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Imudon (polyvalent bacterial lysate)

Other oral cavity preparations (local classification)

ATC code: R02AA-IMUDON

Updated · Methodology

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Chronic tonsillitis and pharyngitis

Not recommended

International guidelines for chronic tonsillitis and pharyngitis ( 2012, NG84, CKS) do not include Imudon. Documented streptococcal infection is treated with antibiotics. Viral and mixed forms are managed symptomatically. Oral bacterial lysates are not used by the international medical community.

Sources

  1. Clinical Infectious Diseases: Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America (2012)
  2. Vestn Otorinolaringol: [Immune reactions of palatine tonsils in the patients with chronic tonsillitis and the possibilities for their immunological rehabilitation with the use of imudon]. (2012)
  3. Pediatric Allergy and Immunology: A critical analysis of the effect of OM‐85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta‐analysis (2024)

ICD-10: J31.2 · ICD-11: CA09.2

F

Immune support and respiratory infection care

Not recommended

Imudon (polyvalent bacterial lysate as oral lozenges) is marketed as an immunomodulator for oropharyngeal infections and for frequently ill people. International clinical guidelines (, , , CDC) do not include the drug; the has not approved it. No systematic reviews with endpoints on oropharyngeal infection frequency exist. If Imudon was recommended, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Imudon (lisado bacteriano polivalente) (2024)
  2. Cochrane (Hemila and Chalker): Vitamin C for preventing and treating the common cold (2013)
F

Prevention of recurrent respiratory infections

Not recommended

Imudon is often prescribed to children with recurrent URIs as an 'immunomodulator' for prevention. International sources do not support oral bacterial lysates for this purpose. ERS 2023 and do not include such products. Evidence-based measures are vaccination, hand hygiene, and cessation of secondhand smoke.

Sources

  1. Vestn Otorinolaringol: [Immune reactions of palatine tonsils in the patients with chronic tonsillitis and the possibilities for their immunological rehabilitation with the use of imudon]. (2012)
  2. Vestn Otorinolaringol: [Clinical efficiency of bacterial lysates used to treat children and adolescents after adenotonsillectomy]. (2011)
  3. Pediatric Allergy and Immunology: A critical analysis of the effect of OM‐85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta‐analysis (2024)
  4. Int Immunopharmacol: Broncho-Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta-analysis. (2018)
  5. EMA Article-31 referral EMEA/H/A-31/1465 (27: EMA Article-31 referral EMEA/H/A-31/1465 (27.06.2019) (2019)

ICD-10: Z29.9

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A mixture of lysates from 13 bacterial and fungal strains typical for the oral cavity: Lactobacillus, Streptococcus, Enterococcus, Staphylococcus, Klebsiella, Corynebacterium, Candida. The manufacturer claims stimulation of local immunity, increased phagocyte activity, and higher lysozyme and secretory IgA levels in saliva. Clinical studies with adequate methodology are virtually absent from PubMed. The drug is registered in Russia, Poland, and Portugal but not in the United States, United Kingdom, or Canada.

Safety

Contraindications

  • Hypersensitivity to any component
  • Autoimmune diseases (per label, with caution)

Serious adverse effects

  • No independent post-marketing surveillance data

Common adverse effects

  • Per manufacturer label: rare allergic reactions, nausea, abdominal pain

Pregnancy: can you take Imudon (polyvalent bacterial lysate)?

Pregnancy data are limited. International sources provide no recommendations.

Breastfeeding: can you take Imudon (polyvalent bacterial lysate)?

Imudon is a lysate of 13 oral bacterial species formulated as oral lozenges. The manufacturer (Solvay/Abbott) withdrew from the Russian market; the product is not registered in Spain. No systematic reviews confirm clinical benefit in stomatitis or tonsillitis. No data exist on the transfer of lysate components into human milk; systemic absorption is presumed minimal. Routine use during breastfeeding is not supported.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

Imudon is sold in Russian pharmacies as lozenges. It is frequently prescribed to children and adolescents for 'frequent tonsillitis' or 'chronic tonsillitis'. Oral bacterial lysates are not used in Western medical practice, and there are no high-quality RCTs for them.

Common myths

Myth: 'Imudon is a throat vaccine that trains local immunity'. Fact: unlike registered vaccines (pneumococcal, Haemophilus, influenza), Imudon bacterial lysates have not undergone phased clinical trials assessing clinical outcomes – tonsillitis frequency, tonsillectomies, hospitalisations. Claims of 'training local immunity' remain hypothetical.

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Frequently asked

What is Imudon (polyvalent bacterial lysate) used for?

Imudon (polyvalent bacterial lysate) is evaluated for the following indications with varying evidence strength: Immune support and respiratory infection care (evidence tier F), Chronic tonsillitis and pharyngitis (evidence tier F), Prevention of recurrent respiratory infections (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Imudon (polyvalent bacterial lysate)?

Common side effects of Imudon (polyvalent bacterial lysate) (≥ 1 in 100): Per manufacturer label: rare allergic reactions, nausea, abdominal pain. See the Safety section for uncommon and serious reactions.

Is Imudon (polyvalent bacterial lysate) safe during pregnancy?

Pregnancy data are limited. International sources provide no recommendations.

Is Imudon (polyvalent bacterial lysate) compatible with breastfeeding?

Imudon is a lysate of 13 oral bacterial species formulated as oral lozenges. The manufacturer (Solvay/Abbott) withdrew from the Russian market; the product is not registered in Spain. No systematic reviews confirm clinical benefit in stomatitis or tonsillitis. No data exist on the transfer of lysate components into human milk; systemic absorption is presumed minimal. Routine use during breastfeeding is not supported.

Who should not take Imudon (polyvalent bacterial lysate)?

Imudon (polyvalent bacterial lysate) is contraindicated in: Hypersensitivity to any component; Autoimmune diseases (per label, with caution). Full list in the Safety section.

Imudon is a throat vaccine that trains local immunity

unlike registered vaccines (pneumococcal, Haemophilus, influenza), Imudon bacterial lysates have not undergone phased clinical trials assessing clinical outcomes – tonsillitis frequency, tonsillectomies, hospitalisations. Claims of 'training local immunity' remain hypothetical.

Official sources

Direct links to regulator labels. Open in a new tab.

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