Arbidol

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Arbidol

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Method of action: Immunostimulants

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Arbidol

Property Description
Active ingredient Umifenovir Hydrochloride Monohydrate
Form Hard capsules, Tablets
Pharmacological class Antiviral medication
Common use Acute Respiratory Viral Infections (ARVI), Influenza
Origin Synthetic organic molecule, Indole derivative

What Type of Medicine is Arbidol (Umifenovir)?

Arbidol is a distinctive antiviral medication used in the general management of respiratory infections. Its active chemical substance is Umifenovir, specifically Umifenovir Hydrochloride Monohydrate, which is a synthetic organic small molecule drug. The official International Nonproprietary Name (INN) for the active compound is Umifenovir.

This substance is recognized for its broad-spectrum activity against various viral pathogens, including strains of Influenza A and Influenza B. The drug is formally classified within the World Health Organization's (WHO) Anatomical Therapeutic Chemical (ATC) system as a systemic antiviral under the code J05AX13.

Composition and Physical Form

Arbidol is supplied as a single-ingredient product intended for oral administration, typically manufactured in solid dosage forms such as hard capsules and tablets. The preparation’s status is region-dependent: for instance, it is legally available as an Over-The-Counter (OTC) medicine in Russia, but often requires a prescription in other markets.

The synthetic organic composition, which is chemically classified as an indole derivative, ensures a stable and precise delivery of the active agent. The presentation as a tablet or capsule is designed for systemic absorption through the gastrointestinal tract, supporting its action against respiratory illnesses.

General Purpose as a Viral Entry Inhibitor

The general purpose of this medication is to help the body combat infections caused by susceptible pathogens responsible for Acute Respiratory Viral Infections (ARVI) and Influenza. This function is achieved through a dual-acting mechanism that addresses both the pathogen and the host’s immune response.

Umifenovir primarily acts as a viral entry inhibitor, effectively impeding membrane fusion—the critical process viruses use to penetrate host cells. Simultaneously, the drug exhibits immunomodulatory properties, contributing to the induction of interferon-production and enhanced macrophage phagocytosis, which bolsters the overall humoral immune response to aid in viral clearance.

What side effects are possible with Arbidol?

Possible Side Effects and Safety Information

The safety profile of Umifenovir (Arbidol) is primarily defined by the potential for reactions related to the immune system. The overall scope of officially documented adverse events centers on hypersensitivity reactions and occasional gastrointestinal disturbances, as noted in regulatory prescribing information.

Most documented side effects, including allergic responses, are generally categorized as rare or of not known frequency, reflecting the varying standards of reporting across regulatory jurisdictions where the medicine is authorized.

Adverse Reactions by System-Organ Class

Adverse effects are grouped into System-Organ Classes (SOC) in regulatory documents:

  • Immune System Disorders: Allergic reactions, Hypersensitivity reactions.
  • Skin and Subcutaneous Tissue Disorders: Manifestations such as rash and pruritus (itching).
  • Gastrointestinal Disorders: Symptoms may include nausea, vomiting, and epigastric discomfort.

Serious Reactions and Safety Constraints

The most severe adverse reaction explicitly associated with the medication is the potential for an anaphylactic reaction, which represents the most serious tier within the documented hypersensitivity spectrum. This risk is acknowledged in post-marketing safety surveillance summaries.

Safety documents impose specific limitations for use. The drug is officially restricted in individuals with a confirmed history of allergic reactions or hypersensitivity to Umifenovir. Furthermore, caution is required for specific populations, including pediatrics (children) and patients with severe hepatic (liver) or renal (kidney) impairment, where complete clinical safety data is limited in official regulatory texts.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Umifenovir (Arbidol) overdose is primarily characterized by a lack of documented clinical experience. Authoritative government sources state that no known overdose cases have been formally reported in human clinical use. Consequently, specific clinical signs, symptoms, or laboratory abnormalities resulting from an acute overdose are not formally listed in the regulatory labeling.

Urgent Medical Action Required

A large therapeutic margin is indicated by non-clinical studies demonstrating the drug's low acute toxicity; doses substantially higher than the therapeutic range failed to cause pathological changes in test animals. Despite this evidence of low inherent toxicity, the official regulatory mandate is clear: Seek immediate medical attention for any suspected overdose or known ingestion of a dose exceeding prescribed limits.

Management and Antidote Status

Because no specific antidote is known for Umifenovir, the required management protocol defined in regulatory documents is restricted to symptomatic and supportive treatment. This includes necessary clinical observation and continuous monitoring of vital functions in a hospital setting to manage potential systemic effects. Immediate help is required for any known or suspected exposure to an excessive dose.

