"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 labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNING AND PRECAUTIONS]
- Malignant Neoplasms [see BOXED WARNING, WARNING 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.
Table 1 summarizes the treatment-emergent adverse reactions with ESTRASORB therapy.
Table 1: Number (%) of Patients Reporting ≥ 5%
Treatment-Emergent Adverse Reactions
|Body system/ Preferred term||Statistic||Placebo
(n = 134)
|ESTRASORB 3.45 grams
(n = 139)
|Number of subjects with ≥ 1 TEAE||n (%)||82 (61)||95 (68)|
|Body as a whole||n (%)||40 (30)||49 (35)|
|Headache||n (%)||17(13)||12 (9)|
|Infection||n (%)||10 (7)||16 (12)|
|Respiratory||n (%)||15(11)||19 (14)|
|Sinusitis||n (%)||6 (4)||9 (6)|
|Skin and appendages||n (%)||7 (5)||15(11)|
|Pruritus||n (%)||0||5 (4)|
|Urogenital||n (%)||20 (15)||44 (32)|
|Breast pain||n (%)||4 (3)||14 (10)|
|Endometrial disorder||n (%)||11 (8)||21(15)|
|TEAE = Treatment-emergent adverse event.|
The following adverse reactions have been identified during post-approval use of ESTRASORB. 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.
Unusual bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; dysmenorrheal; 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; arthralgia; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the Estrasorb (estradiol topical emulsion) Side Effects Center for a complete guide to possible side effects
No drug interaction studies have been conducted for ESTRASORB.
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/23/2015
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