Smoking and Cardiovascular Risk
Smoking while taking Seasonale increases the risk of serious cardiovascular problems, including heart attack, stroke, and blood clots.
This risk increases with age and with the number of cigarettes smoked.
Seasonale should not be used by women over 35 years of age who smoke.
Blood Clots
Seasonale can increase the risk of developing blood clots.
These may occur in the legs or lungs and, more rarely, may contribute to a heart attack or stroke.
The risk may be higher if you:
- Have had a blood clot in the past
- Have an inherited blood-clotting disorder
- Have certain cardiovascular conditions
- Are significantly overweight
- Are inactive for a long period
- Recently had major surgery
- Have other risk factors for blood clots
Seek urgent medical attention if you develop sudden chest pain, shortness of breath, coughing up blood, severe leg pain or swelling, sudden weakness, or difficulty speaking.
Breast Cancer and Other Hormone-Sensitive Cancers
Seasonale should not be used if you currently have, or have had, certain hormone-sensitive cancers such as breast cancer.
Tell your healthcare provider about any personal history of breast cancer or other hormone-sensitive cancers before starting Seasonale.
Liver Disease
Seasonale should not be used in people with certain serious liver conditions.
Combined hormonal contraceptives can affect liver function and have rarely been associated with liver tumors.
Contact your healthcare provider if you develop yellowing of the skin or eyes, dark urine, severe abdominal pain, or other signs of liver problems.
Unexplained Vaginal Bleeding
Tell your healthcare provider if you have unexplained vaginal bleeding before starting Seasonale.
The cause of the bleeding may need to be evaluated before hormonal birth control is started.
Pregnancy
Do not take Seasonale if you are pregnant.
Seasonale is used to prevent pregnancy and does not provide any benefit during pregnancy.
If you think you may be pregnant while taking Seasonale, contact your healthcare provider.
Breastfeeding
Tell your healthcare provider if you are breastfeeding.
Combined hormonal contraceptives may reduce breast milk production, particularly when breastfeeding is first being established.
Your healthcare provider can help determine when Seasonale or another birth control method is appropriate.
Migraines and Headaches
Tell your healthcare provider if you have migraines, especially migraine with aura.
Combined hormonal contraceptives may increase the risk of stroke in certain people with migraines.
Contact your healthcare provider if you develop new, severe, or unusual headaches or if your usual migraines become worse.
Mood Changes
Some people may experience mood changes or worsening depression while taking Seasonale.
Tell your healthcare provider if you have a history of depression or develop persistent sadness, significant mood changes, or thoughts of self-harm.
High Blood Pressure
Seasonale may increase blood pressure in some people.
Tell your healthcare provider if you have high blood pressure before starting treatment. Your blood pressure may be checked before and during use.
Seasonale may not be appropriate if your blood pressure is severely or poorly controlled.
Diabetes
Tell your healthcare provider if you have diabetes.
Hormonal contraceptives may affect blood sugar control in some people. Your healthcare provider may monitor your blood glucose more closely, especially if you have diabetes-related complications.
Changes in Bleeding Patterns
Seasonale is designed to produce fewer scheduled withdrawal bleeds, usually about once every 3 months.
Spotting or breakthrough bleeding is common, especially during the first few treatment cycles.
Contact your healthcare provider if bleeding becomes unusually heavy, persistent, or occurs after previously regular cycles.
Drug Interactions
Seasonale can interact with certain medications and herbal products.
Some medicines can reduce the effectiveness of hormonal birth control and increase the risk of pregnancy.
Tell your healthcare provider about all prescription medications, over-the-counter products, vitamins, supplements, and herbal products you use.
Sexually Transmitted Infections
Seasonale helps prevent pregnancy, but it does not protect against HIV or other sexually transmitted infections (STIs).
Barrier methods such as condoms can help reduce the risk of STI transmission.
Before Surgery or Long Periods of Inactivity
Tell your healthcare provider if you are having major surgery or expect to be inactive for a long period.
Temporary discontinuation of Seasonale may be recommended because prolonged immobility can increase the risk of blood clots.
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