Adverse symptoms during short-term use of ulipristal acetate in women with uterine myomas and/or adenomyosis.

AIM

To evaluate various adverse symptoms during short-term use of ulipristal acetate in women with uterine myomas (n = 90), adenomyosis (n = 3) or both (n = 7).

METHODS

One hundred premenopausal women who received ulipristal acetate for 4-12 weeks during 2016 to 2017 were selected. The medical records were reviewed and the following information was collected; adverse symptoms during medication, presence of menorrhagia or menstrual cramps, blood hemoglobin and liver function test. Adverse symptoms were recorded in the medical records as a checklist form including 76 specific progestin-related symptoms.

RESULTS

Overall, the most frequent adverse symptom was amenorrhea (43%), followed by weight gain (29%), fatigue (27%), abdominal discomfort (21%), decreased menstrual flow (19%) and dizziness (18%). In 89 symptomatic women (with heavy menstrual bleeding and/or menstrual cramping pain and/or anemia), the most frequent adverse symptom was weight gain (27%) and fatigue (27%), followed by abdominal discomfort (21%), dry eye (18%), facial flushing (17%), dizziness (17%), headache (17%) and increased vaginal discharge (15%). Fourteen women stopped the medication due to unwanted adverse symptoms. Of this discontinuation group, major complaint was fatigue (50%), followed by weight gain (36%) and breast discomfort (35.7%).

CONCLUSION

Adverse symptoms were common and discontinuation rate was somewhat higher during short-term course of ulipristal acetate. Information about incidence of various adverse symptoms should be given to women who willing to take ulipristal acetate.