"Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the Uni"...
- Clinician Information:
Nordette-28 Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Nordette-28 (levonorgestrel and ethinyl estradiol) is a combination of two female hormones used as contraception to prevent pregnancy. 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 dosage of Nordette-28 is one light-orange tablet daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days, according to the prescribed schedule. Nordette-28 may interact with rifampin, epilepsy medications, barbiturates, primidone, topiramate, phenylbutazone, HIV/AIDS drugs, modafinil, antibiotics, lamotrigine, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, and topiramate. Tell your doctor all medications and supplements you use. Nordette-28 must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. This drug passes into breast milk and may reduce the quantity and quality of the milk. Consult your doctor before breastfeeding.
Our Nordette-28 (levonorgestrel and ethinyl estradiol) tablets, 0.15mg/0.03mg 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.
Nordette-28 FDA Prescribing Information: Side Effects
An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives:
Thromboembolic disorders and other vascular problems (including thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache.
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
Gastrointestinal symptoms (such as abdominal pain, cramps and bloating)
Change in menstrual flow
Temporary infertility after discontinuation of treatment
Melasma/chloasma which may persist
Breast changes: tenderness, pain, enlargement, secretion
Change in weight or appetite (increase or decrease)
Change in cervical erosion and secretion
Diminution in lactation when given immediately postpartum
Mood changes, including depression
Vaginitis, including candidiasis
Change in corneal curvature (steepening)
Intolerance to contact lenses
Decrease in serum folate levels
Exacerbation of systemic lupus erythematosus
Exacerbation of porphyria
Exacerbation of chorea
Aggravation of varicose veins
Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:
Optic neuritis, which may lead to partial or complete loss of vision
Loss of scalp hair
Impaired renal function
Hemolytic uremic syndrome
Changes in libido
Cerebral-vascular disease with mitral valve prolapse
Read the entire FDA prescribing information for Nordette-28 (Levonorgestrel and Ethinyl Estradiol Tablets) »
Additional Nordette-28 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.
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