Fluarix

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Fluarix

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Method of action: Vacciness

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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 Fluarix

Quick Facts

Property Description
Active Ingredient Influenza virus surface antigens (Hemagglutinin/Neuraminidase)
Form Suspension for Injection (0.5 mL single dose prefilled syringe)
Pharmacological Class Vaccine, Immunological Agent
Common Use Active immunization for seasonal influenza prevention
Origin / Type Biological product (Inactivated, split virion)

What Type of Medicine is Fluarix and What is its Purpose?

Fluarix is a brand name for an Influenza Virus Vaccine manufactured by GlaxoSmithKline (GSK), classified as an Immunological Agent. Its purpose is active immunization, designed to prevent disease caused by the influenza A and B viruses contained in the formulation. This type of vaccine is designed for a broad patient group, typically approved for use in persons aged 6 months and older.

The product is administered via an Intramuscular injection as a sterile Suspension for Injection, often supplied in a prefilled syringe for standardized delivery. Fluarix is a combination product that utilizes a Quadrivalent formulation, protecting against four specific strains—two influenza A subtypes and two distinct influenza B lineages—a design clinically recognized for offering wider coverage against circulating influenza B viruses.

Composition and Origin: The Inactivated Surface Antigens

The active ingredients are the purified hemagglutinin (HA) and neuraminidase (NA) surface antigens. As an inactivated split virion vaccine, Fluarix is manufactured using influenza viruses propagated in embryonated chicken eggs. The viruses are then chemically disrupted using detergents to create the “split virion” and isolate the necessary antigens. The final product is a preservative-free aqueous solution that is engineered to provide the required antigenic stimulation without the risk of causing the flu itself, thereby ensuring successful antibody production.

Regulatory References

  1. NIH DailyMed: FLUARIX QUADRIVALENT Label

What side effects are possible with Fluarix ?

The safety profile of Fluarix (Influenza Virus Vaccine) is established through clinical studies and post-marketing surveillance, primarily reporting temporary and generally mild adverse reactions.

Most Common Adverse Reactions (Very Common: 1 in 10)

The most frequently reported effects are local reactions at the injection site, typically resolving within one to two days. These include:

  • Local Reactions: Pain, redness (erythema), and swelling.
  • Systemic Reactions (Adults 18 years): Muscle aches (myalgia), fatigue, and headache.

Specific systemic reactions can vary by age group. For instance, in young children (e.g., 6 months to <5 years), irritability, loss of appetite, and drowsiness are also commonly reported.

Less Common and Clinically Significant Safety Concerns

Less frequent adverse reactions include shivering, fever, joint pain (arthralgia), and gastrointestinal symptoms. Serious adverse events are rare, but post-marketing experience has included reports of severe allergic reactions (anaphylaxis) and certain neurological disorders like Guillain-Barré syndrome (GBS).

Contraindications and Safety Warnings:

The vaccine is strictly contraindicated for individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous dose of any influenza vaccine. Caution is advised for individuals with bleeding disorders. The decision to administer the vaccine to a person who experienced GBS within six weeks of a prior influenza vaccination requires careful consideration of potential risks and benefits. Procedures for managing potential fainting (syncope) must be in place following administration.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents for the influenza vaccine Fluarix do not define a unique toxicological overdose syndrome. Reports of administering a volume greater than recommended have generally shown adverse reactions that are consistent with those reported following the standard dose. The regulatory profile is therefore structured around the immediate management of severe adverse events involving the Immune System and Nervous System that may occur following administration.


Urgent Help-Seeking Requirements

Immediate medical treatment and supervision are mandated to be available due to the potential for severe allergic reactions, including anaphylaxis, which are considered life-threatening events. Urgent medical attention must be sought for any signs of a severe allergic reaction.

Additionally, syncope (fainting) may occur in association with the injection. If syncope occurs, procedures should be in place to prevent injury from falling, as fainting may be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. The regulatory basis for severe complications also includes consideration of the risk of Guillain-Barré Syndrome (GBS) in its overall safety assessment.


