"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Demulen Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Demulen (ethinyl estradiol and ethynodial diacetate) is used as contraception to prevent pregnancy. It contains a combination of female hormones. Demulen may no longer be available in the U.S. This medication is available in generic form. Common side effects include nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, or breast tenderness/enlargement. Acne may improve or get worse. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.
The dose of Demulen must be taken exactly as directed and at intervals of 24 hours. Take 1 white tablet each day at the same time for 21 days. Then take blue tablets for 7 days, whether bleeding has stopped or not. After all 28 tablets have been taken, whether bleeding has stopped or not, repeat the same dosage schedule beginning the following day. Demulen may interact with acetaminophen, ascorbic acid (vitamin C), phenylbutazone, St. John's wort, antibiotics, seizure medications, barbiturate sedatives, HIV or AIDS medications. Tell your doctor all medications and supplements you use. Demulen must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, consult your doctor and find out when it is safe to use birth control containing estrogen, such as this medication. This medication passes into breast milk. This may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Our Demulen (ethinyl estradiol and ethynodial diacetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Demulen FDA Prescribing Information: Side Effects
Endocrine & metabolic: Amenorrhea, breakthrough bleeding, breast enlargement, breast secretion, breast tenderness, carbohydrate intolerance, lactation decreased (postpartum), glucose tolerance decreased, libido changes, menstrual flow changes, sex hormone-binding globulins (SHBG) increased, spotting, temporary infertility (following discontinuation), thyroid-binding globulin increased, triglycerides increased
Hematologic: Antithrombin III decreased, folate levels decreased, hemolytic uremic syndrome, norepinephrine induced platelet aggregability increased, porphyria, prothrombin increased; factors VII, VIII, IX, and X increased
Renal: Impaired renal function
Miscellaneous: Hemorrhagic eruption
Read the entire FDA prescribing information for Demulen (Ethinyl Estradiol and Ethynodiol Diacetate)
Additional Demulen Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.