Fluad

Last updated on RxList: 7/3/2017
Fluad Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/3/2017

Fluad (influenza virus vaccine, surface antigen, inactivated, adjuvanted with MF59C.1) is a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), approved for the prevention of seasonal influenza in people 65 years of age and older. Fluad Pediatric is intended for use in the pediatric population of 6 months to less than 2 years of age. Common side effects of Fluad and Fluad Pediatric include:

  • injection site reactions (redness, tenderness, swelling, skin discoloration, localized warm skin, and a hard lump),
  • fever,
  • headache,
  • fatigue,
  • general feeling of being unwell (malaise),
  • muscle pain,
  • rash,
  • sweating,
  • joint pain,
  • chills,
  • diarrhea,
  • nausea,
  • vomiting, and
  • changes in appetite.

Additional side effects of Fluad Pediatric in children include sleepiness, irritability, or crying.

The recommended dose of Fluad for adults 65 years of age and older is a single 0.5 mL dose administered once a year. Fluad may interact with other drugs or vaccines. Tell your doctor all medications and supplements you use and other vaccines you recently received. Tell your doctor if you are pregnant before receiving Fluad. Consult your doctor before breastfeeding.

Our Fluad (influenza virus vaccine, surface antigen, inactivated, adjuvanted with MF59C.1) 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.

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Fluad Consumer Information

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

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.

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.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • 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 Fluad (Influenza Virus Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59C.1)

Fluad Professional Information

SIDE EFFECTS

Adverse Drug Reaction Overview

Adverse event information is derived from both controlled and uncontrolled clinical trials and worldwide post-marketing experience.

Vaccination with FLUAD Pediatric™/FLUAD® cannot cause influenza because the vaccine does not contain live virus. Respiratory disease after vaccination represents coincidental illness unrelated to influenza vaccination.

Allergic-type responses, such as urticarial rash, allergic bronchospasm, or systemic anaphylaxis occur extremely rarely.

The most common local adverse drug reactions in the pediatric population are erythema and tenderness. The incidence of pediatric subjects reporting any solicited systemic reactions was generally slightly higher in the FLUAD Pediatric™ group than in the comparator group (42% vs. 38%).

The most common FLUAD® local adverse drug reactions in the elderly are pain at the injection site, temperature at the injection site, and erythema. The incidence of elderly subjects reporting any solicited systemic reactions was generally slightly higher in the FLUAD® group than in the comparator group (17% vs. 12%). Reactions are generally mild or moderate and of limited duration. Prophylactic acetaminophen may decrease the frequency of some side effects in adults.

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

Children 6 Months To Less Than 2 Years Of Age

The safety of FLUAD Pediatric™ was assessed in six randomized clinical trials that involved 4091 infants and children 6 months to less than 2 years of age (FLUAD Pediatric™: 1800; conventional non-adjuvanted trivalent and investigational quadrivalent influenza comparator vaccines: 2083; other non-influenza control vaccines: 208).

The most frequently reported solicited local reaction after each vaccination was erythema, followed by tenderness. Most local reactions were mild or moderate, and 1% or fewer subjects experienced severe reactions.

The most frequently reported solicited systemic reaction after each vaccination was irritability, followed by sleepiness and body temperature ≥ 38°C. Most systemic reactions were mild or moderate, and < 1% of subjects experienced severe reactions. After the first vaccination with FLUAD Pediatric™, 17% of subjects experienced fever (body temperature ≥ 38°C) compared with 12% to 16% after the first vaccination with the non-adjuvanted influenza comparator.

Pooled reactogenicity data are provided in Table 1.

