Femastin

Quick links to important sections

Medically reviewed

Laura Arias

Last updated on 22/12/2025

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 Femastin

Property Description
Active ingredient Estriol (E3)
Form Tablets (Oral Solid Dosage Form)
Pharmacological class Estrogens (Hormone Replacement Therapy)
Common purpose Addressing estrogen deficiency symptoms
Origin Natural estrogen, Steroid hormone

What Type of Medication is Femastin?

Femastin is a pharmaceutical preparation classified as a hormonal medication and is intended for replacement therapy primarily for postmenopausal women. The medicine belongs to the pharmacological class of Estrogens, which are part of the larger group of sex hormones and modulators of the genital system (ATC Code: G03CA04). The overall therapeutic goal of the medication is defined by its role as an estrogen supplement.

The brand is often positioned as a focused approach to hormonal support, emphasizing its role in compensating for physiological deficits. The active compound, Estriol, is chemically defined as a naturally occurring estrogen. Femastin is a systemic treatment option, distinguishing it from products limited to local application, making it suitable for managing deficiency symptoms throughout the body.

Composition and Origin of the Active Ingredient

The active ingredient in Femastin is Estriol (E3), a single-component substance that defines the drug as a monotherapy. This hormone is presented as an oral solid dosage form in the shape of tablets, designed for systemic delivery. The composition strictly includes the active compound Estriol and necessary solid pharmaceutical excipients.

Estriol is characterized as a natural estrogen and is considered a relatively low-potency estrogen when compared to Estradiol (E2). This attribute contributes to the compound’s distinct pharmacological profile. The distinction underscores the product's specialized mechanism within hormone replacement therapy (HRT).

General Purpose of Estriol Replacement Therapy

The overarching general purpose of Femastin is to serve as a focused method of replacement therapy to modulate processes affected by estrogen deficiency. By supplying the body with the essential Estriol component, the medication aims to restore hormonal balance. A neutral and typical use scenario involves its application to alleviate discomfort associated with low sex hormones, often serving as foundational hormonal support. This action relies on Estriol operating as an estrogen receptor agonist, activating specific receptors to mitigate symptoms directly linked to the reduced presence of these steroid hormones.

What side effects are possible with Femastin?

Possible Side Effects and Safety Information

The official safety information for systemic Estriol (Femastin) is structured around frequency classifications and documented systemic risks, consistent with regulatory guidelines for estrogen-only hormone replacement therapy (HRT).


Documented Adverse Reactions

The regulatory label classifies adverse reactions based on their reported frequency in clinical use:

  • Common (occurring in 1 to 10 out of 100 people): Headache, abdominal pain, and events related to the reproductive system, such as vaginal discomfort, vaginal discharge, or vaginal haemorrhage.
  • Uncommon (occurring in 1 to 10 out of 1,000 people): Nausea, rash, hypertension, hot flush, weight increase, and vulvovaginal mycotic infection.

Adverse reactions are organized by the System-Organ Classes (SOC) they affect, which include Nervous System, Gastrointestinal, Reproductive System, Vascular, and Skin disorders.


Serious Safety Considerations

Official regulatory documents emphasize that systemic estrogen therapy carries an increased risk of certain serious conditions:

  • Thromboembolic Events and Stroke: An increased risk of Venous Thromboembolism (VTE), including Deep Vein Thrombosis and Pulmonary Embolism, and Stroke is documented. The VTE risk is noted to be highest during the first year of use.
  • Endometrial Risk: Systemic estrogen use alone in women with an intact uterus for prolonged periods is associated with an increased risk of endometrial hyperplasia and carcinoma.
  • Probable Dementia: An increased risk of probable dementia has been reported in women starting systemic estrogen therapy after the age of 65.

Safety Constraints and Special Populations

Regulatory documents define specific safety constraints. The medication is generally contraindicated in cases of severe hepatic impairment. Immediate withdrawal is required if the patient develops new onset of migraine-type headache, a significant increase in blood pressure, or signs of jaundice indicating liver deterioration. Close follow-up is required for women with pre-existing hypertriglyceridemia due to the rare risk of pancreatitis, and for those with cardiac or renal dysfunction due to the potential for fluid retention.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Estriol (Femastin) overdose establishes the documented presentations and the required immediate emergency actions.

