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Flulaval

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

Last reviewed on RxList 09/25/2017

Flulaval (influenza virus vaccine) is a "killed virus" immunization used to prevent infection caused by influenza virus. The vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year. Common side effects of Flulaval include fever, chills, mild fussiness or crying in children, injection site reactions (redness, bruising, pain, swelling, or a lump), headache, tired feeling, or joint or muscle pain.

Flulaval is administered as a single 0.5-mL dose injection intramuscularly, preferably in the deltoid muscle of the upper arm. Flulaval may interact with phenytoin, theophylline, blood thinner, steroids, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you use and all vaccine you recently received. Vaccines may be harmful to a fetus and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Consult your doctor about whether you should receive Flulaval. It is unknown if Flulaval vaccine passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

 

Our Flulaval (Influenza Virus Vaccine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Flulaval 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 Flulaval (Influenza Virus Vaccine)

Flulaval Professional Information

SIDE EFFECTS

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 FLULAVAL QUADRIVALENT could reveal adverse reactions not observed in clinical trials.

In adults who received FLULAVAL QUADRIVALENT, the most common (≥10%) solicited local adverse reaction was pain (60%); the most common (≥10%) solicited systemic adverse events were muscle aches (26%), headache (22%), fatigue (22%), and arthralgia (15%).

In children aged 6 through 35 months who received FLULAVAL QUADRIVALENT, the most common (≥10%) solicited local adverse reaction was pain (40%); the most common (≥10%) solicited systemic adverse events were irritability (49%), drowsiness (37%), and loss of appetite (29%).

In children aged 3 through 17 years who received FLULAVAL QUADRIVALENT, the most common (≥10%) solicited local adverse reaction was pain (65%). In children aged 3 through 4 years, the most common (≥10%) solicited systemic adverse events were irritability (26%), drowsiness (21%), and loss of appetite (17%). In children aged 5 through 17 years, the most common (≥10%) systemic adverse events were muscle aches (29%), fatigue (22%), headache (22%), arthralgia (13%), and gastrointestinal symptoms (10%).

FLULAVAL QUADRIVALENT has been administered in 8 clinical trials to 1,384 adults aged 18 years and older, 1,965 children aged 6 through 35 months, and 3,516 children aged 3 through 17 years.

FLULAVAL QUADRIVALENT In Adults

Trial 1 (NCT01196975) was a randomized, double-blind, active-controlled, safety and immunogenicity trial. In this trial, subjects received FLULAVAL QUADRIVALENT (n = 1,272), or one of 2 formulations of a comparator trivalent influenza vaccine (FLULAVAL, TIV-1, n = 213 or TIV-2, n = 218), each containing an influenza type B virus that corresponded to one of the 2 B viruses in FLULAVAL 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: 50 years) and 61% were female; 61% of subjects were white, 3% were black, 1% were Asian, and 35% were of other racial/ethnic groups. Solicited adverse events were collected for 7 days (day of vaccination and the next 6 days). The incidence of local adverse reactions and systemic adverse events occurring within 7 days of vaccination in adults are shown in Table 2.

Table 2: FLULAVAL QUADRIVALENT: Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 7 Daysa of Vaccination in Adults Aged 18 Years and Olderb (Total Vaccinated Cohort)

  FLULAVAL QUADRIVALENTc
n = 1,260 %
Trivalent Influenza Vaccine (TIV)
TIV-1 (B Victoria)d
n = 208 %
TIV-2 (B Yamagata)e
n = 216 %
Any Grade 3f Any Grade 3f Any Grade 3f
Local Adverse Reactions
Pain 59.5 1.7 44.7 1.0 41.2 1.4
Swelling 2.5 0.0 1.4 0.0 3.7 0.0
Redness 1.7 0.0 2.9 0.0 1.4 0.0
Systemic Adverse Events
Muscle aches 26.3 0.8 25.0 0.5 18.5 1.4
Headache 21.5 0.9 19.7 0.5 22.7 0.0
Fatigue 21.5 0.8 21.6 1.0 17.1 1.9
Arthralgia 14.8 0.8 16.7 1.0 14.6 2.9
Gastrointestinal symptomsg 9.3 0.8 10.1 1.9 6.9 0.5
Shivering 8.8 0.6 7.7 0.5 6.0 0.9
Feverh 1.3 0.4 0.5 0.0 1.4 0.5
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n = number of subjects with diary card completed.
a7 days included day of vaccination and the subsequent 6 days.
bTrial 1: NCT01196975.
cContained 2 A strains and 2 B strains, one of Victoria lineage and one of Yamagata lineage.
dContained the same 2 A strains as FLULAVAL QUADRIVALENT and a B strain of Victoria lineage.
eContained the same 2 A strains as FLULAVAL QUADRIVALENT and a B strain of Yamagata lineage.
fGrade 3 pain: Defined as significant pain at rest; prevented normal everyday activities.
Grade 3 swelling, redness: Defined as >100 mm.
Grade 3 muscle aches, headache, fatigue, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
Grade 3 (or higher) fever: Defined as ≥102.2°F (39.0°C).
gGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
hFever: Defined as ≥100.4°F (38.0°C)

