Bacterial lysates OM-85

Other immunostimulants

ATC code: L03AX-OM85 (Bacterial lysate OM-85 systemic (local code))

Mechanism of action

Lyophilised lysates of 8 bacterial species: Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Moraxella catarrhalis. The manufacturer claims dendritic cell and T-lymphocyte activation, enhanced secretory IgA synthesis, and modulation of cellular immune response. Unlike many Russian 'immunomodulators', OM-85 has a limited international evidence base: a 2012 Cochrane review found a possible reduction in URI episodes in children, but with high risk of bias.

Indications

Prevention of recurrent respiratory infections

Individual decision

A 2012 Cochrane review of bacterial lysates in children showed a possible reduction of approximately 1.2 URI episodes over 6 months. Authors noted high risk of bias in most included trials and result heterogeneity. The 2023 ERS guideline mentions OM-85 as an option for recurrent respiratory infections in children but without a strong recommendation. There are no data on long-term outcomes – severity, antibiotic use, or hospitalisations.

Adult use is a separate topic with weaker evidence. Decisions are individual with realistic expectations: the effect is limited and long-term benefits have not been demonstrated.

Sources

ICD-10: Z29.9

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.

COVID-19

Not recommended

In 2020-2022 OM-85 was promoted for COVID-19 prevention in children with recurrent URIs. , NIH, CDC, and ERS did not recommend this practice. Evidence-based prevention is vaccination, masks during high-transmission periods, and hand hygiene.

Sources

ICD-10: U07.1 · ICD-11: RA01.0

Immune support and respiratory infection care

Not recommended

Bronchomunal (OM-85, lyophilized bacterial lysate) is promoted by the manufacturer as an immunostimulant for recurrent respiratory tract infections in frequently ill children and adults. Meta-analyses (Schaad 2010 and newer work) show modest reductions in respiratory infection frequency in children with recurrent colds, with modest and heterogeneous effects. International clinical guidelines include the drug to a limited extent (AEMPS Ficha Técnica supports use in patients with recurrent respiratory tract infections); the has not approved it. In healthy children and adults without recurrent infections, prophylactic use is not justified. If OM-85 was recommended without confirmed recurrent respiratory tract infections, consider seeking a second opinion.

Sources

Practical notes

Russian practice note

Bronchomunal (and brands with the same OM-85 – Broncho-Vaxom, Ismigen) is widely prescribed in Russia for children with frequent URIs. Realistic benefit is a possible reduction of a few URI episodes per year without effect on severity or outcomes. Baseline measures – pneumococcal, Haemophilus, and influenza vaccination – work on evidence-robust outcomes: pneumonia, hospitalisations, mortality.

Context

OM-85 stands out among 'immunomodulators' by having been studied in multicentre European RCTs and holding European registration, even if weak. This does not move it to first-line. For recurrent respiratory infections in a child, workup for hidden causes matters more: allergic rhinitis, adenoids, secondhand smoke, immunodeficiency.

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Official sources

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GRLS

Russian State Register of Medicines

Safety

Contraindications

Hypersensitivity to any component
Age under 6 months (pediatric formulation), under 12 years (adult formulation)
Acute intestinal infections

Serious adverse effects

Allergic reactions including angioedema (rare)
Post-marketing reports of thrombocytopenia (rare)

Common adverse effects

Gastrointestinal upset (nausea, abdominal pain, diarrhoea)
Headache
Rash

PregnancyFDA N

Pregnancy data are limited. Avoid use without clear indications.

Breastfeeding

OM-85 is a lysate of 21 respiratory bacterial strains (Broncho-Vaxom, registered in Spain), used for prophylaxis of recurrent respiratory infections. Systemic absorption of lysate components is minimal; no data exist on transfer into human milk. AEMPS does not list a direct contraindication during breastfeeding; the decision is taken case by case.

Calculate RID

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

Frequently asked

What is Bacterial lysates OM-85 used for?

Bacterial lysates OM-85 is evaluated for the following indications with varying evidence strength: Prevention of recurrent respiratory infections (evidence tier D), Immune support and respiratory infection care (evidence tier F), COVID-19 (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Bacterial lysates OM-85?

Common side effects of Bacterial lysates OM-85 (≥ 1 in 100): Gastrointestinal upset (nausea, abdominal pain, diarrhoea), Headache, Rash. See the Safety section for uncommon and serious reactions.

Is Bacterial lysates OM-85 safe during pregnancy?

FDA category N. Pregnancy data are limited. Avoid use without clear indications.

Is Bacterial lysates OM-85 compatible with breastfeeding?

Who should not take Bacterial lysates OM-85?

Bacterial lysates OM-85 is contraindicated in: Hypersensitivity to any component; Age under 6 months (pediatric formulation), under 12 years (adult formulation); Acute intestinal infections. Full list in the Safety section.

Mechanism of action

Practical notes

Russian practice note

Context

Safety

Contraindications

Hypersensitivity to any component
Age under 6 months (pediatric formulation), under 12 years (adult formulation)
Acute intestinal infections

Serious adverse effects

Allergic reactions including angioedema (rare)
Post-marketing reports of thrombocytopenia (rare)

Common adverse effects

Gastrointestinal upset (nausea, abdominal pain, diarrhoea)
Headache
Rash

PregnancyFDA N

Pregnancy data are limited. Avoid use without clear indications.

Breastfeeding

Calculate RID

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

Frequently asked

What is Bacterial lysates OM-85 used for?

What are the side effects of Bacterial lysates OM-85?

Common side effects of Bacterial lysates OM-85 (≥ 1 in 100): Gastrointestinal upset (nausea, abdominal pain, diarrhoea), Headache, Rash. See the Safety section for uncommon and serious reactions.

Is Bacterial lysates OM-85 safe during pregnancy?

FDA category N. Pregnancy data are limited. Avoid use without clear indications.

Is Bacterial lysates OM-85 compatible with breastfeeding?

Who should not take Bacterial lysates OM-85?