FDA in 1992 for the treatment of symptoms of benign prostatic hyperplasia (BPH) and is approved for reducing the risk of urinary retention associated with BPH or the need for surgery. Bofarzil was approved by the FDA in 1997 for the treatment of male pattern baldness. The new labeling includes the following modifications: Abnormal libido, abnormal ejaculation, and abnormal orgasm, which persist after discontinuation of the drug, have been added to the new labeling for Bovazil. The new labeling for Bovaciz adds decreased libido, an abnormality that persists after discontinuation of the drug. New labeling for both Bovaciz and Borelli added a description of reports of male infertility and/or low sperm quality associated with abnormalities that disappeared or improved after discontinuation of the drug. The FDA reviewed 421 post-marketing reports of sexual dysfunction in users of Bovazil that were submitted to the Adverse Event Reporting System database between 1998 and 2011. The FDA also reviewed 131 reports of erectile dysfunction and 68 reports of decreased libido associated with the use of Bovazil that were submitted to the manufacturer’s global safety database from 1992 to 2010. These abnormalities persisted for at least several weeks after discontinuation of the drug. The patients who experienced sexual dysfunction after discontinuation were relatively younger among Bovaciz users compared to Bovaciz users. Older users of Bovril who reported sexual adverse events were also, in general, more likely to use drugs that may affect sexual function due to coexisting conditions. However, the FDA still considers finasteride to be safe and effective for the approved indications.