Do not use NuvaRing if you smoke cigarettes and are over age 35. Smoking increases your risk of serious heart and blood vessel problems from combination hormonal contraceptives (CHCs) including heart attack, blood clots, or stroke which can be fatal. This risk increases with age and the number of cigarettes smoked.
Like pregnancy, combination hormonal birth control methods increase the risk of serious blood clots (see graph below), especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start using a combination hormonal birth control method or when you restart the same or different combination hormonal birth control method after not using it for a month or more. Talk with your health care provider about your risk of getting a blood clot before using NuvaRing or before deciding which type of birth control is right for you.
In some studies of women who used NuvaRing, the risk of getting a blood clot was similar to the risk in women who used combination birth control pills.
Other studies have reported that the risk of blood clots was higher for women who use combination birth control pills containing desogestrel (a progestin similar to the progestin in NuvaRing) than for women who use combination birth control pills that do not contain desogestrel.
It is possible to die or be permanently disabled from a problem caused by a blood clot, such as heart attack or stroke. Some examples of serious blood clots are blood clots in the:
To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use hormonal birth control are followed for one year, between 1 and 5 of these women will develop a blood clot. The figure below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use hormonal birth control, for women who use hormonal birth control, for pregnant women, and for women in the first 12 weeks after delivering a baby.
*CHC=combination hormonal contraception
**Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy duration is 9 months, the rate is 7 to 27 per woman-years.
The most common side effects of NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) are:
Some women have spotting or light bleeding during NuvaRing use. If these symptoms occur, do not stop using NuvaRing. The problem will usually go away. If it doesn’t go away, check with your health care provider.
Other side effects seen with NuvaRing include allergic reaction, hives, and penis discomfort of the partner (such as irritation, rash, itching).
Less common side effects seen with combination hormonal birth control include:
Tell your health care provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of NuvaRing (etonogestrel/ethinyl estradiol vaginal ring). For more information, ask your health care provider or pharmacist. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Do not use NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) if you smoke cigarettes and are over age 35. Smoking increases your risk of serious heart and blood vessel problems from combination hormonal contraceptives (CHCs) including heart attack, blood clots, or stroke which can be fatal. This risk increases with age and the number of cigarettes smoked.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please read the Patient Information for NuvaRing (etonogestrel/ethinyl estradiol vaginal ring), including the information about the increased risk of serious cardiovascular side effects, especially in women who smoke, and discuss it with your health care provider. The physician Prescribing Information is also available.
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