Uro Vaxom

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Uro Vaxom

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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 Uro Vaxom

Quick Facts

Property Description
Active Ingredient Lyophilized bacterial lysate (OM-89)
Form Hard capsule (oral)
Pharmacological Class Immunostimulant / Immunomodulator
Common Use Prevention of recurrent urinary tract infections (UTIs)
Origin Biological (derived from Escherichia coli)

What Type of Medicine is Uro Vaxom?

Uro Vaxom, identified by the substance code OM-89, is a prescription-only medicine classified as an oral immunostimulant within the immunomodulator pharmacological group. It is defined as a specialized biological origin medicine, produced by OM Pharma SA, and is clinically recognized for its high-level purpose of immune prophylaxis, which is the prevention of recurring infections. Unlike conventional antibacterial agents that directly eliminate active bacterial populations, Uro Vaxom stimulates the host's natural defenses, offering a non-antibiotic strategy for patients prone to frequent urinary issues.

Composition: Lyophilized Bacterial Lysate and Form

The core active component of Uro Vaxom is a lyophilized bacterial lysate derived from eighteen distinct strains of Escherichia coli, which is a uropathogen commonly implicated in urinary tract infections (UTIs). The medicine is presented as a hard capsule for oral administration, a form that ensures stability and potency of the biological material (OM-89). This immunologically active E. coli extract is used specifically in the management of recurrent UTIs. The capsule format also contains excipients such as mannitol and sodium glutamate, which stabilize the material for delivery through the gastrointestinal tract.

General Purpose: Non-Antibiotic Immune Prophylaxis

The overall benefit of Uro Vaxom is achieved through the stimulation of the immune system, serving as a strategic, non-antibiotic approach to prevention. The product functions by activating immune cells to increase the production of protective antibodies, notably secretory Immunoglobulin A (IgA), in the mucosal membranes. This systematic enhancement of the body’s humoral and cellular defenses reinforces the patient’s biological resistance, thereby reducing the vulnerability and frequency of bacterial colonization over time.

Regulatory References

  1. Immunoactive prophylaxis of recurrent urinary tract infections: a meta-analysis - NCBI - NIH

What side effects are possible with Uro Vaxom?

Possible Side Effects and Safety Information

The safety profile of Uro Vaxom (OM-89) is formally defined by government regulatory authorities based on clinical trials and post-marketing surveillance, classifying documented adverse reactions by frequency and the body system affected. This classification establishes the official understanding of potential risks associated with the medicine.

Regulatory Classification of Adverse Reactions

Adverse reactions are organized into System-Organ Classes (SOCs), with severity and frequency defined by regulatory standards (e.g., Common, Uncommon, Rare).

Classification System-Organ Class (SOC) Affected Documented Reactions
Common (1/100 to 1/10) Gastrointestinal disorders, Nervous system disorders, Respiratory disorders, General disorders Nausea, Diarrhea, Abdominal pain, Headache, Cough, Fatigue
Uncommon (1/1,000 to 1/100) Immune system disorders, Skin and subcutaneous tissue disorders, General disorders Allergic reactions, Rash, Urticaria, Fever, Vomiting, Dyspepsia
Rare (1/10,000 to 1/1,000) Immune system disorders Angioedema

Serious adverse reactions, such as Angioedema and Systemic allergic reactions, are documented as rare events but warrant specific attention in the official labeling. Furthermore, the regulatory documents note that some effects, particularly fever and gastrointestinal disturbances, may be more frequently observed at the start of treatment.

Safety Restrictions and Special Populations

Use of Uro Vaxom is subject to specific safety constraints detailed in the regulatory prescribing information. The medicine is formally contraindicated in individuals with a known hypersensitivity to the active substance or excipients, and in those diagnosed with autoimmune diseases. The safety and efficacy of the product have not been established for use in children under 4 years of age.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Uro Vaxom (Lyophilized bacterial lysate OM-89) indicates a high degree of safety regarding excessive use. The critical information available in official government prescribing documents is that no cases of adverse reactions or specific toxicity due to overdose have been formally reported in regulatory documentation. This absence of documented events means that no specific symptoms, signs, or severe, life-threatening outcomes resulting from an overdose are detailed in government labeling. This fact establishes a low-toxicity profile as defined by regulatory authorities.

Consequently, no specific antidote is listed as required in the official overdose section, and management is generally described as symptomatic and supportive, based on the patient's individual clinical condition. No specific procedural steps are detailed.

Despite the low documented toxicity, regulatory authorities mandate a specific course of action in the event of a suspected or confirmed overdose.

Regulatory Finding Official Labeling Statement
Documented Symptoms None reported
Specific Antidote None documented
Mandatory Action Consult your doctor or a qualified healthcare professional immediately.

The instruction to consult a doctor is the singular required emergency action, and this applies in all cases where an overdose is suspected, as documented in the official prescribing information.

Therapeutic Uses of Uro Vaxom

What Uro Vaxom Treats: Main Uses and Benefits

Uro Vaxom is commonly used to help manage recurrent lower urinary tract infections (UTIs) and chronic recurrent cystitis, specifically for the prophylaxis of these conditions. This strategy is applied when patients experience conditions involving recurrent or episodic manifestations, relevant for easing symptoms related to inflammatory or irritative states.

The primary therapeutic focus is on prophylaxis, relevant for easing recurrent or episodic manifestations. This approach helps manage the symptom clusters associated with UTI recurrence, including painful voiding, urinary urgency, and frequency. This strategic non-antibiotic method is relevant for easing the overall symptom load by helping manage the need for repeated courses of antimicrobial therapy.

“The primary benefit of this approach is in managing recurrent or episodic manifestations and supporting functional stability.”

In addition to prophylaxis, the medication is considered relevant as an adjunctive therapy in specific clinical scenarios, such as alongside antibiotic treatment during acute episodes to support patients during difficult episodes by easing distress. Furthermore, its application may be part of symptomatic management for patients undergoing complex treatments like intravesical BCG therapy for bladder cancer, where additional symptomatic support is needed.


Quick Fact: Relief for Recurrence

Property Description
Main Condition Conditions involving recurrent or episodic manifestations
Primary Benefit Provides support that helps ease the overall symptom burden
Symptom Focus Symptoms related to inflammatory or irritative states
Clinical Context Prophylaxis and supportive management

Regulatory References

  1. National Institutes of Health (NIH)

Eligibility and Restrictions for Use

Official Eligibility and Exclusion Criteria

Regulatory documents define specific populations who are eligible, restricted, or excluded from using Uro-Vaxom based on their physiological state, age, and known allergies.

Classification Population or Condition
Contraindicated Individuals with known hypersensitivity to the active substance or any other component of the medicine.
Established Use Adults and children from 4 years of age.
Use Not Established Children under 4 years of age, as efficacy and safety have not been studied or confirmed in this age group.
Restricted Use/Avoid Pregnant women (especially the first trimester); use is avoided as a precaution due to limited or absent clinical data.
Conditional Use/Caution Breastfeeding women should exercise caution due to lack of specific studies. Patients taking immunosuppressive drugs should also use caution, as the drug's effect may be reduced or inhibited.

The official eligibility profile is structured by setting an absolute exclusion for anyone with a known allergy to the product's constituents. Use is permitted only for patients who meet the minimum age eligibility of 4 years. Furthermore, the profile mandates special caution or avoidance for those in a state of pregnancy or lactation and for individuals on immunosuppressive therapy, as these conditions may compromise either safety or the intended efficacy of the medicine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes the official interaction profile for Uro Vaxom, as documented in authoritative governmental regulatory documents. The information presented here strictly reflects the findings and statements within the product's official labeling regarding its interaction with other medicines and products.


Official Interaction Profile

Regulatory assessments for Uro Vaxom consistently state a lack of documented drug-drug interactions. The product's official labeling, based on clinical experience and regulatory review, explicitly reports that no cases of drug interactions have been known or reported to date with this product. Consequently, official government-sourced documents include no specific warnings, constraints, or procedural requirements related to co-administration with other medicines. The absence of documented interactions means there are no officially defined timing rules or restrictions on specific interacting medicinal products or substance categories.

Interaction Scope Regulatory Status
Specific Interacting Medicines Listed None (Not Applicable)
Medicinal Product Categories Listed None (Not Applicable)
Interaction-Related Restrictions None Documented

This official finding simplifies the regulatory interaction structure for Uro Vaxom, contrasting it with many pharmaceutical products that require detailed instructions for use with cytochrome P450 inhibitors, inducers, or other pharmacologically active substances. Patients should consult their healthcare provider if they have questions regarding any simultaneous use of medicines or vaccines.