Table 1 : Any Solicited Reactions After First and Second Vaccinations in Children 6 Months to < 2 Years of Age

Percentages of Subjects with Anya Solicited Reactionb
After First Vaccination After Second Vaccination
FLUAD  Pediatric™
N=1799
Comp. 1
N=1457
Comp. 2
N=622
FLUAD  Pediatric™
N=1704
Comp. 1
N=1379
Comp. 2
N=606
Solicited Local Reactions
Erythema 19% 17% 13% 21% 17% 11%
Tenderness 13% 11% 5% 11% 9% 4%
Induration 7% 5% 3% 9% 5% 2%
Ecchymosis 5% 5% 4% 5% 5% 2%
Swelling 3% 3% 1% 4% 3% < 1%
Solicited Systemic Reactionsc
Irritability 23% 22% 16% 18% 17% 9%
Body Temp. ( > 38C) 17%  N=1798 16% 12% 19% 16% 13%
Sleepiness 19% 16% 14% 14% 12% 6%
Change in eating habits 15% 16% 12% 12% 10% 6%
Diarrhea 15% 15% 14% 12% 9% 12%
Persistent 11% 11% 10% 7% 6% 5%
crying N=829 N=560 N=557 N=809 N=539 N=545
Vomiting 7% 7% 5% 5% 4% 5%
a Severe reactions were reported in zero to less than 1% of subjects
b N represents the total number of subjects exposed during the observation period (30 minutes to 7 days) post-vaccination
c After first vaccination: FLUAD Pediatric™ N = 1800, Comp. 1 N= 1458, and Comp. 2 N = 622. After second vaccination: FLUAD Pediatric™ N = 1704, Comp. 1 N= 1379, and Comp. 2 N = 606
Comp. = Comparator; Comp. 1 = Agrippal, Influsplit, Fluzone and Vaxigrip; Comp. 2 = AGRIFLU* and Quadrivalent vaccine comparator

During clinical trials of FLUAD Pediatric™, rhinitis, cough, upper respiratory tract inflammation, and nasopharyngitis were reported as temporally related unsolicited adverse events in both pediatric age groups. In addition, the following unsolicited adverse events of note were reported within 3 weeks of vaccination as at least possibly related: 1 case of febrile convulsion, 13 cases of rash, and 1 case of anaphylactic reaction.

Adults 65 Years of Age and Older

The safety profile of FLUAD® in adults 65 years and older is based on data from 39 studies. Overall 12,889 subjects were exposed to at least one dose with FLUAD®. Of these 492 received a second consecutive vaccination one year later, and 150 a third FLUAD*vaccine dose the following year. In one study, two doses of FLUAD® were administered 4 weeks apart. In 38 studies solicited local (injection site) and systemic reactions were collected from subjects who completed a symptom diary card for at least four days following vaccination.

Safety data after first vaccination for subjects 65 years of age and older were pooled from 31 trials, safety data after second consecutive vaccination were pooled from five studies and after third consecutive vaccination from two studies.

Pooled Reactogenicity data are provided in Table 2, Table 3 and Table 4.

The most frequently reported solicited local adverse events within 4 days of vaccination were injection site pain, followed by temperature at the injection site (“warm” or “hot”) and erythema. Local injection-site reactions (pain and temperature at the injection site) were more frequent in subjects who received the MF59 adjuvanted vaccine than in those who received nonadjuvanted vaccine. The frequency of pain was 26% in the FLUAD®group vs. 14% in the comparator group. Temperature at the injection site was 18% in the FLUAD® group vs 11% in the comparator group. Solicited local reactions were generally of mild or moderate intensity, and generally resolved within 2-3 days with 3% or less of subjects reporting a severe local reaction.

The most frequently reported solicited systemic adverse events were headache, fatigue, malaise and myalgia. Most reports of systemic reactions were mild to moderate in severity and generally transient, with 1% or less of subjects reporting a severe systemic reaction across all studies.

In the subset of subjects who received second and third consecutive vaccinations, for both the FLUAD® and the comparator vaccines groups, there was a trend for an increase in the percentage of subjects reporting each local reaction during the 3 days after the second vaccination, compared to the first vaccination, but no further increase after the third vaccination. Overall, systemic reactions were reported by similar percentages of subjects after the first, second, and third vaccinations in both the FLUAD® and comparator vaccines groups.

