Who Should Not Use NuvaRing?
Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day. Women who use combination hormonal contraceptives, including NuvaRing, are strongly advised not to smoke.
Do not use NuvaRing if you have any of the following conditions:
A history of heart attack or stroke
A history of blood clots in your legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
A history of blood clots in the deep veins of your legs
Chest pain (angina pectoris)
Severe high blood pressure
Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
Headaches with neurological symptoms
Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina (now or in the past)
Unexplained vaginal bleeding (until a diagnosis is reached by your health care professional)
Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal birth control of any kind (the Pill, patch, vaginal ring, injection, or implant)
Liver tumor (benign or cancerous)
Heart valve or heart rhythm disorders that may be associated with formation of blood clots
Need for a long period of bed rest following major surgery
Known or suspected pregnancy
Active liver disease with abnormal liver function tests
An allergy or hypersensitivity to any of the components of NuvaRing
Tell your health care professional if you have ever had any of the conditions just listed. Your health care professional can suggest another method of birth control.
Talk with your health care professional about using NuvaRing if you:
Smoke
Recently had a baby
Recently had a miscarriage or abortion
Are breastfeeding
Are taking other medications
In addition, talk to your health care professional about using NuvaRing if you have any of the following conditions. Women with any of these conditions should be checked often by their doctor or health care professional if they choose to use NuvaRing.
A family history of breast cancer
Breast nodules, fibrocystic disease, an abnormal breast X-ray, or abnormal mammogram
Diabetes
Elevated cholesterol or triglycerides
High blood pressure
Migraine or other headaches or epilepsy
Depression
Gallbladder, liver, heart, or kidney disease
Scanty or irregular menstrual periods
Plan to have major surgery (You may need to stop using NuvaRing for a while to reduce your chance of getting blood clots.)
Any condition that makes the vagina get irritated easily
Prolapsed (dropped) uterus, dropped bladder (cystocele), or rectal prolapse (rectocele)
Severe constipation
History of toxic shock syndrome
Prescription NuvaRing is a flexible vaginal ring approved for the prevention of pregnancy in women.
Important Safety Information
Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day. Women who use combination hormonal contraceptives, including NuvaRing, are strongly advised not to smoke.
- The use of combination oral contraceptives 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. 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. It is unknown if the risk of blood clots is different with NuvaRing use than with the use of certain birth control pills.
- NuvaRing is not for women with certain cancers or those who may be pregnant.
- NuvaRing does not protect against HIV infection and other sexually transmitted diseases.
- The most common side effects reported by NuvaRing users are: vaginal infections and irritation, vaginal secretion, headache, weight gain, and nausea.
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, including the information about the increased risk of serious cardiovascular side effects, especially in women who smoke, and discuss it with your doctor. The physician Prescribing Information is also available.
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