Livifem

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Livifem

Property Description
Active ingredient Tibolone
Form Oral tablet
Pharmacological class Hormone Replacement Therapy (HRT); Selective Tissue Estrogenic Activity Regulator (STEAR)
Common use Relief of menopausal symptoms; Prevention of bone loss
Origin Synthetic steroid

What Type of Medicine is Livifem? (Classification and Origin)

Livifem is a prescription-only medication classified as a unique form of Hormone Replacement Therapy (HRT), designated for the management of symptoms associated with oestrogen deficiency in its target group of postmenopausal women. The medication contains the sole active ingredient tibolone, a potent synthetic steroid compound. It is classified as a Selective Tissue Estrogenic Activity Regulator (STEAR), reflecting its ability to exert differential hormonal activity across various body tissues. This specialized action distinguishes tibolone from traditional HRT and provides an alternative for women requiring hormonal intervention.

Composition: The Single-Ingredient Prodrug Tablet

Livifem is supplied as an oral tablet containing the active ingredient tibolone, a single-ingredient product, alongside common pharmaceutical excipients such as lactose monohydrate and potato starch. Tibolone functions as a prodrug, meaning the administered compound must be rapidly metabolized by the body into three key active substances: 3alpha -hydroxytibolone, 3beta -hydroxytibolone, and the Delta4 -isomer. These active metabolites are responsible for the drug’s pharmacological identity, exhibiting estrogenic activity, progestogenic activity, and a degree of androgenic activity. This identity as a prodrug is a recognized feature of the medicine.

General Therapeutic Purpose for Postmenopausal Women

The primary purpose of Livifem is to relieve general menopausal complaints in its target audience. The selective hormonal activity helps to mitigate oestrogen deficiency symptoms, such as hot flushes and discomfort associated with vaginal dryness. Furthermore, the compound is utilized to prevent progressive bone loss and reduce the risk of osteoporosis in postmenopausal women who are identified as high-risk. The overall intent is to restore a necessary hormonal balance with a focus on tissue specificity to address both vasomotor symptoms and skeletal protection.

What side effects are possible with Livifem?

Possible Side Effects and Safety Information

The safety profile of Livifem (tibolone) is formally documented in government regulatory materials, classifying adverse reactions by frequency and physiological system. This section presents the official safety characteristics without providing clinical advice or usage instructions.

Classification of Documented Adverse Reactions

Adverse effects are categorized based on their incidence in clinical studies, consistent with the framework used by regulatory authorities:

  • Common Reactions (affecting 1 to 10 users in 100): Documented effects include vaginal bleeding or spotting, which may occur particularly during the initial months of treatment, lower abdominal pain, breast pain or tenderness, and systemic effects such as weight increase, headache, and dizziness. Effects on the reproductive system may also include endometrial thickening.
  • Uncommon Reactions (affecting 1 to 10 users in 1,000): These include acne, arthralgia (joint pain), and myalgia (muscle pain), as officially listed in regulatory summaries.

Serious Adverse Risks and Constraints

The use of tibolone is associated with serious risks consistently highlighted in official warnings, primarily relating to the Hormone Replacement Therapy (HRT) class. These documented serious adverse reactions include an increased risk of stroke, venous thromboembolism (e.g., deep vein thrombosis and pulmonary embolism), and malignancies such as breast cancer, endometrial cancer, and ovarian cancer.

Safety constraints define the boundaries for its use. The medicine is contraindicated in individuals with a history of venous thromboembolic disease, severe hepatic disease, or known oestrogen-dependent malignant tumours. Furthermore, regulatory notes indicate a heightened risk of stroke in women aged 60 years and older, a specific population-safety consideration.

Overdose and Emergency Response

A Livifem overdose is defined by government regulatory documents as having a very low acute toxicity profile. Official prescribing information states that toxic symptoms are generally not expected to occur even when several tablets are taken at once, and the outcome is classified as generally not life-threatening.

Documented Manifestations

The clinical signs and manifestations officially documented in regulatory sources following acute overdose primarily involve gastrointestinal upset and a hormonal effect. These documented signs include nausea and vomiting (general gastrointestinal complaints), as well as unexpected vaginal bleeding or withdrawal bleeding.

