title: Assessing finasteride-associated sexual dysfunction using the FAERS database.
abstract: BACKGROUND
  Postmarketing reports suggest that finasteride causes sexual dysfunction despite a low incidence reported in clinical trials. Therefore, the extent of risk remains unknown.
  
  
  OBJECTIVE
  To determine whether the risk of sexual dysfunction is higher among individuals treated with finasteride compared to a baseline risk for all other drugs using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.
  
  
  METHODS
  A case by non-case disproportionality approach was used whereby a reporting odds ratio (ROR) with 95% confidence interval (CI) was calculated. The National Ambulatory Medical Care Survey (NAMCS) was used to confirm results.
  
  
  RESULTS
  A significant disproportionality in reporting of sexual dysfunction with the use of finasteride was observed whether finasteride was indicated for hair loss (ROR = 138.17, 95% CI: 133.13, 143.4), prostatic hyperplasia (ROR = 93.88, 95% CI: 84.62, 104.16) or any indication (ROR = 173.18, 95% CI: 171.08, 175.31). When these results were stratified by age, disproportionality was strongest at 31-45 years.
  
  
  CONCLUSIONS
  Use of finasteride has led to an increase in reports of sexual dysfunction where it is believed to be the primary suspect.
authors.affiliation: Department of Medicine, University of Toronto School of Medicine, Toronto, ON, Canada.|Mediprobe Research Inc., London, ON, Canada.
authors.forename: A K
authors.initials: AK
authors.lastname: Gupta
authors.affiliation: Mediprobe Research Inc., London, ON, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Carviel
authors.affiliation: Mediprobe Research Inc., London, ON, Canada.
authors.forename: M A
authors.initials: MA
authors.lastname: MacLeod
authors.affiliation: Division of Dermatology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
authors.forename: N
authors.initials: N
authors.lastname: Shear
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000009:adverse effects*; D000328:Adult; D016208:Databases, Factual; D007172:Erectile Dysfunction / Q000139:chemically induced*; D018120:Finasteride / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014481:United States
chemical_list: D058891:5-alpha Reductase Inhibitors; D018120:Finasteride