Levonorgestrel and Ethinyl Estradiol Risks, Warnings, and Complications

CIGARETTE SMOKING AND CARDIOVASCULAR RISKS: Smoking cigarettes increases the risk of serious cardiovascular side effects from combined oral contraceptives like levonorgestrel and ethinyl estradiol. This includes an increased risk of stroke, heart attack, and blood clots. Females aged 35 years and older who smoke are at an even greater risk of these serious health complications. Your doctor will strongly advise you to stop smoking if you are on birth control pills. Talk with your provider about other safer birth control alternatives if you continue to smoke.

BLOOD CLOTS AND OTHER VASCULAR PROBLEMS: Taking Vienva (levonorgestrel and ethinyl estradiol) increases the risk of blood clots in different parts of the body, including the brain (stroke), heart (heart attack), lungs (pulmonary embolism or PE), and legs (deep vein thrombosis or DVT). Risk factors include smoking in women over age 35 years, age above 40 years, immobility due to recent surgery, childbirth less than a month ago, high blood pressure, high cholesterol, diabetes, obesity, and taking higher doses of estrogen. Get emergency medical help if you have any signs or symptoms of a blood clot (see serious side effects above). Tell your doctors you are on birth control pills before any surgery. You may have to stop taking hormonal birth control for some time before and after surgery to lower your risk of blood clots.

BREAST CANCER AND CERVICAL CANCER: Studies have not shown a consistent relationship between combined birth control pills and the risk of breast cancer and cervical cancer. However, there may be a small increase in breast cancer and cervical cancer risk with current or recent use of combined oral contraceptives or with a longer duration of use. 

You should not take combined oral contraceptives if you currently have breast cancer because some types of breast cancer are hormonally sensitive and grow faster in the presence of estrogen. If you are concerned about breast cancer risk, talk to your provider about a progestin-only pill. Do monthly self-breast exams and yearly breast exams with your healthcare provider for early detection of breast cancer. Tell your healthcare provider without delay if you notice any changes, such as lumps, pain, or swelling in your breasts. Also, seek immediate medical attention if you have abnormal vaginal bleeding, discharge, or pain during sex (these can be signs of cervical cancer).

LIVER INJURY AND LIVER CANCER: Rarely, levonorgestrel and ethinyl estradiol can cause liver problems, including liver damage and liver tumors. Liver problems are more likely with earlier formulations of birth control pills that contained high doses of estrogen (Vienva has a low dose of estrogen). The risk of liver injury is also higher if you are on concomitant hepatitis C treatment. Your healthcare provider may ask you to discontinue your birth control pills during treatment for hepatitis C. You can restart your OCPs two weeks after finishing hepatitis C treatment. Before starting birth control, tell your doctor if you have a history of liver problems. Call your doctor right away if you experience symptoms such as fatigue, right upper stomach pain, or yellowing of the skin or eyes.

OCULAR LESIONS: There are reports of blood clots in the retina of the eye with the use of oral contraceptives, which can lead to partial or complete blindness. Tell your doctor immediately if you develop symptoms such as loss of vision, double vision, swelling, or protrusion of the eye.

USE DURING EARLY PREGNANCY: Birth defects in infants born to women who used oral contraceptives before pregnancy or inadvertently during early pregnancy are extremely rare. However, you should not use birth control pills to induce withdrawal bleeding as a test for pregnancy. These medications also should not be used during pregnancy to treat a threatened abortion. If you have taken the pills on schedule and miss two consecutive menstrual periods, you should test for pregnancy and discontinue birth control pills if a pregnancy is confirmed.

GALLBLADDER DISEASE: Taking Vienva (levonorgestrel and ethinyl estradiol) can cause or worsen gallbladder problems. Tell your doctor right away if you develop symptoms such as nausea, vomiting, stomach pain, or fever.

METABOLIC EFFECTS: Combined oral contraceptives like levonorgestrel and ethinyl estradiol can raise your blood sugar and triglyceride levels. Tell your provider if you have diabetes or high cholesterol before starting birth control pills. Keep all your laboratory appointments to monitor blood sugar and cholesterol levels. 

ELEVATED BLOOD PRESSURE: Taking Vienva and other combined oral contraceptives can lead to an increase in blood pressure. Talk to your provider about how often you should check your blood pressure at home. Tell your doctor if you notice high blood pressure readings while on this medicine. If you have uncontrolled high blood pressure or kidney problems, you may need to consider other birth control methods. 

HEADACHE: It is not unusual to have headaches as a side effect of levonorgestrel and ethinyl estradiol. However, you should tell your doctor without delay if you develop a new pattern of headaches or persistent, severe, or recurrent headaches.

IRREGULAR BLEEDING: It is common to have spotting or breakthrough bleeding on hormonal birth control pills, especially in the first 3 months. Tell your provider if you experience vaginal bleeding outside your period or if your period stops completely. 

ECTOPIC PREGNANCY: Women who are on combined oral contraceptives are at a higher risk of ectopic pregnancy (pregnancy outside the womb). The risk is higher if you don’t take birth control at the same time every day. Call your doctor immediately or seek emergency medical care if you develop low back pain, cramping, and abnormal vaginal bleeding.