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Elestrin

"March 14, 2013 -- Hormone replacement therapy is the most effective treatment for symptoms like hot flashes, and the benefits are likely to outweigh the risks, major medical societies say.

The statement was published in the April issue "...

Elestrin

Elestrin Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Elestrin (estradiol gel) is a low-dose topical therapy indicated to treat moderate to severe hot flashes and night sweats associated with menopause. Generic estradiol gels are available. Common side effects include headache, breast tenderness, nausea, mood changes, hair and skin changes and vaginal discharge.

Elestrin contains 0.06% estradiol in a hydroalcoholic gel base. The gel is applied onto the skin in a thin layer preferably to the upper arm to shoulder region. One pump actuation delivers Elestrin in a unit dose of 0.87 g, which contains 0.52 mg of estradiol. The 0.87 g dose provides systemic delivery of 0.0125 mg of estradiol daily. The 1.7 g dose, two pump actuations, provides systemic delivery of 0.0375 mg daily. Uncommon, but serious side effects of Elestrin can include breast cancer, uterine cancer, ovarian cancer, stroke, heart attack, blood clots, dementia, and gallbladder disease. Estrogen products, including Elestrin, should not be used in women who are pregnant, suspect pregnancy, or might become pregnant. The hormone in Elestrin can pass into breast milk. Elestrin should not be used in the pediatric population; women that use this drug topically should not let children contact the skin area where the gel is applied.

Our Elestrin 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Elestrin in Detail - Patient Information: Side Effects

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

Stop using estradiol topical and call your doctor at once if you have a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • abnormal vaginal bleeding;
  • pain, swelling, or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes); or
  • a lump in your breast.

Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;
  • swollen breasts;
  • acne or skin color changes;
  • vaginal pain, dryness, or discomfort, decreased sex drive, or difficulty having an orgasm;
  • swelling, weight gain;
  • migraine headaches, dizziness, depression; or
  • break-through bleeding, vaginal itching or discharge.

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 Elestrin (Estradiol Gel) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Elestrin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Cardiovascular Disorders [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]

Malignant Neoplasms [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]

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 practice.

ELESTRIN was studied in a placebo-controlled trial that included a total of 484 postmenopausal women. The adverse reactions that occurred at a rate greater than 5 percent in any of the treatment groups are summarized in Table 1.

TABLE 1 :Incidence of Treatment-Emergent Adverse Reactions Occurring in ≥ 5 Percent of Subjects

Body System / Signs and Symptoms Number (%) of Subjects
Placebo
(n = 137)
ELESTRIN 0.87 g/day
(n = 136)
ELESTRIN 1.7 g/day
(n = 142)
Reproductive system & breast disorders
  Breast tenderness 5 (3.6) 9 (6.6) 11 (7.7)
  Metrorrhagia 3 (2.2) 6 (4.4) 13 (9.2)
Respiratory, thoracic & mediastinal disorders
  Nasopharyngitis 10 (7.3) 14 (10.3) 12 (8.5)
  Upper respiratory tract infection 5 (3.6) 8 (5.9) 5 (3.5)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ELESTRIN. 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; dysmenorrhea; 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.

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, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Additional postmarketing adverse reactions have been reported in women receiving other forms of hormone therapy.

Read the entire FDA prescribing information for Elestrin (Estradiol Gel) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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