Ospemifene
Ospemifene is a once-daily oral estrogen agonist/antagonist used after menopause to treat moderate to severe painful sex and vaginal dryness caused by vulvar and vaginal atrophy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Ospemifene (Osphena) is a once-daily tablet, on the market since about 2013, for moderate to severe painful sex and vaginal dryness after menopause; it acts like estrogen in some tissues, including the vagina and uterine lining, and blocks estrogen in others, and is usually an alternative for women who prefer not to use vaginal estrogen. Most women tolerate it reasonably well, and hot flushes are what people notice most, along with some vaginal discharge or muscle cramps. Its serious boxed warning covers endometrial cancer (cancer of the uterine lining), stroke and blood clots, so report unexplained vaginal bleeding, stroke signs or a swollen, painful leg right away.
Clinical pearls
- Take it with a meal every day, because food raises how much of the drug your body absorbs.
- Fluconazole, a common yeast infection medicine, should not be taken with it, and neither should the antibiotic rifampin.
- Do not combine it with other estrogens, including vaginal estrogen creams, or similar drugs, since the pairing has not been studied.
- Use it for the shortest time that helps, with periodic rechecks, yearly breast exams and regular mammograms.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Osphena can raise the risk of endometrial cancer (cancer of the uterine lining) and of stroke and blood clots.
Estrogen-like effects on the uterine lining raise cancer risk in women with a uterus who use estrogens without a balancing hormone. Women with unexplained, persistent or recurring vaginal bleeding after menopause need testing to rule out cancer.
In trials of up to 15 months, strokes and deep vein thrombosis (leg clots) were reported. Estrogen-alone therapy has also been linked to stroke and DVT in older studies. Your prescriber should use the shortest treatment time that meets your goals. Watch for stroke symptoms, leg swelling or pain, and abnormal bleeding.
Patient information guide A plain-language walkthrough of Ospemifene, written from its FDA label.
What Ospemifene is used for
▾
Ospemifene is used after menopause for symptoms of vulvar and vaginal atrophy.
- Osphena tablets treat moderate to severe dyspareunia (painful sex) due to menopause.
- Osphena tablets treat moderate to severe vaginal dryness due to menopause.
How Ospemifene works
▾
Ospemifene binds to estrogen receptors. In some tissues it activates estrogen pathways. In others it blocks them.
In the uterine lining, it has estrogen-like effects. That is why the label carries an endometrial cancer warning.
Ospemifene dosage
▾
Osphena is a tablet taken by mouth once a day with food. Food increases how much of the drug your body absorbs. Your prescriber should use it for the shortest time that fits your goals and recheck whether you still need it.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Ospemifene prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause
- One 60 mg tablet taken orally with food once daily
- Taken with food
- Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause
- One 60 mg tablet taken orally with food once daily
- Taken with food
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION OSPHENA is an estrogen agonist/antagonist which has agonistic effects on the endometrium [see Warnings and Precautions (5.2) ]. 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. ( 2.1 , 2.2 ) 2.1 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause One 60 mg tablet taken orally with food once daily. 2.2 Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause One 60 mg tablet taken orally with food once daily.
Read the full Dosage and Administration section on DailyMed →
Ospemifene side effects
▾
The most common side effects in trials were:
Common side effects
- Hot flushes
- Vaginal discharge
- Muscle spasms
- Headache
- Excess sweating
- Night sweats
- Vaginal bleeding
When to get medical help
- Get emergency help right away if you have signs of a stroke. The label says to stop Osphena immediately if a stroke occurs or is suspected.
- Get help right away and stop the medicine if you suspect a blood clot in a leg (deep vein thrombosis) or lung (pulmonary embolism).
- Call your doctor about any unexplained vaginal bleeding that is persistent or keeps coming back, since endometrial cancer must be ruled out.
- Seek help for signs of a serious allergic reaction such as swelling (angioedema), hives, rash or itching.
- Report any heart attack symptoms immediately. Heart attacks occurred in two women taking ospemifene in trials.
Ospemifene warnings and precautions
▾
- Endometrial cancer: Osphena acts like estrogen on the uterine lining. Persistent or recurring unexplained bleeding needs evaluation.
