Cardiovascular safety of sildenafil

Drug Saf. 2003;26(7):453-60. doi: 10.2165/00002018-200326070-00002.


Initial reports of myocardial infarction and sudden death in men with erectile dysfunction who had taken sildenafil (sometimes in conjunction with nitrates) raised concerns that sildenafil may increase the risk of cardiovascular events in men with erectile dysfunction and vascular disease. A significant body of evidence now indicates that sildenafil generally has a good safety profile in men with erectile dysfunction and cardiovascular disease. Sildenafil therapy does not appear to be associated with ischaemic events either at the time of introduction of therapy or during longer-term use. Rates of discontinuation from sildenafil therapy due to adverse events are similar to placebo in men with cardiovascular disease. Sildenafil does not interact in a potentially hazardous way with antihypertensive or antianginal therapy, with the exception of nitrates. Nitrates should not be administered within 24 hours of sildenafil therapy, and care should be taken to determine whether sildenafil may have been used before nitrates are administered to patients. Sildenafil appears to be generally well tolerated in most patients with chronic, stable cardiovascular disease.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Antihypertensive Agents / therapeutic use
  • Cardiovascular Diseases / chemically induced*
  • Cardiovascular Diseases / physiopathology
  • Clinical Trials as Topic
  • Drug Interactions
  • Erectile Dysfunction / drug therapy*
  • Hemodynamics
  • Humans
  • Male
  • Nitric Oxide Donors / therapeutic use
  • Piperazines / adverse effects*
  • Piperazines / therapeutic use
  • Purines
  • Safety*
  • Sildenafil Citrate
  • Sulfones
  • Vasodilator Agents / adverse effects*
  • Vasodilator Agents / therapeutic use


  • Antihypertensive Agents
  • Nitric Oxide Donors
  • Piperazines
  • Purines
  • Sulfones
  • Vasodilator Agents
  • Sildenafil Citrate