"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Evamist Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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 include nausea/vomiting, bloating, breast tenderness, headache, or weight changes.
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.
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.
Evamist 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.
Read the entire detailed patient monograph for Evamist (Estradiol )
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Evamist Overview - Patient Information: Side Effects
Nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.
This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Evamist (Estradiol )
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Evamist FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOXED WARNING, 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 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|
(N = 77)
(N = 76)
(N = 76)
(N = 74)
(N = 75)
(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)|
|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)|
|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.
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
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
Read the entire FDA prescribing information for Evamist (Estradiol )
Additional Evamist Information
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