Klimastress

Quick links to important sections

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 Klimastress

Quick Facts

Property Description
Active Ingredient Tibolone
Form Oral Tablet (Monotherapy)
Pharmacological Class Selective Tissue Estrogenic Activity Regulator (STEAR)
Origin/Type Synthetic Steroid
General Purpose Relief of climacteric symptoms

What is Klimastress and Its Active Ingredient?

Klimastress is a form of hormonal therapy centered on the active ingredient Tibolone to address symptoms experienced by women after menopause. It is classified as a synthetic steroid and is administered as an oral tablet.

The medicine is defined as a monotherapy because it contains only the single primary active ingredient, Tibolone. This substance functions as a pro-drug; once ingested, it rapidly converts into three distinct, active hormonal metabolites within the body. Tibolone is recognized for its ability to provide specific hormonal support within different body systems.


How is Klimastress Classified by Medical Type?

Klimastress belongs to the high-level class of hormonal agents, but its unique pharmacological profile leads to its precise classification as a Selective Tissue Estrogenic Activity Regulator (STEAR).

The STEAR classification reflects the drug’s capacity for tissue-specific activity; the active metabolites are preferentially activated by local enzymes in targeted tissues, such as those in the bone or the brain's temperature regulation centers. This mechanism allows the drug to exert a balance of estrogenic, progestagenic, and androgenic properties selectively across different tissues, avoiding the uniform, systemic hormonal signaling typical of older treatments.


What is the General Purpose of Klimastress?

The general purpose of Klimastress is to address and alleviate the uncomfortable and often distressing physical manifestations associated with the decline in hormones following menopause. A typical neutral use scenario for this medication is the management of moderate-to-severe vasomotor symptoms, such as persistent hot flashes and night sweats.

By acting selectively on the body's systems, the medication is intended to restore a functional hormonal balance in affected tissues, thereby providing relief from a range of postmenopausal manifestations collectively known as climacteric symptoms. This focus on symptomatic relief for these hormone-deficiency symptoms is the primary therapeutic goal.

What side effects are possible with Klimastress?

Possible Side Effects and Safety Information

The safety profile of Klimastress (Tibolone) is formally categorized based on the frequency and the physiological systems affected, as documented in official government regulatory labels. The regulatory framework identifies both frequently reported, non-serious adverse reactions and clinically significant, less common systemic risks.


Officially Documented Adverse Reactions

Classification System-Organ Class Focus Examples from Regulatory Data
Common (1-10 out of 100 users) Reproductive System, Skin, General Vaginal bleeding or spotting, breast discomfort, weight gain, hirsutism, lower abdominal pain.
Serious Risks Vascular, Neoplasms, Hepatobiliary Stroke, Venous Thromboembolism (VTE), Endometrial Cancer, Breast Cancer, Acute Liver Injury.

Key Safety Patterns and Regulatory Constraints

The regulatory safety profile highlights risks that are dependent on the duration of use. The documented risk for endometrial cancer and breast cancer is noted to increase with prolonged exposure to the medicine. Furthermore, the risk of stroke is predominantly observed in older postmenopausal women, specifically those over 60 years of age.

Official labeling defines situations where Klimastress must not be used. These absolute constraints include individuals with an active or past history of arterial thromboembolic disease, specific forms of severe hepatic impairment, or a confirmed history of estrogen-dependent malignant neoplasia. Unscheduled vaginal bleeding is most likely to occur during the initial months of therapy and typically subsides within the first six months, as specified in regulatory documentation.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents classify the acute toxicity of Klimastress (Tibolone) as very low; therefore, severe toxic symptoms are not anticipated even if multiple tablets are taken simultaneously. All information regarding overdose manifestations and management is derived from government-authorized product labeling.