Table 2 : Any (Severea) Local and Systemic Reactions in Elderly Subjects ≥ 65 Years (Days 0-3) After One Vaccination - Pooled Studies

Percentages of Subjects with Any (Severea) Solicited Reaction
FLUAD®
N = 3713
Comparator
N = 1656
Subjects with Any Solicited Local Reaction 37% 30%
Pain at injection site 26% ( < 1%) 26% ( < 1%)
N = 3712 14% ( < 1%)
Temperature at injection site 18% (1%) 11% (1%)
N = 2265 N = 1438
Ecchymosis 3% ( < 1%) 2% (0)
N = 1272 N = 44
Induration 11% (1%) 9% (1%)
N = 3712 N = 1655
Erythema 14% (1%) 14% (1%)
N = 3712 N = 1655
Swelling 5% (1%) 6% (1%)
N = 1447 N = 218
Subjects with Any Solicited Systemic Reaction 17% 12%
Chills 3% ( < 1%) 2% ( < 1%)
N = 3712 N = 1655
Fatigue 6% ( < 1%) 7% (1%)
N = 1493 N = 264
Headache 6% ( < 1%) 5% (1%)
N = 3712 N = 1655
Malaise 6% ( < 1%) 5% ( < 1%)
N = 3712 N = 1655
Myalgia 7% ( < 1%) 3% ( < 1%)
N = 3712 N = 1655
Nausea 2% ( < 1%) 2% ( < 1%)
N = 2581 N = 1655
Rash < 1% ( < 1%) < 1% ( < 1%)
N = 2230 N = 1365
Sweating 3% (0) 3% ( < 1%)
N = 1447 N = 218
Arthralgia 4% ( < 1%) 2% ( < 1%)
N = 3666 N = 1609
Fever ( ≥ 38°C/ ≥ 40°C) 1% (0) < 1% (0)
N = 3675 N = 1652
a Defined as ecchymosis, erythema, induration, and swelling > 50mm; temperature at injection site “hot”; rash “urticaria”

Table 3 : Any (Severea) Local and Systemic Reactions in Elderly Subjects ≥ 65 Years (Days 0-3) Who Received Two Consecutive FLUAD* Vaccinations One Year Apart, by Vaccination

Percentages of Subjects with Any (Severea) Solicited Reaction
1st Vaccination 2nd Vaccination
FLUAD®
N=487
Comparator
N=329
FLUAD®
N=487
Comparator
N=329
Solicited Local Reactions
Pain at injection site 19% (1%) 7% (0) 27% (1%) 21% ( < 1%)
Temperature at injection site 6% (2%) 4% (1%) 15% (3%) 12% (2%)
Induration 9% (1%) 6% (1%) 13% (1%) 10% ( < 1%)
Erythema 9% (1%) 6% (0) 23% (2%) 20% (3%)
Solicited Systemic Reactions
Chills 4% ( < 1%) 4% ( < 1%) 3% (0) 2% (0)
Fatigue 15% (0)  N=39 0  N=35 0  N=39 3% (0)  N=35
Headache 5% ( < 1%) 5% ( < 1%) 8% (0) 5% (0)
Malaise 7% ( < 1%) 6% (0) 8% (0) 6% ( < 1%)
Myalgia 4% ( < 1%) 2% ( < 1%) 3% (0) 2% (0)
Nausea 3% (0) 2% (0) 2% (0) 3% ( < 1%)
Rash < 1% ( < 1%)  N=306 < 1% (0)  N=222 < 1% ( < 1%) < 1% (0)
Arthralgia 2% ( < 1%)  N=448 1% ( < 1%)  N=294 1% (0) 2% (0)
Fever ( ≥ 38°C/ ≥ 40°C) 1% (0) 0 1% (0) 1% (0)
aSevere defined as: induration, erythema and swelling > 50mm; temperature at injection site “hot”; rash “urticaria”

