Livial (Tibolone)
Hormone Replacement Therapy for Menopausal Symptoms and Osteoporosis Prevention
Quick Facts About Livial
Key Takeaways About Livial (Tibolone)
- Postmenopausal use only: Livial must only be started at least 12 months after your last natural menstrual period. Starting earlier may increase irregular bleeding.
- Relieves menopausal symptoms: Tibolone effectively reduces hot flushes, night sweats and other vasomotor symptoms associated with the menopause.
- Osteoporosis prevention: Can be used to prevent bone loss and reduce fracture risk in postmenopausal women when other therapies are not suitable.
- Increased stroke risk: Studies show a 2.2-fold increased risk of ischaemic stroke, particularly in women over 60 years of age.
- Cancer risks: Prolonged use increases the risk of breast cancer and endometrial cancer. Regular medical check-ups are essential.
What Is Livial and What Is It Used For?
Livial is a hormone replacement therapy (HRT) containing tibolone, a synthetic steroid used to relieve menopausal symptoms and prevent osteoporosis in postmenopausal women. It is only suitable for women whose last natural period occurred at least 12 months ago.
Livial belongs to a unique class of hormone therapy known as Selective Tissue Estrogenic Activity Regulators (STEARs). After ingestion, tibolone is rapidly converted in the body into three active metabolites: two with oestrogenic activity (3α-hydroxytibolone and 3β-hydroxytibolone) and one with progestogenic and androgenic activity (the Δ4-isomer). This tissue-selective mechanism means that tibolone exerts different hormonal effects depending on the target organ, providing benefits in bone, brain, and vaginal tissue while aiming to minimise stimulation of the breast and endometrium.
Relief of Menopausal Symptoms
During the menopause, the ovaries gradually stop producing oestrogen. This hormonal decline can cause a range of distressing symptoms including hot flushes, night sweats, mood changes, sleep disturbances, vaginal dryness, and decreased libido. For many women, these symptoms significantly affect their quality of life and daily functioning. Livial is prescribed to alleviate these vasomotor and urogenital symptoms when they cause substantial discomfort.
The oestrogenic metabolites of tibolone act on oestrogen receptors in the thermoregulatory centre of the hypothalamus, reducing the frequency and severity of hot flushes. The androgenic component may additionally contribute to improvements in mood, energy levels, and sexual desire—an area where tibolone may offer advantages over conventional oestrogen-only or combined HRT regimens. Clinical trials, including the OPAL study, have demonstrated that tibolone 2.5 mg daily significantly reduces the number of hot flushes compared to placebo.
Prevention of Osteoporosis
After the menopause, the decline in oestrogen levels accelerates bone loss, increasing the risk of osteoporosis and fragility fractures. Tibolone has been shown to maintain bone mineral density and reduce the incidence of vertebral fractures. The LIFT (Long-term Intervention on Fractures with Tibolone) trial, a large randomised controlled study involving 4,538 postmenopausal women aged 60–85, demonstrated that tibolone 1.25 mg daily reduced vertebral fractures by 45% and non-vertebral fractures by 26% over a median of 34 months.
Livial should only be considered for osteoporosis prevention when other medications (such as bisphosphonates or denosumab) are not appropriate for the individual patient. Your doctor will assess all available treatment options and consider the balance of benefits and risks before prescribing Livial for this purpose.
What Should You Know Before Taking Livial?
Before starting Livial, your doctor will assess your complete medical history, family history, and perform relevant examinations. There are several conditions in which Livial must not be used, and others that require careful monitoring throughout treatment.
The use of HRT, including Livial, involves risks that must be carefully weighed against the benefits. Your doctor will discuss these with you before starting treatment and at regular follow-up appointments, which should occur at least once a year. Before prescribing Livial, your doctor will ask about your own and your family's medical history and may perform a general and gynaecological examination, including breast examination.
