"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 clinical practice.
EstroGel was studied in 2 well-controlled, 12-week clinical trials. Incidence of adverse drug reactions ≥ 5 percent for 1.25 g EstroGel 0.06% and placebo is given in Table 1.
TABLE 1 : Incidence of Adverse Drug Reactions ≥ 5
Percent Occurrence in the EstroGel Treatment Group for the Intent-to-Treat Safety
Population in 2 Well-controlled Clinical Studies (Expressed as Percent of
|Body System/ Adverse Drug Reactions||EstroGel 0.06% 1.25 g /day
|BODY AS A WHOLE|
In 2 controlled clinical trials, application site reactions were reported by 0.6 percent of patients who received 1.25 g of EstroGel. Other skin reactions, such as pruritus and rash, were also noted.
The following adverse reactions have been identified during post-approval use of EstroGel. 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.
Pain; tenderness; breast cancer
Nausea; abdominal distension; diarrhea; stomach discomfort
Alopecia; rash; pruritus; application site: dryness, pain, discoloration, reaction, rash
Retinal vein occlusion
Central Nervous System
Drug ineffective; hot flush; arthralgia; night sweats; drug effect decreased; pain in extremity; fatigue; weight increased; pain; hypersensitivity; dyspnea; malignant mesenchymoma; angioedema; hepatitis acute; face edema; accidental exposure; myoclonus; gait disturbance; flushing
Read the EstroGel (estradiol gel) Side Effects Center for a complete guide to possible side effects
No drug-drug interaction studies have been conducted for EstroGel.
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 estrogen 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: 4/4/2014
Additional EstroGel Information
EstroGel - User Reviews
EstroGel User Reviews
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