Annovera Side Effects

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in other sections of the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] The most common adverse reactions (>5%) are headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, abdominal pain lower/upper, dysmenorrhea, vaginal discharge, urinary tract infection, breast tenderness/pain/discomfort, bleeding irregularities including metrorrhagia, diarrhea, genital pruritus.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical trials that evaluated the safety of ANNOVERA were obtained from three 13- cycle trials.

One trial was conducted entirely in the U.S.

(15 sites), and the other two were global studies that included 5 U.S.

sites and 7 international sites (Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, Sweden).

All three trials were open label and enrolled healthy females, desiring contraception, 18 to 40 years of age.

At about 50% enrollment, females with BMI >29 kg/m 2 were excluded due to the occurrence of two VTEs in this subgroup.

In total, 2,308 females contributed 21,590 cycles of exposure for safety evaluation and 999 completed 13 cycles;