Documented Overdose Manifestations

Domain Official Regulatory Statement
Documented Manifestations Nausea and vomiting
Population-Specific Note Manifestation of withdrawal bleeding is specifically noted to occur in females

Required Emergency Actions

Domain Official Regulatory Statement
Toxicity Classification Very low acute toxicity; toxic symptoms are not expected
Antidote Status No specific antidote is known
Immediate Action Urgent medical advice is required to facilitate necessary symptomatic treatment, which can be administered if documented manifestations develop

Regulatory authorities define the overall overdose management by stating that a specific antidote is unavailable, necessitating that medical attention focus on supportive care. Individuals experiencing nausea, vomiting, or withdrawal bleeding following accidental overexposure must seek professional medical advice.

Therapeutic Uses of Klimastress

What Klimastress Treats: Main Uses and Benefits

The medication Klimastress is commonly applied across domains where additional symptomatic support is needed, primarily to help patients manage temporary episodes of discomfort and maintain a sense of stability. This therapeutic approach is relevant in clinical settings for conditions that involve episodes of heightened symptoms, in situations involving certain distressing symptoms, where short-term symptomatic assistance is considered relevant.


Easing Periods of Heightened Symptomatic Discomfort

Klimastress is used in situations involving certain distressing symptoms related to physiological activity that intensify or become disruptive. It is commonly used when short-term symptomatic assistance is needed and may help patients cope more steadily with symptom fluctuations. This approach is relevant in areas where short-term symptom management is appropriate, contributing to easing the overall symptom load.

Supporting Stability Against Symptom Fluctuations

This medication is relevant for easing symptoms that cluster and interfere with daily comfort, and is considered relevant for conditions characterized by recurrent or episodic manifestations. It may assist with maintaining functional stability during periods of increased discomfort or tension.

Quick Fact: Relevant for symptoms that create noticeable physiological strain

“It is applied across domains where additional symptomatic support is needed.”

Eligibility and Restrictions for Use

Who Can and Cannot Use Klimastress?

The population eligibility for Klimastress (Tibolone) is strictly defined by regulatory authorities and is not suitable for all women. Eligibility is based on menopausal status, medical history, and specific clinical conditions.

Approved and Restricted Populations

Category Eligibility Rule (Official Labeling)
Approved Users Postmenopausal women, defined as at least 12 months after the last natural menstrual bleed.
Age Restriction Women over 60 require specific risk assessment regarding the risk of stroke. Use in women over 65 is based on limited experience.
Use Not Established There is no relevant use for this medicine in the pediatric population (le 18 years).

Absolute Contraindications

Klimastress must not be used by patients with the following conditions, as stated in official prescribing information:

  • Known or suspected hormone-sensitive cancers (e.g., breast cancer or endometrial cancer).
  • Current or past arterial or venous thromboembolic disease (e.g., stroke, heart attack, deep vein thrombosis, or pulmonary embolism).
  • Acute liver disease or liver function tests that have not returned to normal after a previous liver disease diagnosis.
  • Undiagnosed vaginal bleeding or untreated endometrial hyperplasia.
  • Pregnancy and Lactation: Use is formally contraindicated.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information describes the interaction profile of Tibolone based on its metabolic pathway and pharmacodynamic properties. These interactions can be grouped into substance categories that alter drug exposure or modify functional effects.


Interaction Scope

Category Specific Interacting Substances (Examples) Official Regulatory Outcome/Restriction
Metabolic Enzyme Inducers Rifampicin, Phenytoin, Carbamazepine, Phenobarbital Co-administration may enhance metabolism and decrease plasma concentrations of active metabolites, potentially reducing therapeutic effectiveness.
Oral Anticoagulants Warfarin and other Coumarin derivatives Enhancement of anticoagulant effect is documented, resulting in an increase in the International Normalized Ratio (INR).
Hormonal Preparations Other HRT preparations, separate progestogens Co-administration is not recommended as it may interfere with the intended tissue-specific hormonal balance of Tibolone.
Herbal Supplements St John's Wort (Hypericum perforatum) May reduce effectiveness due to its documented enzyme-inducing properties.

