Estrace Side Effects
Generic name: estradiol
Medically reviewed by Drugs.com. Last updated on Jan 3, 2024.
Note: This document contains side effect information about estradiol. Some dosage forms listed on this page may not apply to the brand name Estrace.
Applies to estradiol: transdermal gel/jelly, transdermal patch extended release, transdermal spray. Other dosage forms:
Warning
Transdermal route (Gel/Jelly)
Endometrial Cancer, Cardiovascular Disorders, Probable Dementia, and Breast CancerEstrogen-Alone TherapyEndometrial Cancer - There is an increased risk of cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.Cardiovascular Disorders and Probable Dementia - The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.Cardiovascular Disorders and Probable Dementia - Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Cardiovascular Disorders and Probable Dementia - Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen Plus Progestin TherapyCardiovascular Disorders and Probable Dementia - The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with combined medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.Breast Cancer - The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Breast Cancer - Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Breast Cancer - Prescribe estrogens with or without progestogen at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Transdermal route (Patch, Extended Release; Gel/Jelly)
Estrogen Alone TherapyEndometrial Cancer - There is an increased risk of cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding Cardiovascular Disorders and Probable Dementia - Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.Cardiovascular Disorders and Probable Dementia - Only daily oral 0.625 mg CE was studied in the estrogen -alone substudy of the WHI. Therefore, thee relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Cardiovascular Disorders and Probable Dementia - Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen Plus Progestin TherapyCardiovascular Disorders and Probable Dementia - Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with combined medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Breast Cancer - The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Breast Cancer - In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.Breast Cancer - Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Breast Cancer - Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Transdermal route (Spray)
Estrogen Alone TherapyEndometrial Cancer - There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal genital bleeding.Cardiovascular Disorders and Probable Dementia - The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] alone, relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Cardiovascular Disorders and Probable Dementia - Prescribe estrogens with or without progestogen should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen Plus Progestin TherapyCardiovascular Disorders and Probable Dementia - The WHI estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), DVT, stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.Breast Cancer - The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Breast Cancer - Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestogen substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Breast Cancer - Prescribe estrogens with or without progestogen should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Unintentional Secondary ExposureBreast budding and breast masses in prepubertal females and gynecomastia and breast masses in prepubertal males have been reported following unintentional secondary exposure to estradiol transdermal spray by women using this product. In most cases, the condition resolved with the removal of the estradiol transdermal spray exposure. Women should ensure that children should not come in contact with the site(s) where estradiol transdermal spray is applied. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
Serious side effects of Estrace
Along with its needed effects, estradiol (the active ingredient contained in Estrace) 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:
Incidence not known
- Acid or sour stomach
- anxiety
- backache
- belching
- blistering, peeling, or loosening of the skin
- bloating
- blurred vision
- breast tenderness, enlargement, pain, or discharge
- change in vaginal discharge
- changes in skin color
- changes in vision
- chest pain, discomfort, or tightness
- chills
- clay-colored stools
- clear or bloody discharge from the nipple
- confusion
- constipation
- cough
- darkening of the urine
- diarrhea
- difficulty with swallowing
- dimpling of the breast skin
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- fever
- fluid-filled skin blisters
- full or bloated feeling or pressure in the stomach
- headache
- headache, severe and throbbing
- heartburn
- hives, itching, skin rash
- indigestion
- inverted nipple
- irregular heartbeat
- itching of the vagina or genital area
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- loss of bladder control
- lump in the breast or under the arm
- migraine headache
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- muscle spasm or jerking of all extremities
- nausea
- noisy breathing
- numbness and tingling around the mouth, fingertips, or feet
- pain during sexual intercourse
- pain in the ankles or knees
- pain or discomfort in the arms, jaw, back, or neck
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm, foot, or leg
- painful, red lumps under the skin, mostly on the legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- persistent crusting or scaling of the nipple
- poor insight and judgment
- problems with memory or speech
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- redness or swelling of the breast
- seizures
- sensitivity to the sun
- skin thinness
- sore on the skin of the breast that does not heal
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach cramps, discomfort, upset, pain, or swelling
- sudden loss of consciousness
- sudden trouble breathing
- sweating
- thick, white vaginal discharge with no odor or with a mild odor
- tremor
- trouble recognizing objects
- trouble thinking and planning
- trouble walking
- unexpected or excess milk flow from the breasts
- unpleasant breath odor
- unusual tiredness or weakness
- unusually heavy or unexpected menstrual bleeding
- vaginal bleeding or spotting
- vomiting
- vomiting of blood
- yellow eyes or skin
Other side effects of Estrace
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:
Less common
- Back pain
- difficulty with moving
- muscle aches, pain, or stiffness
- stuffy or runny nose
Incidence not known
- Decreased interest in sexual intercourse
- heavy bleeding
- increased hair growth, especially on the face
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- irritability
- leg cramps
- loss in sexual ability, desire, drive, or performance
- loss of scalp hair
- mental depression
- mood disturbances
- patchy brown or dark brown discoloration of the skin
- redness of the skin
- twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
- weight changes
For Healthcare Professionals
Applies to estradiol: compounding powder, intramuscular solution, oral tablet, transdermal emulsion, transdermal film extended release, transdermal gel, transdermal spray, vaginal ring.
