ellaOne® – tolerability profile

With ellaOne®:

  • The majority of adverse events recorded during the complete development programme in 4,718 women were mild or moderate and resolved spontaneously1
  • The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea1
  • The tolerability profile is comparable to levonorgestrel2




ellaOne® effect on the menstrual cycle

Most women had their next menstrual period at the expected time (74.6 % within ±7 days of expected time)1

  • Early period – 6.8% had their period more than 7 days earlier than expected
  • Late period – 18.5% had a delay of more than 7 days1

A minority of women (8.7%) reported intermenstrual bleeding lasting an average of 2.4 days. The majority was reported as spotting (88.2%).1

Only 0.4% reported heavy intermenstrual bleeding1

For full details of adverse events refer to the ellaOne® Summary of Product Characteristics.

Adverse events should be reported. Healthcare professionals are asked to report any suspect adverse events via their national reporting system. Adverse events should also be reported to HRA Pharma at med.info.ie@hra-pharma.com