IMPORTANT RISK INFORMATION
- Do not use ANNOVERA if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious
heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from
heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
- ANNOVERA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
DO NOT USE ANNOVERA IF YOU
- have or have had a blood clot in your arms, legs, lungs, or eyes.
- have had a stroke.
- have reduced blood flow to your brain (cerebrovascular disease).
- have reduced blood flow or blockage in 1 or more of the arteries that supply blood to your heart (coronary artery disease).
- have had a heart attack.
- have heart rhythm or heart valve problems that increase your risk of having blood clots, such as an
infection of the inner lining of the heart and heart valves or a type of irregular heartbeat called atrial fibrillation.
- have a problem with your blood that makes it clot more than normal.
- have high blood pressure that is not controlled with medicine or have high blood pressure with blood vessel damage.
- have diabetes and are over 35 years old; have diabetes with high blood pressure or problems with your kidneys, blood vessels, eyes, or nerves; or have had diabetes for longer than 20 years.
- have headaches with changes in vision, numbness or weakness, have migraine headaches with aura, or are over age 35 years old and have any type of migraine headaches.
- have liver disease or liver tumors.
- have or have had breast cancer or any cancer that is sensitive to the female hormones estrogen or progesterone.
- have unexplained vaginal bleeding.
- are allergic to segesterone acetate, ethinyl estradiol, or any of the ingredients in ANNOVERA.
- take any Hepatitis C drug combination medicine containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
ANNOVERA can cause serious side effects, including: blood clots; toxic shock syndrome (TSS); liver problems, including
liver tumors; high blood pressure; gallbladder problems; changes in the sugar and fat (cholesterol and triglycerides) levels in
your blood; headache; irregular or unusual vaginal bleeding and spotting between your menstrual periods; depression;
possible cancer in your cervix; swelling of your skin especially around your mouth, eyes, and in your throat (angioedema);
dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Call your healthcare provider or get
emergency medical care right away if any of the serious side effects occur.
The most common side effects of ANNOVERA include:
- headache, including migraine
- vaginal yeast infection (candidiasis)
- lower/upper abdomen pain
- painful periods
- vaginal discharge
- urinary tract infection
- breast pain/tenderness
- irregular vaginal bleeding
- genital itching
ANNOVERA is a ring-shaped vaginal system with hormones used by females to prevent pregnancy.
ANNOVERA has not been adequately studied in obese females. Ask your doctor if ANNOVERA is appropriate for you.
The risk information provided here is not complete. To learn more, review the ANNOVERA Patient Information and
talk with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information,
can be found at www.ANNOVERA.com
You may report side effects to the FDA at www.fda.gov/medwatch
or by calling 1-800-FDA-1088. You may also report
side effects to TherapeuticsMD, Inc. at 1-888-228-0150.