Is Tibolone Available in the US?

The HRT Index Editorial TeamIndependent women's health research

Published:August 28, 2026Last reviewed:August 28, 2026

Editorial research — not medically reviewed by a clinician. Why this label

Last updated: August 28, 2026 · Last verified: August 28, 2026 · By The HRT Index Editorial Team. Educational research, not medical advice, and not reviewed by a clinician. See our medical review policy. Full disclosure.

Need a U.S. care route instead?

Tibolone is not an FDA-approved U.S. prescription. If you are comparing alternatives, the right conversation depends on the symptom, your uterus status, risk history, medication route, insurance, and state. Use the free path tool to organize that next step before a consult.

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Is tibolone available in the US? No—not as an FDA-approved prescription drug, and it has never been FDA-approved. Organon announced in June 2006 that FDA had found its application “not approvable” and that it planned to withdraw it. Tibolone remains authorized in several other countries, but there is no exact FDA-approved U.S. equivalent.

Here’s the part almost nobody tells you: for hot flashes and night sweats, the pooled trial evidence found tibolone worked less well than combined hormone therapy. Its appeal was a different package — one tablet, no separately added progestogen under foreign labels, less unscheduled bleeding than combined therapy, and some androgenic activity. That changes what you should ask for in the U.S. Cochrane review, 2016

Your question	The verified answer
Is tibolone FDA-approved in the US?	No. We found no FDA-approved tibolone product in current U.S. approval records.
What happened to the U.S. application?	FDA found it “not approvable,” announced June 2, 2006. Organon said it planned to withdraw the application. Source
Is “banned” the right word?	No. FDA did not approve it, and there was no approved U.S. tibolone product later withdrawn from the market. “Not FDA-approved” is the accurate description.
Is tibolone used elsewhere?	Yes. We verified current authorization or registration in the United Kingdom, Ireland, Canada, and Australia.
Is there an exact FDA-approved U.S. equivalent?	No. There are U.S. treatment paths for the individual jobs tibolone was used for, but no single approved drug reproduces its full profile.
Can a U.S. resident order it from overseas?	In most circumstances, importing an unapproved drug for personal use violates federal law. FDA enforcement discretion is narrow and never guaranteed. FDA
Can a foreign visitor bring her existing supply?	FDA gives foreign nationals separate guidance and says they may bring or ship a 90-day supply with supporting documentation. That is not a routine refill path for a U.S. resident. FDA
Can a compounding pharmacy make it?	We did not verify a routine federal bulk-drug pathway for tibolone under section 503A or 503B. That is not a categorical legal opinion about every pharmacy; the full audit is below.

This page is for you if

You heard about tibolone, Livial, or Tibella and want to know why you cannot get it from a U.S. pharmacy.
Your clinician said “that is not available here,” and you want the full story instead of a brush-off.
You already take tibolone abroad and are visiting or moving to the United States.
You found a website selling it and want to know where you stand before sending money or medication across a border.

This page is not for you if you live in a country where tibolone is prescribed and want personal dosing or side-effect instructions. That belongs with your prescriber under your country’s current product label. We will not pretend otherwise.

Before you go further

The right online HRT provider isn't the same for every woman — it depends on your symptoms, your age and whether you have a uterus, your medication route preference (patch, pill, gel, or vaginal estrogen), your risk history, your insurance or cash-pay situation, and your state. Some situations belong with an in-person clinician first. Because a general answer can't resolve those for you, use The HRT Index's Find My HRT Path tool to match your situation to the right provider — and to flag when online care isn't the right starting point — before your first consult.

The HRT Index is the independent decision resource for online menopause and HRT care — comparing telehealth providers on clinical legitimacy, care quality, medication fit, price transparency, and access, with every claim verified and dated, so women can choose the path that fits their situation before their first consult.

→ Not sure what you would even ask for instead? Get your personalized HRT action plan — free, about 60 seconds.

Is tibolone available in the US right now?

No. There is no FDA-approved tibolone product for a U.S. pharmacy to dispense. The public record shows the 2006 application was found “not approvable,” and our August 2026 search found no later FDA approval. A temporary foreign visitor carrying an existing supply is a separate import situation; it does not create a U.S. prescription or refill route.

We checked the five routes a real person is likely to consider.

The route	What the current record says	Our finding, August 2026
A local U.S. retail pharmacy	No FDA-approved tibolone product appears in current U.S. approval records. A foreign prescription does not create an approved U.S. product for the pharmacy to dispense.	No routine fill
A patient-specific 503A compounder	Tibolone is not a component of an FDA-approved drug and does not appear on the current codified 503A bulks list or FDA’s May 2026 nomination-category document. We could not independently confirm an applicable USP/NF drug-substance monograph from public sources.	No routine federal pathway verified
A 503B outsourcing facility	Tibolone does not appear on FDA’s current 503B clinical-need list. We also found no tibolone entry on the U.S. drug-shortage route that can permit certain 503B bulk compounding.	No routine federal pathway verified
A U.S. resident ordering from a foreign seller	FDA says that, in most circumstances, personal importation of an unapproved drug is illegal. Its enforcement-discretion policy is limited and does not guarantee admission.	Not a reliable lawful access route
A foreign national visiting, studying, or working temporarily in the U.S.	FDA says foreign nationals may bring or ship a 90-day supply and should carry a passport plus a doctor’s letter or valid prescription.	A documented visitor exception — not a U.S. refill

That is the whole practical map.

If you felt like your clinician brushed you off, the core answer was still real: there is no FDA-approved tibolone product she can send to an American pharmacy. What may have been missing was the explanation of why — and what to discuss instead.

Is tibolone banned in the US, or just not FDA-approved?

“Banned” is misleading. Tibolone was not approved for U.S. marketing, and no approved U.S. tibolone product was later removed. The accurate phrase is “not FDA-approved” or, in the context of U.S. marketing law, an unapproved new drug.

That distinction matters because “banned” tells a story the record does not support. It makes it sound as though American women used tibolone, a safety event forced it off shelves, and FDA prohibited its return. That did not happen here.

The documented story is simpler: Organon submitted an application; FDA found it not approvable; Organon said it planned to withdraw the application. Organon announcement

The FDA database trap

Here is a detail that catches people because it looks official enough to settle the question.

Search FDA’s substance registry for tibolone and you will get a result: UNII FF9X0205V2. That record identifies the chemical so regulators and data systems can refer to the same substance. It is not a drug approval. FDA states on the record itself that UNII availability does not imply regulatory review or approval. FDA Global Substance Registration System

A seller can point to an FDA database entry and still be selling a drug that has never been FDA-approved.

An ingredient identity record is a filing-cabinet label, not a permission slip.

What happened to tibolone’s FDA application in 2006?

Organon amended its New Drug Application in December 2005. On June 2, 2006, the company announced that FDA had found the application “not approvable” and that it planned to withdraw it. Four months earlier, the LIFT osteoporosis trial had been stopped after an interim analysis found increased stroke risk — but the public record does not establish that as FDA’s stated reason.

Here is the dated sequence.

When	What happened
December 2005	Organon filed an amendment to its U.S. New Drug Application for tibolone. Source
February 2006	The LIFT trial was stopped on the recommendation of its data and safety monitoring board because the tibolone group had an increased risk of stroke. Trial report
June 2, 2006	Organon announced that FDA had determined the application was “not approvable.” The company said it planned to withdraw it. Source
August 2008	LIFT was published in the New England Journal of Medicine: fewer vertebral and nonvertebral fractures, fewer invasive breast cancers, and a higher stroke hazard in the studied population. Trial report
February 2009	LIBERATE was published in The Lancet Oncology: breast-cancer survivors assigned tibolone had a higher recurrence risk, and the trial was stopped early. PubMed

What the public record does not say

We want to be straight with you here, because a clean story is not the same thing as a documented story.

We did not find FDA’s 2006 letter or a complete FDA review explaining the agency’s reasoning in the public record.

So when a page says, “FDA rejected tibolone because of stroke risk,” it has converted a timeline into a motive. The timing is real: LIFT stopped in February and the not-approvable announcement came in June. The complete regulatory reasoning is not public.

We will give you the dates. We will not invent the missing letter.

What the LIFT and LIBERATE trials actually showed

LIFT enrolled 4,538 women ages 60 to 85 with osteoporosis and compared tibolone 1.25 mg daily with placebo for a median of 34 months. Trial report

Vertebral fractures: relative hazard 0.55
Nonvertebral fractures: relative hazard 0.74
Invasive breast cancer: relative hazard 0.32
Colon cancer: relative hazard 0.31
Stroke: relative hazard 2.19 (95% confidence interval 1.14–4.23)

The trial stopped because of the stroke finding.

LIBERATE enrolled 3,098 women with a history of breast cancer and menopausal symptoms. Breast-cancer recurrence was higher with tibolone: hazard ratio 1.40 (95% confidence interval 1.14–1.70). The trial was stopped early. PubMed

That finding is why the current UK label lists known, past, or suspected breast cancer as a contraindication and explicitly notes the recurrence result. UK Livial label

The fair reading

Leaving out the population would be dishonest in the other direction.

LIFT studied older women with osteoporosis, not a representative group of healthy 51-year-olds starting treatment for night sweats. It also studied 1.25 mg, while the commonly marketed symptom-treatment tablet abroad is 2.5 mg. The trial proves a stroke signal in the population it studied. It does not directly quantify the risk for every younger symptomatic woman.

So: the stroke signal is real, and the exact risk for a different woman at a different age is not supplied by LIFT. Both things are true. Anyone selling only one half is selling you something.

Where is tibolone actually available?

Tibolone remains an authorized prescription medicine in multiple countries. We verified current records in the United Kingdom, Ireland, Canada, and Australia. Those approvals come with real restrictions — including breast-cancer contraindications, postmenopause timing rules, and explicit stroke consideration in older women — and none of them creates U.S. approval.

Jurisdiction	Current status verified	Product or brand	What the current record says
United States	No FDA-approved product found	—	Organon announced “not approvable” in June 2006; no later FDA approval was found in our August 2026 check.
United Kingdom	Authorized, prescription-only	Livial; generic tibolone 2.5 mg	Start at least 12 months after the last natural bleed; surgical-menopause treatment may begin immediately; no separate progestogen should be added; stroke risk deserves particular consideration over age 60. Current SmPC
Ireland	Authorized medicine record verified	Livial 2.5 mg	HPRA product information confirms a current authorized Livial record. HPRA
Canada	Approved in 2019	Tibella 2.5 mg	Short-term treatment of menopausal vasomotor symptoms after more than 12 months since the last period; the approved indication is for women with an intact uterus. Health Canada
Australia	Active ARTG registrations	Livial and multiple generics	Short-term treatment of menopausal symptoms; bone-loss prevention is second-line for women who cannot take or tolerate other approved options. TGA Livial record TGA generic decision

The Canada fact that reframes the argument

Health Canada approved Tibella in 2019. That is recent enough to matter and close enough geographically to feel maddening.

But it proves something different from “America is behind.” It proves that regulators can review the same drug under different submissions, labels, evidence packages, and legal standards and reach different outcomes. Canada’s decision did not cross the border with the tablets.

Foreign approval is real. U.S. approval is still absent. Both facts can exist at once.

One number we will not repeat

You will see claims that tibolone is approved in “90 countries.” That number appears in older papers and press coverage. We did not verify a current worldwide count, so we are not printing it as a 2026 fact.

What we did verify this month is more useful: the named regulator, current status, product, and material label limits in the jurisdictions above.

Can I buy or import tibolone into the United States?

