Ethinyl Estradiol-Desogestrel

Ethinyl Estradiol and Desogestrel are a combination of prescription medications to prevent pregnancy.

• Ethinyl Estradiol and Desogestrel are available under various brand names: Apri, Azurette, Bekyree, Caziant, Cesia, Cyclessa, Cyred, Cyred EQ, Desogen, Emoquette, Enskyce, Isibloom, Juleber, Kalliga, Kariva, Kimidess, Mircette, Ortho-Cept, Pimtrea, Reclipsen, Simliya, Solia, Velivet, Viorele, Volnea

Common side effects of Ethinyl Estradiol and Desogestrel include:

• nausea, vomiting (especially when you first start taking this medicine);
• breast tenderness;
• breakthrough bleeding;
• acne, darkening of facial skin;
• weight gain; or
• problems with contact lenses.

Serious side effects of Ethinyl Estradiol and Desogestrel include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• swelling in your hands, ankles, or feet;
• changes in the pattern or severity of migraine headaches;
• a breast lump; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Rare side effects of Ethinyl Estradiol and Desogestrel include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet, monophasic

• 0.15 mg/0.03 mg

Tablet, biphasic

• 0.15 mg/0.02 mg x 21 days, then inert tabs x 2 days, then 0 mg/0.01 mg x 5 days

Tablet, triphasic

• 0.1 mg/0.025 mg (7 tabs), plus
• 0.125 mg/0.025 mg (7 tabs), plus
• 0.15 mg/0.025 mg (7 tabs)

Contraception

Adult dosage

Monophasic (Apri, Cyred, Cyred EQ, Desogen, Emoquette, Enskyce, Isibloom, Juleber, Ortho-Cept, Reclipsen, Solia)

• 1 tablet orally every day for 28 days, then start a new pack
• Days 1-21: Each tablet contains desogestrel 0.15 mg/Ethinyl Estradiol (EE) 0.03 mg
• Days 22-28: Inactive tablets

Biphasic (Azurette, Bekyree, Kariva, Kimidess, Mircette, Pimtrea, Viorele)

• 1 tablet orally every day for 28 days in the order indicated on the package, then start a new pack
• Days 1-21, Each tablet contains 0.15 mg desogestrel/0.02 mg EE
• Days 22-23: Inactive tablets
• Days 24-28: Each tablet contains 0.01 mg of Ethinyl Estradiol

Triphasic (Cyclessa, Velivet, Caziant)

• 1 tablet orally every day for 28 days in the order indicated on the package, then start new pack Day 1-7, each tablet contains 0.025 mg Ethinyl Estradiol and 0.1 mg desogestrel
• Days 8-14, each tablet contains 0.025 mg Ethinyl Estradiol and 0.125 desogestrel
• Days 15-21, each tablet contains 0.025 mg Ethinyl Estradiol and 0.15 desogestrel
• Days 22-28: Inactive tablets

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ethinyl Estradiol and Desogestrel have severe interactions with the following drugs:
  • cabotegravir
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
• Ethinyl Estradiol and Desogestrel have serious interactions with at least 62 other drugs.
• Ethinyl Estradiol and Desogestrel have moderate interactions with at least 132 other drugs.
• Ethinyl Estradiol and Desogestrel have minor interactions with at least 27 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Untreated or uncontrolled high blood pressure;
• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• circulation problems (especially if caused by diabetes);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills;
• if you smoke and are over 35 years old; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ethinyl Estradiol and Desogestrel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ethinyl Estradiol and Desogestrel?”

Cautions

• Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or you are overweight. Your risk of stroke or blood clots is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.
• Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.
• Do not use birth control pills if you are pregnant or have recently had a baby.
• You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
• Use back-up birth control if you are sick with severe vomiting or diarrhea.
• If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills
• Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
• Breast cancer
  • Epidemiology studies have not found a consistent association between the use of combined oral contraceptives (COCs) and breast cancer risk; studies do not show an association between ever (current or past) use of COCs and risk of breast cancer
  • Some studies report a small increase in the risk of breast cancer among current or recent users(below 6 months since last use) and current users with a longer duration of COC use
  • A woman's risk depends on conditions where naturally high hormone levels persist for long periods including early-onset menstruation before age 12, late-onset menopause, after age 55, first child after age 30, nulliparity

Pregnancy & Lactation

• Do not use it if you are pregnant. Stop using this medicine and tell your doctor immediately if you become pregnant or miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.
• Lactation
  • The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use it if you are breastfeeding a baby.