Documented Overdose Manifestations

Symptoms recognized in the event of an acute overdose of Estrogen-class medications include nausea, vomiting, abdominal pain, and breast tenderness. Other documented manifestations may include drowsiness, fatigue, headache, skin rash, and fluid retention. A key clinical sign is the occurrence of vaginal bleeding (or withdrawal bleeding), which may be excessive and can occur several days following the overdose.

Mandated Emergency Actions

In all overdose situations, it is required to seek immediate medical help and contact a Poison Control Center for guidance.

Urgent, life-threatening outcomes require immediate contact with emergency services (e.g., 911). This action is mandated if the affected person shows signs of collapse, experiences a seizure, has trouble breathing, or is unresponsive (cannot be awakened).

Official Supportive Management

Management involves discontinuation of the product and the institution of symptomatic treatment and supportive care, as no specific antidote is known for Estriol. Monitoring of vital signs, including blood pressure and heart rate, may be required. In serious cases, procedures such as the administration of activated charcoal or Intravenous (IV) fluids may be utilized.

Therapeutic Uses of Femastin

Estriol-based treatments are applied across domains where additional symptomatic support is needed to address menopausal changes and associated discomfort. The medication is commonly used to address conditions presenting with systemic or localized discomfort, particularly urogenital atrophy (VVA), bothersome systemic climacteric complaints, and related lower urinary tract complaints.

These therapeutic areas cover a range of disruptive symptoms, including vaginal dryness, irritation, burning, dyspareunia, urinary frequency, dysuria, hot flushes, and night sweating.

“This therapy assists in managing symptom clusters that may become disruptive, providing supportive relief when symptoms interfere with routine activities.”

Femastin is applied when appropriate for addressing symptom clusters that may become intense, providing support that may assist with easing the overall symptom load when symptoms are more noticeable. It is also relevant in clinical settings that require additional management of discomfort, such as before or after vaginal surgical procedures. This supportive role may help improve day-to-day comfort and assists with maintaining functional stability.


Quick Fact: Supportive Relief for Urogenital Atrophy and Systemic Climacteric Complaints

Eligibility and Restrictions for Use

Eligibility and Contraindications

The eligibility for Femastin (Estriol) is defined by official regulatory criteria, primarily indicating its use for postmenopausal women with established estrogen deficiency symptoms. Eligibility is subject to absolute prohibitions and requirements for careful medical supervision based on the patient's health status.

Absolute Prohibitions (Contraindications)

Systemic Estriol must not be used by women who are pregnant or breastfeeding. It is also strictly contraindicated for patients with a known history of estrogen-dependent malignant tumors (including breast cancer), a history of or current venous thromboembolism (VTE), thrombophilic disorders, arterial thromboembolic disease, active liver disease, untreated endometrial hyperplasia, or undiagnosed genital bleeding.

Conditional Use and Restrictions

Use is conditional for women with an intact uterus, who must be concurrently prescribed a progestin to mitigate the risk of endometrial hyperplasia. Patients with pre-existing conditions like cardiac or renal dysfunction, hypertension, or hypertriglyceridemia require close medical supervision and observation due to regulatory concerns about fluid retention and metabolic risks.

Femastin is not recommended for the pediatric population due to insufficient safety data. Use in women over 65 years is limited and requires careful assessment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Femastin (estriol) is an estrogen, and its metabolism can be affected by other medications. Consult a healthcare professional about all medicines and supplements being taken, as combining them may alter the effects of Femastin or the interacting product.

Potential Drug Interactions

The primary concern for systemic drug interactions involves enzyme-inducing and enzyme-inhibiting medicines, particularly those affecting the liver's Cytochrome P450 3A4 ( CYP3 A4) enzyme system.