A U.S. resident cannot treat a foreign website as a dependable legal tibolone pharmacy. FDA says that, in most circumstances, importing an unapproved drug for personal use is illegal. Its personal-importation policy describes limited enforcement discretion, not approval or a guaranteed right. Foreign nationals temporarily in the U.S. have separate 90-day guidance.

Let’s separate the situations, because collapsing them into one answer creates bad advice.

If you are a U.S. citizen or permanent resident ordering from overseas

FDA’s current consumer guidance says that, in most circumstances, it is illegal for individuals to import an unapproved drug for personal use. A medicine approved in the UK, Canada, or Australia is still unapproved in the United States unless FDA has approved it here. FDA personal-importation guidance

FDA may consider enforcement discretion in limited cases. Its published factors include the nature and seriousness of the condition, domestic treatment availability, promotion to U.S. residents, unreasonable risk, written confirmation of personal use, a supply generally no greater than three months, and physician involvement or evidence that the drug continues treatment begun abroad.

That is not a checkout guarantee. FDA can refuse entry.

The practical answer for a U.S. resident is still no: an offshore order is not a reliable lawful access path.

If you are a foreign national visiting, studying, or working temporarily in the U.S.

This is the exception the original one-line answers usually miss.

FDA says it will allow foreign nationals to bring or ship a 90-day supply of drug products. It recommends carrying or including a passport, a doctor’s letter, and a valid foreign prescription or other evidence that the medication is for personal use during the stay. For stays longer than 90 days, FDA says additional medication may be sent, again with documentation. FDA personal-importation guidance

That helps a temporary visitor continue an existing treatment. It does not turn tibolone into a U.S.-approved product, make a U.S. pharmacy able to refill it, or settle what happens when someone becomes a U.S. permanent resident.

If you are moving to the U.S. permanently

Do not build your transition around future packages clearing the border.

Bring an appropriately documented personal supply under the guidance that applies to your immigration and travel status, then arrange a U.S. clinical handoff before it runs low. The goal is not to find a cleverer shipment. The goal is to avoid an abrupt gap while a U.S. clinician builds a lawful replacement plan around the symptom tibolone was controlling.

What an offshore seller cannot give you

We are not going to lecture you. Looking at an import site when you are exhausted and your clinician said no is a completely human thing to do.

But outside the legitimate U.S. supply chain, FDA cannot give you the same assurance about:

the product’s identity and strength;
who manufactured it;
whether it was stored and transported correctly;
whether the labeling is accurate; or
whether the medicine is counterfeit, contaminated, substandard, or different from what was ordered. FDA human-drug imports

We do not link to any seller of tibolone. Not one. A page that makes money by sending you to an unapproved-drug seller is not resolving your risk; it is becoming part of it.

Can a US compounding pharmacy make tibolone?

We did not verify a routine federal bulk-drug pathway for tibolone under either section 503A or section 503B. Tibolone is not a component of an FDA-approved U.S. drug and does not appear on the current federal lists we checked. Because USP/NF status and state law can matter, this is not a categorical legal opinion about every pharmacy.

Compounding is not one single federal category.

Section 503A generally covers patient-specific compounding by a state-licensed pharmacy, federal facility, or licensed physician that is not registered as an outsourcing facility.
Section 503B covers FDA-registered outsourcing facilities and uses a different bulk-substance framework. FDA comparison of 503A and 503B

The section 503A check

For a 503A compounder using a bulk drug substance, federal law turns on an applicable USP/NF monograph, whether the substance is a component of an FDA-approved drug, or whether it qualifies through the 503A bulks-list process. FDA also maintains an interim policy while nominated substances are evaluated. FDA 503A overview

503A question	What we verified for tibolone
Is tibolone a component of an FDA-approved U.S. drug?	No FDA-approved tibolone product was found. That route is not available on the current approval record.
Is tibolone on the codified 503A bulks list?	No. The current regulation lists six substances; tibolone is not one of them. 21 CFR § 216.23
Is tibolone in FDA’s May 2026 503A nomination categories?	We did not find tibolone in the current Category 1, 2, or 3 document. FDA nomination document
Is there an applicable USP/NF drug-substance monograph?	We could not independently confirm one from publicly accessible USP/NF material. We will not convert that access limitation into a claim that none exists.

The section 503B check

A 503B outsourcing facility may use a bulk drug substance when the drug compounded from it appears on FDA’s shortage list at the relevant times or when the substance appears on FDA’s list of bulk substances for which there is a clinical need. FDA 503B overview

We found no tibolone entry on the current 503B clinical-need list and no U.S. tibolone product on the drug-shortage route. FDA 503B bulks list

What to ask if a pharmacy says it can make tibolone

Ask this, in writing:

“Are you compounding under section 503A or section 503B, and which federal bulk-drug condition and state-law authority are you relying on for tibolone?”

A specific answer can be checked. “We have done it for years” is not a legal pathway.

And keep the categories straight: a compounded preparation is not an FDA-approved medication. FDA does not review compounded drugs for safety, effectiveness, or manufacturing quality before marketing. Compounding can serve legitimate patient needs, but it does not convert tibolone into an FDA-approved U.S. product. FDA compounding basics

You now have the full access picture: no FDA-approved retail path and no routine federal compounding path we could verify. That is the bad news out of the way. The useful question is what you hoped tibolone would fix.

→ Use Find My HRT Path to turn that goal into a U.S. care route you can take to a consult.

Is tibolone actually better than the HRT you can already get here?

For hot flashes and night sweats, no. A 2016 Cochrane review of 46 randomized trials involving 19,976 women found tibolone worked better than placebo but less well than combined hormone therapy. Its advantages were its overall profile — including one-tablet dosing, no separately added progestogen under foreign labels, less unscheduled bleeding than combined therapy, and androgenic activity — not stronger vasomotor control.

We will be honest about the incentive here.

This page would be more dramatic, and probably more shareable, if we told you America was denying you a miracle drug.

The evidence does not say that. So we are not going to.

