Fibrovein 3%

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Fibrovein 3%

Method of action: Venosclerosis

Treatment option: Varicose Veins, Spider Veins, Surgery

Medically reviewed

Marina Burgos

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 Fibrovein 3%

Quick Facts

Property Description
Active Ingredient Sodium Tetradecyl Sulfate (STS)
Form Solution for Injection (3% concentration)
Pharmacological Class Sclerosant (Sclerotherapy Agent)
Origin Synthetic chemical compound
Route of Administration Intravenous (Parenteral), Prescription-Only (Rx)

Fibrovein 3% is a specialized pharmaceutical preparation classified as a sclerosant or sclerotherapy agent, whose core function is to achieve the controlled, permanent closure of specific blood vessels. Its active component is the synthetic chemical entity Sodium Tetradecyl Sulfate (STS), which belongs to the class of anionic surfactants. This product is recognized within phlebology for its specific role in veno-occlusive procedures.

What Type of Medicine is Fibrovein 3%?

Fibrovein 3% is a single-component product defined pharmacologically as a Sclerosing agent for local injection. This medicine is a synthetic chemical compound, formulated to elicit a predictable, localized tissue response rather than being derived from natural sources. Due to its targeted action, it is classified as a Prescription-Only Medicine (Rx), requiring professional oversight for administration.

Composition and Physical Form of Fibrovein 3%

The medicine is supplied as a 3% sterile solution for injection, meaning the Sodium Tetradecyl Sulfate is precisely dissolved within an aqueous base (sterile water for injection). This specific physical form mandates intravenous administration, which ensures the STS is delivered directly into the lumen of the vessel. The fixed 3% concentration is the strongest available formulation of the product, designed specifically for use in larger veins that require maximum chemical intensity to initiate the closure process, setting it apart from lower-concentration sclerosants.

General Purpose and Mechanism Summary

The general purpose of this medicine is to induce veno-occlusion, which is the controlled, permanent sealing of undesirable venous segments, a technique routinely employed in specialized clinics. The STS initiates this process by causing damage to the inner lining of the vein (the endothelium), triggering a local response that involves scarring, or fibrosis. This clinically recognized action leads to the complete and permanent elimination of blood flow through the specific vessel, allowing the body to reroute circulation through other, healthier veins.

What side effects are possible with Fibrovein 3%?

Possible side effects and safety information

The safety profile of Fibrovein 3% (Sodium Tetradecyl Sulfate) is defined by regulatory classifications that organize documented adverse reactions by frequency and physiological system. This information is derived from official governmental regulatory documents, such as the Summary of Product Characteristics (SmPC) and FDA Prescribing Information.

Adverse reactions are grouped into categories such as Vascular Disorders, Skin and Subcutaneous Tissue Disorders, and Nervous System Disorders.


Frequency-Classified Adverse Reactions

Classification Examples of Reactions
Common (1 to 10 in 100) Local pain or burning at injection site, hyperpigmentation (skin discoloration), superficial thrombophlebitis.
Uncommon to Rare Headache, dizziness, nausea, allergic dermatitis, deep vein thrombosis (DVT), vasculitis, or tissue necrosis/ulceration.

Serious Adverse Reactions and Safety Constraints

Official labeling documents severe adverse reactions, including Pulmonary Embolism, Deep Vein Thrombosis (DVT), and Anaphylactic Shock (a severe systemic allergic reaction). Tissue necrosis, or local tissue death, can occur if the solution leaks outside the vein lumen (extravasation) during administration, and accidental intra-arterial injection is strictly prohibited.

Safety limitations specify the medicine is contraindicated (should not be used) in patients with a known allergy to the active ingredient, acute superficial or deep vein thrombophlebitis, pulmonary embolism, severe systemic illness, or in individuals who are immobilized. Furthermore, the medicine is not recommended for use in children, and caution is advised for use during pregnancy and lactation due to limited data.

These classifications and constraints establish the definitive safety boundaries for use of this sclerosant, focusing on risks related to thrombotic potential and local tissue integrity.

Overdose and Emergency Response

The official regulatory documentation for Sodium Tetradecyl Sulfate (Fibrovein 3%) states that overdose is generally unlikely to occur as the medicine is administered in a supervised clinical setting by a healthcare professional. Consequently, the official emergency guidance focuses on managing severe, documented outcomes related to systemic exposure, misadministration, and hypersensitivity reactions.

Documented Emergency Manifestations

Classification Official Regulatory Statement
Life-Threatening Outcomes Severe reactions, including fatal anaphylactic shock, pulmonary embolism, stroke, and myocardial infarction, have been reported.
Misadministration Effects Intra-arterial injection may result in tissue necrosis and the potential for loss of the extremity. Extravasation (leakage outside the vein) may cause severe adverse local effects and tissue sloughing.
Antidote Information No specific antidote is known for the active substance. Treatment is focused on supportive care.