Management and Treatment

Management of reported overdose cases is primarily symptomatic, as no specific antidote is known for this vaccine. The regulatory constraints confirm that continuous medical supervision must be available following administration to manage these potential acute reactions, as required by the prescribing information.

Therapeutic Uses of Fluarix

Fluarix is a vaccine indicated for active immunization to help prevent illness caused by the influenza viruses contained within its annual formulation. The primary goal of this vaccine is the prevention of disease. The benefits extend across several key therapeutic domains where supportive management is appropriate. The vaccine is relevant for managing conditions that involve episodic or fluctuating manifestations, as its use is focused on reducing the risk of symptoms related to physical discomfort, systemic imbalance, and physiological strain associated with the flu.


Preventing Seasonal Influenza

Fluarix is commonly used to help with active immunization against the seasonal influenza strains (Types A and B) that are predicted to circulate each year. This provides support that helps ease the overall symptom burden of the flu by reducing the risk of illness. This prophylactic measure is applied across domains where additional symptomatic support is needed, particularly for conditions characterized by periods of heightened symptoms that interfere with daily functioning.


Reducing Severe Illness and Complications

This measure is relevant in contexts involving heightened systemic burden, as influenza can lead to severe health issues, including hospitalization, especially in vulnerable populations. This measure supports patients in contexts involving heightened systemic burden, and may assist with maintaining functional stability and reducing the risk of conditions characterized by acute or disruptive episodes.


Maintaining Day-to-Day Stability

Vaccination contributes to improved comfort during periods of heightened symptoms. It is applied across domains where additional symptomatic support is needed and may assist with managing symptoms that might otherwise create noticeable physiological strain and interfere with daily functioning, supporting patients during difficult episodes by easing distress.

Quick Fact: Support for Systemic Discomfort

Eligibility and Restrictions for Use

The official regulatory profile for Fluarix (including Fluarix Quadrivalent/Tetra) strictly defines eligibility based on age and allergy history.

Eligibility Scope

Category Official Regulatory Statement
Approved Population Persons aged 6 months and older
Absolute Contraindication History of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component (including egg protein) or following a previous influenza vaccine

Conditional Use and Restrictions

Use of the vaccine requires special consideration in certain populations, as detailed in regulatory documents:

  • Guillain-Barré Syndrome (GBS): The decision to vaccinate must be based on a careful consideration of potential benefits and risks if GBS occurred within six weeks of a prior influenza vaccine.
  • Immunosuppressed Persons: The immune response to the vaccine may be lower in individuals with altered immunocompetence, including those on immunosuppressive therapy.
  • Bleeding Disorders: It should be given with caution in individuals with bleeding disorders (e.g., hemophilia or anticoagulant therapy) to mitigate the risk of hematoma.
  • Children Under 6 Months: Safety and efficacy have not been established in children younger than six months of age.

Pregnancy and Lactation Status

  • US FDA Labeling: Safety and effectiveness have not been established in pregnant women or nursing mothers.
  • European Regulatory Labeling: Inactivated influenza vaccines can be used in all stages of pregnancy and may be used during breast-feeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information describes specific interaction domains for Fluarix, primarily concerning co-administration with other vaccines, immunosuppressive agents, and drugs with narrow therapeutic windows.

Interaction Type Interacting Agents / Conditions
Immunologic Response Immunosuppressive therapies (including corticosteroids)
Procedural Caution Anticoagulant therapy and bleeding disorders
Altered Drug Exposure Warfarin, Phenytoin, Theophylline, Carbamazepine

Pharmacodynamic and Efficacy Interactions

Administration of Fluarix to individuals who are receiving immunosuppressive therapy may result in a lower immune response to the vaccine than in immunocompetent persons. This includes individuals receiving corticosteroids or other treatments that modify the body’s immune function.

Fluarix may be co-administered with other vaccines, such as the Pneumococcal Polysaccharide Vaccine and Adjuvanted Herpes Zoster Vaccine. Regulatory data indicates that co-administration may result in an increase in specific local or systemic adverse reactions compared to when Fluarix is given alone.