The numbers that change the search

Cochrane pooled 46 randomized controlled trials with 19,976 women. Evidence was current to October 2015. Cochrane review

For vasomotor symptoms, its plain-language estimates were:

If 67 of 100 women taking placebo still had vasomotor symptoms, about 35 to 45 of 100 taking tibolone would.
If 7 of 100 women taking combined hormone therapy still had them, about 8 to 14 of 100 taking tibolone would.

Read the second pair again. In the pooled randomized evidence, combined hormone therapy controlled vasomotor symptoms better.

Cochrane rated that comparison moderate-quality evidence. It also reported that 26 of the included studies were funded by drug manufacturers.

Bleeding is where tibolone’s profile looked different

The same review found tibolone caused more unscheduled bleeding than placebo but less than combined hormone therapy:

Placebo: about 18 of 100
Tibolone: about 31 to 44 of 100 when compared with placebo
Combined hormone therapy: about 47 of 100
Tibolone: about 18 to 27 of 100 when compared with combined therapy

That does not mean “no bleeding.” It means less unscheduled bleeding than combined therapy in the pooled trials.

So why did women and clinicians abroad value it?

Because the point was the package, not raw hot-flash potency.

1. One daily tablet.
2. No separately added progestogen under the UK label.
3. Less unscheduled bleeding than combined hormone therapy in pooled trials.
4. Metabolites with estrogenic, progestogenic, and androgenic activity — without literally containing estrogen, progesterone, and testosterone as three ingredients.
5. A distinct option for women whose treatment priorities went beyond vasomotor symptoms alone.

That is a real and unusual package.

It is just not a stronger hot-flash drug.

The better question is not “Am I missing the best HRT?” It is “Which part of tibolone’s profile did I want, and what is the lawful U.S. discussion path for that job?”

What is the US equivalent of tibolone?

There is no single FDA-approved U.S. equivalent. Tibolone’s metabolites create a mixed estrogenic, progestogenic, and androgenic profile that no approved U.S. product reproduces. The United States does have treatment paths for each major goal — vasomotor symptoms, a simpler regimen, sexual concerns, vaginal symptoms, and bone protection — but the right path depends on the job, not the foreign brand name.

This is the table the page needed to exist.

What you wanted tibolone to do	What tibolone evidence or foreign labels show	FDA-approved U.S. discussion paths, August 2026	The honest bottom line
Control hot flashes and night sweats	Better than placebo, less effective than combined hormone therapy in the 2016 Cochrane review.	Systemic estrogen in a patch, gel, spray, or pill, with appropriate endometrial protection when a woman has a uterus; continuous combination products; nonhormonal options including fezolinetant (Veozah) and elinzanetant (Lynkuet). Veozah carries an FDA boxed warning for rare serious liver injury and requires label-directed liver testing. FDA Veozah warning FDA Lynkuet	You are not missing a stronger vasomotor treatment. The U.S. menu is broader, but candidacy and route matter.
Give me one pill without a separately added progestogen	UK labeling says a separate progestogen should not be added to tibolone. Cochrane found less unscheduled bleeding than combined therapy, not zero bleeding.	Single-tablet continuous estrogen/progestogen products exist. Duavee combines conjugated estrogens with bazedoxifene for women with a uterus and does not use a progestin. Duavee label	Duavee shares one practical feature, not the molecule or full profile. Other single-tablet regimens still contain a progestogen.
Help sexual desire or give me the androgenic part	In the 403-woman LISA trial, both tibolone and an estradiol/norethisterone patch improved sexual-function measures. Tibolone’s advantage on the primary FSFI analysis appeared in the per-protocol analysis, not the intent-to-treat analysis; satisfying sexual events improved similarly. PubMed	Addyi is now FDA-approved for women under 65 with acquired, generalized HSDD that meets the label definition, including qualifying postmenopausal women. Vyleesi remains approved for premenopausal women with acquired, generalized HSDD. No testosterone product is FDA-approved for women. Addyi label, revised December 2025 Vyleesi label	This remains the closest thing to a true profile gap. U.S. options exist for specific diagnoses, but no approved drug recreates tibolone’s androgenic component.
Treat vaginal dryness or painful sex	Tibolone can improve vaginal symptoms, but it is systemic treatment.	FDA-approved local vaginal estrogen products; prasterone (Intrarosa) for moderate-to-severe dyspareunia due to menopause; ospemifene (Osphena) for labeled vulvovaginal symptoms. Intrarosa label Osphena label	A targeted local or symptom-specific route may make more sense than chasing a systemic foreign tablet.
Protect bone	LIFT reduced vertebral and nonvertebral fractures but was stopped for stroke. UK and Australian records position tibolone for bone prevention only when other approved options are unsuitable or not tolerated.	Estrogen may be considered for prevention in appropriate women; osteoporosis-specific options include bisphosphonates, denosumab, raloxifene, romosozumab, teriparatide, and abaloparatide, chosen by fracture risk and medical history.	Tibolone is not the missing first-line U.S. bone drug. Bone treatment deserves its own risk-based decision.

The libido row needs a straight answer

We are not going to soften this one because you would be able to tell.

If what drew you to tibolone was the report that it could help desire in a way plain estrogen did not, that is not imaginary. Tibolone has androgenic activity, and the LISA trial did find a larger FSFI improvement in the per-protocol analysis. But the trial did not show a clean across-the-board victory: the intent-to-treat primary analysis was not significant, and satisfying sexual events improved similarly in both treatment groups. LISA trial

The U.S. gap is narrower and more precise than “nothing exists for libido”:

Addyi’s label was expanded in December 2025 to women under 65 with acquired, generalized HSDD, regardless of menopause status, when the label’s diagnostic conditions are met. Current label
Vyleesi is still labeled for qualifying premenopausal women. Current label
Pain, dryness, medication effects, relationship factors, mood, sleep, and other medical causes can require a different path entirely.
No testosterone product is FDA-approved for women. FDA-approved testosterone products are approved for men with low testosterone tied to an associated medical condition. FDA

Some clinicians prescribe testosterone off-label for carefully evaluated women. Testosterone is a Schedule III controlled substance in the United States and requires a prescription from a licensed clinician. Compounded testosterone is not FDA-approved. ISSWSH clinical guideline 21 CFR § 1308.13

That is not a tibolone workaround. It is a separate clinical decision with its own indication, monitoring, risks, and prescription requirements.