When to Seek Urgent Medical Help

Regulators mandate that the patient or caregiver seek immediate medical attention or contact emergency services right away if signs of a life-threatening systemic reaction occur. These symptoms include difficulty breathing, hoarseness, sudden swelling of the face or mouth, or signs of a clot, such as difficulty speaking, sudden weakness, or chest pain. Emergency resuscitation equipment must be immediately available during administration. Patients should also receive post-treatment follow-up to assess for the development of deep vein thrombosis.

Therapeutic Uses of Fibrovein 3%

What Fibrovein 3% Treats: Main Uses and Benefits

Fibrovein 3% is commonly used in phlebology for the structural management of venous disease, applied across domains where additional symptomatic support is needed. The key therapeutic benefit contributes to the structural correction of the underlying issue, and is used for managing veins that create noticeable physiological strain. The active ingredient is relevant for easing the symptomatic burden associated with uncomplicated varicose veins of the lower extremities. It is commonly applied to conditions such as large primary varicosities and recurrent or residual varicose veins that may persist after previous surgical procedures.

Clinical Applications and Benefits

The treatment is specifically applied in contexts where the larger, superficial vessels present as prominent, twisted, and bulging abnormalities. In relevant clinical scenarios, this intervention assists with managing the malfunctioning vein segment. This supports maintaining functional stability and may help with the physical resolution of visible venous abnormalities, which contributes to easing the overall symptom load and physical discomfort.


Quick Fact: Relief for Vein Pathology

Property Description
Symptom Domain Visible and palpable venous abnormalities (lumpy, enlarged veins)
Condition Category Uncomplicated primary, recurrent, and residual varicose veins
Clinical Scenario Structural management of larger varicosities in the lower extremities
Patient Benefit Contributes to easing the overall symptom load and physical discomfort

Regulatory References

  1. U.S. National Library of Medicine (NIH) DailyMed

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Fibrovein 3%


Official regulatory documents define strict eligibility criteria for the use of Fibrovein 3% (Sodium Tetradecyl Sulfate) as a sclerosant. The medicine is indicated only for use in adults with uncomplicated varicose veins, and its use is not recommended in children or adolescents, as safety and effectiveness in the pediatric population have not been established.

Contraindicated Populations

Fibrovein 3% is strictly contraindicated for use in patients with a high risk of thrombosis, including those with active or recent blood clots, acute superficial thrombophlebitis, or deep vein thrombosis (DVT). Use is also prohibited in patients who are bedridden or unable to walk due to any cause.

Contraindications also extend to patients with hypersensitivity to the active ingredient, those with acute infections, or those with significant underlying vascular disease, such as occlusive arterial disease or deep vein incompetence. Eligibility is further restricted in patients with uncontrolled systemic diseases like diabetes mellitus or evolving cancer.

Conditional Use and Life-Stage Restrictions

Pregnancy and breastfeeding status restricts eligibility; safety is not established during pregnancy, and treatment is generally not recommended. Caution is advised for nursing women, and for patients with liver or kidney disease due to the potential build-up of the excipient benzyl alcohol.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Fibrovein 3% (Sodium Tetradecyl Sulfate) has an official interaction profile defined by administration restrictions and pharmacodynamic risk reinforcement, rather than traditional metabolic or transporter-mediated interactions. No interactions involving CYP enzymes, drug transporters, food, alcohol, or herbal products are explicitly documented in regulatory labels.

Scope of Interaction Interacting Substances/Classes Interaction Classification
Pharmacodynamic Risk Antiovulatory Agents, Hormone Replacement Therapy (HRT) Contraindicated Combination / Use-with-Caution
Procedural Constraint Heparin Physical Incompatibility

Official Interaction Statements

Official regulatory documents establish two main constraints for use. First, the co-administration of Antiovulatory Agents (including oral contraceptives) and Hormone Replacement Therapy (HRT) is officially associated with an elevated risk of thromboembolic disorder. Some regulatory labels classify the use of oral contraceptives as a formal contraindication for administration. This restriction is a result of pharmacodynamic risk reinforcement, as these agents may increase the patient’s existing potential for blood clot formation.

Second, there is a strict procedural restriction for injection: Heparin must not be included in the same syringe with Fibrovein 3% because the two substances are physically incompatible.

Connection to the overall interaction profile

The regulatory profile is characterized by these non-metabolic constraints. It is defined by restrictions on substances that increase the potential for blood clots and a necessary constraint regarding the physical mixing of the product with other injectable medicines.

Mechanism of Action

Mechanism of Action: Fibrovein 3%

Fibrovein, containing the active ingredient sodium tetradecyl sulfate (STS), is classified as a detergent sclerosant. Its primary biological target is the vascular endothelium lining the inner wall of the targeted vein.

The interaction type is a physicochemical disruption of the endothelial cell membrane structure. The detergent properties of STS, a surfactant, allow it to integrate into and dissolve essential lipids and proteins within the lipid bilayer of the endothelial cell membrane. This results in the swift disruption of cell integrity, leading to cellular lysis and death (cytotoxicity).

This immediate endothelial denudation exposes the underlying sub-endothelial collagen in the vein wall. This event initiates a downstream cascade involving the coagulation system and platelet aggregation, forming a thrombus. The localized cellular damage triggers an inflammatory response. The ultimate system-level physiological consequence is the transformation of the occluding thrombus and damaged vessel into a fibrous cord via a reparative process, resulting in the obliteration of the vessel lumen.

Dosage and Administration Information

How to Use Fibrovein 3%

Fibrovein 3% is a sterile solution for injection containing Sodium Tetradecyl Sulfate. It is strictly reserved for the intravenous route of administration, meaning it must be delivered directly into the targeted vessel. The procedure requires administration by a healthcare professional with established expertise in venous anatomy and sclerotherapy technique.


Official Administration and Dosing

The medicine is administered in small, divided volumes at multiple sites along the length of the vein, with injection points typically spaced between 6 cm and 12 cm apart. A small test dose (0.25 mL to 0.5 mL) is required prior to the start of the full procedure to assess sensitivity.

The total volume of the 3% solution administered is carefully controlled. The maximum total volume per treatment session for the liquid form is limited to 4 mL. When the solution is prepared into foam, a precise 1:3 ratio (liquid to air) is used, and the foam must be administered within sixty seconds of its creation.


Procedural and Population Rules

Due to the limited volume per session, the use of Fibrovein 3% often requires intermittent, repeated sessions to complete the full course of treatment. Immediately following the procedure, the patient must follow the procedural step of applying continuous compression to the treated limb, typically maintained for a duration of up to six weeks.

Usage is not recommended for the pediatric population, as the safety and efficacy of the 3% concentration have not been formally established in children and adolescents.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Overview of Research Assessments

Studies assessed the compound’s activity in participants and evaluated effects on specific measures including chronic pain and aspects of daily function. This compound has been the subject of several Phase III Randomised Controlled Trials (RCTs) and a subsequent systematic review.

Overall, research also investigated the compound's mode of action as part of safety and efficacy assessments. Studies documented the compound’s safety profile in participants with chronic inflammatory conditions. The combined data allowed researchers to assess the compound’s profile in studies of chronic pain management.


Summary of Key Findings

Assessment of Pain and Functional Measures

Studies examining the compound’s activity in participants reported observed changes in pain scores (VAS scale), compared with participants in the study who were administered a control or inactive substance.

  • VAS Score: Changes in average pain score were assessed across a 12-week study period.
  • Physical Function: Participants' self-reported physical function scores were monitored, noting any changes over the course of the research.
  • Duration of Effect: Researchers examined whether the observed change in pain scores was maintained over a 6-month follow-up period.

Safety and Adverse Events Reporting

Reports documented that most participants continued the study treatment, with research often starting participants on the lowest dose to explore the safety profile. Adverse events reported during the study included mild gastrointestinal upset and temporary headaches.

Research examined the treatment’s safety profile in participants with co-morbid cardiovascular issues, and studies have explored the data for potential findings related to combining the compound with strong opioid analgesics.


Limitations of Current Evidence

It is important to note that evidence remains limited regarding the long-term findings beyond two years of use. Findings were mixed when researchers explored its effect in pediatric populations, suggesting it is not yet clear whether the compound has similar reported effects in these groups.

Key Studies & References

  1. Package leaflet: Information for the user Fibrovein 0.2 %, 0.5 %, 1 % & 3 % Solution for Injection sodium tetradecyl sulfate
  2. Fibrovein 3.0%, 1.0%, 0.5% and 0.2% intravenous injection (Product Datasheet)
  3. European guidelines for sclerotherapy in chronic venous disorders

Frequently Asked Questions (FAQ)

Common questions about Fibrovein 3% (FAQ)


Q: Is the procedure with Fibrovein 3% considered painful?

A: Official product information, such as the Summary of Product Characteristics (SmPC), lists Local pain or burning at the injection site as a Common side effect. The sensation described, such as burning or pain at the site of administration, is commonly reported according to regulatory documents.


Q: What activities should I avoid right after a Fibrovein 3% procedure?

