Brand Names: Alesse, Aviane, Enpresse, Lessina, Levlen, Levlite, Levora, Lutera, Lybrel, Nordette, Portia, Sronyx, Tri-Levlen, Triphasil-21, Triphasil-28, Trivora-28

Generic Name: ethinyl estradiol and levonorgestrel (Pronunciation: ETH in ill ess tra DYE ol and LEE vo nor JESS trel)

• What is ethinyl estradiol and levonorgestrel (Lybrel)?
• What are the possible side effects of ethinyl estradiol and levonorgestrel?
• What is the most important information I should know about ethinyl estradiol and levonorgestrel?
• What should I discuss with my healthcare provider before taking ethinyl estradiol and levonorgestrel?
• How should I take ethinyl estradiol and levonorgestrel?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking ethinyl estradiol and levonorgestrel?
• What other drugs will affect ethinyl estradiol and levonorgestrel?
• Where can I get more information?

What is ethinyl estradiol and levonorgestrel (Lybrel)?

Ethinyl estradiol and levonorgestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and levonorgestrel are used as contraception to prevent pregnancy.

Ethinyl estradiol and levonorgestrel may also be used for other purposes not listed in this medication guide.

Levora

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Trivora

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What are the possible side effects of ethinyl estradiol and levonorgestrel?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• a change in the pattern or severity of migraine headaches;
• nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;
• breast pain, tenderness, or swelling;
• freckles or darkening of facial skin;
• increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge;
• changes in your menstrual periods, decreased sex drive; or
• headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ethinyl estradiol and levonorgestrel?

Do not use ethinyl estradiol and levonorgestrel if you are pregnant or if you recently had a baby.

Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.