Therapeutic Uses of Arbidol

What Arbidol Treats: Main Uses and Benefits

This medication is commonly used in the treatment and prevention of Influenza A and Influenza B, as well as general Acute Respiratory Viral Infections (ARVI). The medication is applied across domains where additional symptomatic support is needed, addressing symptom clusters that may be intense or disruptive, including fever, generalized weakness (asthenia), and muscle aches.

“The therapy is commonly used with the intent of easing the length and intensity of acute manifestations, supporting general well-being.”

Beyond active treatment, Arbidol is considered relevant for prophylaxis (prevention) and may be part of the complex treatment aimed at addressing the risks associated with secondary respiratory manifestations that can follow a primary viral illness, which is a concern for high-risk patients. It assists with maintaining functional stability during symptomatic periods.


Quick Fact: Support for Systemic Viral Distress The medication plays a role in managing the overall symptom load associated with acute viral infections, particularly those symptoms related to systemic imbalance and physical discomfort.

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Arbidol

The official eligibility profile for Umifenovir is strictly defined by regulatory documents, distinguishing between populations permitted for use and those for whom the drug is restricted or contraindicated.


Contraindications and Restrictions

Absolute contraindication applies to individuals with known hypersensitivity to Umifenovir or any of its excipients. The medicine is also officially contraindicated for children under 3 years of age and during the first trimester of pregnancy. Furthermore, use is not recommended for women who are breastfeeding.

Restrictions are also applied based on comorbidities, specifically in patients with severe chronic hepatic impairment and severe chronic renal impairment, where use may be restricted or contraindicated due to the drug's metabolism and excretion route. Specific formulations may also prohibit use for patients with certain rare hereditary diseases, such as lactose intolerance.


Approved Populations

Umifenovir is generally indicated for use in adult patients and children 3 years of age and older, based on the established regulatory approval for specific viral indications. While older adults (over 65 years) are eligible for use, regulatory cautions may apply due to the nature of clinical data in this age group.


Official regulatory documents define who can and cannot use Umifenovir by establishing clear absolute contraindications based on age, hypersensitivity, and early pregnancy, while setting restricted use criteria for severe chronic organ dysfunction. These mandatory statements create the official boundaries for the legal population use of the medicine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Umifenovir is primarily structured around documented pharmacokinetic interaction patterns with co-administered substances.

Interaction Scope Official Regulatory Information for Umifenovir
Medicinal Product Categories Strong CYP3A4 inhibitors are the primary category of concern due to a recognized pharmacokinetic effect via enzyme-mediated metabolism.
Mechanistic Basis Pharmacokinetic interaction resulting from the metabolism of Umifenovir, which is formally described as a substrate for the hepatic enzyme Cytochrome P450 3A4 (CYP3A4).
Exposure Modification Co-administration with strong CYP3A4 inhibitors may lead to a subsequent increase in Umifenovir's systemic exposure (Area Under the Curve, AUC), as documented in regulatory-aligned studies.
Timing-based Rules None are explicitly documented. Regulatory data confirms that food intake does not affect the bioavailability of Umifenovir, eliminating the need for dose separation from meals.
Interaction-related Restrictions No absolute contraindications are explicitly stated in major Western regulatory labeling, which is consistent with the drug's regional licensing status.

Connection to the overall interaction profile:

The regulatory structure defines the drug’s interaction status chiefly through its CYP3A4-mediated metabolic pathway, establishing a formal risk of increased drug exposure when combined with strong inhibitors of this enzyme. The profile provides a key constraint for administration by officially stating the absence of a clinically significant drug-food interaction. This documented information restricts the type of concomitant medication based on metabolic classification.

Mechanism of Action

Umifenovir acts through a concurrent dual mechanism, targeting both the viral pathogen and host immune pathways.


Inhibition of Viral Entry and Fusion

The primary action involves acting as a viral fusion inhibitor by directly binding to the Hemagglutinin protein on the viral surface. This molecular interaction stabilizes the protein, preventing the conformational change necessary for the virus to merge its envelope with the host cell's endosomal membrane. This action arrests the infectious cascade at the entry stage, preventing the transfer of viral genetic material to new cells.


Modulation of Host Innate Immunity

Umifenovir also engages a host-targeting mechanism by modulating cellular signaling, including the p38–MAPK pathway, to influence the body's non-specific defenses. This action facilitates the production of Interferons and increases the efficiency of immune cells like macrophages to perform phagocytosis. These physiological changes involve enhanced non-specific immune function and increased efficiency in the phagocytic removal of viral particles and cellular debris. The molecule exerts its function through this concurrent dual mechanism of viral propagation inhibition and host immune pathway modulation.

