Recommended Topic Related To:


"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"...


Viorele Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Viorele (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) are 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. Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, headache, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.

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 be initiated using either a Sunday start or a Day 1 start. Serious side effects include myocardial infarction and thromboembolism. Women should not take the pill if pregnancy is suspect or if they experience unexplained vaginal bleeding. Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child. Use of this product before menarche is not indicated.

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
(Adverse Reactions)


An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

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:

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

Read the entire FDA prescribing information for Viorele (Deogestrel and Ethinyl Estradiol Tablets)


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.

Women's Health

Find out what women really need.