Uro-Vaxom

Pronunciation: YOOR-oh VAX-om.

Generic name
Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract)
Brand names
Uro-Vaxom
Drug class
Bacterial-lysate oral immunostimulant
Form
Hard capsule, 6 mg
Route
Oral
Legal status
Prescription-only in the countries where it is authorised (e.g. Germany, Switzerland, and other European markets); not an FDA-approved or MHRA-licensed product.

Availability and supply rules vary by country

Trade names by country: United Kingdom · Australia

Australia: Uro-Vaxom (import pathway only) (5) · Full directory

What Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract) is and how it works

Uro-Vaxom is an oral capsule made from an extract of E. coli bacteria, used to help prevent urinary tract infections (UTIs) from coming back. It works by stimulating the immune system rather than killing bacteria directly. (1) (2)

Uro-Vaxom is a preventive (prophylactic) treatment for people who get frequent UTIs -- it is not a treatment for an active infection on its own, and it does not replace antibiotics when you actually have an infection. Availability varies significantly by country: it is a genuine, nationally authorised prescription medicine in Germany, Switzerland, and other European countries, but it is not FDA-approved in the United States and not MHRA-licensed in the United Kingdom.

Mechanism of action: how Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract) works

Uro-Vaxom is a standardised lyophilised lysate of 18 uropathogenic Escherichia coli strains, thought to act as an oral immunostimulant that enhances mucosal and systemic immune responses relevant to the urinary tract, reducing the frequency of recurrent infections. (1)

What Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract) is used for

Prevention of recurrent lower urinary tract infections

Used to help reduce how often lower urinary tract infections (such as cystitis) recur, typically taken once daily for a 3-month course. (2) (1)

Adjuvant alongside treatment of an acute urinary tract infection

In some countries it is also used alongside standard antibiotic treatment during an active infection, as an adjuvant -- it is not a substitute for antibiotics when an infection is active. (2) (1)

Before taking Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract)

Do not take / not appropriate for

  • Do not take Uro-Vaxom if you have had an allergic reaction to lyophilised E. coli bacterial lysates or any ingredient in the capsule. (all countries where authorised) (1)
  • Do not take Uro-Vaxom if you have acute inflammation of the kidneys or renal pelvis (acute pyelonephritis) -- this is a specific contraindication in the German product information. (all countries where authorised) (1)

Tell your clinician about

  • Any previous allergic or skin reaction to Uro-Vaxom or a similar bacterial-lysate product.
  • Whether you currently have symptoms of an active urinary tract infection, so it can be treated appropriately alongside or before starting a prevention course.
  • Any kidney problems, particularly active kidney or renal-pelvis inflammation.
  • Pregnancy, plans for pregnancy, or breastfeeding, since data in these situations are limited.
  • The age of the person being treated -- safety and dosing below 4 years of age has not been established.
(1) (2)

How to take Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract)

  • Take one capsule daily, in the morning on an empty stomach, for the course length your prescriber has set.
  • For prevention of recurrent UTIs, a typical course is once daily for 3 months, as directed by your prescriber; some regimens include additional short 'booster' courses afterward.
  • For adjuvant use during an active infection, take once daily until symptoms resolve, for at least 10 days, alongside any antibiotic your prescriber has given you for the infection itself.
  • If persistent stomach or bowel symptoms occur, your prescriber may decide whether a break in treatment is needed.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)

Missed dose

If you miss a daily capsule, take it when you remember that day and continue your normal schedule the next day -- do not take two capsules together to make up for a missed one. Contact your prescriber or pharmacist if you are unsure how a missed dose affects your specific course.

Overdose

No specific overdose syndrome is described in the sources reviewed for this oral bacterial-lysate product. If you suspect you or someone else has taken more capsules than prescribed, contact a pharmacist, prescriber, or poison-control/emergency service for advice. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea, diarrhoea, vomiting, or general stomach/bowel discomfort.

What to notice: Nausea, diarrhoea, vomiting, or general stomach/bowel discomfort.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Abdominal pain, a non-persistent rash, red spots, or itching (less common).

What to notice: Abdominal pain, a non-persistent rash, red spots, or itching (less common).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Hair loss (rare).

What to notice: Hair loss (rare).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Severe swelling (oedema) of the mouth or limbs — emergency

Symptoms: Noticeable swelling of the mouth, lips, or limbs, which the German product information describes as a rare but severe reaction.

Action: Seek emergency medical help immediately, especially if swelling affects the mouth, lips, tongue, or throat, or is accompanied by difficulty breathing. (1)

Signs of a genuine active urinary tract infection while on a prevention course — high caution

Symptoms: Burning on urination, urgency, fever, or flank/back pain.

Action: Contact your prescriber promptly -- Uro-Vaxom is preventive and is not a substitute for antibiotic treatment of an active infection; your prescriber will decide whether antibiotics or other treatment are needed. (1) (2)

Interactions

  • No clinically significant drug interactions are described in the product information sources reviewed for this dossier; tell your prescriber about all other medicines you take so they can assess your overall treatment. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Data on use in pregnancy are limited, especially in the first trimester. Use during pregnancy should be a decision made with your prescriber, weighing any benefit against the limited safety data available. (1) (2) (3) (4) (5)

Breastfeeding

There is limited data on use during breastfeeding. Discuss use with your prescriber before taking Uro-Vaxom while breastfeeding. (1) (2) (3) (4) (5)

Children

Used from age 4 years and older in the markets where it is authorised; safety and dosing below that age have not been established. (1) (2) (3) (4) (5)

Elderly

No specific dose adjustment based on age alone is described in the sources reviewed. (1) (2) (3) (4) (5)

Hepatic_impairment

No specific guidance is described in the sources reviewed for liver impairment. (1) (2) (3) (4) (5)

Renal_impairment

Contraindicated during active kidney or renal-pelvis inflammation (acute pyelonephritis); tell your prescriber about any kidney problems. (1) (2) (3) (4) (5)

Monitoring

Before starting

  • Confirmation that no active kidney/renal-pelvis inflammation is present
  • Review of infection history to confirm a genuine pattern of recurrent UTIs

During treatment

  • Watching for gastrointestinal symptoms that might require your prescriber to pause treatment.
  • Watching for any swelling of the mouth or limbs, or other allergic-type reactions.
  • Tracking whether UTI frequency reduces over the course of treatment.
(1)

Storage

Store at room temperature as directed on the product packaging, out of reach of children.