Dosage and Administration Information

Official Administration Guidelines for Umifenovir (Arbidol)

The use of Umifenovir (Arbidol) is approved in specific regions, such as China and Russia, and is typically available as capsules or tablets for oral administration.

Dosing and Administration Constraints

Administration Scope Official Guideline (Strictly Labeled)
Route of Administration Oral (by mouth).
Timing in Relation to Meals Must be taken on an empty stomach (before food).
Standard Treatment Frequency Typically four times a day (q.i.d.), often specified as every six hours.

Age-Specific Dosing

The single dose amount is determined strictly by age according to official instructions:

  • Children 2–7 years: 50 mg per single dose.
  • Children 7–12 years: 100 mg per single dose.
  • Individuals over 12 years (including adults): 200 mg per single dose.

Course Duration

For typical treatment regimens, the medication is administered at the prescribed frequency for five consecutive days. For prophylaxis (prevention) following direct contact with an infected person, the duration is commonly 10 to 14 days at a lower frequency, such as once daily.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Arbidol


Evidence for Use in Influenza and Acute Respiratory Viral Infections (ARVI)

Clinical evaluation for the use of Umifenovir in Influenza A and B and general Acute Respiratory Viral Infections (ARVI) has primarily been conducted using short-term Randomized Controlled Trials (RCTs), where the medicine was compared against a placebo or standard supportive care. The populations studied were typically adult patients recruited in the acute phase of their illness.

The trials focused on research exploring short-term symptom changes and outcomes related to systemic or functional imbalance. Specifically, studies examined the time it took for symptoms to resolve. Some studies observed patterns where a shorter duration of heightened symptom activity was measured in the treated groups when compared to control groups. Measurements were reported within the context of short-term follow-up, corresponding to the typical course of an acute infection. The results primarily reflect studies conducted in specific regional contexts, and there is limited information for long-term outcomes.


Research Context for the Treatment of COVID-19

Research examined the use of Umifenovir as a component of complex treatment for COVID-19 (SARS-CoV-2 infection), involving both smaller-scale RCTs and various observational studies. Studies monitored outcomes including viral clearance and major patient outcomes such as the length of hospital stay.

The findings related to COVID-19 were mixed, indicating variability across studies. Some reports described patterns where faster viral clearance was measured in certain cohorts, while others found no difference. Findings related to major patient-important outcomes have been controversial and inconsistent. Current data are insufficient to provide definitive conclusions about the role of Umifenovir in affecting outcomes for COVID-19.


The Overall Evidence Landscape and Key Research Gaps

The evidence landscape is characterized by research primarily rooted in specific regions where the medicine is approved. A key research gap is the limited availability of large-scale, multi-national trials that meet the most stringent regulatory standards globally. Furthermore, controlled comparative evidence against other established antiviral treatments remains limited. The certainty of evidence for non-influenza ARVIs and COVID-19 is lower than that for Influenza, suggesting that research is ongoing and that definitive conclusions are not yet established.

Frequently Asked Questions (FAQ)

Common questions about Arbidol (FAQ)

Q: Does it make you sleepy?

Official regulatory documents and product information list somnolence (sleepiness), dizziness, or drowsiness as potential undesirable effects. These effects are related to the central nervous system (CNS). Because these effects may occur, official labeling advises caution when engaging in activities such as driving or operating heavy machinery. This information summarizes the known safety profile as documented by regulatory authorities.

Q: Can children 2 years old use it?

The official product information specifies the approved age range for Arbidol. The drug is typically indicated for use in adults and adolescents aged 12 years and older, or other specific patient groups listed on the label. The official product information does not include an indication for children 2 years old. Regulatory documents establish the approved use for patients in specific age groups.

How should Arbidol be stored and disposed of?

The storage and disposal of Arbidol (umifenovir) are governed by official regulatory requirements to ensure product stability and public safety.

Storage Conditions

Official labeling mandates that the product must be stored at a temperature not exceeding 25 C. The medicine must be kept protected from light and moisture and should be maintained in its original package. A critical safety requirement is that Arbidol must be kept out of the reach and sight of children at all times.

Disposal Instructions

Unused or expired Arbidol must be disposed of according to national guidelines for pharmaceutical waste. Authorities recommend utilizing an authorized drug take-back program as the preferred disposal method. If a take-back program is unavailable, the product should be mixed with an undesirable substance (such as dirt or coffee grounds), placed in a sealed container, and discarded in the household trash. The empty container's personal information should be scratched out prior to disposal.

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

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