Mechanism of Action

Mucosal Immune System Activation

This domain involves the activation of immunocompetent cells within the gut-associated lymphoid tissue (GALT), specifically in structures like Peyer's patches, following oral administration. Uro-Vaxom modifies early molecular steps by binding to receptors, such as Toll-like Receptor 4 (TLR4), initiating signaling cascades that result in the differentiation and migration of specialized immune cells.


Specific Antibody and Humoral Response

Uro-Vaxom modulates key pathways associated with the adaptive immune response. It stimulates B-lymphocytes (plasma cells) to promote the production of specific antibodies, primarily secretory IgA (sIgA). The specific antibody production contributes to the binding and neutralization capacity of the humoral response, which are then transported to mucosal surfaces; this action contributes to the localized activity of secretory IgA.


Non-Specific Cellular Defense Enhancement

This domain engages mechanisms that regulate innate cellular immunity. Uro-Vaxom promotes the stimulation of white blood cells like macrophages and lymphocytes. The cellular stimulation results in the alteration of cytokine profiles and phagocytic activity. The signaling pathway adjustments modulate the overall innate immune function.

Dosage and Administration Information

Uro Vaxom is an oral medicine used according to a structured regimen defined in official prescribing information. Administration follows a precise protocol for dosing, timing, and total course duration, which is distinguished between preventive treatment and supportive use during an acute episode.

Administration Scope Official Labeled Instruction
Route & Form Hard capsule taken orally (by mouth).
Standard Dose One (1) capsule daily (6 mg lyophilized bacterial lysate).
Timing & Frequency Taken once per day (once daily) on an empty stomach (before a meal).
Course Duration Prophylactic Use: Three (3) consecutive months.
Adjunctive Use At least ten (10) consecutive days when co-administered with conventional antimicrobial therapy.

The consistent daily dose of 6 mg is used across all approved regimens for oral intake. This administration is preferably performed in the morning to align with the prescribed daily schedule. The medicine is indicated for use in adults and children from 4 years of age with the same daily capsule dose, though safety and efficacy are not established below this age threshold. During acute episodes, the medication is explicitly used as a supportive co-medication alongside a full course of antibiotics, not as a standalone treatment. The fixed administration schedule for prophylaxis is a foundational procedural component, designed to complete a cycle of consistent daily use over the full three-month period.

Recent Clinical Evidence

Research evidence / Overview of studies for Uro Vaxom


Evidence for use in Recurrent Urinary Tract Infections (rUTIs)

Research has focused on studying Uro Vaxom in adults with recurrent urinary tract infections (rUTIs) through randomized controlled trials (RCTs) and systematic reviews. Studies examined outcomes like the frequency of new infection episodes, the time between episodes, and the need for antibiotics. Data describe patterns observed in the studies related to the measured recurrence rate compared to placebo, sometimes noting fewer episodes in the study group. Findings also indicated an associated change in antibiotic usage. Long-term effects beyond one year are not fully established, and follow-up durations were often limited.


Evidence for use as Adjunctive Support in Specific Clinical Contexts

Studies have explored the use of Uro Vaxom alongside intravesical BCG therapy for bladder cancer, although this evidence is based on non-randomized, retrospective cohort studies. Research examined outcomes related to the rate of interrupting the BCG treatment due to infectious complications and changes in the usage of antibiotics. The certainty remains low for this specific application because the studies rely on small samples and retrospective designs, and they did not evaluate cancer-specific outcomes, such as tumor recurrence rates.


Follow-up and Long-Term Research

Most research was observed in studies over short periods, primarily lasting three to six months. Some longer-term trials monitored patient responses up to twelve months. Evidence describing the long-term patterns of recurrence or observed response beyond one year is considered restricted.


Evidence in Specific Patient Populations

The majority of studies conducted focused on adult women with recurrent UTIs. Consequently, data for men remain insufficient, and studies exploring this population are limited. Uro Vaxom was also observed in some studies examining outcomes in patients with chronic neurogenic bladder dysfunction.


Research Gaps and Areas of Uncertainty

Research highlights what is still uncertain, including the challenges posed by methodological heterogeneity across studies—such as varied definitions of a "recurrent UTI." Subgroup findings are uncertain, and the evidence quality varies. More research is needed to fully understand the full breadth of observed patterns.

