"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, and WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOXED WARNING, and 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 practice.
ELESTRIN was studied in a placebo-controlled trial that included a total of 484 postmenopausal women. The adverse reactions that occurred at a rate greater than 5 percent in any of the treatment groups are summarized in Table 1.
TABLE 1 : Incidence of Treatment-Emergent Adverse
Reactions Occurring in ≥ 5 Percent of Subjects
|Body System / Signs and Symptoms||Number (%) of Subjects|
(n = 137)
|ELESTRIN 0.87 g/day
(n = 136)
|ELESTRIN 1.7 g/day
(n = 142)
|Reproductive system & breast disorders|
|Breast tenderness||5 (3.6)||9 (6.6)||11 (7.7)|
|Metrorrhagia||3 (2.2)||6 (4.4)||13 (9.2)|
|Respiratory, thoracic & mediastinal disorders|
|Nasopharyngitis||10 (7.3)||14 (10.3)||12 (8.5)|
|Upper respiratory tract infection||5 (3.6)||8 (5.9)||5 (3.5)|
The following adverse reactions have been identified during post-approval use of ELESTRIN. 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.
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; 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; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Additional postmarketing adverse reactions have been reported in women receiving other forms of hormone therapy.
Read the Elestrin (estradiol gel) Side Effects Center for a complete guide to possible side effects »
No drug-drug interaction studies have been conducted for ELESTRIN.
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 result in side effects.
Last reviewed on RxList: 3/9/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Elestrin Information
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