Evamist

Last updated on RxList: 8/29/2019
Evamist Side Effects Center

Last reviewed on RxList 8/29/2019

Evamist (estradiol transdermal) Spray is a form of estrogen, a female sex hormone, used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Common side effects of Evamist Spray include:

Evamist therapy should be initiated with one spray per day. Dosage adjustment should be guided by patient's response. Evamist may interact with St. John's wort, blood thinners, ritonavir, carbamazepine, phenobarbital, antibiotics, or antifungal medications. Tell your doctor all medications and supplements you use. Evamist must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. Evamist passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.

Our Evamist (estradiol transdermal) Spray 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.

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Evamist Consumer Information

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

Call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a blood clot--sudden numbness or weakness, sudden vision loss, slurred speech, stabbing chest pain, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach, severe stomach pain spreading to your back, nausea and vomiting;
  • jaundice (yellowing of the skin or eyes);
  • memory problems, confusion, unusual behavior;
  • unusual vaginal bleeding, pelvic pain;
  • a lump in your breast; or
  • high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss.

Topical estradiol is absorbed through the skin of a child who comes into contact with this medicine. Call your doctor if a child in close contact with you develops swollen nipples or enlarged breasts.

Common side effects may include:

  • nausea, vomiting, stomach cramps;
  • bloating, swelling, weight gain;
  • breast pain or tenderness;
  • headache;
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
  • thinning scalp hair; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Evamist (Estradiol )

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Evamist 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 a 12-week, randomized, placebo-controlled trial of Evamist in 454 women, 80 to 90 percent of women randomized to active drug received at least 70 days of therapy and 75 to 85 percent randomized to placebo received at least 70 days of therapy.

The adverse reactions that occurred in at least 5 percent of women in any treatment group are shown in Table 1.

Table 1: Frequency of Adverse Reactions ( ≥ 5 Percent) in Any Treatment Group in a Controlled Study of Evamist

System Organ Class Preferred Term Frequency n (%)
1 Spray 2 Sprays 3 Sprays
Placebo
(N = 77)
Evamist
(N = 76)
Placebo
(N = 76)
Evamist
(N = 74)
Placebo
(N = 75)
Evamist
(N = 76)
Reproductive System and Breast Disorders
Breast tenderness 0 (0) 4 (5) 4 (5) 5 (7) 0 (0) 4 (5)
Nipple pain 0 (0) 2 (3) 0 (0) 5 (7) 0 (0) 1 (1)
Gastrointestinal Disorders
Nausea 5 (7) 1 (1) 1 (1) 2 (3) 4 (5) 2 (3)
Infections and Infestations
Nasopharyngitis 1 (1) 4 (5) 2 (3) 3 (4) 1 (1) 1 (1)
Musculoskeletal and Connective Tissue Disorders
Back pain 1 (1) 2 (3) 2 (3) 4 (5) 1 (1) 2 (3)
Arthralgia 1 (1) 1 (1) 4 (5) 1 (1) 0 (0) 3 (4)
Nervous system
Headache 4 (5) 7 (9) 5 (7) 9 (12) 7 (9) 8 (11)

Application site reactions were reported in 3 out of 226 (1.3%) women treated with Evamist.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Evamist. 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.

Breasts: Breast swelling, breast mass, breast enlargement

Cardiovascular: Heart rate increased

Central nervous system: Dizziness, dysgeusia, paresthesia, lethargy, hypoesthesia

Eyes: Eye irritation, ocular hyperemia

Gastrointestinal: Abdominal pain, diarrhea, constipation, abdominal distension, dry mouth, decreased appetite

Genitourinary system: Vaginal bleeding

Musculoskeletal: Muscle spasms, arthritis

Psychiatric: Insomnia, mood swings, anxiety, irritability, mood altered, depression

Respiratory tract: Cough, dyspnea, dry throat

Skin: Nipple and areola discoloration, usually on the same side of the body as the inner forearm on which Evamist is applied, rash, pruritus, alopecia, urticaria, dry skin, skin discoloration, chloasma

Miscellaneous: Weight increased, malaise, fatigue, asthenia

Read the entire FDA prescribing information for Evamist (Estradiol )

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

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