Product Category Mechanism/Effect on Femastin Example Substance Class
CYP3 A4 Inducers May decrease estriol plasma concentration, potentially reducing effectiveness. Certain Anti-Epileptics, Rifamycins, St. John's Wort
CYP3 A4 Inhibitors May increase estriol plasma concentration, potentially increasing side effects. Certain Azole Antifungals, Macrolide Antibiotics

Specific Interacting Products

  • Corticosteroids: Estrogens may increase the pharmacological effects of certain corticosteroids. Dose adjustments for the corticosteroid may be necessary.
  • Anticoagulants: There is a potential for interaction that may affect the action of anticoagulant medications.
  • Other: Concurrent use of barbiturates, hydantoins, or rifampicin may decrease estriol effectiveness. Herbal preparations containing St. John's Wort are also noted for their potential to reduce estrogen levels.

Always discuss any new or discontinued medication, including over-the-counter products and herbal supplements, with a healthcare provider to manage the risk of interaction. Do not change the dosage of any medicine without medical advice.

Mechanism of Action

How Femastin Works


Targeted Receptor Modulation

Femastin's action begins by selectively engaging key receptor sites within defined neural or humoral pathways. This primary mechanistic domain involves initiating or suppressing specific signaling events at the cellular level, which fundamentally modulates the transmission of signaling events within the associated cellular pathways.


Pathway Signal Dampening

Following receptor engagement, the drug modulates the intracellular signal transduction cascade, a domain relevant in systems where targeted pathway adjustment is required. By modifying these early molecular steps, Femastin limits the propagation of excessive mediator activity and results in a regulated state within the targeted pathways.


Systemic Homeostatic Modulation

The combined effects influence feedback regulation, engaging mechanisms that regulate overactive or dysregulated physiological processes. The mechanistic influence contributes to the establishment of modulated activity within the associated physiological pathways, leading to physiological adjustments that reflect the drug's mechanism of action.

Dosage and Administration Information

How to Use Femastin

Femastin (Estriol) is administered according to a structured regimen designed to manage estrogen deficiency symptoms, consistent with standard principles for Hormone Replacement Therapy (HRT). The usage protocol involves the use of the lowest effective dosage for the shortest possible duration.


Administration Guidelines

The established usage pattern defines the appropriate route, dose, and frequency, based on prescribing information:

Instruction Detail
Route of Administration Oral (Tablet).
Dosing Frequency Typically once daily administration.
Timing in relation to meals May be taken with or without food.
Preparation The oral solid dosage form must be swallowed whole.

Standard Dosage Regimens

The dosage schedule involves an initial phase followed by a reduction to maintenance levels:

Phase Typical Dosage Range (Estriol)
Initial (Loading) Dose 4 mg to 8 mg per day.
Maintenance Dose 1 mg to 2 mg per day.

Administration begins with the initial dose and requires a gradual reduction (titration) toward the lower maintenance dosage. The maximum dose of 8 mg per day is restricted to short-term use and should not be administered for longer than several weeks. For specific clinical scenarios, such as before and after vaginal surgery, short-term, cyclical regimens are applied.

This protocol ensures the medication is used according to the defined dosage phases and daily frequency.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Oral Estriol


Evidence for Use in Urogenital Atrophy

Estriol, the active ingredient in Femastin, was studied for its application in conditions related to urogenital atrophy. This involves outcomes related to the urogenital system, such as vaginal dryness, irritation, and discomfort during intercourse. Research examined these symptoms in postmenopausal women through various designs, including Randomized Controlled Trials (RCTs) and meta-analyses. These trials primarily focused on patient-reported outcomes describing perceived discomfort and clinical measures. The studies reported on the evolution of symptom scores experienced by women receiving Estriol. Follow-up durations were limited in many studies, meaning long-term effects are not fully established regarding the maintenance of observed symptom patterns.

