Ospemifene

Pronunciation: pronunciation varies by local usage.

Generic name
ospemifene
Brand names
OSPHENA
Drug class
Estrogen agonist/antagonist with tissue-selective effects
Form
60 mg tablet
Route
Oral
Legal status
Prescription-only medicine

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Awaiting verification · Full directory

What ospemifene is and how it works

Ospemifene is an oral prescription estrogen agonist/antagonist medicine with tissue-selective effects. In the United States, it is used for specified moderate-to-severe symptoms of vulvar and vaginal atrophy due to menopause. (1) (2)

Ospemifene has important endometrial-cancer and cardiovascular safety warnings. Persistent or recurring abnormal vaginal bleeding after menopause needs medical assessment, and possible stroke or blood-clot symptoms require urgent emergency assessment. A treating clinician must assess whether it is appropriate for an individual.

Mechanism of action: how ospemifene works

Ospemifene is an estrogen agonist/antagonist with tissue-selective effects. The US label states that it has estrogen-agonist effects in the endometrium. (1) (2)

What ospemifene is used for

Moderate-to-severe dyspareunia due to menopause

Under the US label, ospemifene is used to treat moderate-to-severe dyspareunia (painful sexual intercourse) that is a symptom of vulvar and vaginal atrophy due to menopause. (1) (2)

Moderate-to-severe vaginal dryness due to menopause

Under the US label, ospemifene is used to treat moderate-to-severe vaginal dryness that is a symptom of vulvar and vaginal atrophy due to menopause. (1) (2)

Before taking ospemifene

Do not take / not appropriate for

  • Ospemifene is contraindicated with undiagnosed abnormal genital bleeding. (US OSPHENA label) (1)
  • Ospemifene is contraindicated in people with estrogen-dependent neoplasia. (US OSPHENA label) (1)
  • Ospemifene is contraindicated in people with active or previous deep-vein thrombosis or pulmonary embolism, or active or previous arterial thromboembolic disease including stroke or myocardial infarction. (US OSPHENA label) (1)
  • Ospemifene is contraindicated with hypersensitivity to a product ingredient and in known or suspected pregnancy. (US OSPHENA label) (1)

Tell your clinician about

  • Any abnormal genital or vaginal bleeding, including persistent or recurring bleeding after menopause.
  • Any current or previous blood clot, pulmonary embolism, stroke, myocardial infarction, or other arterial thromboembolic disease.
  • Known, suspected, or previous breast cancer, or any estrogen-dependent neoplasia.
  • Severe liver impairment.
  • Pregnancy, suspected pregnancy, breastfeeding, or pregnancy-related questions.
  • All current prescription medicines, non-prescription medicines, and other treatments, including estrogens, estrogen agonists/antagonists, fluconazole, rifampin, ketoconazole, warfarin, and highly protein-bound medicines.
(1) (2)

How to take ospemifene

  • Take ospemifene only according to the prescription label and treating clinician's instructions.
  • MedlinePlus advises taking it with food as directed.
  • The individual prescription determines use and duration. Do not make self-directed changes to the medicine, dose, duration, or other hormonal treatment.
  • Ospemifene must not be used together with estrogens or other estrogen agonists/antagonists.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2)

Missed dose

Missed-dose instructions are not covered in the supplied research notes. Contact the prescriber or pharmacist for advice based on the prescription; do not take an extra dose without their direction.

Overdose

The supplied research notes do not provide ospemifene overdose instructions. If an overdose is suspected, obtain urgent professional or emergency assessment. (1) (2)

Side effects

Common reported adverse reactions include hot flush, vaginal discharge, muscle spasm, headache, hyperhidrosis, vaginal hemorrhage, and night sweats. Unusual vaginal bleeding needs prompt clinical assessment because of the medicine's endometrial safety warning.

Hot flushes, night sweats, or hyperhidrosis

What to notice: Hot flushes, night sweats, or increased sweating.