- Stroke and blood clots: Strokes and DVT were reported in trials. Stop it immediately if a stroke or clot is suspected.
- Heart attack: Two cases occurred in women taking ospemifene in trials.
- Breast cancer: It should not be used with known, suspected or past breast cancer.
- Liver: It should not be used with severe liver impairment.
- Surgery or immobility: If feasible, stop it at least 4 to 6 weeks beforehand.
Ospemifene interactions
▾
Several medicines change ospemifene levels or should not be combined with it.
- Fluconazole: raises ospemifene levels. Do not combine.
- Rifampin: lowers ospemifene levels. Do not combine.
- Estrogens and other estrogen agonist/antagonists: safety together is unknown. Do not combine.
- Ketoconazole: raises levels and may increase side effects.
- Other CYP3A4 and CYP2C9 inhibitors: may raise the risk of side effects.
- Highly protein-bound drugs: exposure to either drug may increase.
- Warfarin: effect on INR was not studied.
Interactions listed in the FDA-approved label
From the Ospemifene prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Estrogens and estrogen agonists/antagonists: The safety of concomitant use of OSPHENA with estrogens and estrogen agonists/antagonists has not been studied. Do not use OSPHENA concomitantly with estrogens and estrogen agonists/antagonists.
- Fluconazole: Fluconazole, a moderate CYP3A / strong CYP2C9 / moderate CYP2C19 inhibitor, increases the systemic exposure of ospemifene by 2.7-fold and may increase the risk of OSPHENA-related adverse reactions. Do not use OSPHENA concomitantly with fluconazole.
- Rifampin: Rifampin, a strong CYP3A4 / moderate CYP2C9 / moderate CYP2C19 inducer, decreases the systemic exposure of ospemifene by 58%, which may decrease the clinical effect. Do not use rifampin concomitantly with OSPHENA.
- Ketoconazole: Ketoconazole, a strong CYP3A4 inhibitor, increases the systemic exposure of ospemifene by 1.4-fold; chronic administration with ospemifene may increase the risk of OSPHENA-related adverse reactions.
- Warfarin: Repeated administration of ospemifene had no effect on the pharmacokinetics of a single 10 mg dose of warfarin; no study was conducted with multiple doses of warfarin, and the effect of ospemifene on INR or PT was not studied.
- Highly protein-bound drugs: Ospemifene is more than 99% bound to serum proteins and might affect the protein binding of other drugs; use with other highly protein-bound drug products may lead to increased exposure of either that drug or ospemifene.
- Drugs that inhibit CYP3A4 and CYP2C9: Co-administration of OSPHENA with a drug known to inhibit CYP3A4 and CYP2C9 isoenzymes may increase the risk of OSPHENA-related adverse reactions.
Read the label’s full interactions text
7 DRUG INTERACTIONS 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. ( 7.1 , 12.3 ) Do not use fluconazole concomitantly with OSPHENA. Fluconazole increases serum concentrations of OSPHENA. ( 7.2 , 12.3 ) Do not use rifampin concomitantly with OSPHENA. Rifampin decreases serum concentration of OSPHENA. ( 7.2 , 12.3 ) 7.1 Estrogens and Estrogen Agonist/Antagonist Do not use OSPHENA concomitantly with estrogens and estrogen agonists/antagonists. The safety of concomitant use of OSPHENA with estrogens and estrogen agonists/antagonists has not been studied. 7.2 Fluconazole Do not use OSPHENA concomitantly with fluconazole, a moderate CYP3A / strong CYP2C9 / moderate CYP2C19 inhibitor. Fluconazole increases the systemic exposure of ospemifene by 2.7-fold. Administration of fluconazole with ospemifene may increase the risk of OSPHENA-related adverse reactions [see Clinical Pharmacology (12.3) ] . 7.3 Rifampin Rifampin, a strong CYP3A4 / moderate CYP2C9 / moderate CYP2C19 inducer, decreases the systemic exposure of ospemifene by 58%. Therefore, co-administration of OSPHENA with drugs such as rifampin which induce CYP3A4, CYP2C9 and/or CYP2C19 activity would be expected to decrease the systemic exposure of ospemifene, which may decrease the clinical effect [see Clinical Pharmacology (12.3) ] . 7.4 Ketoconazole Ketoconazole, a strong CYP3A4 inhibitor, increases the systemic exposure of ospemifene by 1.4-fold. Administration of ketoconazole chronically with ospemifene may increase the risk of OSPHENA-related adverse reactions [see Clinical Pharmacology (12.3) ] . 7.5 Warfarin Repeated administration of ospemifene had no effect on the pharmacokinetics of a single 10 mg dose of warfarin. No study was conducted with multiple doses of warfarin.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Ospemifene
▾
- Do not use if pregnant or possibly pregnant.
