Safety trial of tadalafil administered for the treatment of preeclampsia

J Matern Fetal Neonatal Med. 2020 Jan;33(1):167-170. doi: 10.1080/14767058.2018.1487946. Epub 2018 Jul 22.

Abstract

Purpose: The aim of this study is to evaluate the safety of clinical usage of tadalafil in women with preeclampsia.Materials and methods: Maternal, fetal, and neonatal adverse events were closely examined in eight preeclampsia patients receiving tadalafil treatment.Results: There were no maternal adverse events associated with 10 mg/day of tadalafil. Even at 20 mg/day, only grade 1 headaches in two cases and grade 1 palpitation in one case were observed, which resolved spontaneously within 3 days. At a dose of 40 mg/day, there was only one case of grade 1 headache. All these adverse events were grade 1 and spontaneously resolved within 3 days. There were no fetal adverse events. All observed neonatal adverse events were thought to be caused by prematurity and not related to tadalafil.Conclusion: This study shows that tadalafil treatment for preeclampsia is deemed sufficiently tolerable. Although there was a dose-dependent increase in maternal adverse events, all the adverse events were mild and deemed to be safe for the mother and fetus at all dosages.

Keywords: Hypertension; neonatal adverse events; phosphodiesterase (PDE)-5 inhibitor; preeclampsia; tadalafil.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Arrhythmias, Cardiac / chemically induced
  • Birth Weight / drug effects
  • Cesarean Section / statistics & numerical data
  • Dose-Response Relationship, Drug
  • Female
  • Headache / chemically induced
  • Humans
  • Pre-Eclampsia / drug therapy*
  • Pregnancy
  • Pregnancy Outcome
  • Tadalafil / administration & dosage*
  • Tadalafil / adverse effects*
  • Treatment Outcome

Substances

  • Tadalafil