Evidence for Use in Systemic Climacteric Complaints

Studies explored how Estriol was evaluated in women experiencing systemic climacteric complaints, such as bothersome hot flushes and night sweating. Research examined these outcomes related to systemic or functional imbalance. Investigators examined symptom patterns in the reported frequency and severity of vasomotor symptoms. Estriol was evaluated in the context of being a low-potency estrogen. Observations varied in specific reports, particularly concerning changes in certain hormone levels, and certainty remains low regarding the consistency of observed changes across all studies.

Research Focus on Endometrial Status

Research specifically examined the long-term patterns of the oral formulation in the context of the endometrium (the lining of the uterus) in women who have not had a hysterectomy. Research examined these outcomes through dedicated multi-center trials involving long-term assessment protocols. These studies monitored changes by measuring endometrial thickness and by performing biopsies to evaluate the tissue. Research describes the observed patterns for the endometrium, based on the specific doses and populations was studied for.

What Research Gaps and Uncertainty Remain

The follow-up durations were limited in many symptom trials, meaning that long-term effects are not fully established for the persistence of observed patterns related to systemic and urogenital complaints. Comparative evidence is lacking against other types of hormonal therapy. The evidence quality varies across studies, and the research provides context but not individual predictions, as the study results reflect the specific conditions under which they were conducted.

Key Studies & References

  1. Genitourinary Syndrome of Menopause (GSM) - British Menopause Society (BMS) Consensus Statement

Frequently Asked Questions (FAQ)

Common questions about Femastin (FAQ)


Q: What is the difference between Femastin and a supplement?

Femastin is defined in regulatory documents as a pharmaceutical medication that requires a prescription. It is classified as an estrogen for Hormone Replacement Therapy (HRT). This official classification and prescription status distinguish it from over-the-counter or unregulated supplements.


Q: Can Femastin be taken with over-the-counter pain relievers like ibuprofen?

Official product information advises general caution when taking Femastin with any other concurrent medicines, including over-the-counter pain relievers. This is because combining medications may alter the overall effect of either product or increase the risk of side effects. Official sources emphasize that any decision regarding concurrent use should be made with a healthcare provider.


Q: Does Femastin treat the cause of the condition or just the symptoms?

Femastin’s role is described as replacement therapy. It works by substituting the body's low levels of endogenous estrogen. This action is intended to alleviate the deficiency symptoms by providing replacement hormones.


Q: Why is the mechanism of action of Femastin important?

Understanding the mechanism of action is important for explaining the drug's therapeutic role. Official documents describe that Femastin acts as an estrogen receptor agonist, meaning it modulates specific signaling events at the cellular level to correct the effects of estrogen deficiency.


Q: Is Femastin the same type of medicine as [Similar Drug Name]?

Femastin contains the active ingredient Estriol, which is categorized as a low-potency, naturally occurring estrogen. This specific classification, documented in official sources, distinguishes it from other forms of hormones, such as Estradiol or synthetic compounds, that may be used in other replacement therapies.


Q: How quickly does Femastin usually start to work?

According to pharmacokinetic data, the active substance is readily absorbed after administration, and its concentration in the bloodstream peaks within a few hours. However, the full clinical benefits, such as significant improvement in persistent symptoms, are typically assessed by studies over several weeks of continuous use.


Q: What should I do if I forget to take Femastin?

Regulatory instructions describe the procedure for a missed dose as taking it as soon as possible. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped entirely. Official documents specifically warn against taking two doses to make up for a single missed dose.


Q: Are there any common foods or drinks that interact with Femastin?

Official warnings note that grapefruit juice is known to interact with some systemic oral estrogens that are metabolized by the same enzyme system as Estriol. This interaction could potentially affect the concentration of the drug in the body.


Q: Is it true that Femastin can affect your sleep?

Regulatory documents list Insomnia, or trouble sleeping, as a reported adverse reaction. This is one of the reactions included in the official safety information for the medication.


Q: How long does the effect of one dose of Femastin last?

The duration the drug remains active in the body is described in the pharmacokinetic data. The elimination half-life of oral Estriol is typically reported as being between 5 to 10 hours.


Q: What happens if I stop taking Femastin suddenly?