→ Want the version of this table that starts with your symptoms, uterus status, state, insurance, and risk history? Get your personalized HRT action plan.

Is Duavee the same as tibolone?

No. Duavee contains conjugated estrogens plus bazedoxifene; tibolone is a different synthetic steroid with different metabolites. Duavee is FDA-approved for moderate-to-severe vasomotor symptoms and prevention of postmenopausal osteoporosis in women with a uterus. It shares one useful feature with tibolone — no separately added progestin — but it is not a generic, equivalent, or automatic substitute.

People bring Duavee up in this conversation for a good reason.

What they share: both can be used, under their respective labels, without adding a separate progestogen or progestin. Duavee pairs estrogen with bazedoxifene, a selective estrogen receptor modulator, to reduce the risk of endometrial hyperplasia in women with a uterus. Duavee prescribing information

What they do not share: the molecules, metabolism, androgenic activity, contraindications, evidence base, and approved indications.

If the part of tibolone you wanted was “one tablet without a separate progestin,” Duavee is a reasonable name to bring to a U.S. consult. If the part you wanted was androgenic activity or a direct molecular equivalent, it is not the answer.

Do not build a treatment plan from this paragraph alone. A clinician still has to decide whether systemic estrogen is appropriate, whether you have a uterus, whether the label’s contraindications apply, and whether your insurance formulary covers the product.

What if I already take tibolone and I’m visiting or moving to the US?

Your first step depends on your status. A foreign national visiting, studying, or working temporarily may bring or ship a documented 90-day supply under FDA’s published guidance. Someone moving permanently should still plan a clinical handoff before the supply runs low, because a foreign prescription cannot make a U.S. pharmacy dispense a drug that is not FDA-approved here.

If this is you, you are the reader we most wanted to get right. You are not curious about a molecule. You are on something that works, and you are about to lose the normal way you obtain it.

If you are a temporary foreign visitor

Carry:

the medicine in its original labeled packaging;
your passport;
a copy of the valid foreign prescription; and
a letter from your prescribing clinician explaining that the medicine is for your personal use during the stay.

FDA’s page says foreign nationals may bring or ship a 90-day supply. Border and admission decisions still involve the relevant agencies, so keep the documentation together and check current FDA and U.S. Customs guidance before travel. FDA

Before a permanent move: get a clinical handover

Ask your current prescriber for an English-language summary on letterhead that includes:

the generic name tibolone, brand, manufacturer, and tablet strength;
your current schedule;
why it was prescribed;
when you started and what you tried before it;
whether you have a uterus and ovaries, plus relevant surgical history;
your bleeding history;
recent relevant monitoring or test results;
contraindications and risk history reviewed by the prescriber;
side effects or prior problems; and
the prescriber’s contact details.

That document is more valuable to a U.S. clinician than the foreign brand name by itself.

What not to assume

❌ A U.S. pharmacy can fill the foreign tibolone prescription.
❌ A mailed replacement will automatically clear the border.
❌ Duavee, an estrogen/progestogen product, or any other U.S. drug is automatically interchangeable.
❌ A compounder can recreate tibolone without a specific, checkable legal basis.
❌ Stopping or switching should be improvised without a clinician who knows your history.

Book before the supply becomes an emergency

Do not wait until you have three tablets left. Six to eight weeks of supply is a sensible planning window, not a medical rule: it gives you room to obtain records, book an appointment, complete any needed evaluation, and adjust a new regimen without turning the last blister pack into a countdown clock.

Lead with this:

“I have been taking tibolone since [date] for [reason]. This is what it controlled, this is what happened before I started it, and here is my prescriber’s summary. I know it is not available here. Can we build the closest appropriate U.S. plan around the same goal?”

When online-first care is the wrong starting point

Arrange direct in-person evaluation for unexplained postmenopausal bleeding or a complex history such as breast cancer, arterial or venous clotting disease, stroke, or active liver disease. New chest pain, shortness of breath, one-sided weakness, facial droop, severe sudden headache, or symptoms of a blood clot require urgent or emergency evaluation — not an online HRT intake.

The point is not to frighten you. The point is to put the right problem through the right door.

Who should not take tibolone — even where it is approved?

Foreign authorization does not mean open eligibility. The labels we verified contain major contraindications and restrictions: breast-cancer history, unexplained genital bleeding, thromboembolic disease, arterial events, active liver disease, and pregnancy or breastfeeding. They also require postmenopause timing and special stroke consideration in older women. Canada’s intact-uterus indication is jurisdiction-specific, not a universal rule.

Situation	What the verified foreign records say
Known, past, or suspected breast cancer	Contraindicated in the current UK label; the label cites increased recurrence in a placebo-controlled trial. LIBERATE reported recurrence HR 1.40. UK label LIBERATE
Less than 12 months since the last natural period	The UK and Canadian records place initiation after at least 12 months without a natural period. Surgical menopause is treated differently under the UK label.
Starting after age 60	Not an automatic ban. The UK label says the decision should particularly consider stroke risk in women over 60.
No uterus	Canada’s approved Tibella indication specifies women with an intact uterus. That is a Canadian indication limit, not a statement that every country contraindicates tibolone after hysterectomy.
Previous or current DVT or pulmonary embolism	Contraindicated in the UK label.
Known thrombophilic disorder	Contraindicated in the UK label.
History of angina, heart attack, stroke, or TIA	Contraindicated in the UK label.
Acute liver disease or liver tests not returned to normal after liver disease	Contraindicated in the UK label.
Unexplained genital bleeding	Contraindicated or requires investigation before treatment.
Osteoporosis as the first and only reason	UK and Australian positioning is not first-line: it is reserved for women at high fracture risk who cannot use or tolerate other approved options.
Pregnancy or breastfeeding	Contraindicated; tibolone is a postmenopausal prescription medicine.

