Femtrace

Last updated on RxList: 8/25/2014
Femtrace Side Effects Center

Last reviewed on RxList 6/14/2016

Femtrace (estradiol acetate) is a form of the female hormone estrogen used to treat moderate to severe vasomotor symptoms due to menopause. Common side effects of Femtrace include:

Start therapy with Femtrace at a dose of 0.45 mg/day taken once daily. Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. Femtrace may interact with St. John's wort, phenobarbital, carbamazepine, rifampin, antibiotics, azole antifungals, ritonavir, and grapefruit juice. Tell your doctor all medications and supplements you use. Femtrace is not recommended for use during pregnancy or while breastfeeding.

Our Femtrace (estradiol acetate) 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.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Femtrace Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding, pelvic pain;
  • a breast lump;
  • memory problems, confusion, unusual behavior; or
  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

  • headache, back pain;
  • stuffy nose, sinus pain, sore throat;
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
  • bloating, stomach cramps, nausea, vomiting;
  • breast pain;
  • redness or irritation where the patch was worn;
  • thinning scalp hair; or
  • fluid retention (swelling, rapid weight gain).

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.

Read the entire detailed patient monograph for Femtrace (Estradiol Acetate Tablets)

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
Femtrace Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In two 12-week clinical trials that included 327 postmenopausal women treated with Femtrace and 221 women treated with placebo tablets, adverse reactions that occurred in any treatment group at a rate of ≥ 2 percent associated with the use of Femtrace are summarized in Table 1.

Table 1: Associated Adverse Reactions Reported by ≥ 2 Percent of Subjects in Any Treatment Group by Body Systema

BODY SYSTEM/ Adverse Reaction Number (percent) of Subjects
Placebo
(n = 221)
n (%)
Femtrace 0.45 mg/day
(n = 132)
n (%)
Femtrace 0.9 mg/day
(n = 100)
n (%)
Femtrace 1.8 mg/day
(n = 95)
n (%)
REPRODUCTIVE SYSTEM AND BREAST DISORDERS 6 (2.7) 2 (1.5) 9 (9.0) 16 (16.8)
  Vaginal Hemorrhage 2 (0.9) 1 (0.8) 3 (3.0) 7 (7.4)
  Breast Tenderness 3 (1.4) 0 (0.0) 0 (0.0) 5 (5.3)
  Vaginal Discharge 0 (0.0) 1 (0.8) 4 (4.0) 3 (3.2)
  Intermenstrual Bleeding 2 (0.9) 0 (0.0) 2 (2.0) 3 (3.2)
  Genital Pruritus - Female 0 (0.0) 0 (0.0) 1 (1.0) 2 (2.1)
GASTROINTESTINAL DISORDERS 3 (1.4) 2 (1.5) 3 (3.0) 4 (4.2)
  Abdominal Pain - NOS 0 (0.0) 0 (0.0) 0 (0.0) 2 (2.1)
NERVOUS SYSTEM DISORDERS 7 (3.2) 1 (0.8) 4 (4.0) 3 (3.2)
  Headache - NOS 5(2.3) 1 (0.8) 4 (4.0) 3 (3.2)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS 1 (0.5) 0 (0.0) 4 (4.0) 0 (0.0)
  Acne - NOS 0 (0.0) 0 (0.0) 2 (2.0) 0 (0.0)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS 1 (0.5) 0 (0.0) 3 (3.0) 1 (1.1)
  Fatigue 0 (0.0) 0 (0.0) 2 (2.0) 0 (0.0)
AE = adverse event; NOS = not otherwise specified
aEach subject is counted only once in the body system's total using the most related adverse event. Only the most related for a subject is counted in each adverse event's total. Subjects may be counted more than once in the total number of subject's with AEs.

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of Femtrace. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary System

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; ovarian cyst.

Breasts

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

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; cerebrovascular accident (stroke); chest pain; increase in blood pressure; dyspnea; transient ischemic attack.

Gastrointestinal

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

Skin

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

Eyes

Retinal vascular thrombosis; visual impairment; intolerance to contact lenses.

Central Nervous System (CNS)

Headache; migraine; dizziness; 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; back pain; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; hypersensitivity.

Read the entire FDA prescribing information for Femtrace (Estradiol Acetate Tablets)

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

Health Solutions From Our Sponsors