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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|
(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.
Additional Adverse Reactions Reported With Estrogen and/or Progestin Therapy
The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
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.
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System
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 Evamist (estradiol) Side Effects Center for a complete guide to possible side effects »
No formal drug interaction studies have been conducted for Evamist.
In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.
Last reviewed on RxList: 11/10/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Evamist Information
Evamist - User Reviews
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