Read that table honestly against your own history.

Some women searching for tibolone would be excluded or require extra caution even in countries where it sits on the pharmacy shelf. If several rows describe you, the feeling that America is withholding a simple answer may be pointing at a door that would not have opened cleanly in London, Toronto, or Sydney either.

That is not a consolation prize. It is useful information. It lets you stop chasing the wrong permission slip and start asking for the care path that can actually fit.

Which tibolone claims are true — and which ones fall apart?

Most tibolone claims circulating online contain a true fragment wrapped in a misleading conclusion. The table below separates chemical identity, FDA approval, foreign authorization, import rules, compounding, and U.S. alternatives so one true fact cannot be used to smuggle in a false promise.

The claim	Verdict	What we verified
“Tibolone is banned in America.”	Misleading	FDA did not approve it; no approved U.S. tibolone product was later withdrawn. “Not FDA-approved” is accurate.
“It is in an FDA database, so it must be approved.”	False	FDA’s UNII record expressly says substance registration does not imply review or approval.
“It is estrogen, progesterone, and testosterone in one pill.”	Oversimplified	Tibolone is one synthetic steroid. Its metabolites have estrogenic, progestogenic, and androgenic activity; the tablet does not contain those three hormones as separate ingredients.
“Livial and tibolone are different drugs.”	False	Livial is a brand of tibolone. Tibella is a Canadian brand.
“Tibella is the American version.”	False	Tibella was approved by Health Canada in 2019. There is no FDA-approved American version.
“It is approved abroad, so a U.S. resident can order it.”	False	Foreign approval does not equal FDA approval. Personal importation is generally illegal, and enforcement discretion is limited and not guaranteed.
“A foreign visitor cannot bring her existing medicine.”	False as a blanket statement	FDA gives foreign nationals separate guidance allowing a documented 90-day supply. That is not a U.S. refill route.
“A compounding pharmacy can just make it.”	Unsupported without a specific pathway	We did not verify a routine 503A or 503B bulk-drug pathway. A pharmacy should identify the exact federal condition and state-law authority it relies on.
“FDA rejected it because of the stroke risk.”	Not established by the public record	LIFT stopped for stroke in February 2006; the not-approvable announcement came in June. The complete FDA reasoning was not found publicly.
“Duavee is the same thing.”	False	Different drugs, different mechanisms, different labels. They share the practical feature of avoiding a separately added progestin.
“There has to be one U.S. equivalent.”	False	No one approved product recreates tibolone’s full profile. The U.S. answer changes by symptom and treatment goal.
“Addyi is only for premenopausal women.”	Outdated	The label revised in December 2025 covers women under 65 with qualifying acquired, generalized HSDD, including qualifying postmenopausal women.
“It is used worldwide, so it must be safe for everyone.”	False	Every current label we checked carries restrictions, contraindications, and individualized risk requirements.

What should I say at a US consult instead of asking for tibolone?

Lead with the job you wanted tibolone to do, not only the unavailable drug name. A U.S. clinician cannot dispense tibolone through a U.S. pharmacy, but she can evaluate the symptom, route preference, uterus status, risk history, and FDA-approved options behind your request. The scripts below keep the appointment from dying at “we do not prescribe that here.”

Pick the one that matches the row you cared about.

If you wanted it for hot flashes or night sweats:

“My vasomotor symptoms are still disrupting my sleep and daily life. Can we compare systemic hormone therapy with the FDA-approved nonhormonal options, including the route, benefits, monitoring, and risks that fit my history?”

If you wanted one tablet and no separately added progestin:

“The progestogen part of prior therapy was difficult for me. What single-tablet regimens could fit, and is Duavee worth discussing given that it uses bazedoxifene rather than a progestin?”

If desire is the main problem:

“Hot flashes are not my main issue — low desire is. Can we work out whether this is acquired, generalized HSDD, pain or vaginal symptoms, a medication effect, or something else? I also want to understand FDA-approved options, what would be off-label, and what monitoring each path requires.”

If vaginal dryness or painful sex is the main problem:

“My main problem is dryness and pain with sex. Can we compare local vaginal estrogen, prasterone, ospemifene, and any non-drug steps that fit my history instead of starting with a systemic tablet?”

If you are transferring from tibolone:

“I have taken tibolone since [date] for [reason], and this is what it controlled. I know it is not FDA-approved here. Here is my prescriber’s handover. Can we build the closest appropriate U.S. regimen around the same goal?”

Write your sentence down before the visit. Fifteen-minute appointments punish people who improvise.

Where can I discuss FDA-approved US alternatives online?

A menopause-focused telehealth visit can be a reasonable starting point for a straightforward case, but this page is not a reason to choose a compounded-first program or a clinic that promises tibolone. We verified two different U.S. care models that can discuss FDA-approved systemic, local, and nonhormonal options. Neither can turn tibolone into a U.S.-approved prescription.

Provider	What the provider says	What we independently checked in August 2026	Who this model may fit
Midi Health	Virtual menopause-focused care in all 50 states. Self-pay is $250 for the first visit and $150 for a returning visit; no membership fee is shown. Midi pricing	In-network with most PPO plans, with plan-specific coverage. Medicare is out of network; beneficiaries may self-pay but cannot submit Midi-related claims. Midi does not accept Medicaid or Medi-Cal patients. Appointment cancellation or rescheduling should be completed at least 24 hours ahead to avoid the stated fee. Midi cancellation	Stronger fit when you want a menopause-specialist model that can bill many commercial insurance plans and discuss FDA-approved hormone and nonhormone options.
Sesame Care	Cash-pay menopause subscription with provider selection, video visits as needed, messaging, and prescriptions sent to a local pharmacy when clinically appropriate. Medication costs are separate. Sesame menopause care	Sesame does not bill insurance for the program. Provider-ordered basic labs are included in most states, with stated payment exceptions in NY, NJ, RI, and ND. The page says members may self-cancel before the next billing cycle. One universal subscription price was not exposed in crawlable text, so confirm it during enrollment.	Better fit when you want a cash-pay subscription instead of insurance billing, plus messaging and included basic labs when ordered.