- Do not use with undiagnosed abnormal vaginal bleeding.
- Do not use with estrogen-dependent cancer or breast cancer (known, suspected or past).
- Do not use with active or past DVT, PE, stroke or heart attack.
- Do not use with allergy to ospemifene or its ingredients.
- Do not use with severe liver impairment.
- Not for children.
- Older adults had no meaningful differences in safety or effectiveness.
- It is not known whether it passes into breast milk.
What Ospemifene does in the body
▾
Blood estrogen levels do not predict how well an individual woman responds to ospemifene or her risk of side effects.
How your body processes Ospemifene
▾
Ospemifene peaks in the blood about 2 hours after a dose when fasting and about 2.5 hours with food. Food increases absorption about 2- to 3-fold. It is more than 99 percent bound to proteins and is broken down in the liver mainly by CYP3A4, CYP2C9 and CYP2C19. Its half-life is about 26 hours, steady state is reached in about nine days, and most of it leaves in the stool.
How to store Ospemifene
▾
Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Ospemifene
155 supplements and herbal products have documented interactions with Ospemifene in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 112
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Ospemifene: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Ospemifene — the kind of thing our pharmacy team would talk through with you at the counter.
What is Osphena for?
▾
How should I take it?
▾
What side effects should I expect?
▾
What warning signs mean I should get help right away?
▾
Are there medicines I shouldn't take with it?
▾
Can I take it if I might be pregnant or have a history of breast cancer?
▾
Is Ospemifene available over the counter?
▾
When was Ospemifene first available?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Ospemifene on HelloPharmacist
Ospemifene forms and strengths (how it comes)
Ospemifene is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Osphena treats moderate to severe dyspareunia (painful sex) due to menopause.
- Osphena treats moderate to severe vaginal dryness due to menopause.
- Osphena is taken by mouth as one tablet once a day.
- Osphena should be taken with food.
- Osphena should be used for the shortest duration that fits your treatment goals and risks.
Ospemifene on the U.S. market: products, makers and brands
How Ospemifene appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Ospemifene product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2013. Brand names on the directory include Osphena; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Ospemifene is used (Medicaid data)
A general measure of how commonly Ospemifene is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ospemifene is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ospemifene prescribed? Of the 1,601 medications we measure, Ospemifene ranks #1,336 by Medicaid prescriptions — more than 17% of them.
Utilization by Ospemifene product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
ospemifene 60 MG Oral Tablet
Summed across the 1 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1370976
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ospemifene, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 10 listed Ospemifene NDCs with Medicaid activity.
Compare Ospemifene products
A representative set of FDA-listed product records for Ospemifene — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 60 mg | Oral | Duchesnay USA, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Ospemifene NDCs →
Ospemifene side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ospemifene — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ospemifene in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ospemifene FDA approval history
How Ospemifene went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Ospemifene recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Ospemifene recalls since July 2021.
✅No Ospemifene recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1370971 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 1370975In current FDA listingsClinical drug / strength (SCD) 60 MGRxCUI 1370976
Look up RxCUI 1370971 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Ospemifene supply and shortage status
Whether Ospemifene is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Ospemifene costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 60 mg | $8.17 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Ospemifene brand names
Ospemifene is sold under one brand name in the FDA directory — Osphena. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ospemifene: manufacturers and labelers
One company lists Ospemifene products with the FDA. By number of product records, the largest are Duchesnay USA, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Ospemifene drug class (RxNorm)
Ospemifene belongs to the Estrogen Agonist/Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Ospemifene page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Duchesnay USA, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →