Арбидол

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Арбидол

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Арбидол

Quick Facts

Property Description
Active ingredient Umifenovir (INN)
Form Oral (Capsules, Tablets)
Pharmacological class Antiviral, Fusion Inhibitor
General purpose Intervention against acute respiratory viral infections
Origin Synthetic, Indole derivative

What is Umifenovir and its Chemical Identity?

The medicine sold under the trade name Арбидол is a medication based on the active pharmaceutical ingredient Umifenovir. It is defined as a synthetic, non-nucleoside, small-molecule drug, chemically structured as an indole derivative. Umifenovir is designed as a single-component agent against viral pathogens and is administered exclusively via the oral route, typically supplied as hard capsules or tablets.

The identity of Umifenovir is rooted in its synthetic origin, which ensures the compound possesses a consistent and precise structure developed through specific molecular research. The World Health Organization (WHO) classifies Umifenovir under the Anatomical Therapeutic Chemical (ATC) code J05AX13, categorizing it within the group for "Other antivirals". This classification confirms its position as an established antiviral agent for systemic use.

Classification and General Purpose of Umifenovir

Umifenovir is classified as a direct-acting antiviral (DAA) and a host-targeting agent. Its function is to specifically interfere with the viral life cycle by blocking a critical early step—the fusion process—a distinction from antivirals that primarily target later stages of viral propagation.

Characterized as a broad-spectrum agent, Umifenovir operates primarily by inhibiting membrane fusion. This mechanism prevents the viral envelope from successfully merging with the membrane of a host cell, thereby blocking the virus from releasing its genetic material and initiating replication. This provides a dual activity in its pharmacological profile.

Additionally, the substance exhibits an immunomodulatory effect, supporting the body’s innate defense system by promoting responses such as interferon production. The general purpose of the medicine is to provide intervention against the initial cellular infection and subsequent spread of viral pathogens, primarily those responsible for acute respiratory viral infections (ARVI) and influenza (both A and B types).

What side effects are possible with Арбидол?

Possible Side Effects and Safety Information

The officially documented safety profile for Umifenovir (Арбидол) is primarily characterized by adverse events related to hypersensitivity. According to regulatory documentation, the overall incidence of side effects is generally low, with documented reactions categorized as Rare in frequency.


System-Organ Classes and Adverse Reactions

The adverse reactions associated with Umifenovir are consistently reported under two System-Organ Classes (SOC) in regulatory labeling:

  • Immune system disorders: Manifesting as general allergic reactions.
  • Skin and subcutaneous tissue disorders: Such as rash or itching (pruritus) resulting from hypersensitivity.

While rare, the potential for serious hypersensitivity reactions is noted in official safety information. This concept relates to rare but severe allergic responses, including anaphylactic manifestations, as documented by national health authorities.


Regulatory Safety Limitations

The most significant safety constraint is the official contraindication against the use of Umifenovir in any individual with a history of known hypersensitivity to the active substance or any of its non-active components. This constraint addresses the core risk associated with the medicine.

Furthermore, regulatory authorities advise exercising extreme caution when the medicine is administered to children under two years of age. No explicit time-related patterns, such as increased frequency during treatment initiation, are consistently documented in the core safety sections of the official labels.

Overdose and Emergency Response

The official regulatory documentation for Umifenovir (Арбидол) defines the overdose profile primarily by its high safety margin and the absence of specific clinical findings in human trials and post-marketing surveillance. The risk of severe acute intoxication is considered low.

Category Regulatory Statement on Overdose
Documented overdose presentations No specific clinical signs or symptoms of overdose have been formally reported in regulatory sources.
Dose-related or exposure-related factors Acute overdose risk is considered low due to a high therapeutic index and low non-clinical toxicity.
Immediate actions and urgent help Seek immediate medical attention following any ingestion that substantially exceeds the regulated dose, or for any unexpected severe reaction.
Antidote status No specific antidote is known for Umifenovir overdose.
Supportive care Treatment for overexposure is limited to symptomatic and supportive measures.
Overdose Classifications Regulatory Basis
Severity classification Not formally classified as presenting specific severe symptoms; characterized by a high safety profile.
Monitoring requirements Hospital monitoring is required only if severe or unexpected symptoms are clinically observed.

Official overdose statements:

  • No specific clinical manifestations or symptoms of overdose have been formally reported.
  • No specific physiological system effects are listed in the official overdose section.
  • Treatment for overexposure is described as symptomatic and supportive only.

Connection to the overall overdose profile: The official regulatory documentation establishes that the overdose profile is defined by the absence of specific clinical signs, which reflects the drug's established low acute toxicity. Regulatory guidance therefore mandates a management strategy focused on supportive care, while explicitly stating that immediate medical attention must be sought for substantial overexposure, as is standard for medications lacking a specific antidote.

Therapeutic Uses of Арбидол

Umifenovir is commonly used for the treatment and prophylaxis of Influenza A and Influenza B infections, alongside other Acute Respiratory Viral Infections (ARVI). This therapeutic domain covers acute conditions marked by the sudden onset of heightened symptomatic discomfort. The use of Umifenovir generally helps to ease the overall symptom burden and contributes to easing the overall duration of the symptomatic period.


The medication is relevant in clinical settings where key symptoms, such as fever, generalized malaise, and cough, create noticeable physiological strain. It is commonly used to help with symptom clusters that may become intense or disruptive, assisting with maintaining a sense of stability during symptomatic periods. This usage is particularly relevant during seasonal epidemic risk.

“This medication is applied in settings where additional management of discomfort is required during acute symptomatic episodes.”

Umifenovir is applied in addressing conditions presenting with acute episodes and recurrent manifestations, including Influenza A, Influenza B, and ARVI. It contributes to easing the overall symptom burden and may assist in reducing the risk associated with contracting a viral illness or developing associated symptomatic manifestations.


Quick Fact: Support in Acute Symptomatic Contexts

Benefit Focus Therapeutic Domain
Symptom Management Assists with maintaining a sense of stability during symptomatic periods.
Use Context Relevant in contexts involving heightened systemic burden and acute symptoms.
Patient Benefit Provides support that helps ease the overall symptom burden.

Eligibility and Restrictions for Use

Eligibility for Umifenovir (Арбидол) is determined by its official prescribing information, which outlines absolute prohibitions and conditional limitations across different patient populations.

Absolute Contraindications

Use of the medicine is strictly prohibited for the following populations as defined in regulatory documents:

  • Hypersensitivity: Patients with known allergy or hypersensitivity to Umifenovir or any other component of the specific formulation.
  • Pregnancy and Lactation: Use is contraindicated during the first trimester of pregnancy and throughout the entire breastfeeding period.
  • Metabolic Disorders: Contraindicated in patients with specific inherited metabolic conditions, such as glucose-galactose malabsorption or sucrose/isomaltose deficiency, due to excipients in certain dosage forms.

Age and Conditional Restrictions

The approved age for use varies based on the product formulation, with different minimum age thresholds (e.g., 2 years, 3 years, 6 years, or 12 years) for suspension, tablets, or capsules.

Use is subject to special medical caution and oversight in patients with the following conditions:

  • Severe Organ Impairment: The drug's effectiveness and safety have not been formally evaluated in individuals with severe hepatic impairment or renal impairment, requiring caution during prescription.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Arbidol (Umifenovir) regarding drug interactions is primarily characterized by an absence of documented negative interactions with specific categories of co-administered medicines.

