Ugurol

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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 Ugurol

Property Description
Active ingredient Tranexamic Acid (C8H15NO2)
Form Oral tablet, Injectable solution (Parenteral)
Pharmacological class Antifibrinolytic Agent (Antihemorrhagic)
General purpose Reduction and control of excessive blood loss
Origin Synthetic molecule (Lysine derivative)

Ugurol is a pharmaceutical product primarily defined by its sole active component, Tranexamic Acid, which is classified as an Antifibrinolytic Agent. The active ingredient is a synthetic small molecule derived from the amino acid lysine, confirming its chemical, non-natural origin. It functions as a targeted Coagulation Modifier, playing an essential role in stabilizing the body's natural mechanisms for hemorrhage control and reducing excessive bleeding.

Composition and Available Forms

The composition of Ugurol centers entirely on Tranexamic Acid, formulated for flexible administration. The medicine is supplied as an oral tablet for systemic use, as well as an injectable solution for parenteral routes, often utilizing an aqueous vehicle for the liquid form. The availability of both forms ensures the drug can be used effectively either through the oral route or administered directly via injection, accommodating diverse clinical scenarios without changing the fundamental action of the compound.

General Purpose

The overarching purpose of Ugurol is to reduce and control blood loss by strengthening and preserving the integrity of blood clots. It achieves this by the targeted inhibition of fibrinolysis, the process by which the body naturally dissolves a clot. By acting as a clot stabilizer, Tranexamic Acid protects the fibrin meshwork from enzymatic dissolution. This medicine is clinically recognized for its role in managing bleeding in various settings; this mechanism helps prevent the breakdown of fibrin clots, supporting the maintenance of hemostasis.

Regulatory References

  1. Tranexamic Acid: MedlinePlus Drug Information

What side effects are possible with Ugurol?

Possible Side Effects and Safety Information

The safety profile for Ugurol, whose active substance is Tranexamic Acid, is classified according to the likelihood and type of adverse reactions documented in official regulatory sources.


Adverse Reactions by Frequency

Side effects are categorized based on their rate of occurrence in clinical data:

  • Common Reactions (occurring in 1/100 to < 1/10 treated individuals) primarily involve gastrointestinal disorders such as nausea, vomiting, and diarrhea. Other common reactions include headache, back pain, and musculoskeletal pain.
  • Uncommon Reactions (1/1,000 to < 1/100) are typically confined to allergic skin reactions.
  • Rare Reactions (1/10,000 to < 1/1,000) include thromboembolic events (blood clots, such as deep vein thrombosis or pulmonary embolism) and visual disturbances, including impaired color vision.

Serious Safety Concerns

The most clinically significant adverse reactions explicitly documented in official labeling include thromboembolic events, which are a serious consequence of the medicine's clot-stabilizing function. Convulsions/seizures have also been reported, particularly following high-dose intravenous administration. Severe hypersensitivity reactions, including anaphylaxis, are listed as a risk, though the frequency is classified as Not Known.


Safety Considerations for Specific Populations

Official regulatory documents detail specific constraints based on patient characteristics:

  • Renal Impairment: Due to the risk of drug accumulation and toxicity, the dosage must be adjusted in patients with renal insufficiency, and the medicine is contraindicated in severe renal impairment.
  • Vascular Risk: The use of Ugurol is contraindicated in patients with active thromboembolic disease or a history of specific vascular conditions, such as subarachnoid hemorrhage. Concomitant use with combined hormonal contraceptives is also contraindicated in females of reproductive potential due to an increased risk of thrombosis.

These safety classifications reflect the official regulatory framework used to organize and communicate the medicine's established risk profile.

Overdose and Emergency Response

Ugurol Overdose and when to seek help

Official regulatory documents define the overdose profile of Ugurol (Tranexamic Acid) by outlining specific manifestations and regulator-mandated emergency actions.

Property Description (Strictly Regulatory)
Documented overdose presentations Severe gastrointestinal symptoms (nausea, vomiting, diarrhea), visual impairment and ocular symptoms, mental status changes, giddiness, dizziness, and rash.
Physiological systems affected Gastrointestinal, Visual, Central Nervous System (seizures), Cardiovascular (hypotension, arrhythmias), and Coagulation system (thromboembolism).
Exposure-related factors Overdose symptoms are strongly associated with higher-than-recommended doses, rapid intravenous injection, and inadvertent administration into the spine (neuraxial system).
Population-specific overdose notes The potential for toxic reactions is increased in patients with impaired renal function due to the drug’s primary route of elimination.
Emergency-response statements Seek immediate medical attention is required for severe allergic or hypersensitivity reactions. Immediately discontinue use if visual disturbances or ocular symptoms are noticed.
Management Overdose management involves symptomatic and supportive treatment. Official regulatory documents state that no specific antidote is known.