Emergency Management and Seeking Help

In all cases of suspected overdose or ingestion exceeding the prescribed dose, official government guidance mandates that an individual seek immediate medical attention for professional assessment and monitoring. This urgent action is required because, as explicitly stated in regulatory prescribing information, no specific antidote is known for tibolone. Management must therefore be strictly directed towards symptomatic and supportive treatment provided in a clinical setting to address any developing clinical signs.

Therapeutic Uses of Livifem

What Livifem Treats: Main Uses and Benefits

Livifem is used in contexts involving oestrogen deficiency. The medication is applied in scenarios where additional management of discomfort is required and contributes to easing the overall symptom load. The primary therapeutic applications include the supportive management of vasomotor symptoms (such as hot flushes and night sweats), easing urogenital symptoms (such as vaginal dryness and irritation), and addressing conditions marked by long-term structural risk, such as postmenopausal osteoporosis in high-risk women.

Symptomatic Relief and Supportive Management

Livifem is relevant in contexts marked by increased discomfort, addressing symptoms related to systemic imbalance. By managing these manifestations, it provides support that helps patients cope with symptom fluctuations, which may assist with maintaining functional stability and supports general well-being. It is also applied in addressing associated psychological symptoms such as low mood, anxiety, and fatigue, and may contribute to easing the overall symptom load. Furthermore, its long-term application may assist in managing bone loss, supporting patients in maintaining functional stability.


Quick Fact: Supports Management of Vasomotor and Urogenital Discomfort

Eligibility and Restrictions for Use

Official Eligibility Profile for Livifem (Tibolone)

The use of Livifem is strictly governed by authoritative regulatory eligibility rules, primarily restricting its use to a specific patient group and strictly prohibiting its use in certain high-risk populations.

Classification Rule Summary (Official Labeling)
Eligible Population Post-menopausal women only. Treatment should be avoided until 12 months after the last natural menstrual bleed.
Contraindicated Populations Pre-menopausal women; pregnant or breastfeeding women; patients with known, suspected, or past history of breast cancer or other hormone-dependent tumours (e.g., endometrial cancer).

Absolute Contraindications

The medicine is formally contraindicated and must not be used in patients with:

  • A history of or current venous thromboembolism (VTE) (including DVT or PE) or arterial thromboembolic disease (including stroke, TIA, or MI).
  • Known thrombophilic disorders (e.g., Protein C, Protein S, or Antithrombin deficiency).
  • Severe liver disease or liver function tests that have not returned to normal.
  • Undiagnosed abnormal genital bleeding or untreated excessive thickening of the womb lining (endometrial hyperplasia).
  • Known Porphyria or hypersensitivity to the drug's components.

Age and Condition-Specific Restrictions

The risk of stroke is observed to be higher in women over 60 years of age, and the risk of memory loss may be higher if therapy is started after age 65. Women with specific conditions such as uterine fibroids, endometriosis, diabetes mellitus, or migraine require close medical supervision during use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies specific patterns of interaction for Livifem (tibolone) with other medicinal products and substances. These interactions are classified primarily as pharmacokinetic (affecting drug concentrations) and pharmacodynamic (affecting the activity of a co-administered drug).


Pharmacokinetic Interactions (Exposure Modification)

Co-administration with agents that are strong CYP3A4 inducers may result in reduced plasma concentrations of tibolone's active metabolites. Documented enzyme-inducing agents include the antibiotic Rifampicin, certain anticonvulsants (such as Phenytoin and Carbamazepine), and the herbal product St John's Wort (Hypericum perforatum). Conversely, strong CYP3A4 inhibitors may increase the serum concentration of the estrogenic derivatives.

Pharmacodynamic and Hormonal Restrictions

Livifem may enhance the anticoagulant effect of medicines such as Warfarin, potentially increasing the International Normalized Ratio (INR). Patients already receiving anticoagulant treatment require careful monitoring for changes in coagulation status. Due to tibolone's inherent hormonal activity, regulatory guidance restricts the co-administration of a separate progestogen and advises avoiding combination with certain aromatase inhibitors (e.g., Anastrozole).

