One of the criteria for a medecine to become available OTC is for it to be well tolerated.1
With ellaOne® :
• The vast majority of adverse events recorded during clinical trials in 2637 women were mild or moderate and resolved spontaneously3
• The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea2
• The safety profile is comparable to levonorgestrel3
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)2
- Early period – 6.8% had their period more than 7 days earlier than expected2
- Late period – 18.5% had a delay of more than 7 days2
A minority of women (8.7%) reported intermenstrual bleeding lasting an average of 2,4 days. The majority was reported as spotting (88.2%)2
Only 0.4% reported heavy intermenstrual bleeding2
For full details of adverse events refer to the ellaOne® European 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 firstname.lastname@example.org.