Procedural and Pharmacokinetic Interactions

Individuals on anticoagulant therapy or those with a bleeding disorder should receive Fluarix with caution due to the intramuscular injection route, which poses a risk of forming a hematoma at the injection site.

Post-marketing reports cited in regulatory advisories suggest that influenza vaccine can affect the metabolism of certain medicines, potentially leading to altered drug exposure or toxicity. These reports involve agents like warfarin, phenytoin, theophylline, and carbamazepine. If Fluarix is to be given at the same time as another injectable vaccine, the vaccines must always be administered at different injection sites and must not be mixed in the same syringe.

Mechanism of Action

The mechanism of Fluarix, an inactivated split-virion vaccine, is to utilize purified viral surface proteins to induce an adaptive immune response, which creates long-term immunological memory and functional, systemic readiness.

Specific Antigenic Stimulation and Immune Recognition

This mechanistic domain covers the initiation of the adaptive immune response, targeting Antigen-Presenting Cells (APCs) and B/T lymphocytes. The vaccine delivers Hemagglutinin (HA) and Neuraminidase (NA) antigens, which APCs capture and present to T helper cells. The cascade results in the proliferation and differentiation of B cells into plasma cells, leading to the systemic production of highly specific IgG antibodies.

Dual Antibody Action for Viral Lifecycle Blockade

The generated anti- HA antibodies block the viral protein's ability to attach to sialic acid receptors on host cells, which interferes with viral entry. Complementarily, anti- NA antibodies inhibit the viral enzyme that is crucial for cleaving new virus particles from the infected cell surface. This dual action leads to Viral Functional Interference by restricting both the initial HA-mediated attachment and the subsequent NA-mediated release of new virions.

Mechanistic Constraint

This protective mechanism is intrinsically limited by antigenic specificity: the magnitude of the immune response is lower or lost if the wild-type virus undergoes substantial antigenic drift, leading to a mismatch between the circulating virus epitopes and the vaccine-induced antibodies.

Dosage and Administration Information

Fluarix (Influenza Vaccine) is administered as a sterile suspension for intramuscular injection only and is approved for use in persons aged 6 months and older. The vaccine is typically supplied as a single 0.5 mL dose in a prefilled syringe.

Administration Details

  • Preparation: The vaccine should be shaken well immediately before administration. A healthcare professional must visually inspect the product for any particulate matter or discoloration; if either is present, the vaccine should not be administered.
  • Injection Site: The preferred site for intramuscular injection is the deltoid muscle of the upper arm for persons aged 12 months and older with adequate muscle mass. For children aged 6 through 11 months, the anterolateral thigh is the preferred site. The vaccine must not be injected into the gluteal area or areas where there may be a major nerve trunk.

Dosage and Schedule

Vaccination usually occurs annually and the specific dose schedule is determined by the recipient's age and prior influenza vaccination status, following established clinical guidelines.

Age Group Prior Vaccination Status Dose and Schedule
6 months through 8 years Not previously vaccinated with influenza vaccine Two doses (0.5 mL each) administered at least 4 weeks apart
6 months through 8 years Vaccinated with influenza vaccine in a previous season One or two doses (0.5 mL each), depending on vaccination history
9 years and older Not applicable One 0.5 mL dose

Note: If two doses are required for children 6 months through 8 years, they must be administered at least 4 weeks apart.


Important Consideration

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following the administration of the vaccine. Do not administer Fluarix to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Fluarix

The body of research for Fluarix, an inactivated quadrivalent influenza vaccine, consists primarily of Randomized Controlled Trials (RCTs) and real-world observational studies. Research was conducted during specific influenza seasons to examine the vaccine's ability to trigger an immune response and to measure the occurrence of seasonal influenza disease.


Evidence for Active Immunization Against Seasonal Influenza

This area of research centers on whether research shows patterns related to a reduced incidence of illness caused by the four influenza strains (two A subtypes and two B lineages) included in the annual formulation.

Studies monitored the measured occurrence of laboratory-confirmed influenza illness as a main research outcome. The findings describe patterns observed in the studies regarding the occurrence of the flu in vaccinated groups compared to control groups. These patterns were reported to vary across studies, reflecting the yearly changes in the circulating virus strains and the degree of match with the vaccine strains. The data show patterns related to prevention that are limited to the specific season and strain types studied.