Official Overdose Summary

The official overdose profile defines the full spectrum of acute risks, linking documented clinical signs to mandated emergency actions. Regulatory guidelines require urgent medical attention for severe systemic responses, such as anaphylaxis or severe allergic reactions. The profile confirms that management is limited to supportive care, as a specific antidote for Ugurol overdose is not currently available in the regulatory documentation.

Therapeutic Uses of Ugurol

What Ugurol Treats: Main Uses and Benefits

Ugurol, whose active substance is tranexamic acid, is a medication primarily relevant for managing symptoms associated with excessive or high-risk blood loss. It is applied across domains where short-term symptomatic assistance is needed to help manage bleeding. This medicine is commonly used across conditions presenting with acute episodes of bleeding risk.


The medicine is relevant for easing symptoms related to heavy menstrual periods (menorrhagia), and is commonly used when short-term assistance is needed to manage bleeding risk in high-risk surgical contexts. It is also applied in acute clinical settings that involve unstable symptom patterns of blood loss from internal sources, such as gastrointestinal or urinary tract bleeding.

It provides support that helps ease the overall symptom burden by assisting in the management of distressing manifestations. This treatment contributes to improved comfort during periods of heightened symptoms and contributes to easing the overall symptom load related to blood loss. It assists with maintaining a sense of stability when symptoms interfere with daily comfort.


Quick Fact: Supportive Management of Bleeding

This treatment helps address symptom clusters that may become intense or disruptive due to symptoms that create noticeable physiological strain, supporting general well-being.

Eligibility and Restrictions for Use

Ugurol (Tranexamic Acid) is subject to strict population eligibility rules documented in official governmental prescribing information. The medicine is contraindicated and must not be used by patients with a history of thrombosis or active thromboembolic disease (such as deep vein thrombosis or pulmonary embolism), or those with a known hypersensitivity to the medicine. Severe impairment of renal function also constitutes an absolute contraindication, as the drug can accumulate in the body. The injectable form is strictly contraindicated for neuraxial injection.

Use is restricted or requires conditional consideration in several patient populations. Individuals with mild to moderate renal impairment are eligible but require a mandatory dose reduction. Official labeling states that the medicine is not recommended for women who are breastfeeding or during the first trimester of pregnancy. Furthermore, the oral form is not indicated for use in postmenopausal women. While Ugurol is indicated for children from one year of age, clinical experience is limited in infants under one year. Patients with a history of convulsions or those with high-risk thrombophilia require specialist consultation before use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe clinically significant interactions for Ugurol, primarily based on its antifibrinolytic activity, which affects the body's clotting and breakdown of clots. These interactions are categorized by their potential to increase the risk of thrombosis or counteract the desired therapeutic effect.

Documented Interaction Categories

Interacting Product Category Regulatory Constraint or Implication
Thrombolytic Agents Concomitant use is generally avoided due to mutual antagonism, which compromises the effectiveness of both medicines.
Other Hemostatic Agents Not recommended due to an additive or synergistic effect, increasing the overall risk of developing a thromboembolic event.
Hormonal Contraceptives Co-administration requires careful assessment as it may increase the risk of thromboembolic events.

Specific Interacting Medicines

The product label specifically lists interactions with other fibrinolysis-affecting medicines such as urokinase, streptokinase, and Tissue Plasminogen Activator (t-PA), which are all thrombolytic agents. Additionally, the risk of thrombosis is increased when Ugurol is combined with Anti-inhibitor Coagulant Complex (AICC) and tretinoin.

Interaction-Related Requirements

The regulatory guidance emphasizes that because of the established pharmacodynamic effects, use with other procoagulant medicines or agents known to increase clotting risk requires careful consideration and heightened patient monitoring to manage the combined risk of thromboembolism.

Mechanism of Action

Molecular Inhibition of Clot Degradation

Ugurol (Tranexamic Acid) functions as a competitive inhibitor by structurally mimicking the amino acid lysine. It leverages this similarity to bind with high affinity to the Lysine Binding Sites (LBS) on the zymogen plasminogen. This molecular binding prevents plasminogen from adhering to the lysine residues exposed on the fibrin meshwork of a clot. Adhesion to fibrin is the essential first step required for plasminogen's activation into the clot-dissolving enzyme, plasmin.

Maintenance of the Fibrinolysis Pathway

By successfully blocking these molecular anchor points, the drug interrupts the fibrinolysis cascade at its initiation step. This suppression leads to a profound reduction in the localized generation of active plasmin at the clot surface. The resulting physiological effect is the maintenance of clot integrity against enzymatic attack for a sustained duration. This action is confined to supporting the structural presence of the already formed fibrin scaffold.