For a wider provider comparison by medication model, insurance, pricing, and access, see our best online HRT providers guide.

Why we did not route you to a compounded-first affiliate

We work with providers whose core offerings include compounded hormone therapy. We deliberately left them out of this section.

This page is about the absence of FDA approval. Sending you from “the drug you want is not FDA-approved” directly to “here is a compounded substitute” would blur the exact distinction the page spent thousands of words making clear.

Compounded preparations can be a legitimate category of care for a patient whose needs cannot be met by an approved product. They are still not FDA-approved, and we will not imply equivalence to tibolone or to any FDA-approved medication.

The honest limits

Midi does not accept Medicaid or Medi-Cal patients, even as self-pay patients. Medicare is out of network, although Medicare beneficiaries may self-pay under Midi’s stated policy. If either limitation applies, it may be the wrong door.

Sesame’s menopause program is a subscription, not the one-off pay-per-visit model the original draft described. Medication costs are separate, and the provider decides what is clinically appropriate. Its current program page also says its providers cannot prescribe controlled substances online, so it is not a route for online testosterone prescribing. Sesame program

And some situations should not begin with online-first care at all: unexplained postmenopausal bleeding, urgent clot or neurological symptoms, and complex cancer or vascular histories need direct clinical evaluation.

→ Does a specialist-insurance model, cash-pay subscription, or in-person route fit you better? Use Find My HRT Path before you book.

How did The HRT Index verify this page?

We did not search “Why is tibolone banned?” and copy the first answer. We started with the 2006 sponsor announcement, checked current U.S. approval, substance, import, shortage, and compounding records, opened current foreign regulator records, read the pivotal trials and Cochrane review, and re-checked provider claims against primary commercial pages.

This page was produced under The HRT Index Verification Standard. It evaluates provider information on five pillars, always in this order: clinical legitimacy, care quality, medication fit, price transparency, access.

What we actually verified

Claim type	Provider-stated or source-stated evidence	What The HRT Index independently checked	Refresh trigger
U.S. FDA status	Organon’s June 2, 2006 “not approvable” announcement	Current FDA approval and substance records; no later approval found	Monthly approval-record search; immediate refresh after an FDA or sponsor announcement
Personal importation	FDA’s current personal-importation page	Separate rules for U.S. residents and foreign nationals; the 90-day visitor guidance	Quarterly; immediate refresh after FDA or CBP policy change
503A compounding	FDA 503A pages, 21 CFR § 216.23, and the May 14, 2026 nomination-category document	No tibolone in the current codified list or nomination categories; USP/NF monograph status left explicitly unresolved	Quarterly; immediate refresh when FDA updates the lists or interim policy
503B compounding	FDA 503B clinical-need list and shortage records	No tibolone entry found on either current route	Quarterly; immediate refresh after list or shortage changes
Foreign availability	MHRA/eMC, HPRA, Health Canada, and TGA records	Product name, authorization status, dose, and material label limits in the jurisdictions shown	Quarterly; immediate refresh after safety alert, suspension, or label revision
Clinical evidence	LIFT, LIBERATE, LISA, and the 2016 Cochrane review	Population, dose, endpoint, analysis set, hazard ratio, confidence interval, and funding note where reported	Annual literature review; immediate refresh after major trial or guideline publication
U.S. drug labels	Current FDA or DailyMed prescribing information	Addyi’s December 2025 expansion, Duavee composition and indication, Veozah warning, and other label-specific statements	Quarterly; immediate refresh after label or safety-communication change
Midi commercial facts	Midi pricing, insurance, FAQ, and cancellation pages	$250 initial visit; $150 follow-up; no membership; all-state statement; PPO, Medicare, Medicaid/Medi-Cal, and 24-hour cancellation details	Monthly and before every page update
Sesame commercial facts	Sesame menopause-program and help pages	Subscription model; no insurance billing; medication separate; lab exceptions; self-cancellation; no universal crawlable price	Monthly and before every page update

Research limitations: FDA’s full 2006 review letter was not located in the public record. We could not independently verify an applicable USP/NF tibolone drug-substance monograph from public material. Those gaps are stated as gaps; neither was converted into a factual conclusion.

Affiliate disclosure: The HRT Index may earn a commission if you use an eligible link. That does not change your price. Affiliate status did not determine the regulatory conclusion, the U.S.-equivalent analysis, or which provider models were excluded.

Testimonial decision: We did not add patient testimonials. A customer review cannot prove FDA status, establish an import or compounding pathway, or show that a treatment is safe or effective for another woman. The firsthand language on this page is used only to frame the decision, not as medical evidence.

Frequently asked questions about tibolone in the United States

These short answers close the most common follow-up searches about availability, importation, compounding, equivalents, safety, libido, and moving to the United States. Each answer stays inside the verified record and points back to the detailed evidence above.

Is tibolone available in the US?

No. Tibolone is not available as an FDA-approved prescription drug in the United States. Organon announced on June 2, 2006 that FDA had found its application “not approvable” and that the company planned to withdraw it. We found no later FDA approval in our August 2026 check.

Has tibolone ever been FDA-approved?

No. Tibolone has never been FDA-approved. The 2006 application did not produce an approved U.S. product.

Why is tibolone not approved in the USA?

The verified public record says FDA found the application “not approvable,” but we did not find the agency’s complete review letter explaining every reason. The LIFT trial had been stopped four months earlier because of an increased stroke risk, but the public record does not establish that finding as FDA’s sole or stated reason.

