"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 adverse reactions have been identified during post-approval use of OGEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Abnormal uterine bleeding, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata; vaginitis (including vaginal candidiasis), change in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer, leukorrhea.
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System
Increase or decrease in weight, glucose intolerance, aggravation of porphyria, edema, arthralgias, leg cramps, urticaria, angioedema, anaphylactoid/anaphylactic reactions, exacerbation of asthma, changes in libido, increased triglycerides.
Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.
Read the Ogen (estropipate) Side Effects Center for a complete guide to possible side effects
Drug-Laboratory Test Interactions
- Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII- X complex, II-VII- X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
- Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Women on thyroid replacement therapy may require higher doses of thyroid hormone.
- Other binding proteins may be elevated in serum, (for example, corticosteroid binding globulin (CBG), SHBG, leading to increased circulating corticosteroids and sex steroids, respectively. Free hormone concentrations, such as testosterone and estradiol, may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-l-antitrypsin, ceruloplasmin).
- Increased plasma high-density lipoprotein (HDL) and HDL cholesterol subfraction concentrations, reduced low-density lipoprotein (LDL) cholesterol concentration, increased triglycerides levels.
- Impaired glucose tolerance.
Read the Ogen Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/9/2017
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