Unsolicited adverse events occurring within 21 days of vaccination were reported in 19%, 23%, and 23% of subjects who received FLULAVAL QUADRIVALENT (n = 1,272), TIV-1 (B Victoria) (n = 213), or TIV-2 (B Yamagata) (n = 218), respectively. The unsolicited adverse events that occurred most frequently (≥1% for FLULAVAL QUADRIVALENT) included nasopharyngitis, upper respiratory tract infection, headache, cough, and oropharyngeal pain. Serious adverse events occurring within 21 days of vaccination were reported in 0.4%, 0%, and 0% of subjects who received FLULAVAL QUADRIVALENT, TIV-1 (B Victoria), or TIV-2 (B Yamagata), respectively.

FLULAVAL QUADRIVALENT In Children

Trial 4 (NCT02242643) was a randomized, observer-blind, active-controlled immunogenicity and safety trial. The trial included subjects aged 6 through 35 months who received FLULAVAL QUADRIVALENT (n = 1,207) or FLUZONE QUADRIVALENT, a U.S.-licensed inactivated influenza vaccine (n = 1,217) used as comparator, manufactured by Sanofi Pasteur Inc. Children with no history of influenza vaccination received 2 doses of FLULAVAL QUADRIVALENT or the comparator vaccine approximately 28 days apart. Children with a history of influenza vaccination received one dose of FLULAVAL QUADRIVALENT or the comparator vaccine. In the overall population, 53% were male; 64% were white, 16% were black, 3% were Asian, and 17% were of other racial/ethnic groups. The mean age of subjects was 20 months. Subjects were followed for safety for 6 months; solicited local adverse reactions and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days) postvaccination. The incidence of local adverse reactions and systemic adverse events occurring within 7 days of vaccination in children are shown in Table 3.

Table 3: FLULAVAL QUADRIVALENT: Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 7 Daysa of Firs t Vaccination in Children Aged 6 through 35 Monthsb (Total Vaccinated Cohort)

  FLULAVAL QUADRIVALENT % Active Comparatorc %
Any Grade 3d Any Grade 3d
Local Adverse Reactions n = 1,151 n= 1,146
Pain 40.3 2.4 37.4 1.4
Swelling 1.0 0.0 0.4 0.0
Redness 1.3 0.0 1.3 0.0
Systemic Adverse Events n = 1,155 n = 1,148
Irritability 49.4 3.8 45.9 3.0
Drowsiness 36.7 2.7 36.9 2.6
Loss of appetite 28.9 1.6 28.6 1.3
Fever e 5.6 1.4 5.8 1.0
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available (i.e., diary card completed for solicited symptoms). n = number of subjects with diary card completed.
a7 days included day of vaccination and the subsequent 6 days.
bTrial 4: NCT02242643.
cU.S.-licensed quadrivalent, inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc).
Grade 3 pain: Defined as cried when limb was moved/spontaneously painful.
Grade 3 swelling, redness: Defined as >100 mm.
Grade 3 irritability: Defined as crying that could not be comforted/prevented normal activity.
Grade 3 drowsiness: Defined as prevented normal activity.
Grade 3 loss of appetite: Defined as not eating at all.
Grade 3 (or higher) fever: Defined as >102.2°F (39.0°C).
eFever: Defined as ≥100.4°F (38.0°C).

In children who received a second dose of FLULAVAL QUADRIVALENT or the comparator vaccine, the incidences of solicited adverse events following the second dose were generally similar or lower than those observed after the first dose.

Unsolicited adverse events occurring within 28 days of vaccination were reported in 46% and 44% of subjects who received FLULAVAL QUADRIVALENT (n = 1,207) and the comparator vaccine (n = 1,217), respectively. The unsolicited adverse reactions that occurred most frequently (≥1%) for FLULAVAL QUADRIVALENT included upper respiratory tract infection, cough, diarrhea, pyrexia, vomiting, and rash. Serious adverse events occurring during the study period (approximately 6 months) were reported in 2% of subjects who received FLULAVAL QUADRIVALENT and in 2% of subjects who received the comparator vaccine. There were no deaths reported during the study period.

