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.

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.

REPORTS OF SUSPECTED ESTRACE SIDE EFFECTS / ADVERSE REACTIONS

Possible Estrace side effects / adverse reactions in 54 year old female

Reported by a lawyer from United States on 2011-10-04

Patient: 54 year old female

Reactions: Breast Cancer, Nervous System Disorder, Injury

Suspect drug(s):
Aygestin
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Aygestin

Cenestin
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Climara
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Estrace
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol Transdermal
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Premarin
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Premphase (Premarin;cycrin 14/14)
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Prometrium
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Other drugs received by patient: Vitamin TAB; Avelox; Levaquin; Ziac

Possible Estrace side effects / adverse reactions in 77 year old female

Reported by a physician from United States on 2011-10-05

Patient: 77 year old female weighing 81.6 kg (179.5 pounds)

Reactions: Speech Disorder

Suspect drug(s):
Estrace
    Dosage: 0.5 g, qd, vaginal, 0.5 g, biw, vaginal, 1-3 g,qw, vaginal
    Indication: Atrophic Vulvovaginitis
    Start date: 2007-01-01
    End date: 2011-09-01

Estrace
    Dosage: 0.5 g, qd, vaginal, 0.5 g, biw, vaginal, 1-3 g,qw, vaginal
    Indication: Atrophic Vulvovaginitis
    End date: 2007-01-01

Estrace
    Dosage: 0.5 g, qd, vaginal, 0.5 g, biw, vaginal, 1-3 g,qw, vaginal
    Indication: Atrophic Vulvovaginitis
    Start date: 2006-01-01

Other drugs received by patient: Zegerid; Losartan Potassium; Omeprazole

Possible Estrace side effects / adverse reactions in 72 year old female

Reported by a consumer/non-health professional from United States on 2011-10-20

Patient: 72 year old female weighing 81.6 kg (179.6 pounds)

Reactions: Speech Disorder

Adverse event resulted in: disablity

Suspect drug(s):
Estrace