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Fluarix

Last reviewed on RxList: 9/25/2017
Fluarix Side Effects Center

Last reviewed on RxList 09/26/2017

Fluarix (influenza virus vaccine) is a "killed virus" vaccine used to prevent infection caused by influenza virus. The flu shot vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year. Fluarix is available in generic form. Common side effects of Fluarix include injection site reactions that may last for up to 1-2 days (soreness, redness, swelling, bruising, pain, or a lump), fever, chills, muscle aches, joint pain, headache, tired feeling, weakness, fussiness or crying (in children). Tell your doctor if you have serious side effects of Fluarix including severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine), high fever, seizures (convulsions), or unusual bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fluarix Consumer Information

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever;
  • seizure (convulsions); or
  • unusual bleeding.

Common side effects may include:

  • low fever, chills;
  • mild fussiness or crying;
  • redness, bruising, pain, swelling, or a lump where the vaccine was injected;
  • headache, tired feeling; or
  • joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Fluarix (Influenza Virus Vaccine)

Fluarix Professional Information

SIDE EFFECTS

The safety experience with FLUARIX (trivalent influenza vaccine) is relevant to FLUARIX QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions [see DESCRIPTION].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. There is the possibility that broad use of FLUARIX QUADRIVALENT could reveal adverse reactions not observed in clinical trials.

In adults who received FLUARIX QUADRIVALENT, the most common (≥10%) injection site adverse reaction was pain (36%). The most common (≥10%) systemic adverse events were muscle aches (16%), headache (16%), and fatigue (16%).

In children aged 3 through 17 years who received FLUARIX QUADRIVALENT, injection site adverse reactions were pain (44%), redness (23%), and swelling (19%). In children aged 3 through 5 years, the most common (≥10%) systemic adverse events were drowsiness (17%), irritability (17%), and loss of appetite (16%); in children aged 6 through 17 years, the most common systemic adverse events were fatigue (20%), muscle aches (18%), headache (16%), arthralgia (10%), and gastrointestinal symptoms (10%).

FLUARIX QUADRIVALENT In Adults

Trial 1 (NCT01204671) was a randomized, double-blind (2 arms) and open-label (one arm), activecontrolled, safety, and immunogenicity trial. In this trial, subjects received FLUARIX QUADRIVALENT (n = 3,036) or one of 2 formulations of comparator trivalent influenza vaccine (FLUARIX, TIV-1, n = 1,010 or TIV-2, n = 610), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The population was aged 18 years and older (mean age: 58 years) and 57% were female; 69% were white, 27% were Asian, and 4% were of other racial/ethnic groups. Solicited events were collected for 7 days (day of vaccination and the next 6 days). The frequencies of solicited adverse events are shown in Table 2.

Table 2: FLUARIX QUADRIVALENT: Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 7 Daysa of Vaccination in Adultsb (Total Vaccinated Cohort)

  FLUARIX QUADRIVALENTc
n = 3,011-3,015 %
Trivalent Influenza Vaccine (TIV)
TIV-1 (B Victoria)d
n = 1,003 %
TIV-2 (B Yamagata)e
n = 607 %
Any Grade 3f Any Grade 3f Any Grade 3f
Local
Pain 36.4 0.8 36.8 1.2 31.3 0.5
Redness 1.9 0.0 1.7 0.0 2.0 0.0
Swelling 2.1 0.0 2.1 0.0 1.3 0.0
Systemic
Muscle aches 16.4 0.5 19.4 0.8 16.1 0.5
Headache 15.9 0.9 16.4 0.8 13.2 0.7
Fatigue 15.8 0.7 18.4 0.6 14.8 0.5
Arthralgia 8.4 0.5 10.4 0.7 9.4 0.3
Gastrointestinal symptomsg 6.5 0.4 6.5 0.2 5.9 0.3
Shivering 4.2 0.4 5.0 0.3 4.3 0.2
Feverh 1.6 0.0 1.2 0.0 1.5 0.0
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.
n = number of subjects with diary card completed.
aSeven days included day of vaccination and the subsequent 6 days.
bTrial 1: NCT01204671.
cContained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
dContained the same composition as FLUARIX manufactured for the 2010-2011 season (2 influenza A subtype viruses and an influenza type B virus of Victoria lineage).
eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
fGrade 3 pain: Defined as significant pain at rest; prevented normal everyday activities. Grade 3 redness, swelling: Defined as >100 mm.
Grade 3 muscle aches, headache, fatigue, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
Grade 3 fever: Defined as >102.2°F (39.0°C).
gGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
hFever: Defined as ≥99.5°F (37.5°C).

