"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"...
Seasonale Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Seasonale (levonorgestrel, ethinyl estradiol) extended-cycle 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) may occur, especially during the first few months of use.
The dosage of Seasonale is one pink (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets. Seasonale may interact with acetaminophen, ascorbic acid (vitamin C), phenylbutazone, prednisolone, theophylline, cyclosporine, St. John's wort, antibiotics, seizure medicines, barbiturates, or HIV medicines. Tell your doctor all medications and supplements you use. Seasonale 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 use birth control containing estrogen, such as this medication. This medication passes into breast milk. This may affect how much milk you make and may have undesirable effects on the nursing infant. Consult your doctor before breastfeeding.
Our Seasonale (levonorgestrel, ethinyl estradiol) 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.
Seasonale 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.
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, pain behind the eyes, 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, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet; 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Seasonale (Levonorgestrel, Ethinyl Estradiol) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Seasonale Overview - Patient Information: Side Effects
You should not have your period during the 3 months that you are taking the active pills. Instead, you will have your period once every 3 months during the week that you are taking the inactive pills. This effect is normal with this product. However, if you do not have your period while taking the inactive pills, contact your doctor for a pregnancy test.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods while taking the inactive pills), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet, weight changes (gain or loss).
This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.
Tell your doctor immediately if any of these rare but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Seasonale (Levonorgestrel, Ethinyl Estradiol)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Seasonale 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):
- 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
- Edema/fluid retention
- Melasma/chloasma which may persist
- Breast changes: tenderness, enlargement, and secretion
- Change in weight or appetite (increase or decrease)
- Change in cervical ectropion and secretion
- Possible diminution in lactation when given immediately postpartum
- Cholestatic jaundice
- Migraine headache
- Rash (allergic)
- 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:
- Premenstrual syndrome
- Optic neuritis which may lead to partial or complete loss of vision
- Cystitis-like syndrome
- Loss of scalp hair
- Erythema multiforme
- Erythema nodosum
- Hemorrhagic eruption
- Impaired renal function
- Hemolytic uremic syndrome
- Budd-Chiari syndrome
- Changes in libido
Read the entire FDA prescribing information for Seasonale (Levonorgestrel, Ethinyl Estradiol) »
Additional Seasonale Information
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