Few cases (0.36%) of adverse reactions of cystitis, pyelonephritis and other upper urinary tract infection (UTI) have been reported in Phexxi™ clinical studies. Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of Phexxi™ in females of reproductive potential with history of recurrent urinary tract infection or urinary tract abnormalities.
Most common adverse reactions were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.
Patients should be counseled on the following:
To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1‑833‑EVFMBIO or you may contact FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Phexxi™ is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Phexxi™ is not effective for the prevention of pregnancy when administered after intercourse.
Please see full Prescribing Information for Phexxi™.