Tilorone

Other antivirals (local classification)

ATC code: J05AX-TILORONE (Tilorone (local code))

Mechanism of action

The manufacturer claims induction of endogenous interferons (alpha, beta, gamma) in intestinal epithelium and lymphocytes. Tilorone was synthesised in the United States in the 1970s as an oral interferon inducer, but clinical trials were discontinued due to lack of clinical efficacy and toxicity signals. Current international sources do not mention tilorone as an antiviral agent.

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.

Common cold

Not recommended

Viral URI is a self-limited illness that does not require etiotropic therapy. International guidelines support only symptomatic care: antipyretics for fever, adequate hydration, and rest. Tilorone is not considered for this purpose in international sources.

Sources

ICD-10: J00 · ICD-11: CA00

COVID-19

Not recommended

The Therapeutics Living Guideline and NIH COVID-19 Treatment Guidelines do not mention tilorone. In 2020-2022 Russia massively prescribed the drug in outpatient COVID-19 care without international evidence support. Agents with established benefit are nirmatrelvir/ritonavir in high-risk outpatients, remdesivir, corticosteroids, and tocilizumab in hospitalised patients.

Sources

ICD-10: U07.1 · ICD-11: RA01.0

Herpes simplex

Not recommended

For herpes simplex management, international guidelines (CDC STI Treatment Guidelines 2021, IUSTI 2017) list aciclovir, valaciclovir, and famciclovir. Tilorone is not mentioned.

Sources

ICD-10: B00 · ICD-11: 1F00.Z

Immune support and respiratory infection care

Not recommended

Tilorone (Amixin, Lavomax) is a Soviet-era interferon inducer prescribed in Russia and the CIS for colds, flu, herpes, and immunity. International clinical guidelines (, , , CDC) do not include the drug; the , , and AEMPS have not approved it. No independent international clinical studies with endpoints on cold duration exist. The drug causes GI disturbances, allergic reactions, and hepatotoxicity has been described. If tilorone was recommended, consider seeking a second opinion.

Sources

Influenza

Not recommended

International influenza guidelines (, 2018, NG191) do not mention tilorone. Proven antivirals are neuraminidase inhibitors (oseltamivir, zanamivir) and the cap-dependent endonuclease inhibitor baloxavir. Independent RCTs of tilorone have not been published in the Cochrane Library or PubMed outside Russian and Ukrainian sources.

Sources

ICD-10: J10-J11 · ICD-11: 1E32

Practical notes

Russian practice note

Tilorone is widely sold in Russia as Amiksin and Lavomax. It is included in Russian Ministry of Health guidelines for influenza and URI but is not recognised by the international medical community. The drug is not registered as a medicine in the United States, EU, Canada, Australia, or the United Kingdom.

Safety concerns

Early US studies in the 1970s documented tilorone accumulation in cornea and retina, with deposits clinically resembling those from chloroquine. This signal contributed to discontinuation of US development. Systematic surveillance of ocular adverse effects in Amiksin users has not been performed in publicly available Russian sources.

Common myths

Myth: 'Amiksin is a real antiviral, it triggers interferon'. Fact: interferon induction in vitro or in animal models does not translate to clinical efficacy in influenza or URI in humans. Without independent RCTs measuring clinical outcomes (illness duration, complications, hospitalisation), the manufacturer's claims remain marketing statements.

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Official sources

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GRLS

Russian State Register of Medicines

Safety

Contraindications

Hypersensitivity to any component
Pregnancy and breastfeeding
Age under 7 years

Serious adverse effects

Potential ocular toxicity (corneal and retinal deposits) from historical US data; no systematic post-marketing surveillance in Russia

Common adverse effects

Per manufacturer label: dyspepsia, brief chills
Allergic reactions

PregnancyFDA N

Contraindicated in pregnancy. Safety data have not been published.

Breastfeeding

Contraindicated during breastfeeding.

Calculate RID

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

Frequently asked

What is Tilorone used for?

Tilorone is evaluated for the following indications with varying evidence strength: Immune support and respiratory infection care (evidence tier F), COVID-19 (evidence tier F), Herpes simplex (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Tilorone?

Common side effects of Tilorone (≥ 1 in 100): Per manufacturer label: dyspepsia, brief chills, Allergic reactions. See the Safety section for uncommon and serious reactions.

Is Tilorone safe during pregnancy?

FDA category N. Contraindicated in pregnancy. Safety data have not been published.

Is Tilorone compatible with breastfeeding?

Contraindicated during breastfeeding.

Who should not take Tilorone?

Tilorone is contraindicated in: Hypersensitivity to any component; Pregnancy and breastfeeding; Age under 7 years. Full list in the Safety section.

Amiksin is a real antiviral, it triggers interferon

interferon induction in vitro or in animal models does not translate to clinical efficacy in influenza or URI in humans. Without independent RCTs measuring clinical outcomes (illness duration, complications, hospitalisation), the manufacturer's claims remain marketing statements.

Mechanism of action

Practical notes

Russian practice note

Safety concerns

Common myths

Safety

Contraindications

Hypersensitivity to any component
Pregnancy and breastfeeding
Age under 7 years

Serious adverse effects

Potential ocular toxicity (corneal and retinal deposits) from historical US data; no systematic post-marketing surveillance in Russia

Common adverse effects

Per manufacturer label: dyspepsia, brief chills
Allergic reactions

PregnancyFDA N

Contraindicated in pregnancy. Safety data have not been published.

Breastfeeding

Contraindicated during breastfeeding.

Calculate RID

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

Frequently asked

What is Tilorone used for?

What are the side effects of Tilorone?

Common side effects of Tilorone (≥ 1 in 100): Per manufacturer label: dyspepsia, brief chills, Allergic reactions. See the Safety section for uncommon and serious reactions.

Is Tilorone safe during pregnancy?

FDA category N. Contraindicated in pregnancy. Safety data have not been published.

Is Tilorone compatible with breastfeeding?

Contraindicated during breastfeeding.

Who should not take Tilorone?

Tilorone is contraindicated in: Hypersensitivity to any component; Pregnancy and breastfeeding; Age under 7 years. Full list in the Safety section.

Amiksin is a real antiviral, it triggers interferon