Mechanism of Action

How Livifem Works: Mechanism of Action


Selective Activation of Hormone Receptors

The administered compound, tibolone, functions as a prodrug and is rapidly metabolized into three primary active substances. These metabolites act as agonists (activators) at Estrogen Receptors (ER) in specific tissues, including bone and the central nervous system, and at Progesterone Receptors (PR) and Androgen Receptors (AR) in other peripheral sites. This multi-receptor activation profile modulates various hormonal pathways and influences downstream physiological processes.


Dual Mechanism for Anti-Proliferative Regulation

This mechanism involves the counter-regulation of local estrogenic activity in the endometrium and breast tissue. This is achieved through a dual approach: one metabolite activates PRs, while the drug components strongly inhibit the enzyme Estrogen Sulfatase (STS). This enzymatic inhibition limits the local formation of potent estrogen ( E2), which in combination with the PR agonism, results in an inactive, atrophic state in these tissues.


Modulation of Central and Skeletal Systems

The ER agonism exerted by two of the metabolites drives primary physiological consequences. In the central nervous system, it modulates the hypothalamic thermoregulatory set-point, which regulates autonomic pathways controlling body temperature. In the skeletal system, it modulates bone homeostasis by suppressing the activity of bone-resorbing cells (osteoclasts), influencing the retention of bone mineral density and structure.

Dosage and Administration Information

Administration Scope: Oral and Fixed Dose

Livifem is a medicine with standard usage parameters that define a fixed-dose, continuous oral therapy. The administration involves taking one 2.5 mg tablet of tibolone once every day. The tablet is intended for oral use only and is swallowed whole with water; it is not crushed or chewed. To maintain consistency, the dose is typically administered at the same time each day, regardless of food intake.


Procedural Rules and Duration

The initiation of treatment is governed by a timing rule: administration does not commence until at least 12 months following a woman's final natural menstrual period. This requirement is waived in cases of surgical removal of the ovaries (surgical menopause), where the medicine may be started immediately. The fixed daily schedule involves continuous use with no scheduled breaks, and it is specified that a separate progestogen compound should not be added to the regimen.

There is a defined protocol for delayed administration: A missed dose is taken immediately only if the delay is less than 12 hours. If the regular time is exceeded by more than 12 hours, the missed tablet is skipped, and the continuous schedule is resumed with the next dose. The continuation of this therapy is reassessed by a healthcare professional at least every six months.

Recent Clinical Evidence

Research evidence / Overview of Studies for Livifem


Evidence for Relief of Vasomotor Symptoms (Hot Flushes and Sweats)

Research on Livifem was studied for its potential role in addressing menopausal symptoms primarily involves short-term Randomized Controlled Trials (RCTs). These studies were used in research exploring how symptoms change over time, often comparing the medication against a placebo or against other forms of hormone therapy. The primary outcomes related to physical discomfort that were monitored included the daily frequency and intensity of hot flushes and night sweats. The findings describe patterns observed in the studies regarding changes in symptom scores over defined time intervals, typically ranging up to six months.

What remains uncertain is the long-term characterization of these outcomes. Long-term effects are not fully established, as follow-up durations were limited in many symptom-focused trials. Furthermore, the evidence quality varies across studies when looking at secondary outcomes like changes in mood or anxiety, and the consistency of these specific findings is not entirely certain.


Evidence for the Prevention of Bone Loss and Osteoporosis

Evidence related to outcomes involving skeletal protection comes from both short-term research and large-scale, long-term Randomized Controlled Trials (RCTs). Shorter studies monitored changes in Bone Mineral Density (BMD), a measure used by researchers as a surrogate marker for bone health. The long-term trials were used in research exploring fracture risk and tracked data on the total number of new fractures recorded in the observed populations.

Livifem was evaluated in trials involving postmenopausal women, including those recently past menopause (was studied for its potential in addressing bone loss) and those who were older with established osteoporosis (research examined outcomes related to fracture risk). Data show patterns related to the monitored outcomes, with long-term studies describing fracture rates over follow-up periods that extended beyond three years.


What is Still Uncertain About the Research Evidence

Research provides context but not individual predictions, and evidence highlights what is known—and what is still uncertain. Several limitations exist in the current evidence landscape. Follow-up durations were limited for certain outcomes, particularly the long-term patterns observed on urogenital symptoms and mood. Comparative evidence is lacking for head-to-head comparisons against some of the newest treatment options. Furthermore, findings were mixed in areas such as changes in libido and psychological measures, and data are still emerging, meaning certainty remains low for these specific aspects.

Frequently Asked Questions (FAQ)

Common questions about Livifem (FAQ)

Q: How quickly can I expect Livifem to start working?

Studies indicate that for menopausal symptoms like hot flashes and sweating, relief often begins within a few weeks of starting treatment. For the intended full effect, research indicates that outcomes are typically monitored over a period of a few months of continuous use.

Q: Does Livifem have a generic version available?

The active ingredient in this medicine is tibolone. The official product information in most regions is specific to the branded medicine; the availability of a generic version is dependent on your specific country’s drug regulations.

Q: Are the side effects of Livifem generally considered mild?

Official regulatory documentation categorizes side effects into different frequency groups. While the most frequently reported effects, such as vaginal bleeding or headache, are listed as Common reactions, the drug is also associated with Serious risks inherent to the Hormone Replacement Therapy (HRT) class, including stroke and blood clots.

Q: Is Livifem safe for long-term use?

The necessity of continuing this therapy is subject to formal review by a healthcare professional at least every six months. As with all Hormone Replacement Therapies, regulatory guidance notes that use extending beyond five years is associated with specific risk changes, and caution is specifically advised for women aged 60 and older due to an increased risk of stroke.

Q: Do I need to change my diet while taking Livifem?

Official product information does not document any specific dietary changes required while taking this medicine. The drug can be administered at the same time each day regardless of whether it is taken with or without food.

Q: Is Livifem used for purposes other than its main indication?

Regulatory documents clearly state that the medicine is approved only for two main purposes in postmenopausal women: relieving symptoms of oestrogen deficiency and preventing bone loss (osteoporosis) in those at high risk of fracture. Official information does not describe any other approved therapeutic uses.

Q: Does Livifem interact with common vitamins or supplements?

The official label specifically lists interactions with medicines, and the product label advises against the co-administration of the herbal product St. John’s Wort. There are no documented warnings for common, non-herbal vitamins in the authoritative source material.

Q: Can older adults use Livifem?

The medicine is indicated for postmenopausal women, including older adults. However, regulatory warnings note a heightened risk of stroke in women aged 60 years and older taking the drug. Official documents state that close medical supervision is required for use in this age group.

Q: How long does Livifem stay in your system?

According to regulatory pharmacokinetics data, the active metabolites produced by the drug have an apparent elimination half-life of about 45 hours. This means it typically takes a few days for the drug’s active forms to be cleared from the body after the last dose.

Q: Will Livifem affect my ability to drive or operate machinery?

Official product information states that this medicine is documented as having no, or negligible, influence on a person’s ability to drive a vehicle or operate machinery.

Q: Are there any known issues with taking Livifem and consuming alcohol?

The official product information does not document any direct contraindication or interaction between the medicine and alcohol.

Q: If Livifem doesn't work for me, what should I do next?

Regulatory guidance specifies that if the medicine is not providing the intended benefit or if symptoms worsen, the treatment’s necessity and efficacy is subject to formal reassessment by a healthcare professional. Continuing any therapy without benefit is generally not advised due to associated risks.

Q: What are the most common reasons people stop taking Livifem?

Data from clinical studies show that common reasons for discontinuing the medicine include concerns over long-term risks, a decision to stop Hormone Replacement Therapy, or the occurrence of side effects. Notably, unwanted vaginal bleeding or spotting is a common reason for patients to stop treatment, particularly in the initial months.

Q: Is Livifem a controlled substance?

The active ingredient, tibolone, is classified as a prescription-only medicine. However, according to major international drug regulatory schedules, the medication is not classified or listed as a controlled substance.

Q: What are the possible signs of a serious interaction with Livifem?

Official warnings on drug interactions note that if the medicine enhances the effect of a blood thinner (like Warfarin), signs of unusual bleeding may occur. If a severe drug interaction affects the liver, symptoms such as jaundice (yellowing of the skin or eyes) may be observed. Official warnings indicate that any concerning new or worsening symptoms, especially those that might suggest a blood clot, should be discussed with a medical professional immediately.

