Possible Risks and Side Effects of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring)

Possible Risks and Side Effects for NuvaRing

NuvaRing may cause serious side effects, including: NuvaRing may cause serious side effects, including: Blood clots. 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:

Legs (deep vein thrombosis)
Lungs (pulmonary embolus)
Eyes (loss of eyesight)
Heart (heart attack)
Brain (stroke)

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.

Likelihood of Developing a Serious Blood Clot (Venous Thromboembolism [VTE])

*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 nine months, the rate is 7 to 27 per 10,000 woman-years.

Call your health care provider right away if you have:

Leg pain that does not go away
Sudden shortness of breath
Sudden blindness, partial or complete
Severe pain or pressure in your chest
Sudden, severe headache unlike your usual headaches
Weakness or numbness in an arm or leg, or trouble speaking
Yellowing of the skin or eyeballs

Other serious risks include:

Toxic Shock Syndrome (TSS). Some of the symptoms are much the same as the flu, but they can become serious very quickly. Call your health care provider or get emergency treatment right away if you have the following symptoms:

Sudden high fever
Vomiting
Diarrhea
A sunburn-like rash
Muscle aches
Dizziness
Fainting or feeling faint when standing up

Allergic reaction, including hives, swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (anaphylaxis and/or angioedema)
Liver problems, including liver tumors
High blood pressure
Gallbladder problems
Accidental insertion into bladder
Symptoms of a problem called angioedema if you already have a family history of angioedema

The most common side effects of NuvaRing^® (etonogestrel/ethinyl estradiol vaginal ring) are:

Tissue irritation inside your vagina or on your cervix
Headache (including migraine)
Mood changes (including depression, especially if you had depression in the past). Call your health care provider immediately if you have any thoughts of harming yourself
NuvaRing problems, including the ring slipping out or causing discomfort
Nausea and vomiting
Vaginal discharge
Weight gain
Vaginal discomfort
Breast pain, discomfort, or tenderness
Painful menstrual periods
Abdominal pain
Acne
Less sexual desire

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 breast discharge; vaginal injury (including pain, discomfort, and bleeding) associated with broken rings; and penis discomfort of the partner (such as irritation, rash, itching).

Less common side effects seen with combination hormonal birth control include:

Blotchy darkening of your skin, especially on your face
High blood sugar, especially in women who already have diabetes
High fat (cholesterol, triglycerides) levels in the blood

There have been reports of the ring becoming stuck to the vaginal tissue and having to be removed by a healthcare provider. Call your healthcare provider if you are unable to remove your NuvaRing.

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. For more information, ask your health care provider or pharmacist. Call your health care provider for medical advice about side effects. 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.

Important Safety Information

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.
The use of a CHC, like NuvaRing, is associated with increased risks of several serious side effects, including blood clots, stroke, or heart attack. NuvaRing is not for women with a history of these conditions or any condition that makes your blood more likely to clot. The risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills. The risk of blood clots is highest when you first start using CHCs and when you restart the same or different CHC after not using it for a month or more.
NuvaRing is also not for women with high blood pressure that medicine can’t control; diabetes with kidney, eye, nerve, or blood vessel damage; certain kinds of severe migraine headaches; liver disease or liver tumors; take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood; unexplained vaginal bleeding; breast cancer or any cancer that is sensitive to female hormones; or if you are or may be pregnant.
NuvaRing does not protect against HIV infection (AIDS) and other sexually transmitted infections.
The most common side effects reported by users of NuvaRing are irritation inside your vagina or on your cervix; headache (including migraine); mood changes (including depression); the ring slipping out or causing discomfort; nausea and vomiting; vaginal discharge; weight gain; vaginal discomfort; breast pain, discomfort, or tenderness; painful menstrual periods; abdominal pain; acne; and less sexual desire.

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 also is available.

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