Dosage and Administration Information

Ugurol, whose active ingredient is Tranexamic Acid, involves specific parameters regarding administration methods, dose ranges, and duration of therapy. The medicine is supplied as an oral tablet (650 mg strength is common) for systemic use and as an injectable solution (100 mg/mL concentration) for the intravenous route.

Administration Routes and Standard Dosing

The medicine is administered through two systemic routes, each with established dosing parameters:

  • Oral Use: For cyclic use (e.g., during menstruation), the standard adult dose is 1300 mg (two 650 mg tablets) taken three times a day, for a maximum of 5 days during the monthly period. Oral tablets may be taken with or without food, and are intended to be swallowed whole.

  • Intravenous (IV) Use: For short-term systemic use, such as to reduce bleeding following tooth extraction in certain patients, the dose is typically 10 mg/kg of actual body weight, administered three to four times daily for 2 to 8 days. The IV injection is administered slowly, generally at a rate not exceeding 1 mL per minute.

Special Procedural Constraints

Administration via the intramuscular (IM) route is avoided. Furthermore, the injectable solution is not intended for intrathecal or epidural administration. The IV solution may be diluted with compatible electrolyte or carbohydrate solutions, but is not mixed with blood or penicillin-containing solutions.

Dosage Adjustments

Dosage adjustments occur for specific patient populations. For patients with impaired renal function, the dose is reduced to prevent accumulation, with specific regimens based on serum creatinine concentration. For older adults, dose adjustment is typically not required unless evidence of renal impairment is present. Pediatric dosing for clinical uses is usually weight-based, often in the region of 20 mg/kg/day.

Recent Clinical Evidence

Ugurol, whose active ingredient is Tranexamic Acid, was evaluated in research exploring the control of blood loss across several medical and surgical settings. Research primarily uses Randomized Controlled Trials (RCTs) and Systematic Reviews to examine how symptoms change over time and to monitor physiological strain related to blood loss. The information below details the structure of this evidence and highlights what aspects remain uncertain.


Evidence for Use in Heavy Menstrual Bleeding

This section summarizes the structure of short-term RCTs and Systematic Reviews that have measured changes in menstrual blood loss and quality of life in premenopausal females.

Research has explored the use of Ugurol in conditions characterized by fluctuating or episodic manifestations such as heavy menstrual bleeding. Studies involved premenopausal women and research examined primary outcomes related to physical discomfort and patient-reported outcomes describing perceived discomfort and daily functioning.

Findings describe patterns observed in the studies related to changes in the volume of menstrual blood loss recorded over the study period. Trials also reported how symptoms evolved in the observed populations concerning limitations in social or physical activities. Reported findings were generally consistent across major systematic reviews encompassing these intermediate-term trials. However, long-term effects are not fully established, as most follow-up durations were limited to monitoring women over a relatively short period, such as four to six cycles. Comparative evidence against non-drug interventions is limited.


Evidence for Use in Major Surgical Contexts

This area details the extensive research landscape, primarily RCTs and numerous Meta-analyses, that have examined the administration of Ugurol in major operations, focusing on the outcomes that track blood loss volume and transfusion requirements.

A large number of studies was studied in research administering Ugurol to adult patients undergoing major procedures like hip or knee replacement, spinal fusion, and cardiac bypass surgery. Researchers monitored outcomes such as total blood loss volume and the need for blood transfusions. These are outcomes related to systemic or functional imbalance that can occur during and immediately after surgery.

Data show patterns related to the amount of blood loss collected in the immediate postoperative period. Findings describe patterns observed in the studies in the frequency of patients needing a blood transfusion compared to control groups. Studies described patterns in the length of hospitalization between the observed groups. Evidence quality varies across studies concerning the precise timing and amount of Ugurol administration across different surgical procedures. Follow-up durations were limited almost exclusively to the hospital stay, meaning that long-term effects are not fully established regarding patient recovery or complications after discharge.

Key Studies & References

  1. Local Tranexamic Acid for Preventing Hemorrhage in Anticoagulated Patients Undergoing Dental and Minor Oral Procedures: A Systematic Review and Meta-Analysis
  2. Tranexamic Acid - StatPearls (Regulatory context and indications overview)

Frequently Asked Questions (FAQ)

Common questions about Ugurol (FAQ)

Q: Is Ugurol used for any other conditions besides the main one?

Ugurol is primarily described in official documents as a medicine used to reduce and control excessive blood loss in various medical and surgical settings. Regulatory information also lists its use for the short-term reduction of bleeding in patients with hemophilia during and after tooth extraction, and in the prophylaxis of hereditary angioedema (a condition that causes episodes of swelling).