Contraindications
Livial must not be taken if any of the following conditions apply. If you are uncertain whether any of these apply to you, speak with your doctor before taking Livial:
- Have or have ever had breast cancer, or if breast cancer is suspected
- Have an oestrogen-dependent cancer, such as endometrial (uterine lining) cancer, or if such cancer is suspected
- Have unexplained vaginal bleeding that has not been investigated by a doctor
- Have untreated endometrial hyperplasia (excessive thickening of the uterine lining)
- Have or have ever had a blood clot in a vein (venous thromboembolism), including deep vein thrombosis or pulmonary embolism
- Have a blood clotting disorder (e.g. protein C, protein S, or antithrombin deficiency)
- Have or have recently had a disease caused by blood clots in the arteries, such as heart attack, stroke, or angina
- Have or have ever had liver disease and your liver function tests are still abnormal
- Have porphyria, a rare inherited blood disorder
- Are allergic to tibolone or any of the other ingredients in the tablets
If any of these conditions develop for the first time while you are taking Livial, stop the medication immediately and contact your doctor.
Warnings and Precautions
Tell your doctor if you have or have ever had any of the following conditions, as they may recur or worsen during treatment with Livial:
- Conditions affecting the uterine lining, such as fibroids (myomas), endometriosis, or a history of endometrial hyperplasia
- Increased risk of blood clots (see the section on venous thromboembolism below)
- A close relative who has had breast cancer or other oestrogen-dependent cancer
- High blood pressure
- Liver disease, including liver adenoma (a benign tumour)
- Diabetes mellitus
- Gallstone disease
- Migraine or severe headaches
- Systemic lupus erythematosus (SLE), an autoimmune disease
- Epilepsy
- Asthma
- Otosclerosis (calcification in the middle ear leading to hearing loss)
- Raised levels of blood fats (hypertriglyceridaemia)
- Fluid retention due to heart or kidney disease
- Your skin or the whites of your eyes turn yellow (jaundice) — this may indicate liver disease
- Your blood pressure rises sharply (symptoms may include headache, tiredness, or dizziness)
- You experience migraine-like headaches for the first time
- You become pregnant
- You notice symptoms of a blood clot: painful swelling and redness of the legs, sudden chest pain, or difficulty breathing
Note: Livial is not a contraceptive. If it has been less than 12 months since your last period, or if you are under 50 years of age, you may still need to use contraception to prevent pregnancy. Consult your doctor for advice.
HRT and Cancer Risks
Endometrial cancer: Reports and studies indicate an increased risk of endometrial cancer (cancer of the uterine lining) in women using Livial. The risk increases with the duration of treatment. If you experience unexpected vaginal bleeding, particularly after the first 6 months of treatment or after you have stopped taking Livial, you should consult your doctor promptly, as this may need further investigation.
Breast cancer: Evidence indicates that tibolone increases the risk of breast cancer. The additional risk depends on how long you use tibolone. In HRT studies, the excess risk decreased over time after stopping treatment, but could persist for 10 years or more in women who had used HRT for more than 5 years. Compared to combined (oestrogen-progestogen) HRT, the risk with tibolone appears to be lower, but comparable to oestrogen-only HRT. You should check your breasts regularly and contact your doctor if you notice any changes such as dimpling, changes to the nipple, or lumps you can see or feel.
Ovarian cancer: Ovarian cancer is rare—much less common than breast cancer. The use of oestrogen-only or combined HRT has been associated with a slightly increased risk. For women aged 50–54, approximately 2 in 2,000 will be diagnosed with ovarian cancer over 5 years. Among those who have taken HRT for 5 years, there will be about 3 cases per 2,000 users (approximately 1 extra case). The risk with Livial is similar to that of other types of HRT.
HRT and Cardiovascular Risks
Venous thromboembolism (blood clots): The risk of blood clots in the veins is 1.3 to 3 times higher in women taking HRT compared to non-users, particularly during the first year of treatment. Blood clots can be serious—if one travels to the lungs, it may cause chest pain, breathlessness, collapse, or even death. The risk is greater in older women and in those with additional risk factors such as obesity (BMI over 30), prolonged immobility, personal or family history of blood clots, cancer, or systemic lupus erythematosus. The increased risk with Livial is similar to that of other types of HRT.
Heart disease: There is no evidence that HRT prevents heart attacks. Women over 60 taking combined HRT have a slightly higher risk of developing heart disease. There is no evidence that the risk of heart attack with Livial differs from other HRT.
