アブストラクト | 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, 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). CONCLUSION: ADRs reported by consumers for PDE5 inhibitors were relatively low, and only few ADRs were serious. |
ジャーナル名 | Journal of research in pharmacy practice |
投稿日 | 2013/4/1 |
投稿者 | Aagaard, Lise; Hansen, Ebba Holme |
組織名 | Clinical Pharmacology, Institute of Public Health, University of Southern;Denmark, Copenhagen, Denmark ; Danish Pharmacovigilance Research Project;(DANPREP), Copenhagen, Denmark.;Section for Clinical and Social Pharmacy, Department of Pharmacy, University of;Copenhagen, Copenhagen, Denmark ; Danish Pharmacovigilance Research Project |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/24991611/ |