title: Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women.
abstract: OBJECTIVE
  To describe the safety of ulipristal acetate in emergency contraception.
  
  
  METHODS
  Postmarketing pharmacovigilance data collection.
  
  
  RESULTS
  A total of 553 women experienced 1049 adverse drug reactions. The most frequent (n,%) were pregnancies (282, 6.8%); nausea, abdominal pain and vomiting (139, 13.3%); headache, dizziness (67, 6.4%); and metrorrhagia, menses delay and breast symptoms (84, 8.0%). Including data from clinical trials, 376 pregnancies have been reported in total, 232 (62%) with a known outcome: 28 live births (29 newborns), 34 miscarriages, 151 induced abortions, 4 ectopics and 15 which are ongoing.
  
  
  CONCLUSIONS
  No safety concern emerges from a sizable database of reported adverse reactions following ulipristal acetate exposure among varying ethnicities and regions. Postapproval data confirm the safety profile described during the clinical trials.
  
  
  CONCLUSIONS
  Use of ulipristal acetate for emergency contraception in a variety of settings and among diverse populations indicate that it is safe and without unexpected or serious adverse events.
authors: Laboratoire HRA Pharma, Paris, France.
authors: Delphine P
authors: DP
authors: Levy
authors: Laboratoire HRA Pharma, Paris, France.
authors: Martine
authors: M
authors: Jager
authors: Laboratoire HRA Pharma, Paris, France. Electronic address: n.kapp@hra-pharma.com.
authors: Nathalie
authors: N
authors: Kapp
authors: Laboratoire HRA Pharma, Paris, France.
authors: Jean-Louis
authors: JL
authors: Abitbol
mesh_terms: D000328:Adult; D044363:Contraception, Postcoital; D003270:Contraceptive Agents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D009649:Norpregnadienes / Q000009:adverse effects*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011358:Product Surveillance, Postmarketing
chemical_list: D003270:Contraceptive Agents; D009649:Norpregnadienes; C555622:ulipristal acetate
keywords: Adverse drug reactions; Drug safety; Ella; EllaOne; Pharmacovigilence; Safety of EC; Safety profile of ella