Stroke: Data suggest that both HRT and Livial increase the risk of stroke, with the increase primarily observed in older postmenopausal women over 60. A randomised controlled trial of 2.9 years’ duration estimated a 2.2-fold increase in stroke risk in women (mean age 68) using tibolone 1.25 mg compared to placebo. The majority (80%) of these strokes were ischaemic. The underlying risk of stroke is strongly age-dependent: for women aged 50–59, approximately 3 per 1,000 over 5 years; for women aged 60–69, approximately 11 per 1,000 over 5 years. For women using tibolone for 5 years, the estimated additional cases are approximately 4 per 1,000 in the 50–59 age group and 13 per 1,000 in the 60–69 age group.
Other Considerations
HRT does not prevent memory loss. There may be a slightly higher risk of dementia in women who begin HRT after the age of 65. Consult your doctor for advice.
Pregnancy and Breastfeeding
Livial is intended for postmenopausal women and must not be used during pregnancy or breastfeeding. If you become pregnant while taking Livial, stop the medication immediately and contact your doctor.
How Does Livial Interact with Other Drugs?
Several medications can reduce the effectiveness of Livial or increase the risk of side effects, particularly irregular bleeding. Always inform your doctor about all medications you are taking, including over-the-counter medicines and herbal supplements.
Certain medicines can affect how tibolone works in the body, potentially reducing its effectiveness or leading to unexpected vaginal bleeding. Conversely, Livial may also affect the action of some other medicines. It is important to tell your doctor about all medications you take, including prescription, over-the-counter, and herbal remedies.
Major Interactions
The following drug interactions are considered clinically significant and may require dose adjustments, additional monitoring, or avoidance of the combination:
| Interacting Drug | Category | Effect | Clinical Advice |
|---|---|---|---|
| Warfarin and other anticoagulants | Blood thinners | Tibolone may enhance the anticoagulant effect, increasing bleeding risk | Close INR monitoring required; dose adjustment may be necessary |
| Rifampicin | Anti-tuberculosis | Strong CYP3A4 inducer that can significantly reduce tibolone levels | May substantially reduce effectiveness; consider alternative HRT or anti-TB therapy |
| Phenytoin, carbamazepine, phenobarbital | Anticonvulsants | Hepatic enzyme inducers that reduce tibolone plasma levels | May reduce effectiveness of Livial; discuss alternatives with your doctor |
| Ritonavir, nelfinavir, efavirenz, nevirapine | Antiretrovirals (HIV) | CYP3A4 inducers/inhibitors that alter tibolone metabolism | May affect tibolone levels; close monitoring and possible dose adjustment |
| St John’s Wort (Hypericum perforatum) | Herbal supplement | Potent CYP3A4 inducer that can substantially reduce tibolone levels | Avoid concurrent use; may cause breakthrough bleeding and reduced efficacy |
Minor Interactions
Some medications may have less significant interactions with tibolone but should still be mentioned to your doctor:
- Other hormone preparations: Livial should not be combined with other oestrogen, progestogen, or androgen preparations, as this may lead to unpredictable hormonal effects and increased side effects.
- Midazolam and other benzodiazepines: Tibolone may slightly increase the clearance of midazolam, though this is generally not clinically significant.
- Lamotrigine: Hormone therapies may potentially affect lamotrigine levels; monitoring of seizure control is advisable.
What Is the Correct Dosage of Livial?
The recommended dose of Livial is one 2.5 mg tablet taken once daily at approximately the same time each day. Your doctor will prescribe the lowest effective dose for the shortest duration necessary.
Always take Livial exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist. The tablet should be swallowed whole with a small amount of water and can be taken with or without food.
Adults
Standard Dose – Postmenopausal Women
Dose: 2.5 mg once daily
Administration: Oral, at approximately the same time each day
Duration: Use the lowest effective dose for the shortest time needed. Review with your doctor at least annually.
When to start: At least 12 months after last natural menstruation. If surgically menopausal, treatment can begin immediately.
The tablet blister pack is marked with the days of the week. Start by taking the tablet corresponding to the current day, then follow the day markings and take one tablet daily until the pack is empty. Begin a new pack immediately without a break.
Children
Livial is not indicated for use in children or adolescents. There is no relevant use of tibolone in the paediatric population.
