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Viorele Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Viorele (desogestrel and ethinyl estradiol, and ethinyl estradiol) is a combination of female hormones indicated for the prevention of pregnancy in women who elect to use this combination product as a method of contraception. Viorele is available as a generic. Common side effects of Viorele include:
- nausea and vomiting (especially within the first few months of taking Viorele),
- stomach cramps,
- bleeding between menstrual periods,
- weight gain,
- breast tenderness,
- dizziness, and
- difficulty wearing contact lenses.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use, especially in women over 35 years of age and who smoke more than 15 cigarettes per day. Women who use oral contraceptives are strongly advised not to smoke.
Viorele tablets come in packets containing tablets of variable strengths; desogestrel and ethinyl estradiol tablets strengths of 0.15 mg/0.02 mg and ethinyl estradiol Tablets at 0.01 mg strength. To achieve maximum contraceptive effectiveness, Viorele must be taken exactly as directed and at intervals not exceeding 24 hours. Viorele may interact with rifampin, barbiturates, phenylbutazone, phenytoin sodium, carbamazepine, griseofulvin, ampicillin, tetracycline antibiotics, and lamotrigine. Tell your doctor all medications and supplements you use. Viorele is not recommended for use during pregnancy. Viorele passes into breast milk and may cause adverse effects on a nursing baby. Viorele may also decrease the quantity and quality of breast milk. Breastfeeding while using Viorele is not recommended.
Our Viorele 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.
Viorele FDA Prescribing Information: Side Effects
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
- Thrombophlebitis and venous thrombosis with or without embolism
- Arterial thromboembolism
- Pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives:
- Mesenteric thrombosis
- Retinal thrombosis
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
- Gastrointestinal symptoms (such as abdominal cramps and bloating)
- Breakthrough bleeding
- Change in menstrual flow
- Temporary infertility after discontinuation of treatment
- Melasma which may persist
- Breast changes: tenderness, enlargement, secretion
- Change in weight (increase or decrease)
- Change in cervical erosion and secretion
- Diminution in lactation when given immediately postpartum
- Cholestatic jaundice
- Rash (allergic)
- Mental depression
- Reduced tolerance to carbohydrates
- Vaginal candidiasis
- Change in corneal curvature (steepening)
- Intolerance to contact lenses
The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
- Pre-menstrual syndrome
- Changes in appetite
- Cystitis-like syndrome
- Loss of scalp hair
- Erythema multiforme
- Erythema nodosum
- Hemorrhagic eruption
- Impaired renal function
- Hemolytic uremic syndrome
- Changes in libido
- Budd-Chiari Syndrome
Read the entire FDA prescribing information for Viorele (Deogestrel and Ethinyl Estradiol Tablets)
Additional Viorele 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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