Q: How does the dosage of Livifem relate to the effect it has?

The medicine is prescribed as a fixed, continuous daily dose. Regulatory documents indicate that this specific dosage is designed to provide the intended therapeutic effects, such as symptom relief and bone protection, while simultaneously helping to minimize effects on the uterine lining and other tissues.

Q: What happens if I accidentally take two doses of Livifem?

Official data on accidental high doses indicates that acute toxicity is considered low. Symptoms reported after taking more than the prescribed dose usually involve temporary issues such as nausea, vomiting, or unexpected vaginal bleeding. No specific antidote is required, and medical intervention is typically limited to managing these symptoms.

Q: Do I need any special monitoring (like blood tests) while on Livifem?

According to official guidance, regular health check-ups with a medical professional (at least annually) are required while taking this medicine. Additional, specific medical monitoring (such as blood tests for blood-thinning effects or liver function) may be required if you are taking certain interacting medications or have specific pre-existing health conditions.

Q: Can Livifem cause changes in mood or sleep patterns?

Changes in mood or sleep are not listed among the commonly reported side effects in official documents. Research into this medicine does acknowledge its influence on the central nervous system, particularly its role in regulating body temperature, which may indirectly lead to improvements in sleep quality for some menopausal women.

Q: How does Livifem impact existing medical conditions?

The medicine’s use is strictly defined by regulatory eligibility rules based on pre-existing health status. Conditions such as a history of blood clots, severe liver disease, or hormone-dependent cancers are listed as contraindications in official documents, meaning the medicine must not be used by patients with this medical history. Other conditions like migraine or diabetes require close medical supervision during the entire course of use.

Q: How reliable is the evidence supporting Livifem's use?

Regulatory bodies base the approval of this medicine on evidence from controlled clinical trials that support its effectiveness for both menopausal symptom relief and the prevention of bone loss. While the core evidence is considered strong, official documents note that findings regarding some secondary outcomes, such as changes in mood or libido, have been mixed or limited.

Q: Is it necessary to have a medical diagnosis before starting Livifem?

Yes, because this is a prescription-only medication, it can only be obtained after a medical professional has conducted a full assessment. The official label specifies that initiation is conditional upon a formal medical assessment confirming postmenopausal status (at least 12 months since the last natural menstrual period).

Q: Does the effectiveness of Livifem change over time?

Studies show that the relief of menopausal symptoms is typically established early in the treatment course, while protection against bone loss is measured over periods of years. The need for continued treatment is subject to periodic re-evaluation by a health professional to determine if the benefits continue to outweigh any associated risks, as mandated by regulatory guidance.

Q: Do official documents mention any rare but serious side effects of Livifem?

Yes, official documents categorize side effects into different frequency groups, including those that affect less than 1 in 100 people, such as acne, joint pain (arthralgia), or muscle pain (myalgia). Furthermore, the label highlights serious, though infrequent, adverse risks specific to the Hormone Replacement Therapy class, including stroke and blood clots.

Q: Is there ongoing research into new uses for Livifem?

While the official product information focuses only on the approved indications, the active ingredient tibolone remains a subject of continued clinical investigation. New studies are sometimes registered on international trials databases, examining the compound’s effects on conditions related to its unique tissue-selective hormonal activities.

How should Livifem be stored and disposed of?

Livifem tablets must be stored according to specific regulatory requirements to maintain the stability of the active ingredient, tibolone. The medicine must be stored at or below 25 C (77 F) and must be protected from light and moisture. Storage environments that are subject to extreme temperatures, such as refrigeration or freezing, are prohibited.

Official Storage and Disposal Rules

Storage Component Regulatory Requirement
Temperature Store at or below 25 C (Do not refrigerate or freeze)
Protection Keep in the original container; protect from light and moisture
Child Safety Store out of the sight and reach of children
Disposal Dispose of according to local requirements; do not discard in wastewater

Storage must always be in the original container. The product must not be used after the labeled expiry date. Unused or expired Livifem must be disposed of following local pharmaceutical waste guidelines, and should not be placed in household trash or poured down the drain.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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