Elderly
No dose adjustment is required for elderly patients. However, the risks associated with Livial, particularly the risk of stroke, increase significantly with age. Women over 60 years of age should have a thorough discussion with their doctor about the individual balance of benefits and risks before starting or continuing treatment. The risk of stroke is approximately 2.2-fold higher in tibolone users compared to non-users, and the absolute risk increases substantially in older age groups.
Missed Dose
If you forget to take a tablet, take it as soon as you remember if it is within 12 hours of your usual time. If more than 12 hours have passed, skip the missed dose and take the next tablet at your usual time the following day. Do not take a double dose to compensate for a missed tablet. Missing a dose may increase the likelihood of breakthrough bleeding or spotting.
Overdose
If you take too many Livial tablets, or if a child accidentally ingests the medication, contact your doctor, hospital emergency department, or poison control centre immediately for advice. Overdose may cause nausea, vomiting, and vaginal bleeding. There is no specific antidote; treatment is supportive and symptomatic.
What Are the Side Effects of Livial?
Like all medicines, Livial can cause side effects, although not everyone experiences them. The most clinically significant risks include an increased incidence of breast cancer, endometrial cancer, stroke, and venous thromboembolism. Most common side effects are mild and may resolve over time.
The following conditions are more common in women taking HRT, including Livial, compared to those not using HRT: breast cancer, endometrial hyperplasia or cancer, ovarian cancer, venous thromboembolism, heart disease, stroke, and probable memory loss if HRT is started after age 65. Most side effects are mild to moderate and do not usually require stopping treatment.
Irregular bleeding: Irregular spotting or breakthrough bleeding may occur during the first 3–6 months of treatment. If bleeding persists beyond 6 months, begins after you have been taking Livial for 6 months, or continues after you stop taking Livial, consult your doctor promptly for investigation.
Common Side Effects
Affects 1–10 in 100 people
- Abdominal pain or pelvic pain
- Weight gain
- Breast tenderness or pain
- Abnormal hair growth (hirsutism)
- Vaginal discharge
- Genital itching
- Vaginal bleeding or spotting
- Vaginal inflammation or yeast infection
- Thickening of the endometrium (uterine lining)
Uncommon Side Effects
Affects 1–10 in 1,000 people
- Oedema (fluid retention)
- Gastrointestinal disturbances
- Acne
- Nipple pain
Rare Side Effects
Affects fewer than 1 in 1,000 people
- Generalised itching (pruritus)
The following side effects have also been reported in association with Livial, though not necessarily with established frequency: dizziness, headache, migraine, depression, skin disorders, visual disturbances, joint pain, muscle pain, and abnormal liver function tests.
Side effects reported with other HRT products that may also occur with Livial include:
- Gallbladder disease
- Various skin disorders, including chloasma (dark patches on the face), erythema nodosum (painful reddish-purple skin lumps), and erythema multiforme (ring-shaped reddened or blistered rashes)
- Painful swelling of one leg, sudden chest pain, or difficulty breathing (may indicate blood clots)
- Yellowing of the skin or eyes (may indicate liver problems)
- A sudden, severe headache or migraine for the first time
- A new breast lump or change in breast appearance
How Should You Store Livial?
Store Livial at room temperature below 25°C (77°F) in the original packaging to protect from light. Keep out of the sight and reach of children.
Livial tablets should be stored at a temperature not exceeding 25°C (77°F). Keep the tablets in the original blister packaging, as tibolone is sensitive to light. Do not use this medicine after the expiry date printed on the carton and blister pack. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment and prevent accidental exposure.
What Does Livial Contain?
Each Livial tablet contains 2.5 mg of tibolone as the active ingredient, along with several inactive excipients including potato starch, magnesium stearate, ascorbyl palmitate, and lactose monohydrate.
The active substance is tibolone (2.5 mg per tablet). Tibolone is a synthetic steroid compound that is structurally related to norethynodrel, a progestogen used in some contraceptive preparations.
The inactive ingredients (excipients) are:
- Potato starch: used as a filler and disintegrant
- Magnesium stearate: a lubricant that facilitates tablet manufacturing
- Ascorbyl palmitate: an antioxidant that helps preserve the active ingredient
- Lactose monohydrate: a sugar used as a filler and binder
Livial tablets are white, round, flat, and marked “MK 2” on one side and “ORGANON” on the other. They are available in blister packs of 28 and 84 tablets. Livial is manufactured by N.V. Organon, Oss, The Netherlands.
