Estrace (Estradiol Vaginal) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

See BOXED WARNINGS, 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.

1. 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.

2. Breasts

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

3. Cardiovascular

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

4. Gastrointestinal

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

5. Skin

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

6. Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

7. Central nervous system

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

8. 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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ESTRACE

Possible Estrace side effects / adverse reactions in 78 year old female

Reported by a consumer/non-health professional from United States on 2007-01-10

Patient: 78 year old female

Reactions: Breast Cancer

Suspect drug(s):
Estrace
    Indication: Menopausal Symptoms
    Start date: 1979-01-01
    End date: 2003-01-01

Estradiol
    Indication: Menopausal Symptoms
    Start date: 1979-01-01
    End date: 2003-01-01

Premarin
    Indication: Menopausal Symptoms
    Start date: 1979-01-01
    End date: 2003-01-01

Possible Estrace side effects / adverse reactions in 59 year old female

Reported by a lawyer from United States on 2007-01-12

Patient: 59 year old female

Reactions: Breast Cancer

Adverse event resulted in: death

Suspect drug(s):
Estrace
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2004-01-01

Estradiol
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2004-01-01

Medroxyprogesterone
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2004-01-01

Prometrium
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2004-01-01

Provera
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2004-01-01

Possible Estrace side effects / adverse reactions in 59 year old female

Reported by a consumer/non-health professional from United States on 2007-01-18

Patient: 59 year old female

Reactions: Breast Cancer, Death

Adverse event resulted in: death

Suspect drug(s):
Estrace
    Indication: Menopausal Symptoms
    Start date: 1995-01-01
    End date: 2004-01-01

Estrace
    Indication: Osteoporosis
    Start date: 1995-01-01
    End date: 2004-01-01

Estradiol
    Indication: Menopausal Symptoms
    Start date: 1995-01-01
    End date: 2004-01-01

Medroxyprogesterone
    Indication: Menopausal Symptoms
    Start date: 1995-01-01
    End date: 2004-01-01

Prometrium
    Indication: Menopausal Symptoms
    Start date: 1995-01-01
    End date: 2004-01-01

Provera
    Indication: Menopausal Symptoms
    Start date: 1995-01-01
    End date: 2004-01-01