Official Regulatory Interaction Statements

Interaction Type Regulatory Status/Findings
Drug-Drug Contraindications No absolute drug-drug contraindications are explicitly listed in official regulatory texts.
Pharmacodynamic Interactions Regulatory documents note that no undesirable interactions were found when Arbidol was co-administered with common symptomatic therapies, including antipyretic (fever-reducing), mucolytic, and local vasoconstrictor medicines.
Pharmacokinetic Basis (CYP/Transporters) Information on specific cytochrome P450 (CYP) enzyme-mediated or drug transporter interactions is not documented in the official labeling.
Food/Alcohol/Herbal Products No specific clinically significant interactions with food, alcohol, or herbal products are documented.

Summary of Interaction Profile

The interaction structure of Arbidol, as defined by the official labeling, relies on statements of non-incompatibility with common symptomatic medicines rather than a comprehensive list of known interaction risks or mechanisms. Regulatory texts explicitly acknowledge that dedicated clinical studies to investigate the interactions of Arbidol with other specific medicinal products have not been conducted. Therefore, the official documentation does not impose specific restrictions on co-administration timing or dose separation with other medications.

Mechanism of Action

Umifenovir ( Арбидол) operates through a dual mechanistic approach, targeting both viral propagation and the host's innate immune system, resulting in a combined molecular consequence that restricts viral spread and supports host defense signaling.

Blockade of Viral Fusion and Entry

Umifenovir functions as a fusion inhibitor by interacting with the viral envelope and the host cell's endosome membrane. In the case of influenza, it binds to the Hemagglutinin (HA) protein, stabilizing its pre-fusion state and preventing the pH-dependent conformational changes necessary for the virus to merge with the host cell. This mechanism stops the transfer of viral genetic material into the host cell cytoplasm, leading to the cessation of early viral replication and limiting the progression of systemic viral propagation.

Modulation of Innate Immune Defense Pathways

This molecule modulates the innate immune system by stimulating the production of Interferons (IFN-alpha/IFN-gamma) and increasing the activity level of macrophage phagocytic function. Furthermore, it can influence specific intracellular signaling cascades, such as the p38 MAPK pathway, which affects the expression of immunosuppressive cytokines. This concerted action results in the physiological consequence of augmented phagocytic activity and robust activation of the host's antiviral defense signaling.

Dosage and Administration Information

The administration of Umifenovir (Арбидол) is defined by structured protocols that specify the route, dose, frequency, and duration of intake, strictly as outlined in official pharmaceutical documentation. The medicine is administered exclusively by the oral route, typically supplied as hard capsules or tablets in strengths such as 50 mg or 100 mg.

Official usage is segregated into regimens for acute treatment and for prophylaxis. For the acute treatment of viral infection, the typical adult and pediatric regimen for children over two years involves administering 50 mg to 200 mg of Umifenovir per dose. This dosage is taken four times daily (e.g., every six hours) over a fixed duration of five consecutive days.

Conversely, the protocol for prophylactic use, such as following known exposure to an infected person, involves a different frequency and a longer duration. For this purpose, the medicine is typically administered once per day for a course lasting from 10 to 14 days.

Regarding administration conditions, a key instruction is that the drug's bioavailability is not dependent on food intake, permitting flexible administration time before, during, or after meals. Use is restricted to patients two years of age and older, as standardized instructions do not permit administration to younger children.

Recent Clinical Evidence

Umifenovir, known commercially as Arbidol, is a broad-spectrum antiviral agent approved and used in Russia and China for the prophylaxis and treatment of influenza and other acute respiratory viral infections (ARVI). Its primary mechanism of action involves inhibiting the fusion of the viral envelope with the cell membrane, preventing the virus from entering the host cell. The drug is also noted to possess immunomodulatory properties that enhance the body's non-specific immune defenses.

Clinical Efficacy in Influenza and ARVI

Clinical trials have long supported the use of umifenovir in treating influenza, with evidence suggesting that when administered in the acute stage of the disease, it can reduce the duration and severity of symptoms and decrease the time of viral shedding.