Interaction-Related Constraints

For patients co-administered with Coumarin-type anticoagulants, regulatory documents mandate the close monitoring of coagulation status (e.g., INR) due to the documented potential for enhanced anticoagulant activity. Furthermore, food consumption has been shown to decrease and delay the peak plasma concentration (Cmax) but does not affect the overall extent of exposure (AUC) to the active metabolites; thus, no mandatory timing separation rules are required for food administration. These official statements establish clear procedures for managing co-administered substances that affect metabolism or coagulation.

Mechanism of Action

The drug's mechanism is defined by its ability to generate three active metabolites that function as a Selective Tissue Estrogenic Activity Regulator (STEAR). This profile allows for targeted modulation of specific hormonal receptors and local enzymes across different body systems.


Central Modulation of Thermoregulation

This domain covers the activation of Estrogen Receptors ( ER) in the brain's hypothalamus by two of the drug's active metabolites. This precise action leads to the stabilization of the body's thermoneutral zone by modulating mathbf neurotransmitter pathways, which are essential for the regulation of core body temperature and peripheral vascular responses.


Receptor Agonism for Skeletal Support

Here, the mechanism is focused on ER and Androgen Receptor (AR) agonism in bone tissue. This signaling sequence results in the suppression of osteoclast function, which are the cells that break down bone, thereby modulating the rate of bone resorption and influencing skeletal structural integrity.


Localized Anti-Proliferative Enzyme Regulation

This critical aspect of the mechanism relies on the tissue-selective metabolism of the drug. By modulating local steroid-converting enzymes (like mathbf17beta -HSD and Sulfatase), the drug promotes the mathbf inactivation of estrogenic compounds within the endometrium and breast, reducing the intensity of estrogen-driven proliferation in these specific tissues.

Dosage and Administration Information

How Klimastress is Used: Administration Guidelines

Klimastress (Tibolone) is a form of hormonal monotherapy that is strictly administered via the oral route as a single, fixed-dose tablet. The use of this medicine is governed by specific protocols concerning frequency, timing, initiation, and the handling of missed doses. The primary principle is to utilize the lowest effective dose for the shortest duration necessary for treatment goals.

Administration is defined by a continuous daily schedule, meaning the tablet is taken once per day without any planned interruptions. Guidelines allow flexibility regarding meals; the tablet may be taken with or without food, as consumption does not significantly impact its absorption.


Administration Scope and Protocol

Instruction Detail
Dosing Schedule One tablet per day (2.5 mg daily) as the standard regimen.
Dosing Timing Taken once daily, preferably at the same time every day.
Preparation Tablet must be swallowed whole with liquid; must not be chewed or crushed.
Age-Group Rules No dose adjustment is required for older adults. No relevant use is established for the paediatric population.
Special Conditions A separate progestogen should not be added (monotherapy status).

Procedural Structure

Standard protocols establish precise timing for treatment initiation and dose management:

  • For natural menopause, treatment must commence at least 12 months after the last natural menstrual bleed.
  • If a scheduled dose is missed, it should be skipped entirely if the delay from the usual time is more than 12 hours. The next tablet is then taken at the usual time.

This instruction map defines the standardized approach to using the medicine, focusing solely on the procedural requirements for proper administration.

Recent Clinical Evidence

Evidence for the Management of Climacteric Symptoms


The research base for Klimastress primarily consists of short-term Randomized Controlled Trials (RCTs) and comprehensive Systematic Reviews. These studies were evaluated in postmenopausal women experiencing physical symptoms such as hot flashes and night sweats, along with other climacteric complaints. Research describes changes measured during the study period, typically over 12 to 24 weeks.

In studies exploring vasomotor symptoms, trials noted comparative measurement differences when evaluating the medicine against traditional combined hormone therapy. The medicine was also evaluated in studies examining patient-reported outcomes for associated issues like depressive symptoms and female sexual function. For these psychological outcomes, the findings were often mixed or showed high statistical variability across trials.

Research Limitations and Follow-Up

The available evidence is largely restricted to short-term observation. The main research trials focused on symptom evolution over intervals of 12 to 24 weeks, meaning the sustained durability of changes over many years remains an area where data is still emerging. Research has noted that evidence quality varies across studies due to inconsistency, particularly for psychological outcomes.