What to do: Discuss persistent or troublesome symptoms with the prescribing clinician or pharmacist. (1)

Vaginal discharge or vaginal hemorrhage

What to notice: Vaginal discharge or vaginal bleeding.

What to do: Contact a clinician promptly for unusual vaginal bleeding, particularly if it is persistent or recurring after menopause. (1) (2)

Muscle spasm or headache

What to notice: Muscle spasm or headache.

What to do: Discuss persistent or troublesome symptoms with the prescribing clinician or pharmacist. (1)

Persistent or recurring abnormal vaginal bleeding

What to notice: Abnormal genital or vaginal bleeding, especially bleeding that persists or recurs after menopause.

What to do: Contact a clinician promptly for assessment to rule out malignancy. (1) (2)

Serious warnings

Possible stroke or arterial thromboembolic event — emergency

Symptoms: Slow or difficult speech; dizziness or faintness; weakness or numbness of an arm or leg; sudden severe headache; sudden vision changes; or pain in the chest, arms, back, neck, or jaw.

Action: Seek emergency assessment immediately. (1) (2)

Possible deep-vein thrombosis or pulmonary embolism — emergency

Symptoms: Leg swelling or pain, or skin that is warm or red; chest pain; or shortness of breath.

Action: Seek emergency assessment immediately. (1) (2)

Endometrial-cancer risk context — urgent

Symptoms: Persistent or recurring abnormal genital or vaginal bleeding after menopause.

Action: Arrange prompt medical assessment to rule out malignancy. (1) (2)

Interactions

Medicine or testEffectAction
Estrogens or other estrogen agonists/antagonistsConcomitant use is not permitted under the US label.Give the prescriber and pharmacist a complete hormonal-treatment list; do not alter or substitute treatment without clinician direction. (1)
Fluconazole or rifampinConcomitant use is not permitted under the US label.Tell the prescriber and pharmacist if either medicine is used or may be prescribed; they must review the medication list. (1)
Ketoconazole, warfarin, highly protein-bound medicines, and medicines causing multiple enzyme inhibitionThe US label discusses interaction considerations with these medicines or medicine categories.Ask the prescriber or pharmacist to review all medicines individually before and during treatment. Do not change another medicine yourself. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Known or suspected pregnancy is a contraindication under the US label. Discuss pregnancy or suspected pregnancy promptly with the treating clinician. (1) (2)

Breastfeeding

Breastfeeding questions should be discussed with the treating clinician. The supplied research notes do not provide a breastfeeding recommendation. (2)

Severe hepatic impairment

Severe hepatic impairment requires prescriber assessment. The supplied notes do not provide an impairment-specific dosing approach. (1)

Children and adolescents

Paediatric use information is unresolved because it is not covered in the supplied research notes. (1) (2)

Monitoring

Before starting

  • Confirm the US-labelled menopause-related symptom and assess contraindications, including abnormal genital bleeding, estrogen-dependent neoplasia, thromboembolic disease, arterial thromboembolic disease, hypersensitivity, and known or suspected pregnancy.
  • Assess relevant breast-cancer history and severe hepatic impairment.
  • Review all medicines and hormonal treatments, including estrogens, estrogen agonists/antagonists, fluconazole, rifampin, ketoconazole, warfarin, highly protein-bound medicines, and medicines causing multiple enzyme inhibition.

During treatment

  • Assess any persistent or recurring abnormal genital or vaginal bleeding promptly to rule out malignancy.
  • Review possible adverse reactions and symptoms that could suggest stroke, deep-vein thrombosis, pulmonary embolism, chest symptoms, or breathing difficulty.
  • Keep clinician appointments and laboratory monitoring as directed.
(1) (2)

Storage

Storage requirements are not covered in the supplied research notes. Follow the dispensing label, package information, and pharmacist's instructions for the exact product.