Trial 2 (NCT01198756) was a randomized, double-blind, active-controlled trial. In this trial, subjects received FLULAVAL QUADRIVALENT (n = 932) or one of 2 formulations of a comparator trivalent influenza vaccine [FLUARIX (Influenza Vaccine), TIV-1 (B Victoria), n = 929 or TIV-2 (B Yamagata), n = 932], each containing an influenza type B virus that corresponded to one of the 2 B viruses in FLULAVAL QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The population was aged 3 through 17 years (mean age: 9 years) and 53% were male; 65% were white, 13% were Asian, 9% were black, and 13% 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 for 7 days (day of vaccination and the next 6 days). The incidence of local adverse reactions and systemic adverse events occurring within 7 days of vaccination in children are shown in Table 4.

Table 4: FLULAVAL QUADRIVALENT: Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 7 Daysa of Firs t Vaccination in Children Aged 3 through 17 Yearsb (Total Vaccinated Cohort)

  FLULAVAL 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 Adverse Reactions n = 913 n = 911 n = 915
Pain 65.4 3.2 54.6 1.8 55.7 2.4
Swelling 6.2 0.1 3.3 0.0 3.8 0.0
Redness 5.3 0.1 3.2 0.0 3.5 0.0
  Aged 3 through 4 Years
Systemic Adverse Events n = 185 n = 187 n = 189
Irritability 25.9 0.5 16.6 0.0 21.7 1.6
Drowsiness 21.1 0.0 19.8 1.6 23.3 0.5
Loss of appetite 17.3 0.0 16.0 1.6 13.2 1.1
Feverg 4.9 0.5 5.9 1.1 3.7 1.6
  Aged 5 through 17 Years
Systemic Adverse Events n = 727 n = 724 n = 725
Muscle aches 28.5 0.7 24.9 0.6 24.7 1.0
Fatigue 22.1 0.7 23.6 1.8 23.0 1.0
Headache 22.0 1.0 22.1 1.0 20.1 1.2
Arthralgia 12.9 0.4 11.9 0.6 10.5 0.1
Gastrointestinal symptomsh 9.6 1.0 9.7 1.0 9.0 0.7
Shivering 7.0 0.4 6.9 1.2 6.9 0.6
Feverg 1.9 0.6 3.6 1.1 2.5 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.
7 days included day of vaccination and the subsequent 6 days.
aTrial 2: NCT01198756.
bContained 2 A strains and 2 B strains, one of Victoria lineage and one of Yamagata lineage.
cContained the same 2 A strains as FLULAVAL QUADRIVALENT and a B strain of Victoria lineage.
dContained the same 2 A strains as FLULAVAL QUADRIVALENT and a B strain of Yamagata lineage.
eGrade 3 pain: Defined as cried when limb was moved/spontaneously painful (children 5 years), or significant pain at rest, prevented normal everyday activities (children ≥5 years).
Grade 3 swelling, redness: Defined as >100 mm.
Grade 3 irritability: Defined as crying that could not be comforted/prevented normal activity.
Grade 3 drowsiness: Defined as prevented normal activity.
Grade 3 loss of appetite: Defined as not eating at all.
Grade 3 (or higher) fever: Defined as ≥102.2°F (39.0°C).
Grade 3 muscle aches, fatigue, headache, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
gFever: Defined as ≥100.4°F (38.0°C).
hGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

In children who received a second dose of FLULAVAL QUADRIVALENT, FLUARIX TIV-1 (B Victoria), or TIV-2 (B Yamagata), 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 vaccination were reported in 30%, 31%, and 30% of subjects who received FLULAVAL QUADRIVALENT (n = 932), FLUARIX TIV-1 (B Victoria) (n = 929), or TIV-2 (B Yamagata) (n = 932), respectively. The unsolicited adverse events that occurred most frequently (≥1% for FLULAVAL QUADRIVALENT) included vomiting, pyrexia, bronchitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, and rhinorrhea. Serious adverse events occurring within 28 days of any vaccination were reported in 0.1%, 0.2%, and 0.2% of subjects who received FLULAVAL QUADRIVALENT, FLUARIX TIV-1 (B Victoria), or TIV-2 (B Yamagata), respectively.

Trial 3 (NCT01218308) was a randomized, observer-blind, non-influenza vaccine-controlled trial evaluating the efficacy of FLULAVAL QUADRIVALENT. The trial included subjects aged 3 through 8 years who received FLULAVAL QUADRIVALENT (n = 2,584) or HAVRIX (Hepatitis A Vaccine) (n = 2,584) as a control vaccine. Children with no history of influenza vaccination received 2 doses of FLULAVAL QUADRIVALENT or HAVRIX approximately 28 days apart (this dosing regimen for HAVRIX is not a U.S.-licensed schedule). Children with a history of influenza vaccination received one dose of FLULAVAL QUADRIVALENT or HAVRIX. In the overall population, 52% were male; 60% were Asian, 5% were white, and 35% were of other racial/ethnic groups. The mean age of subjects was 5 years. Solicited local adverse reactions and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days). The incidence of local adverse reactions and systemic adverse events occurring within 7 days of vaccination in children are shown in Table 5.