Frequently Asked Questions About Livial
Livial (tibolone) is used for hormone replacement therapy (HRT) in postmenopausal women. It relieves menopausal symptoms such as hot flushes and night sweats, and it can also be used to prevent osteoporosis in women at high risk of fractures when other treatments are not suitable. It should only be started at least 12 months after the last natural menstrual period.
Unlike conventional HRT that contains oestrogen alone or combined with a progestogen, Livial contains tibolone, a synthetic steroid that breaks down into metabolites with oestrogenic, progestogenic, and weak androgenic activity. This tissue-selective mechanism (called STEAR) may result in less breast tenderness and a lower incidence of vaginal bleeding compared to some conventional HRT regimens, though it carries similar cardiovascular and cancer risks.
The most serious risks include an increased risk of stroke (approximately 2.2-fold in women over 60), an increased risk of breast cancer with prolonged use, an increased risk of endometrial cancer, and an increased risk of venous thromboembolism (blood clots). These risks increase with longer duration of use and with age. Regular medical check-ups are essential during treatment.
No. Livial is strictly contraindicated in women who have or have previously had breast cancer, or where breast cancer is suspected. Tibolone has been shown to increase the risk of breast cancer recurrence. If you have a personal or family history of breast cancer, discuss alternative treatment options with your doctor.
Your doctor will prescribe the lowest effective dose for the shortest duration necessary to relieve your symptoms. The benefits and risks should be reassessed at least annually. The risks of breast cancer, endometrial cancer, stroke, and blood clots increase with longer duration of use. There is no fixed maximum duration, but regular review with your doctor is essential to determine whether continued treatment is appropriate.
If you miss a dose and it has been less than 12 hours since your usual time, take the missed tablet as soon as you remember. If more than 12 hours have passed, skip the missed dose and take the next tablet at your usual time the following day. Do not take a double dose to make up for a forgotten tablet.
References
- Cummings SR, Ettinger B, Delmas PD, et al. The effects of tibolone in older postmenopausal women. N Engl J Med. 2008;359(7):697–708. doi:10.1056/NEJMoa0800743 (LIFT Trial)
- Kenemans P, Bundred NJ, Foidart JM, et al. Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: a double-blind, randomised, non-inferiority trial (LIBERATE). Lancet Oncol. 2009;10(2):135–146. doi:10.1016/S1470-2045(08)70341-3
- International Menopause Society (IMS). Updated 2024 IMS Recommendations on menopausal hormone therapy. Climacteric. 2024;27(1):1–13.
- European Medicines Agency (EMA). Summary of Product Characteristics – Livial (tibolone). Accessed January 2026.
- National Institute for Health and Care Excellence (NICE). Menopause: diagnosis and management. NICE guideline [NG23]. Updated December 2024.
- Beral V; Million Women Study Collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet. 2003;362(9382):419–427.
- Archer DF, Hendrix S, Ferenczy A, et al. Tibolone histology of the endometrium and breast endpoints study: design of the trial and endometrial histology at baseline in 3,519 postmenopausal women. Fertil Steril. 2007;88(4):866–878.
- World Health Organization (WHO). Medical eligibility criteria for contraceptive use. 6th edition, 2024.
- European Menopause and Andropause Society (EMAS). Position statement on tibolone in postmenopausal women. Maturitas. 2023;175:107780.
- British National Formulary (BNF). Tibolone. Accessed January 2026.
Medical Editorial Team
This article has been developed and medically reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in gynaecology, endocrinology, and clinical pharmacology.
All content is reviewed by board-certified physicians with specialisation in gynaecology and reproductive endocrinology. Our team follows the GRADE evidence framework and adheres to international guidelines from IMS, EMAS, NICE, and WHO.
This article is based on Level 1A evidence from systematic reviews, randomised controlled trials, and international clinical guidelines. All references are from peer-reviewed medical literature and authoritative regulatory bodies.
Last medical review: | Next review due:
No conflicts of interest declared. No pharmaceutical company sponsorship or advertising.