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Estrace Vaginal Cream

Last reviewed on RxList: 9/20/2016
Estrace Vaginal Cream Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/14/2016

Estrace (estradiol) vaginal cream is a preparation of estrogen, a female hormone, for topical application to the vaginal area used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area and urgency or irritation with urination. Common side effects of Estrace Vaginal Cream include nausea, vomiting, bloating, stomach pain, breast tenderness, headache, weight changes vaginal itching or discharge, mood changes, breast lumps, spotting or breakthrough bleeding, dark areas of the skin on the face (melasma), or problems wearing contact lenses. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.

The usual dosage range of Estrace Vaginal Cream is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one half initial dosage for a similar period. Estrace Vaginal Cream may interact with aromatase inhibitors, fulvestrant, ospemifene, raloxifene, tamoxifen, toremifene, and tranexamic acid. Tell your doctor all medications and supplements you use. It is not indicated for pregnant women. If you become pregnant or think you may be pregnant while using Estrace Vaginal Cream, tell your doctor immediately. Estrace Vaginal Cream passes into breast milk and may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.

Our Estrace vaginal cream Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Estrace Vaginal Cream Consumer Information
SIDE EFFECTS: See also Warning section.

Nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Estrace Vaginal Cream (Estradiol Vaginal Cream)

Estrace Vaginal Cream Professional Information

SIDE EFFECTS

See BOX WARNING, WARNINGS and PRECAUTIONS.

Systemic absorption may occur with the use of ESTRACE (estradiol vaginal cream, USP, 0.01%). The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.

The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

Genitourinary System

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; application site reactions of vulvovaginal discomfort including burning and irritation; genital pruritus; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma, that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria, angioedema, hypersensitivity, anaphylactoid/anaplylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Read the entire FDA prescribing information for Estrace Vaginal Cream (Estradiol Vaginal Cream)

Related Resources for Estrace Vaginal Cream

Read the Estrace Vaginal Cream User Reviews »

© Estrace Vaginal Cream Patient Information is supplied by Cerner Multum, Inc. and Estrace Vaginal Cream Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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