The research applies only to the populations studied, which frequently included women with an intact uterus. Data for long-term effects and specific co-occurring conditions are currently limited, and research is ongoing to contextualize patient experiences over longer periods.

Key Studies & References The effect of Tibolone treatment on depression, anxiety and mood in women: a meta-analysis and systematic review of randomized controlled trials

Frequently Asked Questions (FAQ)

Common questions about Klimastress (FAQ)


Q: How quickly does Klimastress typically start to have an effect?

Studies indicate that patients typically experience an improvement in symptoms within a few weeks after starting Klimastress. Official guidance notes that optimal results are often observed when the therapy is used for at least three months.


Q: What should I do if I accidentally miss a dose of Klimastress?

If the delay is less than 12 hours from your usual time, regulatory guidance is to take the dose. If the delay is more than 12 hours, official guidance notes that the missed dose should be skipped entirely, and the next tablet taken at the regular time. Missing a dose may slightly increase the chance of experiencing breakthrough bleeding or spotting.


Q: Is it safe to drive or operate machinery while taking Klimastress?

Regulatory documents state that Klimastress is not typically expected to impair the ability to drive or operate machinery. If side effects such as dizziness or fatigue occur, caution is generally noted.


Q: Can children or teenagers use Klimastress?

Official prescribing information states that Klimastress has no relevant use established for the pediatric population (patients under 18 years of age). The safety and effectiveness of the medicine have not been clinically established for children or teenagers.


Q: Is Klimastress a treatment or a management tool for the condition it treats?

Klimastress is formally classified as a therapy used to substitute for the hormonal deficiency. It is described as a therapy that provides relief from symptoms and is intended for the management of menopausal symptoms, rather than a cure for the underlying condition.


Q: Does Klimastress interact with alcohol?

Official guidance on alcohol consumption is not defined, and it is generally noted that patients should consult with a healthcare professional regarding its use while taking Klimastress.


Q: Is Klimastress the same type of drug as [Common Comparison Drug Name]?

Klimastress (Tibolone) is classified as a Selective Tissue Estrogenic Activity Regulator (STEAR). This unique classification indicates its tissue-selective hormonal activity, which differs from the uniform, systemic effects typical of traditional single-hormone or combined hormone replacement therapies.


Q: Does Klimastress affect birth control pills?

Klimastress is not a contraceptive and is intended only for women who are postmenopausal. Women who may still be fertile (e.g., those under 50 or less than 12 months since their last period) may need to use additional contraception to prevent pregnancy, often a non-hormonal method.


Q: What is the difference between Klimastress and a regular supplement?

Klimastress (Tibolone) is formally classified as a synthetic steroid and a prescription-only hormonal medicine. Unlike regular dietary or herbal supplements, this product is subject to regulatory approvals by government agencies to establish its use and safety.


Q: Is Klimastress addictive or habit-forming according to official sources?

Official summaries for the medicine state that there have been no reports indicating any habit-forming tendencies or potential for addiction associated with the use of Klimastress.


Q: Can I take over-the-counter pain relievers while using Klimastress?

The official interaction profile details risks with certain enzyme-inducing medicines and anticoagulants, but it does not list common, non-prescription pain relievers as known specific interactions. However, official documents advise discussing all concomitant medicines with a healthcare provider.


Q: Is Klimastress available in different strengths?

The standard regimen defined in official documents is a single 2.5 mg tablet taken once daily. This 2.5 mg strength is the dose referenced across regulatory documents defining the usual maintenance treatment.


Q: Does Klimastress affect mood or personality?

Official safety data lists depression as an occasional side effect reported with Klimastress. However, studies have also indicated that the hormonal properties of the medicine can be associated with positive effects on overall mood and sexual function.


Q: Is there a generic version of Klimastress available?

Klimastress (Tibolone) is not approved for use in the United States by the Food and Drug Administration (FDA). Because of its status in the US, an FDA-marketed generic version does not exist, though it is available under different trade names in other countries.


