Depo-Estradiol injection

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Estradiol injection is used to treat certain symptoms of menopause such as hot flashes and vaginal dryness, burning, or irritation. It is also used to treat a lack of estrogen that is caused by ovarian failure or a condition called hypogonadism.

Some forms of estradiol injection are used in men to treat the symptoms of prostate cancer.

Estradiol injection may also be used for purposes not listed in this medication guide.

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• swelling or tenderness in your stomach;

• jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding;

• a lump in your breast;

• fluid retention (swelling, rapid weight gain);

• high levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or

• dangerously high blood pressure--severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure.

Common side effects may include:

• breast pain;

• headache;

• vaginal itching or discharge, changes in your menstrual periods, light vaginal bleeding or spotting;

• thinning scalp hair; or

• nausea, vomiting, bloating, stomach cramps.

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.

Other drugs may interact with estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to estradiol: vaginal cream, vaginal insert extended release, vaginal tablet

Other dosage forms:

• transdermal emulsion, transdermal gel/jelly, transdermal patch extended release, transdermal spray

Along with its needed effects, estradiol (the active ingredient contained in Depo-Estradiol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estradiol:

• Vaginal yeast infection

• Change in vaginal discharge
• clear or bloody discharge from the nipple
• decrease in the amount of urine
• dimpling of the breast skin
• fast heartbeat
• fever
• hives, itching, or rash
• hoarseness
• inverted nipple
• irritation
• joint pain, stiffness, or swelling
• lump in the breast or under the arm
• noisy, rattling breathing
• pain or feeling of pressure in the pelvis
• pain, redness, or swelling in the arm or leg
• persistent crusting or scaling of the nipple
• redness of the skin
• redness or swelling of the breast
• sore on the skin of the breast that does not heal
• swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs
• tightness in the chest
• troubled breathing at rest
• troubled breathing or swallowing
• vaginal bleeding

Get emergency help immediately if any of the following symptoms of overdose occur while taking estradiol:

• Abdominal or stomach pain
• dizziness
• drowsiness
• nausea or vomiting
• tenderness of the breasts
• unusual tiredness or weakness

Some side effects of estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• headache
• itching or pain of the vagina or genital area
• thick, white vaginal discharge with mild or no odor
• weight gain

• Body aches or pain
• chills
• cough
• diarrhea
• ear congestion
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat

• Feeling sad or empty
• headache, severe and throbbing
• irritability
• lack of appetite
• tiredness
• trouble concentrating
• trouble sleeping
• welts