Q: Is Ugurol considered a long-term treatment option?

Official documents indicate that Ugurol is intended for short-term treatment. Approved uses, such as for heavy menstrual bleeding or certain surgical settings, are defined by regulatory documents with duration limits. These limits typically range from a few days up to a maximum of 5 days or 2 to 8 days, depending on the specific condition.


Q: Does Ugurol have a Black Box Warning in the United States?

Official U.S. safety communications indicate that the injectable form of Ugurol has a Boxed Warning. This warning highlights the serious risks associated with the inadvertent neuraxial administration (injection into the spinal fluid space or surrounding area), which is strictly prohibited.


Q: Why is Ugurol restricted for use in certain medical conditions?

The restrictions are related to Ugurol's mechanism of action, which is clot-stabilizing (antifibrinolytic). For patients with existing or a history of clotting disorders, this action can increase the risk of thromboembolic events (blood clots). For patients with renal impairment (kidney problems), it is restricted because the drug is primarily excreted by the kidney, raising the risk of drug accumulation.


Q: Are there any specific warnings about driving or operating machinery while taking Ugurol?

Official guidance for the oral tablet form of Ugurol generally indicates that the medicine is not expected to affect a person's ability to drive a car or operate heavy machinery.


Q: Are there long-term studies available for Ugurol?

Long-term studies have been performed in animals for durations of up to 22 months. For patients treated continually for longer than several days, regulatory documents include a recommendation for regular ophthalmological examinations (eye exams) to monitor for potential changes.


Q: Why might Ugurol be discontinued by a healthcare provider?

Regulatory guidance indicates that a healthcare professional may discontinue the medicine if bleeding does not improve or gets worse after a specific treatment period. The drug may also be stopped if certain serious adverse reactions, such as visual impairment or convulsions, are noted.


Q: Are there any specific foods or drinks that should be avoided when taking Ugurol?

Official product information states that the oral tablets may be taken with or without food, and does not generally list food restrictions.


Q: Are there any known interactions between Ugurol and alcohol?

Official guidance for Ugurol does not typically list specific restrictions on alcohol consumption.


Q: Why do some people say Ugurol made them feel tired?

While Ugurol's official common reactions primarily involve gastrointestinal effects, unusual tiredness or weakness are noted in some post-marketing reports as a side effect. This reaction may occur, but it is not always listed among the most frequent (1% to 10%) official common reactions.


Q: Can Ugurol be used by women who are or may become pregnant?

Ugurol is known to pass the placenta and appear in cord blood. Regulatory documents note that there are no adequate and well-controlled studies in pregnant women. Due to the lack of sufficient data, use in pregnancy is often subject to careful assessment.


Q: Are there specific instructions for what to do if a side effect occurs (general, non-directive)?

For common side effects such as nausea or headache, they may lessen as the body adjusts. Official documents often instruct that for signs of a serious side effect (such as symptoms of a blood clot or severe allergic reaction), emergency medical assistance should be sought immediately.


Q: How is Ugurol different from other similar treatments I've seen advertised?

Ugurol is classified as an antifibrinolytic agent, meaning it works by protecting blood clots from breaking down. It is described in some regulatory documents as being significantly more active in laboratory settings (in vitro) than the structurally similar drug, aminocaproic acid.


Q: Is Ugurol a common or popular treatment for its approved use?

For its approved use in heavy menstrual bleeding, Ugurol is widely recognized in research contexts as a simple intervention used in the management of these conditions.


Q: What type of research has been done to support the use of Ugurol?

In addition to the randomized controlled trials (RCTs) that study outcomes, research types include studies required under regulatory acts, such as pharmacokinetics (PK) studies. These PK studies examine how the body processes the medicine in specific patient populations, such as pediatric female subjects for heavy menstrual bleeding.


Q: Does Ugurol interact with common vitamins (e.g., Vitamin D or C)?

Official interaction lists primarily focus on medicines that affect the body's clotting ability. Some regulatory guidance suggests there is not enough information to definitively exclude potential interactions with all herbal remedies and supplements, which include common vitamins.

How should Ugurol be stored and disposed of?

How to Store and Dispose of Ugurol

Official regulatory guidelines for Tranexamic Acid (Ugurol) mandate specific conditions to ensure product integrity and safety.

Product Form Storage Requirements Handling and Safety
Oral Tablets Store in the original package below 30 C in a cool, dry place. Must be kept out of the sight and reach of children.
Injectable Solution Store at 20 C to 25 C and protected from light. Do not freeze. The solution is for single use only and must be discarded after opening.

All unused or expired medicine and waste materials, including needles and syringes, must be disposed of in accordance with local regulatory requirements. Disposal must not be carried out via household waste or wastewater systems.

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

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