Genitourinary
Very common (10% or more): Breast pain (29%)
Common (1% to 10%): Vulvovaginal pruritus, leukorrhea, vaginal hemorrhage, vaginal discharge, vaginal discomfort, menopause symptoms, breakthrough bleeding or spotting, dysmenorrhea, breast swelling, menorrhagia, metrorrhagia, endometrial hyperplasia
Uncommon (0.1% to 1%): Urinary problems
Rare (less than 0.1%): Galactorrhea
Postmarketing reports: Vaginal irritation, vaginal pain, genital pruritus, changes in bleeding pattern, pelvic pain, breast tenderness, vaginal ulceration, uterine fibroids[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (16%),
Common (1% to 10%): Flatulence, nausea, diarrhea
Uncommon (0.1% to 1%): Vomiting
Postmarketing reports: Abdominal distension[Ref]
Musculoskeletal
Very common (10% or more): Back pain (11%), arthralgia (11%)
Common (1% to 10%): Leg cramps[Ref]
Cardiovascular
Common (1% to 10%): Varicose veins, cardiac symptoms (e.g. palpitations)
Uncommon (0.1% to 1%): Hot flush, hypertension, venous thromboembolic disease
Rare (less than 0.1%): Arterial hypertension
Postmarketing reports: Deep vein thrombosis, changes in blood pressure[Ref]
Nervous system
Very common (10% or more): Headache (18%)
Uncommon (0.1% to 1%): Vertigo, migraine
Rare (less than 0.1%): Aggravation of epilepsy
Postmarketing reports: Migraine aggravated, paresthesia, dizziness[Ref]
Oncologic
Uncommon (0.1% to 1%): Benign breast neoplasm, increased volume of uterine leiomyoma
Postmarketing reports: Endometrial cancer, breast cancer[Ref]
Other
Very common (10% or more): Pain (11%)
Common (1% to 10%): Edema
Uncommon (0.1% to 1%): Weight increased, asthenia
Postmarketing reports: Drug ineffectiveness, blood estrogen increase, fatigue, exacerbation of hereditary angioedema[Ref]
Psychiatric
Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Sleep disorders, nervousness, mood swings
Rare (less than 0.1%): Change in libido
Postmarketing reports: Vaginismus, insomnia, anxiety, irritability[Ref]
Dermatologic
Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Rash
Rare (less than 0.1%): Skin discoloration, acne
Postmarketing reports: Urticaria, erythematous or pruritic rash, alopecia, hyperhidrosis, night sweats, contact dermatitis, eczema[Ref]
Ocular
Uncommon (0.1% to 1%): Vision abnormal NOS
Postmarketing reports: Visual disturbances, contact lens intolerance[Ref]
Hepatic
Rare (less than 0.1%): Liver function tests abnormalities
Postmarketing reports: Cholestatic jaundice[Ref]
Metabolic
Rare (less than 0.1%): Glucose intolerance
Postmarketing reports: Fluid retention[Ref]
Hypersensitivity
Rare (less than 0.1%): Anaphylactic reaction (with a past history of allergic reaction)
Postmarketing reports: Anaphylactic reactions, hypersensitivity[Ref]
Immunologic
Very common (10% or more): Upper respiratory tract infection (17%)
Common (1% to 10%): Vulvovaginal mycotic infection, pharyngitis, rhinitis, sinusitis, moniliasis genital
Uncommon (0.1% to 1%): Vaginitis/vaginal candidosis[Ref]
Local
Common (1% to 10%): Skin irritation (topical gel)
Postmarketing reports: Application site reaction[Ref]
Frequently asked questions
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References
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.