Cardiovascular Safety of Phosphodiesterase Type 5 Inhibitors After Nearly 2 Decades on the Market

Sex Med Rev. 2018 Oct;6(4):583-594. doi: 10.1016/j.sxmr.2018.03.008. Epub 2018 Jun 28.


Background: The phosphodiesterase-5 (PDE5) inhibitors that have been available for nearly 20 years are highly effective in treating erectile dysfunction and have been consistently shown to be safe when used according to package insert instructions.

Aim: To review the cardiovascular (CV) safety of PDE5 inhibitors used to treat erectile dysfunction.

Methods: PubMed, the Derwent Drug File, and Embase were searched to identify papers published from 1990-2016 presenting CV safety data for PDE5 inhibitors.

Outcomes: This narrative review focuses mainly on papers published in the last 10 years with CV safety data for sildenafil, tadalafil, or vardenafil.

Results: Similar to earlier studies, newer studies demonstrate that PDE5 inhibitors do not show an increased incidence of serious CV adverse events such as cardiac death or myocardial infarction. There are drug-drug interactions with PDE5 inhibitors that for the most part are now commonly known, and PDE5 inhibitors are generally safe to use with other commonly used drugs including antihypertensive agents.

Conclusion: PDE5 inhibitors are a class of drugs that when used appropriately demonstrate a favorable CV safety profile and present some encouraging signals for new CV indications, which will require additional study. Kloner RA, Goldstein I, Kirby MG, et al. Cardiovascular Safety of Phosphodiesterase Type 5 Inhibitors After Nearly 2 Decades on the Market. Sex Med Rev 2018;6:583-594.

Keywords: Cardiovascular System; Erectile Dysfunction; Phosphodiesterase Inhibitors; Safety.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Erectile Dysfunction / drug therapy
  • Heart Failure / epidemiology*
  • Humans
  • Male
  • Myocardial Infarction / epidemiology*
  • Phosphodiesterase 5 Inhibitors / adverse effects*
  • Phosphodiesterase 5 Inhibitors / therapeutic use
  • Vasodilator Agents / adverse effects*
  • Vasodilator Agents / therapeutic use


  • Phosphodiesterase 5 Inhibitors
  • Vasodilator Agents