"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.
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 Evamist (estradiol) Side Effects Center for a complete guide to possible side effects
No 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 (Hypericum perforatum) preparations, 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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/7/2014
Additional Evamist Information
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