Professional information

Clinician-facing context only, sourced from the German Fachinformation and Swiss compendium.ch product information; verify against the current local product information before prescribing, and note this product's genuinely mixed international regulatory status.

European Union (Germany, representative member state)

Indication: Prophylaxis of recurrent lower urinary tract infections; adjuvant in acute urinary tract infections

Dose summary: One 6 mg capsule daily, morning, empty stomach. Prophylaxis: 3-month course, sometimes followed by short monthly booster courses. Acute adjuvant use: daily until symptom resolution, minimum 10 days. Approved from age 4 years.

Renal context: Contraindicated in acute pyelonephritis; no specific dose adjustment for chronic renal impairment described in the source reviewed. (1) (2)

Mechanism of action

Hepatic guidance

No specific hepatic guidance described in the sources reviewed.

Overdose note

No specific overdose syndrome described in the sources reviewed for this product. (1)

Frequently asked questions

Is Uro-Vaxom available in the US, UK, Europe, Canada, Australia, and New Zealand?

Availability is genuinely mixed. It is a nationally authorised prescription medicine in Germany, Switzerland, and other European countries. It is not FDA-approved in the United States, and in the United Kingdom it is only accessible as a specialist unlicensed import, not an MHRA-licensed product. In Australia it can be accessed via an individual import pathway with prescriber and regulator approval, but is not a standard registered product. Its current status in Canada and New Zealand could not be conclusively confirmed and is described here as unable to verify rather than guessed. (1) (3) (4) (5)

Can Uro-Vaxom treat a urinary tract infection I already have?

Uro-Vaxom is mainly a preventive treatment to reduce how often UTIs come back. In some countries it is used alongside antibiotics as an adjuvant during an active infection, but it is not a substitute for antibiotic treatment of an active infection. (1) (2)

Who should not take Uro-Vaxom?

Anyone with a known allergy to E. coli bacterial lysates or the capsule's ingredients, and anyone with acute inflammation of the kidneys or renal pelvis, should not take it. Discuss your full medical history with your prescriber before starting. (1)

What is the mechanism of action of Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract)?

Uro-Vaxom is a standardised lyophilised lysate of 18 uropathogenic Escherichia coli strains, thought to act as an oral immunostimulant that enhances mucosal and systemic immune responses relevant to the urinary tract, reducing the frequency of recurrent infections. (1)

What is the generic name of Uro-Vaxom?

The generic name is Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract). It is sold under brand names including Uro-Vaxom. (1) (2)

What class of drug is Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract)?

Uro-Vaxom is classed as: Bacterial-lysate oral immunostimulant. (1) (2)

References

  1. Uro-Vaxom 6 mg Hartkapseln -- FachinformationGerman Fachinformation (SmPC), OM Pharma -- nationally authorised in Germany (representative EU/EEA member-state authorisation) · European Union · dated 2022-09-01 · accessed 2026-07-29 · source 1
  2. Uro-Vaxom Kapseln -- product informationcompendium.ch, the official Swissmedic-authorised medicines information portal -- product information for Uro-Vaxom (OM Pharma SA) · European Union · dated 2020-01-01 · accessed 2026-07-29 · source 2
  3. Uro-Vaxom 6mg capsules -- Actual Medicinal Product (AMP) entryNHS Business Services Authority dm+d (Dictionary of Medicines and Devices) browser · United Kingdom · dated 2026-01-01 · accessed 2026-07-29 · source 3
  4. UTI Vaccines in the United States -- availability summaryCross-checked patient-information and clinical-review sources describing UTI-vaccine availability in the United States (Let's Talk UTI patient-advocacy summary; Katie Couric Media health explainer), consistent with no US FDA-approved product identified via a direct accessdata.fda.gov search this session · United States · dated 2025-06-01 · accessed 2026-07-29 · source 4
  5. Uro-Vaxom -- prevention of recurrent UTIs (import access pathway)Visionary Health Compounding Chemist (Australian specialist pharmacy providing TGA-pathway imported Uro-Vaxom), cross-checked against TGA ARTG search finding no standard Uro-Vaxom registration · Australia · dated 2026-01-01 · accessed 2026-07-29 · source 5

Brand names by country

Single-ingredient Escherichia coli bacterial lysate (OM-89, standardised lyophilised extract) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United Kingdom

  • Uro-Vaxom (unlicensed import only) (3)accessible as specialist unlicensed import not mhra licensed · 6 mg · OM Pharma (import route only, no UK marketing authorisation holder)

Australia

  • Uro-Vaxom (import pathway only) (5)accessible via prescription plus individual tga approval not a standard artg registered product · 6 mg · import route only, no standard Australian sponsor found
View brands in additional countries.

European Union

Uro-Vaxom (Germany, representative EU member-state authorisation) (1) (2)

This page provides general reference information about Uro-Vaxom and is not a substitute for advice from the prescriber managing your treatment. Availability and legal status vary significantly by country -- confirm with a local prescriber or pharmacist before seeking to obtain this medicine.

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