Unsolicited events occurring within 21 days of vaccination (Day 0 to 20) were reported in 13%, 14%, and 15% of subjects who received FLUARIX QUADRIVALENT, TIV-1, or TIV-2, respectively. The unsolicited adverse reactions that occurred most frequently (≥0.1% for FLUARIX QUADRIVALENT) included dizziness, injection site hematoma, injection site pruritus, and rash. Serious adverse events occurring within 21 days of vaccination were reported in 0.5%, 0.6%, and 0.2% of subjects who received FLUARIX QUADRIVALENT, TIV-1, or TIV-2, respectively.

FLUARIX QUADRIVALENT In Children

Trial 2 (NCT01196988) was a randomized, double-blind, active-controlled, safety, and immunogenicity trial. In this trial, subjects received FLUARIX QUADRIVALENT (n = 915) or one of 2 formulations of comparator trivalent influenza vaccine (FLUARIX, TIV-1, n = 912 or TIV-2, n = 911), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). Subjects were aged 3 through 17 years and 52% were male; 56% were white, 29% were Asian, 12% were black, and 3% were of other racial/ethnic groups. Children aged 3 through 8 years with no history of influenza vaccination received 2 doses approximately 28 days apart. Children aged 3 through 8 years with a history of influenza vaccination and children aged 9 years and older received one dose. Solicited local adverse reactions and systemic adverse events were collected using diary cards for 7 days (day of vaccination and the next 6 days). The frequencies of solicited adverse events are shown in Table 3.

Table 3: FLUARIX QUADRIVALENT: Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 7 Daysa after First Vaccination in Children Aged 3 through 17 Yearsb (Total Vaccinated Cohort)

  FLUARIX QUADRIVALENTc % Trivalent Influenza Vaccine (TIV)
TIV-1 (B Victoria)d % TIV-2 (B Yamagata)e %
Any Grade 3f Any Grade 3f Any Grade 3f
  Aged 3 through 17 Years
Local n = 903 n = 901 n = 905
Paing 43.7 1.6 42.4 1.8 40.3 0.8
Redness 23.0 1.0 21.3 0.2 20.9 0.7
Swelling 18.5 0.8 17.2 1.1 14.9 0.2
  Aged 3 through 5 Years
Systemic n = 291 n = 314 n = 279
Drowsiness 17.2 1.0 12.4 0.3 13.6 0.7
Irritability 16.8 0.7 13.4 0.3 14.3 0.7
Loss of appetite 15.5 0.3 8.0 0.0 10.4 0.7
Feverh 8.9 0.3 8.9 0.3 8.2 1.1
  Aged 6 through 17 Years
Systemic n = 613 n = 588 n = 626
Fatigue 19.7 1.5 18.5 1.4 15.5 0.5
Muscle aches 17.5 0.7 16.0 1.4 15.8 0.5
Headache 16.3 1.3 19.2 0.7 15.2 0.6
Arthralgia 9.8 0.3 9.4 0.7 7.3 0.2
Gastrointestinal symptomsi 9.8 1.0 9.5 0.7 7.2 0.3
Shivering 6.4 0.5 4.4 0.5 5.0 0.0
Feverh 6.0 1.1 8.5 0.5 6.1 0.3
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.� n = number of subjects with diary card completed.
aSeven days included day of vaccination and the subsequent 6 days.
bTrial 2: NCT01196988.
cContained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
dContained the same composition as FLUARIX manufactured for the 2010-2011 season (2 influenza A subtype viruses and an influenza type B virus of Victoria lineage).
eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
fGrade 3 pain: Defined as cried when limb was moved/spontaneously painful (children 6 years), or significant pain at rest, prevented normal everyday activities (children ≥6 years).
Grade 3 redness, swelling: Defined as >50 mm.
Grade 3 drowsiness: Defined as prevented normal activity.
Grade 3 irritability: Defined as crying that could not be comforted/prevented normal activity.
Grade 3 loss of appetite: Defined as not eating at all.
Grade 3 fever: Defined as >102.2°F (39.0°C).
Grade 3 fatigue, muscle aches, headache, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
gPercentage of subjects with any pain by age subgroup: 39%, 38%, and 37% for FLUARIX QUADRIVALENT, TIV-1, and TIV-2, respectively, in children aged 3 through 8 years and 52%, 50%, and 46% for FLUARIX QUADRIVALENT, TIV-1, and TIV-2, respectively, in children aged 9 through 17 years.
hFever: Defined as ≥99.5°F (37.5°C).
iGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