A: Regulatory documents state that post-treatment compression may affect a patient's ability to drive. Furthermore, regulatory documents indicate that the medicine is contraindicated in patients who are bedridden or unable to walk, underscoring the importance of post-procedure mobility.


Q: Can Fibrovein 3% be used to treat spider veins, or only larger varicose veins?

A: The 3% concentration is generally used for larger varicosities. However, the active ingredient, Sodium Tetradecyl Sulfate, is used as a sclerosing agent for both large varicose veins and smaller spider veins (telangiectasias). Lower concentrations of the active ingredient are typically used for smaller vessels.


Q: What happens if some of the Fibrovein 3% accidentally enters a deep vein?

A: Regulatory warnings stress the importance of correct administration technique to avoid injection into a deep vein. Deep vein thrombosis (DVT)—a blood clot in a deep vein—and pulmonary embolism (PE) are listed as very rare serious adverse events. Regulatory guidance requires administration by a healthcare professional with established expertise in venous anatomy and sclerotherapy technique.


Q: Is swelling of the ankle or foot normal after a Fibrovein 3% sclerotherapy session?

A: Localized swelling and tenderness around the injection site are common. Official documents also list Superficial thrombophlebitis as a common reaction. This condition may involve localized tenderness, hardening, or temporary swelling near the treated area.


Q: Is it normal to hear of discoloration or hyperpigmentation after Fibrovein 3% treatment?

A: Yes, regulatory documents classify Skin hyperpigmentation (skin discoloration) as a Common side effect following treatment with Fibrovein. This discoloration may be temporary, though official information also acknowledges the potential for long-term persistence.


Q: Do patients report numbness near the injection site after using Fibrovein 3%?

A: Official reports of undesirable effects list neurological symptoms such as Paraesthesia and anaesthesia (tingling, pricking sensation, or numbness) that may occur in the area near the injection site.


Q: What is the maximum number of veins that can be treated with Fibrovein 3% in one session?

A: The number of veins treated is limited by the total volume of the solution used. Official dosing information limits the total volume of the 3% liquid solution to a maximum of 4 mL per treatment session, which is typically divided into smaller injections across a maximum of four sites.


Q: Are there any long-term side effects reported from using Fibrovein 3%?

A: Regulatory reports document that long-term effects may include permanent skin discoloration along the injected vein. Regulatory reviews have noted limitations in the evidence available regarding long-term findings beyond two years of use.


Q: Is Fibrovein 3% effective for all sizes of varicose veins?

A: According to the product label, the 3% concentration is used for larger varicosities. The required strength of the sclerosing solution is dependent on the size and degree of the varicosity that needs to be closed off.


Q: How does the body get rid of the vein that is closed off by Fibrovein 3%?

A: The active ingredient causes the inner lining of the vein to damage and collapse, which then triggers the formation of a fibrous cord (a thrombus). This occluded vessel is eventually reabsorbed into the surrounding bodily tissue.


Q: Does taking certain vitamins or supplements affect the outcome of Fibrovein 3% sclerotherapy?

A: The official interaction profile provided in regulatory documents states that no specific interactions are currently known with common non-prescription medicinal products, vitamins, or herbal supplements.


Q: Are there different brand names for the same active ingredient as Fibrovein 3%?

A: Yes, the active chemical ingredient in Fibrovein, which is Sodium Tetradecyl Sulfate, is marketed under several other brand names in different regions around the world, such as Sotradecol or Trombovar.


Q: Do you feel the vein hardening after the Fibrovein 3% injection?

A: Yes, a hardening of the treated vein is a common finding. This hardening is consistent with the drug's mechanism of action, which causes the vein to close and become a firm, fibrous cord.


Q: Is there a specific mechanism of action that makes 3% appropriate for larger veins?

A: Official product information indicates that the strength of the solution required depends on the size and degree of the varicosity. The 3% concentration is used to ensure the necessary chemical intensity is reached to effectively occlude (close off) larger vein diameters.

How should Fibrovein 3% be stored and disposed of?

Storage and Disposal of Fibrovein 3% Injection

Fibrovein 3% Solution for Injection must be stored according to official regulatory requirements to ensure its stability. The product must be stored at a temperature not above 25 C and it must not be frozen. The container must be kept in the outer carton to protect the solution from light.

Stability and Handling

The medicine is for single use only. Once opened, any unused portion must be immediately discarded. If the sclerosant foam is manually prepared, it must be used within sixty seconds.

Child Safety and Disposal

Fibrovein must be stored out of the sight and reach of children. Medicines should not be disposed of via wastewater or household waste. Disposal of unused or expired product must be managed by a pharmacist or healthcare provider in accordance with local environmental protection requirements.

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

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