Synthetic Steroid (Tissue-Selective Oestrogen Activity) Pregnancy: SPC §4.6: tibolone is CONTRAINDICATED during pregnancy. If pregnancy occurs during medication, treatment should be withdrawn immediately. No clinical data on exposed pregnancies are available; animal studies have shown reproductive toxicity and the potential risk for humans is unknown. Tibolone is also contraindicated during lactation. Fertility: in animal studies tibolone had anti-fertility activity by virtue of its hormonal properties.

Tibolone

Brand names: Livial

Tibolone is a synthetic steroid with combined oestrogenic, progestogenic, and weak androgenic activity, used as a single-agent menopausal hormone therapy in postmenopausal women.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One tablet per day (the fetched SPC is for Tibolone 2.5 mg tablets)

Route: Oral — swallow the tablets with some water or other drink, preferably at the same time every day

Frequency: Once daily

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used. A SEPARATE PROGESTOGEN SHOULD NOT BE ADDED with tibolone treatment. STARTING: women experiencing a natural menopause should commence treatment at least 12 months after their last natural bleed; in surgical menopause treatment may commence immediately; women being treated with GnRH analogues (for example for endometriosis) may commence immediately. Any irregular/unscheduled vaginal bleeding, either on or off HRT, should be investigated to exclude malignancy before starting. SWITCHING: from a sequential HRT preparation, start the day following completion of the prior regimen; from a continuous combined HRT preparation, treatment can start at any time. MISSED DOSE: take as soon as remembered unless more than 12 hours overdue, in which case skip it and take the next dose at the normal time; missing a dose may increase the likelihood of breakthrough bleeding and spotting. PAEDIATRIC: 'There is no relevant use of Tibolone in the paediatric population.' ELDERLY: no dose adjustment is necessary; there is limited experience in treating women over age 65 years.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Pregnancy and lactation
Known, past or suspected breast cancer — tibolone increased the risk of breast cancer recurrence in a placebo-controlled trial
Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
Undiagnosed genital bleeding
Untreated endometrial hyperplasia
Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency)
Any history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke or TIA)
Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
Porphyria

Side effects

Reproductive/breast (common): vaginal discharge, endometrial thickening, postmenopausal haemorrhage, breast tenderness, genital pruritus, vaginal candidiasis, vaginal haemorrhage, pelvic pain
Lower abdominal pain (common); abdominal discomfort (uncommon, post-marketing)
Abnormal hair growth (common); acne (uncommon); pruritus (rare, post-marketing)
Weight increase and abnormal cervical smear (common — the majority of smear changes were benign; cervical carcinoma was not increased versus placebo)
Oedema (uncommon, post-marketing)
Also observed in market use: dizziness, rash, seborrhoeic dermatosis, headache, migraine, visual disturbances including blurred vision, depression, arthralgia or myalgia, and changes in liver function parameters. Class risks: increased risk of stroke, breast cancer (Million Women Study: risk ratio 1.3, about 3 extra cases per 1000 users aged 50–65 over 5 years) and, in women with an intact uterus, endometrial cancer.

Clinical monograph

How it works

After absorption it is metabolised to compounds with tissue-selective oestrogenic, progestogenic, and androgenic effects, relieving vasomotor symptoms while providing endometrial protection without separate progestogen.

Prescribing in practice

Like other menopausal hormone therapies it increases the risk of venous thromboembolism, stroke, and certain hormone-sensitive cancers, and it should generally be started only after a woman has been postmenopausal for an adequate interval to limit bleeding.
It is contraindicated in known, past, or suspected breast cancer and other oestrogen-dependent malignancies, and in undiagnosed vaginal bleeding.
It is contraindicated in active or previous arterial thromboembolic disease and in active venous thromboembolism.

Monitoring

Undertake periodic review of treatment benefit versus risk, attend breast screening, and investigate any unexpected vaginal bleeding.

Counselling the patient

Take the tablet once daily at about the same time each day.
Report any unexpected vaginal bleeding, breast changes, or symptoms of clot such as leg swelling or breathlessness.
Continue with routine breast and cervical screening.

Evidence & guidelines

Licensed as menopausal hormone therapy with cardiovascular and cancer risks characterised in randomised and observational studies and summarised by the MHRA.

Reference: LIFT trial (Cummings et al. NEJM 2008); LIBERATE trial (Sismondi et al. Lancet Oncol 2011); MHRA SPC Livial; NICE NG23 (Menopause); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators