Alesse

levonorgestrel - ethinyl estradiol

By Wyeth

What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses. It can be mild or severe, temporary or permanent, but does not occur in everyone.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away over time. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

  • abdominal cramping or bloating
  • acne (usually less common after 3 months of treatment, and may improve if acne already exists)
  • allergic reactions
  • breast pain, tenderness, or swelling
  • changes in appetite
  • changes in the bleeding pattern during periods or between periods, such as:
    • breakthrough bleeding or spotting between periods
    • complete stopping of menstrual bleeding that occurs over several months in a row
    • decreased bleeding during periods
    • prolonged bleeding during periods
    • stopping of menstrual bleeding that only occurs sometimes
  • depression
  • dizziness
  • headache
  • loss of scalp hair
  • nausea
  • nervousness
  • rash
  • spotty darkening of the skin, especially the face
  • swelling of ankles and feet
  • unusual tiredness or weakness
  • vaginal infections
  • vomiting
Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

This medication does not protect against transmission of HIV and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Bleeding irregularities: Breakthrough bleeding and spotting can occur with this medication, especially in the first few months. If you experience persistent bleeding or spotting, contact your doctor.

Breast cancer: The chance of having breast cancer diagnosed may be slightly higher for women who use combination birth control pills, especially if you started using them at a younger age. You should have regular breast examinations by your doctor and examine your own breasts monthly. Women who currently have or have had breast cancer should not use birth control pills because the hormones in the pills may stimulate the cancer to grow.

Cholesterol: Birth control pills can increase cholesterol and triglycerides levels. Increases in triglycerides have led to inflammation of the pancreas (pancreatitis) in some cases. Your doctor may monitor for this with blood tests.

Cigarette smoking: Cigarette smoking increases the risk of serious heart disease from birth control pills. This risk increases with age and the amount smoked. Women over 35 years of age who are heavy smokers (more than 15 cigarettes per day) should not use birth control pills. All women are urged not to smoke while taking this medication.

Depression: Women with a history of depression may be more likely to have a recurrence while taking oral birth control medications. Contact your doctor if you experience symptoms of depression (e.g., changes in appetite, changes in sleep, difficulty concentrating, loss of interest in activities, depressed mood) while taking this medication.

Diabetes: Birth control pills have very little effect on blood sugar in healthy women. However, women with diabetes or a family history of diabetes should have their blood sugar carefully monitored when taking hormonal contraceptives to detect any worsening of blood sugar control after starting birth control pills.

Fluid retention: Birth control pills may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor.

Gallbladder disease: Birth control pill users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens. Oral contraceptives may worsen existing gallbladder disease or accelerate the development of gallbladder disease in women previously without symptoms.

Headache: Birth control pills may cause or worsen headaches. If you have a migraine, notice a change in your headaches, or develop severe headaches that keep coming back, see your doctor as soon as possible.

High blood pressure: Birth control pills can increase blood pressure. If you have a history of high blood pressure or kidney disease, you should use another method of birth control. If you have high blood pressure and choose to use birth control pills, have your blood pressure monitored regularly by their doctor.

Liver disease: Birth control pills rarely cause liver problems. If you develop yellowing of the eyes or skin, fever, fatigue, loss of appetite, dark urine, or light-colored stools, stop taking this medication and contact your doctor.

Liver tumors: There is a small chance of developing non-cancerous liver tumors while using hormonal contraceptives. Some studies have also shown a risk of developing cancerous liver tumors, but these cancers are extremely rare in the US, with less than one person developing liver cancer out of one million users. Contact your doctor immediately if you experience severe pain or a lump in the abdomen. If you have, or have had, a liver tumor, do not use hormonal birth control.

Melasma: A spotty darkening of the skin (called melasma), particularly on the face, is possible while taking this medication. It may persist after you stop using the medication.

Missed periods: If you miss a period while using this medication, you will need to determine if you are pregnant or not. Contact your doctor if you miss a period.

Regular checkups: Physical examinations and follow-up visits should be done yearly by your doctor.

Return to fertility: After stopping birth control pills, women may experience some delay (about 1 or 2 months) in becoming pregnant.

Vascular (blood vessel) disease: The use of hormonal contraceptives such as this medication is associated with an increased risk of several serious blood vessel conditions, including heart attack, blood clots in the legs and lungs, and stroke. Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives and can cause death or serious disability. The risk of these conditions is very small in healthy women but the risk increases in women with high blood pressure, high cholesterol, obesity, or diabetes.

If you take birth control pills and need elective surgery, need to stay in bed for a prolonged illness or injury, or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping birth control pills 3 to 4 weeks before surgery and not taking birth control pills for 2 weeks after surgery or during bed rest. You should also not take birth control pills soon after delivery of a baby. It is advisable to wait for at least 4 weeks after delivery if you are not breast-feeding.

Vision and contact lenses: Women who are taking birth control pills may experience vision changes or changes in tolerance to contact lenses. If you experience these changes, contact your doctor.

Warning signals: If any of these adverse effects occur while you are taking birth control pills, call your doctor immediately:

  • breast lumps (indicating possible breast cancer or fibrocystic disease of the breast)
  • crushing chest pain or heaviness in the chest (indicating a possible heart attack)
  • difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
  • jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements (indicating possible liver problems)
  • pain in the calf (indicating a possible clot in the leg)
  • severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
  • sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
  • sudden partial or complete loss of vision (indicating a possible clot in the eye)
  • sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)

Pregnancy: Studies have shown that there is no increased risk of birth defects when women have used birth control pills before getting pregnant. Do not take birth control pills if you are pregnant. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: This medication passes into breast milk. When taken by breast-feeding women, this medication can affect the quality or quantity of breast milk and may cause yellowing of the skin (jaundice) or breast enlargement in the baby. Breast-feeding women should use other forms of birth control. Talk to your doctor about your options.

Children: Birth control pills should not be used until menstrual periods have started.

Seniors: The safety and effectiveness of this medication have not been established for women over the age of 65 years.

What other drugs could interact with this medication?

There may be an interaction between levonorgestrel - ethinyl estradiol and any of the following:

  • acetaminophen
  • ampicillin
  • atorvastatin
  • barbiturates (e.g., phenobarbital)
  • carbamazepine
  • clofibric acid
  • cyclosporine
  • dexamthasone
  • felbamate
  • fluconazole
  • griseofulvin
  • itraconazole
  • ketoconazole
  • lamotrigine
  • modafinil
  • morphine
  • oxcarbazapine
  • phenylbutazone
  • phenytoin
  • prednisolone
  • primidone
  • protease inhibitors (e.g., ritonavir, nelfinavir, indinavir)
  • rifabutin
  • rifampin
  • salicylic acid
  • St. John's wort
  • temazapam
  • tetracycline
  • theophylline
  • topiramate
  • troleandomycin
  • vitamin C

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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The contents of this health site are for informational purposes only. Always seek the advice of your physician or other qualified healthcare provider regarding any questions you may have about a medical condition.

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