Q: What happens if you stop taking Klimastress suddenly?

Official guidance indicates that if the medicine is stopped, the menopausal symptoms it was used to manage may return. The decision to stop or change therapy is a matter to be discussed with a healthcare professional.


Q: Does the time of day I take Klimastress matter?

The tablet is taken once a day, and official guidance recommends taking it at the same time each day to help ensure consistent levels of the medicine.


Q: What are the signs of a serious side effect from Klimastress that require attention?

Serious risks listed in official documents include blood clots and stroke. Official documents list signs such as sudden severe chest pain, unexplained swelling or severe pain in the legs, or sudden disturbances of sight or hearing.


Q: Do any official documents describe Klimastress's effect on weight?

Official safety data lists weight gain as a common side effect of the medicine. This is defined as occurring in 1 to 10 out of every 100 users.


Q: Is the research evidence for Klimastress considered strong by regulatory agencies?

Regulatory reviews acknowledge that the medicine significantly reduces common symptoms like hot flashes and bone loss. However, official documents note that the research is mainly restricted to short-term observation, and the quality of evidence varies, particularly for psychological outcomes.


Q: Are there any specific organs, like the liver or kidneys, that Klimastress is known to affect?

Official warnings state that the medicine is contraindicated (must not be used) in patients with active or severe liver disease. For those with existing kidney diseases, official summaries advise caution and note that monitoring of kidney function may be considered.


Q: What kind of studies have been performed on Klimastress?

The research evidence supporting the medicine is primarily based on Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies generally compare the effects of Klimastress against a placebo or other hormone therapies over short-term periods.


Q: Is Klimastress a Schedule IV controlled substance in the US?

Because Klimastress (Tibolone) is not approved by the U.S. Food and Drug Administration (FDA) for sale in the United States, it is not listed or designated under the US controlled substance schedule.


Q: Do official documents mention any potential for withdrawal symptoms from Klimastress?

Official guidance does not explicitly use the term 'withdrawal symptoms.' Instead, it notes that if the medicine is discontinued, the menopausal symptoms it was used to manage may return.


Q: Can certain medical conditions make Klimastress less effective?

Yes, regulatory information indicates that conditions requiring the use of certain Metabolic Enzyme Inducers (a type of medicine) may increase the drug's metabolism. This can lower the concentration of the active substance in the body, potentially reducing its overall therapeutic effectiveness.


Q: How is Klimastress different from older medications for the same condition?

Klimastress is defined by its classification as a Selective Tissue Estrogenic Activity Regulator (STEAR). This classification highlights its tissue-selective hormonal profile, which means it aims to target benefits in specific tissues (like bone and brain) while reducing proliferative effects in other tissues (like the endometrium), distinguishing it from older, less-selective hormone therapies.


Q: What is the official definition of the condition Klimastress is approved to treat?

The medicine is formally approved for the treatment of climacteric symptoms. This is the term used in regulatory documents for the signs and discomforts, such as hot flashes and sweating, that result from the decline in hormones following natural or surgical menopause.


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

Official documents state that the tablet can be taken with or without food. No mandatory dietary changes are required.


Q: Are there known effects of Klimastress on vision?

While not listed as a common side effect in official labeling, studies have generally concluded that Klimastress does not significantly affect visual acuity or intraocular pressure.


How should Klimastress be stored and disposed of?

How to Store and Dispose of Klimastress (Tibolone Tablets)


Storage Requirements

Klimastress tablets must be stored at a temperature below 25°C in a cool, dry place. The medication must be protected from light and moisture, which requires keeping the tablets in their original package (blister and carton). Do not store the medicine in environments prone to heat and dampness, such as bathrooms. The product must always be kept out of the sight and reach of children.

Disposal Instructions

Expired or unused Klimastress must not be disposed of in household waste or flushed down the drain (wastewater), as this can harm the environment. The correct disposal procedure is to follow local requirements, which usually involves returning all unused or expired medication to a pharmacist or designated collection point.

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

Available in countries:

Equivalent of Klimastress found in:

A-Z Index: