"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"...
Seasonique Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Seasonique (levonorgestrel and ethinyl estradiol) is used as a contraceptive to prevent pregnancy. Levonorgestrel and estradiol and are forms of progesterone and estrogen, 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 Seasonique is one light blue-green tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. Seasonique must be taken as directed and at intervals not exceeding 24 hours. Seasonique may interact with antibiotics, barbiturates, seizure or pain medicines, or rifampin. Tell your doctor all medications you are taking. Seasonique must not be used during pregnancy. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication. This medication passes into breast milk. This may affect how much milk you make and may also have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.
Our Seasonique (levonorgestrel and 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.
Seasonique 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 Seasonique (Levonorgestrel, Ethinyl Estradiol) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Seasonique Overview - Patient Information: Side Effects
You should not have your period during the 3 months that you are taking the combination pills. Instead, you will have your period once every 3 months during the week that you are taking the estrogen-only pills. This effect is normal with this product. However, if you do not have your period while taking the estrogen-only 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 unlikely but serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods while taking the estrogen-only pills), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet/hands, 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 Seasonique (Levonorgestrel, Ethinyl Estradiol)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Seasonique FDA Prescribing Information: Side Effects
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and smoking [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Vascular events [see WARNINGS AND PRECAUTIONS]
- Liver disease [see WARNINGS AND PRECAUTIONS]
Adverse reactions commonly reported by COC users are:
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical trial that evaluated the safety and efficacy of Seasonique (levonorgestrel, ethinyl estradiol) was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18-40, of whom 1,006 took at least one dose of Seasonique (levonorgestrel, ethinyl estradiol) .
Adverse Reactions Leading to Study Discontinuation: 16.3% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation were irregular and/or heavy uterine bleeding (5.9%), weight gain (2.4%), mood changes (1.5%), and acne (1.0%).
Common Treatment-Emergent Adverse Reactions (≥ 5% of women):
irregular and/or heavy uterine bleeding (17%), weight gain (5%), acne (5%).
The following adverse reactions have been identified during post-approval use of Seasonique (levonorgestrel, ethinyl estradiol) . Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency of establish a causal relationship to drug exposure.
Gastrointestinal disorders: abdominal distension, vomiting
Immune system disorders: hypersensitivity reaction
Investigations: blood pressure increased
Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity
Nervous system disorders: dizziness, loss of consciousness
Psychiatric disorders: insomnia
Reproductive and breast disorders: dysmenorrhea
Respiratory, thoracic and mediastinal disorders: pulmonary embolism, pulmonary thrombosis
Skin and subcutaneous tissue disorders: alopecia
Vascular disorders: thrombosis
Read the entire FDA prescribing information for Seasonique (Levonorgestrel, Ethinyl Estradiol) »
Additional Seasonique Information
Seasonique - User Reviews
Seasonique User Reviews
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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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