"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"...
Cyclessa Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Cyclessa (desogestrel/ethinyl estradiol tablets) is used as contraception to prevent pregnancy. It is a combination of female hormones. 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.Cyclessa is a 28-day regimen of tablets, taken as prescribed. The first light yellow tablet is taken on the first day of menstrual bleeding. Tablets are taken without interruption as follows: One light yellow tablet daily for 7 days, then 1 orange tablet daily for 7 days, followed by 1 red tablet daily for 7 days and then 1 green (inactive) tablet daily for 7 days. Begin a new 28-tablet regimen on the next day after taking the last green tablet. Cyclessa may interact with acetaminophen, ascorbic acid (vitamin C), antibiotics, phenylbutazone, St. John's wort, seizure medicines, barbiturates, or HIV medicines. Tell your doctor all medications and supplements you use. Cyclessa 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 about birth control, 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 Cyclessa (desogestrel/ethinyl estradiol tablets) 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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Cyclessa in Detail - Patient Information: Side Effects
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;
- increased hair growth, loss of scalp hair;
- changes in weight or appetite;
- problems with contact lenses;
- vaginal itching or discharge;
- changes in your menstrual periods, decreased sex drive; or
- headache, nervousness, dizziness, tired feeling.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cyclessa (Desogestrel Ethinyl Estradiol Tablets) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cyclessa 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:
| • Nausea
• Gastrointestinal symptoms (such as
abdominal pain, cramps and bloating)
• Breakthrough bleeding
• Change in menstrual flow
• Temporary infertility after
discontinuation of treatment
• Edema/fluid retention
• Melasma/chloasma which may persist
• Breast changes: tenderness, pain,
enlargement, and secretion
• Decrease in serum folate levels
• Exacerbation of porphyria
• Aggravation of varicose veins
| • Change in weight or appetite (increase or decrease)
• Change in cervical ectropion and secretion
• Possible diminution in lactation when given
• Cholestatic jaundice
• Migraine headache
• Rash (allergic)
• Mood changes, including depression
• Vaginitis, including candidiasis
• Change in corneal curvature (steepening)
• Intolerance to contact lenses
• Exacerbation of systemic lupus erythematosus
• Exacerbation of chorea
• 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:
| • Pre-menstrual syndrome
• 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
• Optic neuritis, which may lead to partial or complete loss of vision
Read the entire FDA prescribing information for Cyclessa (Desogestrel Ethinyl Estradiol Tablets) »
Additional Cyclessa 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.