Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids

Emanuela Tafi, Carolina Scala, Umberto Leone Roberti Maggiore, Nicolò Bizzarri, Massimo Candiani, Pier Luigi Venturini, Simone Ferrero

Research output: Contribution to journalArticlepeer-review


Introduction: Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). SPRMs are a new class of progesterone-receptor ligands that exert tissue selective agonist, antagonist or mixed agonist-antagonist activity in target cells. UPA inhibits the proliferation, induces apoptosis of leiomyoma cells in vitro and demonstrates potent progesterone antagonist activity in vitro and in vivo.Areas covered: This manuscript aims to review the available data on safety of UPA in the treatment of uterine fibroids. Data and articles included in this manuscript were obtained via PubMed, Medline and Embase up to November 2014.Expert opinion: UPA is efficacious in the treatment of uterine fibroids before surgery; it decreases leiomyoma volume and uterine bleeding; furthermore, it improves quality of life. Short-term administration of UPA has been shown to be safe at short follow-up (months) and it is associated with minimal adverse side effects; further studies with longer follow-up are required to define the safety profile of UPA on endometrial histology.

Original languageEnglish
Pages (from-to)965-977
Number of pages13
JournalExpert Opinion on Drug Safety
Issue number6
Publication statusPublished - Jun 1 2015


  • Safety
  • Selective progesterone-receptor modulators
  • Tolerability
  • Treatment
  • Ulipristal acetate
  • Uterine fibroids

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)


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