Measuring the Immune Response (Immunogenicity)

Researchers evaluated immunogenicity, which is the vaccine's ability to stimulate the body to produce protective antibodies. Studies focused on laboratory outcomes, monitoring specific measurements of antibody responses, such as Geometric Mean Titer (GMT) levels and seroconversion rates. For initial licensing, these antibody levels served as a key piece of evidence, even without extensive data on the measured occurrence of clinical illness in those specific trials.


Evidence in Different Age Groups and Populations

Studies examined how the immune response was observed across various groups. Research has focused on three key populations: children (6 months and older), healthy adults (18 to 64 years), and older adults (65 years). The findings indicate that the immune response profiles differ across these age strata. Data for certain groups, particularly those with underlying health conditions, remain insufficient to draw broad conclusions.


What Remains Uncertain in the Research Record

While studies contribute to the broader evidence landscape, several aspects remain uncertain or limited. The evidence quality varies across studies, and the findings regarding the measured occurrence of illness are highly sensitive to the seasonal characteristics of the circulating virus strains. Furthermore, long-term effects are not fully established because the evidence is largely focused on single seasons. Evidence for outcomes related to very severe clinical outcomes (like hospitalization or mortality) in the general population often relies on less certain data or observational studies.

Frequently Asked Questions (FAQ)

Common questions about Fluarix (FAQ)

Q: What is the difference between Fluarix and other general flu vaccines?

Official product information describes Fluarix as an inactivated, split-virion, quadrivalent vaccine. This means it does not contain weakened live virus, unlike some other types of flu vaccines. It is designed to provide protection against four different strains of the influenza virus, as specified in the annual formulation.

Q: What is the expected duration of protection described for Fluarix?

Protection from the vaccine typically lasts throughout the flu season. Because circulating influenza strains change each year, and the body's immune response naturally wanes over time, regulatory guidelines indicate annual vaccination is used.

Q: Does Fluarix contain thimerosal or any other preservatives?

According to official labeling, Fluarix Quadrivalent, when supplied in a single-dose syringe, is manufactured as a preservative-free aqueous solution. This formulation does not contain thimerosal, which is a type of preservative used in some multi-dose vials.

Q: Is a low-grade fever considered a normal side effect of Fluarix?

The product's safety information lists fever as a reported adverse reaction. While a low-grade fever is generally classified as a less common systemic reaction, the documents indicate it is an expected response that may occur following use.

Q: Can people with a history of fainting from injections still receive Fluarix?

The official label advises that procedures for managing potential fainting (syncope) should be in place following the use of Fluarix. This procedural caution is noted due to the risk of fainting associated with injections, but having a history of fainting does not itself prohibit use.

Q: Why is it necessary to receive Fluarix every year?

Annual use is due to two main reasons described in official guidelines. Firstly, the circulating influenza virus strains often change (antigenic drift) from year to year. Secondly, the protection provided by the vaccine naturally wanes over the course of time.

Q: What is the official guidance regarding Fluarix for people over 65 years old?

Fluarix is approved for persons aged 6 months and older. However, ACIP guidelines often describe a preference for certain other specific influenza vaccine formulations for people aged 65 years and older.

Q: What is the process for updating Fluarix each year?

The composition of the vaccine is updated annually to ensure it matches the influenza strains expected to circulate. This decision is based on recommendations from the World Health Organization (WHO) and the FDA, who continuously monitor and predict seasonal virus changes.

Q: How long does it typically take for Fluarix to start working after use?

Official public health guidance indicates that it takes about two weeks following the use of any influenza vaccine for protective antibodies to form in the body. This is the period required to achieve the full benefit described in the research.

Q: What signs indicate a potential serious allergic reaction to Fluarix?

Official patient information states that signs of a serious allergic reaction (anaphylaxis) may include symptoms such as difficulty breathing, swelling of the face or throat, a fast heartbeat, dizziness, or a severe rash. Official guidance states that medical treatment should be immediately available following administration to manage these potential reactions.

