The most common adverse reactions in clinical studies (≥10%) were1:
- Vulvovaginal burning sensation (18.0%)
- Vulvovaginal pruritus (14.5%)
The majority of adverse reactions were mild and few led to discontinuation1
- 1.6% of patients discontinued due to adverse reactions
- Two subjects discontinued due to male partner symptoms. 9.8% of male partners reported local discomfortb
Warnings and precautions1
- There were few cases (0.36%) of cystitis, pyelonephritis, and other upper urinary tract infections. Of these, one case of pyelonephritis was considered serious and required hospitalization
- Should be avoided in women who have had recurrent urinary tract infections or abnormalities1
- Should be avoided if the woman or her partner is allergic to any of the ingredients in Phexxi1
- May be used with other contraceptives, including latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid Phexxi use with vaginal rings1
- Is not expected to lead to safety concerns from systemic exposure to ingredients following vaginal exposurec
aThe safety of Phexxi has been evaluated in 2 clinical trials in 2804 subjects.
bIn the AMPOWER study.
cPharmacokinetic studies have not been performed.