Other oral cavity preparations (local classification)
ATC code: R02AA-IMUDON (Imudon (polyvalent bacterial lysate, local code))
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.
Not recommended
International guidelines for chronic tonsillitis and pharyngitis (IDSA 2012, NICE 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.
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 AAP do not include such products. Evidence-based measures are vaccination, hand hygiene, and cessation of secondhand smoke.
Pregnancy data are limited. International sources provide no recommendations.
Imudon (polyvalent bacterial lysate) is evaluated for the following indications with varying evidence strength: 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.
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.
Pregnancy data are limited. International sources provide no recommendations.
Imudon (polyvalent bacterial lysate) is contraindicated in: Hypersensitivity to any component; Autoimmune diseases (per label, with caution). Full list in the Safety section.
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.