Authors
1 1 Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark
2 Section for Clinical and Social Pharmacy, Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark
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.
Findings:Totally,328ADRs 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).
Conclusion: ADRs reported by consumers for PDE5 inhibitors were relatively low, and
only few ADRs were serious.
Keywords
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