Evamist
HRT for Menopause Symptoms: Timing Is Everything »
"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 "...
Read the HRT for Menopause Symptoms: Timing Is Everything article »
Evamist
Evamist Side Effects Center
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.
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 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
(Adverse Reactions)
SIDE EFFECTS
Clinical Study 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.
In a 12-week, randomized, placebo-controlled trial of Evamist in 454 women, 80-90 percent of women randomized to active drug received at least 70 days of therapy and 75-85 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%) 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.
Additional Adverse Reactions Reported With Estrogen and/or Progestin Therapy
The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
Genitourinary System
Abnormal uterine bleeding/spotting, dysmenorrhea/pelvic pain, 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, exacerbation of chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia.
Miscellaneous
Increase or decrease in weight, glucose intolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, urticaria, angioedema, anaphylactoid/anaphylactic reactions, hypocalcemia (preexisting condition), exacerbation of asthma, increased triglycerides.
Read the entire FDA prescribing information for Evamist (Estradiol ) »
Additional Evamist Information
Evamist - User Reviews
Evamist User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Evamist sorted by most helpful.
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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