BIOIDENTICAL ESTRADIOL is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

 

BIOIDENTICAL 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.

You should not take BIOIDENTICAL ESTRADIOL if you are allergic to it, or if you have:

 

- liver disease;

- abnormal vaginal bleeding that a doctor has not checked;

- any type of breast, uterine, or 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 risk factors such as diabetes, high blood pressure, high cholesterol or triglycerides, smoking, or being overweight.

 

If you have any of these other conditions, your doctor may need to adjust your estradiol dose or order special tests:

 

- heart disease;
- kidney disease;

- family history of blood clots;

- a history of jaundice caused by pregnancy or taking hormones;

- endometriosis;

- lupus;

- porphyria;

- gallbladder disease;

- underactive thyroid;

- asthma;

- epilepsy or other seizure disorder;

- migraines;

- low levels of calcium in your blood; or

- if you have had your uterus removed (hysterectomy).

 

FDA pregnancy category X. BIOIDENTICAL ESTRADIOL can harm an unborn baby or cause birth defects. Do not use BIOIDENTICAL ESTRADIOL if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Estradiol can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. You should not breast-feed while you are taking BIOIDENTICAL ESTRADIOL. BIOIDENTICAL ESTRADIOL should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.

 

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

 

Get emergency medical help if you have any of these signs of an allergic reaction to estradiol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using BIOIDENTICAL 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 estradiol 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.

 

Take BIOIDENTICAL ESTRADIOL exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

 

Long-term BIOIDENTICAL ESTRADIOL treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using BIOIDENTICAL ESTRADIOL long-term.

 

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.

 

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using BIOIDENTICAL ESTRADIOL. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.

 

If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking estradiol.

 

 

Keep BIOIDENTICAL ESTRADIOLin the original container and keep the container closed. Store it in a dry place at room temperature.

 

Keep BIOIDENTICAL ESTRADIOL and all medications out of the reach of children.