In children who received a second dose of FLUARIX QUADRIVALENT, TIV-1, or TIV-2, the incidences of adverse events following the second dose were generally lower than those observed after the first dose.

Unsolicited adverse events occurring within 28 days of any vaccination were reported in 31%, 33%, and 34% of subjects who received FLUARIX QUADRIVALENT, TIV-1, or TIV-2, respectively. The unsolicited adverse reactions that occurred most frequently (≥0.1% for FLUARIX QUADRIVALENT) included injection site pruritus and rash. Serious adverse events occurring within 28 days of any vaccination were reported in 0.1%, 0.1%, and 0.1% of subjects who received FLUARIX QUADRIVALENT, TIV-1, or TIV-2, respectively.

FLUARIX (Trivalent Formulation)

FLUARIX has been administered to 10,317 adults aged 18 through 64 years, 606 subjects aged 65 years and older, and 2,115 children aged 6 months through 17 years in clinical trials. The incidence of solicited adverse events in each age-group is shown in Tables 4 and 5.

Table 4: FLUARIX (Trivalent Formulation): Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 4 Daysa of Vaccination in Adults (Total Vaccinated Cohort)

  Trial 3b Trial 4c
Aged 18 through 64 Years Aged 65 Years and Older
FLUARIX
n = 760 %
Placebo
n = 192 %
FLUARIX
n = 601-602 %
Comparator
n = 596 %
Any Gr 3d Any Gr 3d Any Gr 3d Any Gr 3d
Local
Pain 54.7 0.1 12.0 0.0 19.1 0.0 17.6 0.0
Redness 17.5 0.0 10.4 0.0 10.6 0.2 13.1 0.7
Swelling 9.3 0.1 5.7 0.0 6.0 0.0 8.9 0.7
Systemic
Muscle aches 23.0 0.4 12.0 0.5 7.0 0.3 6.5 0.0
Fatigue 19.7 0.4 17.7 1.0 9.0 0.3 9.6 0.7
Headache 19.3 0.1 21.4 1.0 7.5 0.3 7.9 0.3
Arthralgia 6.4 0.1 6.3 0.5 5.5 0.5 5.0 0.2
Shivering 3.3 0.1 2.6 0.0 1.7 0.2 2.2 0.0
Fevere 1.7 0.0 1.6 0.0 1.7 0.0 0.5 0.0
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n = number of subjects with diary card completed. Gr 3 = Grade 3.
aFour days included day of vaccination and the subsequent 3 days.
bTrial 3 was a randomized, double-blind, placebo-controlled, safety, and immunogenicity trial (NCT00100399).
cTrial 4 was a randomized, single-blind, active-controlled, safety, and immunogenicity trial (NCT00197288). The active control was FLUZONE , a U.S.-licensed trivalent, inactivated influenza vaccine (Sanofi Pasteur Inc.).
dGrade 3 pain, muscle aches, fatigue, headache, arthralgia, shivering: Defined as prevented normal activity.
Grade 3 redness, swelling: Defined as >50 mm.
Grade 3 fever: Defined as >102.2°F (39.0°C).
eFever: Defined as ≥100.4°F (38.0°C) in Trial 3, and ≥99.5°F (37.5°C) in Trial 4.

