Note: This document contains side effect information about estradiol. Some dosage forms listed on this page may not apply to the brand name Femtrace.
Applies to estradiol: vaginal capsule liquid filled, vaginal cream, vaginal insert extended release, vaginal tablet. Other dosage forms:
- transdermal gel/jelly, transdermal patch extended release, transdermal spray
Warning
Vaginal route (Insert, Extended Release; Cream)
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. 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 - 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 - Do not use estrogen and progestin 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, 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 - 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 - Prescribe estrogens with or without progestins 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 and progestin 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 progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Vaginal route (Insert, Extended Release)
Use of unopposed estrogens increases the risk of endometrial cancer, while addition of a progestin decreases the risk of endometrial hyperplasia. Rule out malignancy if abnormal vaginal bleeding develops. Do not use estrogen alone or in combination with progestin to prevent cardiovascular disease or dementia. There is an increased risk of cardiovascular disorders (ie, DVT, pulmonary embolism, stroke, myocardial infarction) with combination therapy in women 50 years or older, and an increased risk of dementia in women 65 years or older with estrogen monotherapy or combination therapy. Combination therapy also increases the risk of invasive breast cancer. Prescribe estrogens with or without progestins at the lowest effective dose and for the shortest duration consistent with risks and treatment goals.
Serious side effects of Femtrace
Along with its needed effects, estradiol (the active ingredient contained in Femtrace) 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:
Less common
- Vaginal yeast infection
Incidence not known
- 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:
Symptoms of overdose
- Dizziness
- drowsiness
- nausea
- stomach pain
- tenderness of the breasts
- unusual tiredness or weakness
- vomiting
Other side effects of Femtrace
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:
More common
- Back pain
- headache
- itching or pain of the vagina or genital area
- thick, white vaginal discharge with mild or no odor
- weight gain
Less common
- Body aches or pain
- chills
- cough
- diarrhea
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sneezing
- sore throat
Incidence not known
- Feeling sad or empty
- headache, severe and throbbing
- irritability
- lack of appetite
- tiredness
- trouble concentrating
- trouble sleeping
- welts
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]