Table 5: FLULAVAL QUADRIVALENT: Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 7 Daysa of Firs t Vaccination in Children Aged 3 through 8 Yearsb (Total Vaccinated Cohort)

  FLULAVAL QUADRIVALENT % HAVRIXc %
Any Grade 3d Any Grade 3d
Aged 3 through 8 Years
Local Adverse Reactions n = 2,546 n = 2,551
Pain 39.4 0.9 27.8 0.7
Swelling 1.0 0.0 0.3 0.0
Redness 0.4 0.0 0.2 0.0
  Aged 3 through 4 Years
Systemic Adverse Events n = 898 n = 895
Loss of appetite 9.0 0.3 8.2 0.4
Irritability 8.1 0.4 7.5 0.1
Drowsiness 7.7 0.4 7.3 0.0
Fevere 3.8 1.2 4.4 1.3
  Aged 5 through 8 Years
Systemic Adverse Events n = 1,648 n = 1,654
Muscle aches 12.0 0.1 9.7 0.2
Headache 10.5 0.4 10.6 0.8
Fatigue 8.4 0.1 7.1 0.3
Arthralgia 6.3 0.1 4.5 0.1
Gastrointestinal symptomsf 5.5 0.2 5.9 0.3
Shivering 3.0 0.1 2.5 0.1
Fevere 2.7 0.6 2.7 0.7
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n = number of subjects with diary card completed.
a7 days included day of vaccination and the subsequent 6 days.
bTrial 3: NCT01218308.
cHepatitis A Vaccine used as a control vaccine.
dGrade 3 pain: Defined as cried when limb was moved/spontaneously painful (children 5 years), or significant pain at rest, prevented normal everyday activities (children ≥5 years).
Grade 3 swelling, redness: Defined as >100 mm.
Grade 3 loss of appetite: Defined as not eating at all.
Grade 3 irritability: Defined as crying that could not be comforted/prevented normal activity.
Grade 3 drowsiness: Defined as prevented normal activity.
Grade 3 (or higher) fever: Defined as ≥102.2°F (39.0°C).
Grade 3 muscle aches, headache, fatigue, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
eFever: Defined as ≥100.4°F (38.0°C).
fGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

In children who received a second dose of FLULAVAL QUADRIVALENT or HAVRIX, the incidences of adverse events following the second dose were generally lower than those observed after the first dose.

The frequency of unsolicited adverse events occurring within 28 days of vaccination was similar in both groups (33% for both FLULAVAL QUADRIVALENT and HAVRIX). The unsolicited adverse events that occurred most frequently (≥1% for FLULAVAL QUADRIVALENT) included diarrhea, pyrexia, gastroenteritis, nasopharyngitis, upper respiratory tract infection, varicella, cough, and rhinorrhea. Serious adverse events occurring within 28 days of any vaccination were reported in 0.7% of subjects who received FLULAVAL QUADRIVALENT and in 0.2% of subjects who received HAVRIX.

Postmarketing Experience

The following adverse events have been spontaneously reported during postapproval use of FLULAVAL QUADRIVALENT or FLULAVAL (trivalent influenza vaccine). Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their incidence rate or establish a causal relationship to the vaccine. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to FLULAVAL QUADRIVALENT or FLULAVAL.

Blood And Lymphatic System Disorders

Lymphadenopathy.

Eye Disorders

Eye pain, photophobia.

Gastrointestinal Disorders

Dysphagia, vomiting.

General Disorders And Administration Site Conditions

Chest pain, injection site inflammation, asthenia, injection site rash, influenza-like symptoms, abnormal gait, injection site bruising, injection site sterile abscess.

Immune System Disorders

Allergic reactions including anaphylaxis, angioedema.

Infections And Infestations

Rhinitis, laryngitis, cellulitis.

Musculoskeletal And Connective Tissue Disorders

Muscle weakness, arthritis.

Nervous System Disorders

Dizziness, paresthesia, hypoesthesia, hypokinesia, tremor, somnolence, syncope, Guillain-Barr´┐Ż syndrome, convulsions/seizures, facial or cranial nerve paralysis, encephalopathy, limb paralysis.

Psychiatric Disorders

Insomnia.

Respiratory, Thoracic, And Mediastinal Disorders

Dyspnea, dysphonia, bronchospasm, throat tightness.

Skin And Subcutaneous Tissue Disorders

Urticaria, localized or generalized rash, pruritus, sweating.

Vascular Disorders

Flushing, pallor.

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

Related Resources for Flulaval

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

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