Regulatory principles emphasize that Femastin should be used for the shortest possible duration and at the lowest effective dose. Any decision regarding discontinuation or dose change is typically advised to be made under medical supervision to manage the return of symptoms or any other potential effects.


Q: Is Femastin known to interact with birth control pills?

Because Femastin is an estrogen, regulatory documents state that combining it with other estrogen-containing products, such as certain birth control pills, is generally contraindicated due to the increased risk of serious side effects associated with elevated total estrogen levels.


Q: Is it possible to be allergic to Femastin?

Regulatory documents list a known allergy or hypersensitivity to the active substance (Estriol) or any other component (excipient) as an absolute contraindication for use. As a contraindication, the drug is not authorized for use by individuals with a confirmed allergy to any of its components.


Q: Why do some people feel tired after taking Femastin?

Regulatory and post-marketing data have included reports of fatigue or asthenia (a lack of energy) in some individuals. This is noted as a potential adverse reaction to the medication.


Q: Is Femastin known to interact with alcohol?

Official labeling typically notes precautions regarding alcohol consumption. This is a general precaution because alcohol can affect liver function, which is critical for the proper metabolism of estrogen medications like Femastin.


Q: What should be done if I experience a side effect listed in the leaflet?

Official guidance describes the process of reporting any side effect to the healthcare provider for evaluation. The guidance also outlines the procedure for reporting adverse reactions directly to national regulatory bodies, such as the FDA or the MHRA.


Q: Can Femastin affect mood or anxiety levels?

Yes, regulatory documents report that anxiety and general mood disturbances are potential adverse reactions associated with the use of this medication.


Q: Is Femastin a controlled substance?

Estrogens, including the active ingredient in Femastin (Estriol), are classified as prescription medications. However, official records indicate that these hormones are not listed as controlled substances by major national regulatory bodies.


Q: Does Femastin require a special diet or lifestyle changes?

The official label requires specific caution for patients with certain pre-existing conditions, such as high blood fat levels (hypertriglyceridemia). The management of these conditions while on Femastin may involve concurrent review of diet or lifestyle by a healthcare provider.


Q: Is it safe to drive or operate machinery after taking Femastin?

Regulatory documents for similar estrogen products often state that the drug has no or negligible influence on the ability to drive. However, patients should be cautious, and if they experience side effects such as dizziness, official guidance suggests that caution should be exercised.


Q: Why is it necessary to take Femastin regularly?

Regulatory instructions describe the need for regular, daily administration. This precise schedule is necessary to maintain the constant therapeutic plasma levels of the hormone required for effective and stable estrogen replacement.


Q: What kind of monitoring (e.g., blood tests) might be needed while on Femastin?

Routine monitoring is described in regulatory documents as a necessary part of therapy. This typically includes yearly medical and breast examinations, blood pressure checks, and, for women with an intact uterus, specific monitoring for abnormal genital bleeding.


Q: Does Femastin interact with caffeine?

Regulatory information notes that related estrogens can have a moderate interaction with caffeine. This potential interaction may increase the blood levels of caffeine, which could lead to increased side effects associated with caffeine consumption.

How should Femastin be stored and disposed of?

How to Store and Dispose of Femastin

The storage and disposal of Femastin (Estriol) tablets are governed by official regulatory guidelines to ensure the stability of the medicine and prevent environmental contamination.

Required Storage Conditions

Femastin must be stored at controlled room temperature, typically maintained between 20°C and 25°C (68°F and 77°F). The tablets must be protected from both moisture and light and should remain in their original, tightly closed container or blister pack. It is explicitly required that the product must not be refrigerated or frozen, as extreme temperatures can compromise stability.

Child Safety and Disposal

The medication must always be stored out of the sight and reach of children.

For disposal, unused or expired Femastin must be discarded according to local regulations for pharmaceutical waste. Due to the nature of the hormonal component, the product must not be thrown into household waste or disposed of via wastewater, such as flushing it down the toilet.

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

Available in countries:

Equivalent of Femastin found in:

A-Z Index: