title: Side effects reported by European consumers for medications for erectile dysfunction.
abstract: OBJECTIVE
  To characterise consumer adverse drug reaction (ADR) reports for phosphodiesterase type 5 (PDE5) inhibitors.
  
  
  METHODS
  We included ADR reports submitted by adults to the European ADR database (EudraVigialnce) from 2007 to 2011. ADRs were classified according to type, seriousness and age and sex of consumers. The unit of analysis was one ADR.
  
  
  RESULTS
  Totally, 328 ADRs were reported for sildenafil and vardenafil, and only 5% of these were serious. The largest number of reported ADRs was found for sildenafil, i.e., "lack of efficacy" and/or "drug efficacy decreased" (n = 134) and "headache" (n = 21).
  
  
  CONCLUSIONS
  ADRs reported by consumers for PDE5 inhibitors were relatively low, and only few ADRs were serious.
authors.affiliation: Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark ; Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark.
authors.forename: Lise
authors.initials: L
authors.lastname: Aagaard
authors.affiliation: Section for Clinical and Social Pharmacy, Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark ; Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark.
authors.forename: Ebba Holme
authors.initials: EH
authors.lastname: Hansen
keywords: Adverse drug reactions; EudraVigilance; consumers; erectile dysfunction; pharmacovigilance