Key Studies & References

  1. Efficacy and Safety of Uro-Vaxom in Urinary Tract Infection Prevention: A Systematic Literature Review

Frequently Asked Questions (FAQ)

Common questions about Uro Vaxom (FAQ)


Q: Do Uro Vaxom capsules cause stomach upset or digestive issues?

According to official product information, common side effects can include gastrointestinal issues such as nausea, diarrhea, abdominal pain, and gastric intolerance. Regulatory documents note these effects are typically classified by their frequency and may be observed when starting treatment.


Q: Can Uro Vaxom be taken with vitamins or herbal supplements?

Official regulatory documents consistently state that no drug interactions have been known or reported to date with Uro Vaxom. This indicates that there are no specific warnings or restrictions in the labeling regarding co-administration with vitamins or herbal supplements.


Q: What is the typical maintenance schedule for Uro Vaxom after the initial treatment?

The officially recommended duration for preventive treatment involves taking the medicine daily for three consecutive months. The official labeling does not explicitly define a separate long-term maintenance schedule after this initial course is complete.


Q: Does Uro Vaxom interact with common pain relievers like ibuprofen or acetaminophen?

Official labeling states that no drug interactions have been known up to now. This lack of documented constraints implies there is no known specific interaction with common pain relievers like ibuprofen or acetaminophen, according to regulatory findings.


Q: Are there studies supporting the long-term use of Uro Vaxom?

The standard preventive course is three months. While some studies have monitored patient response for up to a year, official research summaries indicate that evidence describing long-term patterns or effects beyond one year is restricted.


Q: Does Uro Vaxom work against all types of bacteria that cause UTIs?

The medicine is a specialized immunostimulant derived from a lyophilized bacterial lysate of eighteen different strains of Escherichia coli. While E. coli is a common cause of UTIs, regulatory documents do not specify its full breadth of action against all other bacteria that may cause urinary tract infections.


Q: Is it normal to feel slightly worse when starting Uro Vaxom?

Regulatory documents note that certain effects, particularly fever and gastrointestinal disturbances like nausea or diarrhea, may be more frequently observed when starting the medicine. This is a documented occurrence in the official safety profile.


Q: Is Uro Vaxom available over the counter, or do I need a prescription?

Uro Vaxom is consistently classified by regulatory authorities as a prescription-only medicine (POM). Therefore, it is only available with a prescription from a licensed healthcare provider.


Q: Is it normal to experience headache as a side effect of Uro Vaxom?

Yes, headache is listed as a Common side effect in the official product information. This means that, according to clinical data, it may affect up to 1 in 10 people taking the medicine.


Q: Does Uro Vaxom have to be taken with food, or can it be taken on an empty stomach?

The official administration instructions state that the capsule should be taken once per day on an empty stomach. It is preferably taken in the morning before a meal.


Q: Are there any known severe allergic reactions associated with Uro Vaxom?

Allergic reactions are documented as Uncommon side effects, and more serious reactions like Angioedema (swelling, often of the face or throat) are documented as Rare events. These types of reactions require prompt medical attention.


Q: Can Uro Vaxom be used by individuals with autoimmune conditions?

The official safety information states that the medicine is formally contraindicated in individuals who have been diagnosed with autoimmune diseases. This is an absolute exclusion criteria listed in the regulatory documents.


Q: Does Uro Vaxom contain any common allergens like lactose or gluten?

The capsule contains excipients such as starch, magnesium stearate, sodium glutamate, and mannitol. Based on official product documentation, the full list of excipients should be confirmed against specific sensitivities like lactose or gluten.


Q: Are there any known constraints related to co-administration with other medicines?

Regulatory assessments for Uro Vaxom state that no cases of drug interactions have been known or reported to date. Based on documented findings, no official constraints are currently listed for co-administration with other medicines.

How should Uro Vaxom be stored and disposed of?

Storage Requirements

Condition Requirement (Official Labeling)
Temperature Store in a temperature below 25 C (defined as room temperature storage).
Protection Must be kept in the original blister pack and carton until the time of use.
Stability Limit Do not use the medicine after the expiry date printed on the packaging.
Child Safety Mandatory instruction to keep out of the sight and reach of children.

Disposal Instructions

Official regulations strictly govern the disposal of unused or expired Uro Vaxom to prevent environmental contamination.

  • The medicine should not be disposed of via wastewater or household waste.
  • Individuals must ask a pharmacist how to properly dispose of medicines that are no longer required, ensuring adherence to local pharmaceutical waste guidelines.

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

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