Ella Adverse Reactions

Summary of safety profile: The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea.
Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.
Tabulated list of adverse reactions: The adverse reactions reported in the phase III program of 2,637 women are provided in the table as follows.
Adverse reactions listed as follows are classified according to frequency and system organ class. Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.
The table lists adverse reactions according to system organ class and frequency: very common (≥1/10), common (≥1/100 to ≤1/10), uncommon (≥1/1,000 to ≤1/100) and rare (≥1/10,000 to ≤1/1,000). (See Table 4.)

Click on icon to see table/diagram/image

Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see Dosage & Administration).
Post-marketing experience: the adverse reactions spontaneously reported in post-marketing experience were similar in nature and frequency to the safety profile described during the phase III program.
Description of selected adverse reactions: The majority of women (74.6%) in the phase III studies had their next menstrual period at the expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses. The delay was greater than 20 days in 4% of the women.
A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days. In a majority of cases (88.2%), this bleeding was reported as spotting. Among the women who received Ella in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.
In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of Ella (73 women enrolled twice and 9 enrolled three times). There were no safety differences in these subjects in terms of incidence and severity of adverse events, change in duration or volume of menses or incidence of intermenstrual bleeding.