Is tibolone banned in the United States?

“Banned” is misleading. Tibolone was not approved for U.S. marketing; there was no approved U.S. product later withdrawn. “Not FDA-approved” is the accurate description.

What is tibolone called in America?

There is no American brand because no tibolone product is FDA-approved. Livial and Tibella are foreign brands, not U.S. equivalents.

Is Livial available in the US?

No. Livial is a brand of tibolone and is not FDA-approved in the United States. A U.S. pharmacy cannot dispense it as an approved domestic product.

Is Tibella available in the US?

No. Tibella is a Canadian tibolone product approved by Health Canada in 2019. It is not an FDA-approved American product.

Is tibolone available in Canada?

Yes. Health Canada approved Tibella 2.5 mg in 2019 for the short-term treatment of menopausal vasomotor symptoms in postmenopausal women with an intact uterus after more than 12 months since the last period. That approval does not authorize U.S. marketing.

Is tibolone available in the UK?

Yes. Current UK records include Livial and generic tibolone 2.5 mg as prescription-only medicines. The UK label contains contraindications and specific warnings; foreign availability is not evidence that the drug is right for every woman.

Can I order tibolone from the UK, Canada, or another country?

A U.S. resident should not treat a foreign seller as a dependable legal route. FDA says that, in most circumstances, importing an unapproved drug for personal use is illegal. Limited enforcement discretion is not approval and does not guarantee that a shipment will be admitted.

Can I bring tibolone into the US while visiting?

FDA gives foreign nationals separate guidance and says they may bring or ship a 90-day supply with supporting documentation, such as a passport, a doctor’s letter, and a valid prescription. That visitor guidance does not create a U.S. refill path.

Can a US pharmacy fill my foreign tibolone prescription?

Not as an FDA-approved U.S. product. A foreign prescription does not create a U.S.-approved drug for the pharmacy to dispense. Arrange a clinical handoff rather than assuming the prescription can simply be transferred.

Can a compounding pharmacy make tibolone?

We did not verify a routine federal pathway under either section 503A or 503B. Tibolone is not a component of an FDA-approved U.S. drug, does not appear on the current codified 503A list or May 2026 nomination-category document, and does not appear on the current 503B clinical-need list. Because USP/NF status and state law can matter, ask the pharmacy for the exact legal basis rather than relying on a blanket yes or no.

Is compounded tibolone FDA-approved?

No. A compounded preparation is not FDA-approved. FDA does not review compounded drugs for safety, effectiveness, or manufacturing quality before marketing.

Is Duavee the US equivalent of tibolone?

No. Duavee contains conjugated estrogens plus bazedoxifene. Tibolone is a different synthetic steroid. Duavee shares the practical feature of not requiring a separately added progestin under its label, but it is not tibolone, a generic, or a pharmacologic equivalent.

Is tibolone better than standard HRT for hot flashes?

The pooled randomized evidence did not show that. A 2016 Cochrane review found tibolone better than placebo but less effective than combined hormone therapy for vasomotor symptoms.

Does tibolone contain testosterone?

No. Tibolone is one synthetic steroid; the tablet does not contain testosterone. Some metabolites have androgenic activity, which is why the shorthand can be confusing.

Is testosterone for women the same as tibolone?

No. Testosterone is a different hormone and does not reproduce tibolone’s estrogenic and progestogenic effects. No testosterone product is FDA-approved for women, and testosterone is a Schedule III controlled substance that requires a prescription.

Is Addyi only for premenopausal women?

No. That statement became outdated in December 2025. The current Addyi label covers women under 65 with acquired, generalized hypoactive sexual desire disorder that meets the label definition, including qualifying postmenopausal women.

Does tibolone increase stroke risk?

In LIFT, 1.25 mg daily increased the stroke hazard in women ages 60 to 85 with osteoporosis: hazard ratio 2.19. That finding is real, but the trial does not directly quantify the risk for every younger symptomatic woman taking a different dose.

Can a woman with a history of breast cancer take tibolone?

Current UK labeling lists known, past, or suspected breast cancer as a contraindication. In LIBERATE, breast-cancer survivors assigned tibolone had higher recurrence risk, with a hazard ratio of 1.40. This is not a situation for an offshore purchase or a routine online intake.

Does tibolone require progesterone if I have a uterus?

The current UK Livial label says a separate progestogen should not be added. That is a foreign product instruction, not permission to improvise a U.S. regimen or treat another product the same way.

Why does Canada’s indication mention an intact uterus?

Health Canada approved Tibella for postmenopausal women with an intact uterus. That is the wording of Canada’s approved indication, not a universal statement that tibolone is contraindicated after hysterectomy in every jurisdiction.

What should I do if I take tibolone and am moving to the US?

Get a written clinical handover, keep the drug in original packaging, check the import guidance that applies to your status, and book a U.S. clinician before your supply becomes urgent. Ask for a U.S. plan based on the symptom tibolone controlled rather than assuming one drug is automatically interchangeable.

What should I ask a US clinician for instead?

Name the job: hot flashes, sleep disruption, vaginal pain or dryness, desire, bleeding or progestogen concerns, bone protection, or continuity after a move. Then ask the clinician to compare FDA-approved U.S. options that fit your uterus status, risk history, route preference, insurance, and state.

Sources

Primary and authoritative sources used for this page:

Still not sure which HRT program is right for you? Take our free 60-second matching quiz.

Educational research only — not medical advice, diagnosis, or treatment. This page was produced by The HRT Index Editorial Team and was not medically reviewed by a clinician. Decisions about starting, stopping, or switching prescription treatment belong with a licensed clinician who can review your history. Emergency symptoms require urgent care.

Want to make the next step specific to you?

Compare tibolone and estradiol across the trial evidence, review the best online HRT providers, or use the Find My HRT Path tool before discussing the symptom or treatment goal with a licensed U.S. clinician.

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