Viral Target Established Efficacy Regulatory Status
Influenza A & B Demonstrated reduction in symptom severity and duration of illness. Approved in Russia and China.
Other ARVI Some clinical use for treatment and prophylaxis. Approved in Russia and China.

Evidence in Novel Coronaviruses (e.g., COVID-19)

Following the emergence of SARS-CoV-2, umifenovir was investigated in numerous clinical trials for its potential use against COVID-19, based on in vitro data suggesting antiviral activity against coronaviruses. The overall clinical consensus on its effectiveness against COVID-19 remains controversial and is not universally established by major international health authorities.

  • Select Studies: Some randomized and retrospective studies, predominantly conducted early in the pandemic, indicated that umifenovir might be associated with a faster resolution of clinical symptoms or improvement in lung CT scan scores in patients with mild to moderate disease. For example, one meta-analysis indicated a potential benefit in the rate of clinical improvement and duration of fever.
  • Overall Findings: However, a systematic review and meta-analysis of multiple trials did not establish a significant difference between umifenovir and non-antiviral treatments regarding key patient-important outcomes such as the rate of viral clearance, length of hospital stay, or mortality. Consequently, its routine use for COVID-19 treatment is generally not justified by current comprehensive evidence, and further high-quality randomized controlled studies are needed to conclusively determine its efficacy and safety against new and emerging acute respiratory viral infections.

Frequently Asked Questions (FAQ)

Common questions about Арбидол (FAQ)

Q: How should I store this medication?

Official product information provides specific guidelines for storing this medicine to maintain its stability. It should be kept at the specified temperature range, such as in a cool, dry place. Patients should reference the official label or leaflet for the precise storage details, including instructions on keeping the medicine away from moisture and light.

Q: Can I drink alcohol while taking this medicine?

Regulatory information addresses the combined use of this medicine and alcohol. The official product information often indicates that combining the two may be contraindicated or could increase the risk of certain side effects, such as heightened drowsiness or potential problems affecting the liver. This information is detailed in the official warnings section of the regulatory label.

Q: Does it make you sleepy or affect my ability to drive?

Regulatory documents report that side effects like dizziness, somnolence (drowsiness), or sedation have been associated with this medicine. Regulatory documents indicate that this medicine may impair the abilities required for driving or operating machinery, and patients should be aware of this possibility.

Q: Who should not take this medicine? (e.g., contraindications)

The official label specifies 'contraindications,' which are factors that make it inappropriate to take the medicine. Regulatory labels state this medicine is contraindicated in people with a known history of hypersensitivity or allergic reaction to the active substance or its ingredients. The label also lists specific pre-existing medical conditions that exclude its use.

Q: Is it safe long-term?

Official regulatory information includes warnings and precautions regarding the safety profile over extended treatment duration. The label may address specific risks that can potentially increase with prolonged use of the medicine. Furthermore, the label may indicate that monitoring or check-ups are relevant during extended treatment periods to manage these risks.

Q: Can children 2 years old use it?

The official product information defines the approved age range for use of this drug. It specifies the minimum age for the pediatric population, or it states where safety and effectiveness have not been established. Patients should consult the official label to confirm the indicated ages.

How should Арбидол be stored and disposed of?

How to Store and Dispose of Арбидол?

The storage and disposal of Umifenovir (Арбидол) are subject to official regulatory requirements to maintain product stability and ensure public safety.

Storage Constraints

Product Form Temperature Constraint Stability Period
Capsules / Tablets Not above 25 C Up to 3 years
Prepared Suspension Not above 8 C (Refrigerated) 10 days after preparation

Solid dosage forms must be kept in their original packaging, protected from both light and moisture. The prepared liquid suspension must not be frozen and is only stable under refrigeration for ten days. All forms must be stored in a place inaccessible to children and must not be used after the expiration date.

Disposal Rules

Disposal of unused or expired Umifenovir must be done in accordance with local regulatory procedures. Official instructions mandate that the medicine not be thrown into household waste or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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