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.

Indications

Acute respiratory viral infection

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.

COVID-19

Not recommended

The WHO 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.

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.

Influenza

Not recommended

International influenza guidelines (WHO, IDSA 2018, NICE 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.

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.

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

Pregnancy

Contraindicated in pregnancy. Safety data have not been published.

Breastfeeding

Contraindicated during breastfeeding.

Frequently asked

What is Tilorone used for?

Tilorone is evaluated for the following indications with varying evidence strength: COVID-19 (evidence tier F), Influenza (evidence tier F), Acute respiratory viral infection (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?

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.