Table 4 : Any (Severea) Solicited Local and Systemic Reaction in Elderly Subjects ≥ 65 Years (Days 0-3) Who Received Three Consecutive FLUAD* Vaccinations One Year Apart, by Vaccination

1st Vaccination 2nd Vaccination 3rd Vaccination
FLUAD® 
N=149
Comp.
  N=87
FLUAD®
  N=150
Comp. 
N=87
FLUAD®
  N=150
Comp. 
N=87
Solicited Local Reactions
Pain at injection site 28% (1%) 5% (0) 29% (1%) 15% (0) 28% (1%) 16% (0)
Temperature at injection site 4% (1%) 5% (0) 7% (1%) 2% (1%) 12% (1%) 7% (0)
Induration 8% (0) 5% (0) 12% (1%) 6% (0) 13% (1%) 6% (0)
Erythema 9% (0) 6% (0) 14% (1%) 7% (1%) 22% (3%) 9% (0)
Solicited Systemic Reactions
Chills 4% (0) 6% (1%) 1% (0) 2% (0) 3% (0) 0
Fatigue 17% (0) 0 0 (N=35) 3%(N=32) #NAME? #NAME?
Headache 4% (0) 2% (0) 8% (0) 5% (0) 4% (1%) 3% (0)
Malaise 7% (0) 3% (0) 5% (0) 3% (0) 7% (0) 3% (0)
Myalgia 3% (0) 1% (1%) 5% (0) 2% (0) 1% (0) 2% (0)
Nausea 2% (0) 0 3% (0) 2% (0) 3% (0) 2% (0)
Rash - (N=0) - (N=0) 0 (N=115) 0 (N=55) 0 0
Arthralgia 2% (0) 2% (2%) 1% (0) 3% (0) 1% (0) 3% (0)
Fever ( ≥ 38°C/ ≥ 40°C) 0 0 1% (0) 0 1% (0) 0
aSevere defined as: induration, erythema and swelling > 50mm; temperature at injection site “hot”; rash “urticaria”; Comp.= comparator vaccine

Post-Market Adverse Drug Reactions

FLUAD® was first licensed in Italy in 1997. The authorization was extended to other European Union countries through a Mutual Recognition Procedure that concluded in 2000 and currently FLUAD® is registered for marketing authorization in many countries worldwide. The initial formulation contained the preservative thimerosal, and thimerosal was also used in the manufacturing process. Since 2003 FLUAD® has been thimerosal-free (see Pharmaceutical Information section).

The post-marketing experience with FLUAD® in the elderly is extensive. Because post-marketing reporting is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

The adverse events described below have been included because: a) they represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; b) they are potentially serious; or c) of the frequency of reporting. The following additional adverse reactions have been the subject of spontaneous reports during post-approval use of FLUAD® since 2003.

General Disorders And Administration Site Conditions

Local injection site reactions including redness, swelling, pain at the injection site, ecchymosis, induration. Injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week). Extensive swelling of injected limb lasting more than one week.

Immune System Disorders

Allergic reactions in rare cases leading to shock, angioedema.

Vascular Disorders

Vasculitis (in rare cases associated with transient renal involvement), exudative erythema multiforme.

Blood and Lymphatic System Disorders

Thrombocytopenia (including very rare severe cases, < 0.01%, with platelet counts less than 5,000 per mm³), lymphadenopathy.

Musculoskeletal And Connective Tissue Disorders

Muscular weakness

Nervous System Disorders

Neuralgia, paraesthesia, convulsion, myelitis (including encephalomyelitis and transverse myelitis), neuritis and Guillain-Barré Syndrome.

Skin And Subcutaneous Tissue Disorders

Generalized skin reactions including pruritus, urticaria, and non-specific rash.

There is no post-marketing experience with FLUAD Pediatric™ in infants and children.

Read the entire FDA prescribing information for Fluad (Influenza Virus Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59C.1)

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

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