Professional information

Clinician-facing context only. Use the current US OSPHENA prescribing information for indication, contraindications, duration, administration, interaction assessment, evaluation of abnormal bleeding, and cardiovascular risk assessment. Availability and product information outside the United States are unresolved in the supplied notes.

United States

Indication: Moderate-to-severe dyspareunia or moderate-to-severe vaginal dryness, each due to vulvar and vaginal atrophy from menopause

Dose summary: The supplied sources identify OSPHENA as a 60 mg ospemifene tablet but this draft does not provide a dosing schedule, duration recommendation, calculator, or treatment-selection approach. Follow the current prescription and US product information.

Renal context: Renal impairment dosing information is unresolved because it is not covered in the supplied research notes. (1) (2)

Australia, Canada, European Union, United Kingdom, and New Zealand

Indication: Availability, product details, and indication status are unresolved in the supplied research notes.

Dose summary: No regional dosing information is provided.

Renal context: No regional renal information is provided. (1) (2)

Mechanism of action

Hepatic guidance

Severe hepatic impairment requires prescriber assessment. The supplied research notes do not provide impairment-specific dosing.

Overdose note

Overdose management information is (1) (2)

Frequently asked questions

What is ospemifene used for in the United States?

The US label covers moderate-to-severe painful sexual intercourse (dyspareunia) and moderate-to-severe vaginal dryness when either is a symptom of vulvar and vaginal atrophy due to menopause. (1) (2)

Why does abnormal bleeding need assessment?

Ospemifene has estrogen-agonist effects in the endometrium and carries an endometrial-cancer risk warning. Persistent or recurring abnormal genital or vaginal bleeding after menopause needs prompt medical assessment to rule out malignancy. (1) (2)

What symptoms need emergency assessment?

Seek emergency assessment for possible stroke or blood-clot symptoms, such as sudden weakness or numbness, speech or vision changes, sudden severe headache, dizziness or fainting, leg pain or swelling with warm/red skin, chest pain, or shortness of breath. (1) (2)

Can ospemifene be used with estrogen or fluconazole?

No. The US label states not to use ospemifene concomitantly with estrogens, other estrogen agonists/antagonists, fluconazole, or rifampin. A prescriber or pharmacist should review the complete medication list. (1)

What is the mechanism of action of ospemifene?

Ospemifene is an estrogen agonist/antagonist with tissue-selective effects. The US label states that it has estrogen-agonist effects in the endometrium. (1) (2)

What is the generic name of Ospemifene?

The generic name is ospemifene. It is sold under brand names including OSPHENA. (1) (2)

What class of drug is ospemifene?

Ospemifene is classed as: Estrogen agonist/antagonist with tissue-selective effects. (1) (2)

References

  1. OSPHENA (ospemifene) tablets — prescribing informationU.S. Food and Drug Administration · United States · dated 2025-02 · accessed · source 1
  2. Ospemifene: MedlinePlus Drug InformationMedlinePlus, U.S. National Library of Medicine · United States · accessed 2026-08-01 · source 2
  3. OSPHENA (OSPEMIFENE) TABLET, FILM COATED [DUCHESNAY USA, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
  4. Osphena — FDA approval record (Drugs@FDA NDA203505)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
  5. ospemifene — RxNorm normalized drug concept (RXCUI 1370971)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5

Brand names by country

Single-ingredient ospemifene names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Osphena60 mg · duchesnay usa, inc.

United Kingdom

  • Awaiting verificationbeing checked · Unresolved

Canada

  • Awaiting verificationbeing checked · Unresolved

Australia

  • Awaiting verificationbeing checked · Unresolved

New Zealand

  • Awaiting verificationbeing checked · Unresolved
View brands in additional countries.

European Union

Awaiting verification

This page provides general medicine information, not a diagnosis, hormone-treatment recommendation, eligibility assessment, prescription, dosing plan, or substitute for urgent assessment of abnormal bleeding or possible stroke, blood-clot, chest, or breathing symptoms.

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