"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Estrace Patient Information Including Side Effects
Brand Names: Estrace, Femtrace, Gynodiol
Generic Name: estradiol oral (Pronunciation: ess tra DYE ole)
- What is estradiol oral (Estrace)?
- What are the possible side effects of estradiol oral (Estrace)?
- What is the most important information I should know about estradiol oral (Estrace)?
- What should I discuss with my health care provider before using estradiol oral (Estrace)?
- How should I use estradiol oral (Estrace)?
- What happens if I miss a dose (Estrace)?
- What happens if I overdose (Estrace)?
- What should I avoid while using estradiol oral (Estrace)?
- What other drugs will affect estradiol oral (Estrace)?
- Where can I get more information?
What is estradiol oral (Estrace)?
Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.
Estradiol is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Estradiol is sometimes used as part of cancer treatment in women and men.
Estradiol may also be used for other purposes not listed in this medication guide.
Estrace 0.5 mg
round, white, imprinted with 021, MJ
Estrace 1 mg
round, purple, imprinted with MJ 755
Estrace 2 mg
round, turquoise, imprinted with MJ 756
Estradiol 0.5 mg-APH
round, white, imprinted with AP 025
Estradiol 0.5 mg-BAR
oval, white, imprinted with b, 899 1/2
Estradiol 0.5 mg-MYL
round, white, imprinted with M, E 3
Estradiol 0.5 mg-WAT
round, white, imprinted with WATSON 528
Estradiol 1 mg-APH
round, purple, imprinted with AP 026
Estradiol 1 mg-MYL
round, pink, imprinted with M, E 4
Estradiol 1 mg-WAT
round, gray, imprinted with WATSON 487
oval, lavender, imprinted with b, 886 1
Estradiol 2 mg-APH
round, turquoise, imprinted with AP 027
Estradiol 2 mg-BAR
oval, green, imprinted with b, 887 2
Estradiol 2 mg-MYL
round, blue, imprinted with M, E 5
Estradiol 2 mg-WAT
round, green, imprinted with WATSON 488
Femtrace 0.45 mg
round, white, imprinted with WC 389, LOGO
Femtrace 0.9 mg
round, white, imprinted with WC 390, LOGO
Gynodiol 0.5 mg
round, lavender, imprinted with 0768, Diamond
Gynodiol 1 mg
round, pink, imprinted with 1259, Diamond
Gynodiol 1.5 mg
round, blue, imprinted with 0158, Diamond
What are the possible side effects of estradiol oral (Estrace)?
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 estradiol and call your doctor at once if you have a serious side effect such as:
- unusual vaginal bleeding (especially if you are past menopause);
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- stabbing chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;
- pain, swelling, warmth, or redness in one or both legs;
- nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;
- a lump in your breast;
- feeling like you might pass out;
- pain, swelling, or tenderness in your stomach; or
- jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- mild nausea, vomiting, bloating, stomach cramps;
- breast pain, tenderness, or swelling;
- freckles or darkening of facial skin;
- loss of scalp hair;
- vaginal itching or discharge; or
- changes in your menstrual periods, break-through bleeding.
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.
Read the Estrace (estradiol) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about estradiol oral (Estrace)?
Estradiol can harm an unborn baby or cause birth defects. Do not use estradiol if you are pregnant.
You should not take estradiol if you have abnormal vaginal bleeding, liver disease, breast or uterine cancer, hormone-dependent cancer, a recent history of heart attack or stroke, if you are pregnant, if you have ever had a blood clot (especially in your lung or your lower body), or if you are allergic to any medicines or food dyes.
Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you have diabetes, high blood pressure, high cholesterol or triglycerides, if you smoke, or if you are overweight.
Long-term estradiol treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.
Taking progestin while using estradiol may lower your risk of uterine cancer. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol.
Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.
Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using estradiol.
Additional Estrace Information
- Estrace Drug Interactions Center: estradiol oral
- Estrace Side Effects Center
- Estrace Overview including Precautions
- Estrace FDA Approved Prescribing Information including Dosage
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