"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"...
- Clinician Information:
Low-Ogestrel Patient Information Including Side Effects
Brand Names: Cryselle 28, Lo/Ovral-28, Low-Ogestrel, Ogestrel-28
Generic Name: ethinyl estradiol and norgestrel (Pronunciation: ETH in il ess tra DYE ol and nor JESS trel)
- What is ethinyl estradiol and norgestrel (Low-Ogestrel)?
- What are the possible side effects of ethinyl estradiol and norgestrel (Low-Ogestrel)?
- What is the most important information I should know about ethinyl estradiol and norgestrel (Low-Ogestrel)?
- What should I discuss with my healthcare provider before taking ethinyl estradiol and norgestrel (Low-Ogestrel)?
- How should I take ethinyl estradiol and norgestrel (Low-Ogestrel)?
- What happens if I miss a dose (Low-Ogestrel)?
- What happens if I overdose (Low-Ogestrel)?
- What should I avoid while taking ethinyl estradiol and norgestrel (Low-Ogestrel)?
- What other drugs will affect ethinyl estradiol and norgestrel (Low-Ogestrel)?
- Where can I get more information?
What is ethinyl estradiol and norgestrel (Low-Ogestrel)?
Ethinyl estradiol and norgestrel 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 norgestrel is used as contraception to prevent pregnancy.
Ethinyl estradiol and norgestrel may also be used for other purposes not listed in this medication guide.
white, imprinted with WATSON 847
round, white, imprinted with 848, WATSON
What are the possible side effects of ethinyl estradiol and norgestrel (Low-Ogestrel)?
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, 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, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a breast lump; 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;
- changes in weight or appetite;
- problems with contact lenses;
- vaginal itching or discharge;
- changes in your menstrual periods, decreased sex drive; or
- 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.
Read the Low-Ogestrel (norgestrel and ethinyl estradiol tablets) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about ethinyl estradiol and norgestrel (Low-Ogestrel)?
Do not use birth control pills if you are pregnant or if you have 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, unusual vaginal bleeding, liver disease or liver cancer, severe high blood pressure, severe migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.
Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use.
Additional Low-Ogestrel 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.