Q: Can Fluarix be used by people who have an active minor illness, such as a cold?

According to official guidelines, mild illnesses, with or without fever (such as an upper respiratory tract infection or a common cold), are generally not considered a reason to withhold or delay the vaccine. They are not expected to increase the risk of adverse events.

Q: Are there any specific chronic health conditions that prevent the use of Fluarix?

The only absolute contraindication is a history of a severe allergic reaction to the vaccine components or a prior dose. Official warnings state that caution should be exercised for individuals with a history of Guillain-Barré syndrome (GBS) or bleeding disorders.

Q: How does Fluarix interact with common over-the-counter pain relievers?

Regulatory interaction data has examined the relationship between influenza vaccines and common over-the-counter pain relievers like Acetaminophen (Tylenol) and Aspirin. These are generally listed as minor or moderate interactions in specific contexts, but official documents do not list any major contraindications for co-administration.

Q: Is there any informational guidance regarding Fluarix and alcohol consumption?

Official public health advisories state there are no direct interactions between the vaccine and alcohol. However, regulatory advisories often mention alcohol should be avoided or limited, as it might worsen common systemic side effects (such as headache and fatigue) or may influence the body's expected immune response.

Q: Is it possible to receive Fluarix too late in the flu season?

Official guidelines state that vaccination is recommended as long as influenza viruses are circulating in the community. Since the flu season can extend through May, official guidelines state that vaccination may be beneficial even when received as late as January or later.

Q: How long has Fluarix been approved and available?

The original formulation of Fluarix (trivalent) was first approved by the FDA in 2005. The newer Fluarix Quadrivalent formulation was first approved in December 2012.

Q: Has the formulation of Fluarix changed significantly since its initial approval?

While the specific strains of the active ingredients are updated every year based on official monitoring, the base formulation type has also evolved over time. Notably, the vaccine transitioned from a trivalent (3 strain) formulation to the current quadrivalent (4 strain) formulation.

Q: What happens if Fluarix is received more than once in the same season?

The regulatory schedule only defines a two-dose primary series for some young children. Official documents do not provide specific guidance addressing accidental re-dosing in individuals for whom only a single dose is indicated in a given season.

Q: What official resources provide the strains covered by Fluarix for the current season?

The specific strains included in the vaccine are determined by the World Health Organization (WHO). The FDA issues the official recommendation for the US formulation each season, which is then used by the manufacturer.

Q: Is Fluarix interchangeable with other quadrivalent flu vaccines?

Regulatory bodies generally state that available licensed influenza vaccines, specifically Quadrivalent Inactivated Vaccines, are licensed and generally considered to be suitable against circulating strains for the approved population.

Q: Are there different versions of Fluarix depending on the region or country?

Yes, there can be regulatory differences in the product information. For instance, the US FDA label and the European regulatory labels contain different statements regarding use during pregnancy and lactation.

Q: Is there research evidence suggesting Fluarix works differently for men versus women?

Official clinical trial summaries often do not disaggregate efficacy or immunogenicity data by sex. However, some studies noted in regulatory reviews indicate that females report adverse events more frequently than males.

Q: How is the potency of Fluarix ensured each season?

The potency of the vaccine's active ingredients is typically measured using validated laboratory testing methods. These tests, such as Single Radial Diffusion (SRD), are required by regulatory bodies to confirm the stated potency before the product is released for use each season.

How should Fluarix be stored and disposed of?

Storage and Disposal Requirements

Fluarix must be stored under specific conditions to maintain its effectiveness, as documented in official regulatory labeling.

The vaccine requires refrigeration between 36 F and 46 F (2 C and 8 C). The product must not be frozen; if freezing occurs, the vaccine must be discarded. To ensure protection from light, Fluarix should be kept in its original package/carton until the time of use.

For stability, do not use the vaccine past the printed expiration date. The product must be stored out of the sight and reach of children.

Disposal of any unused vaccine or waste materials, including the syringe and packaging, must be carried out in accordance with applicable federal, state, and local regulations for pharmaceutical waste.

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

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