Table 5: FLUARIX (Trivalent Formulation): Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 4 Daysa of First Vaccination in Children Aged 3 through 17 Yearsb (Total Vaccinated Cohort)

  Aged 3 through 4 Years Aged 5 through 17 Years
FLUARIX
n = 350 %
Comparator
n = 341 %
FLUARIX
n = 1,348 %
Comparator
n = 451 %
Any Gr 3c Any Gr 3c Any Gr 3c Any Gr 3c
Local
Pain 34.9 1.7 38.4 1.2 56.2 0.8 56.1 0.7
Redness 22.6 0.3 19.9 0.0 17.7 1.0 16.4 0.7
Swelling 13.7 0.0 13.2 0.0 13.9 1.5 13.3 0.7
Systemic
Irritability 20.9 0.9 22.0 0.0
Loss of appetite 13.4 0.9 15.0 0.9
Drowsiness 13.1 0.6 19.6 0.9
Feverd 6.6 1.4 7.6 1.5 4.2 0.3 3.3 0.2
Muscle aches 28.8 0.4 28.8 0.4
Fatigue 19.9 1.0 18.8 1.1
Headache 15.1 0.5 16.4 0.9
Arthralgia 5.6 0.1 6.2 0.2
Shivering 3.1 0.1 3.5 0.2
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n = number of subjects with diary card completed. Gr 3 = Grade 3.
aFour days included day of vaccination and the subsequent 3 days.
bTrial 6 was a single-blind, active-controlled, safety, and immunogenicity U.S. trial (NCT00383123). The active control was FLUZONE, a U.S.-licensed trivalent, inactivated influenza vaccine (Sanofi Pasteur Inc.).
cGrade 3 pain, irritability, loss of appetite, drowsiness, muscle aches, fatigue, headache, arthralgia, shivering: Defined as prevented normal activity.
Grade 3 swelling, redness: Defined as >50 mm.
Grade 3 fever: Defined as >102.2°F (39.0°C).
dFever: Defined as ≥99.5°F (37.5°C).

In children who received a second dose of FLUARIX or the comparator vaccine, the incidences of adverse events following the second dose were similar to those observed after the first dose.

Serious Adverse Events

In the 4 clinical trials in adults (N = 10,923), there was a single case of anaphylaxis within one day following administration of FLUARIX (<0.01%).

Postmarketing Experience

Beyond those events reported above in the clinical trials for FLUARIX QUADRIVALENT or FLUARIX, the following adverse events have been spontaneously reported during postapproval use of FLUARIX (trivalent influenza vaccine). This list includes serious events or events which have causal connection to FLUARIX. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Blood And Lymphatic System Disorders

Lymphadenopathy.

Cardiac Disorders

Tachycardia.

Ear And Labyrinth Disorders

Vertigo.

Eye Disorders

Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling.

Gastrointestinal Disorders

Abdominal pain or discomfort, swelling of the mouth, throat, and/or tongue.

General Disorders And Administration Site Conditions

Asthenia, chest pain, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches.

Immune System Disorders

Anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, serum sickness.

Infections And Infestations

Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis.

Nervous System Disorders

Convulsion, encephalomyelitis, facial palsy, facial paresis, Guillain-Barr� syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia, syncope.

Respiratory, Thoracic, And Mediastinal Disorders

Asthma, bronchospasm, dyspnea, respiratory distress, stridor.

Skin And Subcutaneous Tissue Disorders

Angioedema, erythema, erythema multiforme, facial swelling, pruritus, Stevens-Johnson syndrome, sweating, urticaria.

Vascular Disorders

Henoch-Sch�nlein purpura, vasculitis.

Read the entire FDA prescribing information for Fluarix (Influenza Virus Vaccine)

Related Resources for Fluarix

© Fluarix Patient Information is supplied by Cerner Multum, Inc. and Fluarix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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