Ospemifene is an estrogen agonist/antagonist indicated for oSPHENA is an estrogen agonist/antagonist indicated for, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Ospemifene for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
OSPHENA is indicated for: OSPHENA is an estrogen agonist/antagonist indicated for: The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.
Source: US FDA prescribing information
OSPHENA is an estrogen receptor agonist/antagonist with tissue selective effects. Its biological actions are mediated through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism).
Source: US FDA prescribing information
OSPHENA is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Use OSPHENA for the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary. One tablet taken orally once daily with food.
Source: US FDA prescribing information
OSPHENA is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Estrogen-dependent neoplasia. Active DVT, PE, or a history of these conditions. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) to OSPHENA or any ingredients. OSPHENA is contraindicated in women who are or may become pregnant. OSPHENA may cause fetal harm when administered to a pregnant woman.
Source: US FDA prescribing information
Boxed warning (endometrial cancer and cardiovascular disorders warning: endometrial cancer and cardiovascular disorders osphena): is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Venous Thromboembolism: Risk of DVT and PE. Known, suspected, or history of breast cancer. Severe Hepatic Impairment
Source: US FDA prescribing information
The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders Malignant Neoplasms The most common adverse reactions (≥1 percent) with OSPHENA are: hot flush, vaginal discharge, muscle spasms, headache, hyperhidrosis, vaginal hemorrhage, night sweats.
Source: US FDA prescribing information
OSPHENA is primarily metabolized by CYP3A4 and CYP2C9. CYP2C19 and other pathways contribute to the metabolism of ospemifene. Do not use estrogens or estrogen agonist/antagonist concomitantly with OSPHENA. Do not use fluconazole concomitantly with OSPHENA. Fluconazole increases serum concentrations of OSPHENA. Do not use rifampin concomitantly with OSPHENA. Rifampin decreases serum concentration of OSPHENA.
Source: US FDA prescribing information
Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ospemifene, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Osphena 60 mg tabletOral | Duchesnay | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Ospemifene in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Ospemifene and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ospemifene, including Osphena.
Yes. The US FDA first approved Ospemifene on 26 February 2013, according to Drugs@FDA.
Yes. Ospemifene has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Ospemifene is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ospemifene is classified under ATC code G03XC05 (Ospemifene).
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