Applies to estradiol / norgestimate: oral tablet.
Warning
You should not use this medicine if you have had a hysterectomy, or if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.
Do not use if you are pregnant.
Estradiol and norgestimate may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.
Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
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signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
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signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
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swelling or tenderness in your stomach;
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jaundice (yellowing of the skin or eyes);
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memory problems, confusion, unusual behavior;
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unusual vaginal bleeding, pelvic pain;
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a lump in your breast; or
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high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.
Common side effects may include:
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nausea, vomiting, bloating, stomach cramps;
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fluid retention (swelling, rapid weight gain);
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headache;
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breast pain;
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thinning scalp hair; or
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vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to estradiol / norgestimate: oral tablet.
Nervous system
Very common (10% or more): Headache (23%)
Common (1% to 10%): Dizziness[Ref]
Immunologic
Very common (10% or more): Upper respiratory tract infection (21%)
Common (1% to 10%): Sinusitis, pharyngitis, viral infection[Ref]
Genitourinary
Very common (10% or more): Breast pain (16%)
Common (1% to 10%): Vaginal bleeding (all), dysmenorrhea[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (12%)
Common (1% to 10%): Nausea, flatulence, tooth disorder[Ref]
Musculoskeletal
Very common (10% or more): Back pain (12%)
Common (1% to 10%): Arthralgia, myalgia[Ref]
Other
Very common (10% or more): Influenza-like symptoms (11%)
Common (1% to 10%): Fatigue, pain[Ref]
Psychiatric
Common (1% to 10%): Depression[Ref]
Respiratory
Common (1% to 10%): Coughing[Ref]
