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Afluria

"The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in peopl"...

Afluria

Afluria

Afluria Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Afluria (influenza virus vaccine) is a vaccine used to prevent infection caused by the influenza virus. The vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus recommended by public health officials for that year. It is a "killed virus" vaccine. Common side effects include pain or redness at the injection site, fever, muscle aches, headache, or fatigue.

The dosage of Afluria is 0.5-mL intramuscular injection administered preferably in the upper arm. Children aged 5 to 8 years should receive 2 doses of vaccine, 4 weeks apart, if they have not been vaccinated previously with any influenza virus vaccine. Afluria may interact with phenytoin (Dilantin), theophylline (Respbid, Slo-Bid, Theodur, Uniphyl), blood thinners (warfarin, Coumadin), steroids, medications to treat or prevent organ transplant rejection, and medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you take. During pregnancy, Afluria should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Afluria (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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Afluria in Detail - Patient Information: 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.

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 a serious side effect such as:

  • 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.

Less serious 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 Afluria (Influenza Virus Vaccine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Afluria Overview - Patient Information: Side Effects

SIDE EFFECTS: Soreness/redness/swelling/bruising at the injection site may occur and may last for up to 1-2 days. Fever, muscle aches, headache or weakness may also occur. If any of these effects continue beyond 2 days or become bothersome, tell your doctor.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

If your doctor has directed you to receive this vaccine, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these rare but very serious side effects occur: mental/mood changes, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, severe dizziness, itching/swelling (especially of the face/tongue/throat), trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Afluria (Influenza Virus Vaccine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Afluria FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA were pain ( ≥ 60%), redness ( ≥ 20%) and swelling ( ≥ 10%). The most common systemic adverse events were headache, myalgia ( ≥ 20%), malaise and fever ( ≥ 10%). In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness ( ≥ 60%) and pain ( ≥ 40%). The most common systemic adverse events observed were headache, malaise, and muscle aches ( ≥ 20%).

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness ( ≥ 30%) and pain ( ≥ 10%).

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in the clinical studies of another vaccine and may not reflect the rates observed in clinical practice.

Children

In clinical studies, AFLURIA has been administered to, and safety information collected for, 3,009 children ages 6 months to less than 18 years. Clinical safety data for AFLURIA in children is presented from three clinical studies (Studies 1, 2 and 3). Data from a comparator-controlled trial (Study 1) are presented, followed by pooled data from two open label studies (Studies 2 and 3). Subjects 6 months through 8 years of age received one or two vaccinations as determined by previous vaccination history (for further details on clinical study design, dosing and demographics see Clinical Studies).

Study 1 included 1,468 subjects for safety analysis, ages 6 months to less than 18 years, randomized to receive AFLURIA (735 subjects) or another U.S.-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur, Inc.) (733 subjects).

Study 2 included 1,976 subjects for safety analysis, ages 6 months to less than 18 years. All subjects received AFLURIA.

Study 3 included 298 subjects for safety analysis, ages 6 months to less than 9 years. All subjects received AFLURIA.

The safety assessment was similar for the three pediatric studies. Local (injection site) and systemic adverse events were solicited for 7 days post-vaccination (Tables 2 and 3). Unsolicited adverse events were collected for 30 days post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.

Among the pediatric studies, there were no vaccine-related deaths or vaccine-related serious adverse events reported in children 5 years of age and older.

In the comparator-controlled trial (Study 1), the rate of fever after the first dose of AFLURIA in subjects aged 5 to less than 9 years was 16% as compared to 8% in subjects who received the comparator. The rate of fever in subjects aged 9 to less than 18 years following a single dose of AFLURIA was 6% as compared to 4% in subjects who received the comparator. In all three pediatric studies, the rates of fever in subjects aged 5 to less than 9 years who received AFLURIA were lower after dose 2 than dose 1.

Data in Tables 2 and 3 are presented for children 5 years and older.

Table 2: Proportion of Subjects 5 through 17 Years of Age with Solicited Local or Systemic Adverse Events within 7 Days after Administration of First or Second Dose of AFLURIA, Irrespective of Causality (Study 1)

Solicited Adverse Event Age Group
Subjects ≥ 5 to < 9 years Subjects ≥ 9 to < 18 years
AFLURIA
N=161
Comparator
N=166
AFLURIA
N=254
Comparator
N=250
After the First Dose
Local
Pain 63% 60% 66% 60%
Redness 23% 27% 17% 17%
Induration 17% 17% 15% 16%
Systemic
Myalgia 34% 30% 40% 37%
Malaise 24% 13% 22% 20%
Headache 21% 20% 27% 26%
Any Fever 16% 8% 6% 4%
  Fever ≥ 102.2°F 5% 1% 3% 1%
Nausea/vomiting 12% 8% 9% 10%
Diarrhea 7% 7% 8% 10%
  AFLURIA
N=39
Comparator
N=53
After the Second Dose
Local
Pain 36% 38% - -
Redness 10% 19% - -
Induration 8% 17% - -
Systemic
Diarrhea 13% 6% - -
Headache 13% 13% - -
Myalgia 13% 17% - -
Malaise 5% 8% - -
Nausea/vomiting 3% 8% - -
Any Fever 0% 2% - -
  Fever ≥ 102.2°F 0% 0% - -

Table 3: Proportion of Subjects 5 through 17 Years of Age with Solicited Local or Systemic Adverse Events Within 7 Days after Administration of AFLURIA, Irrespective of Causality (Studies 2 and 3)

Solicited Adverse Event Studies 2 and 3 Subjects ≥ 5 to < 9 years Study 2 Subjects ≥ 9 to < 18 years
Dose 1
N=595
Dose 2
N=430
Dose 1
N=398
Local
Pain 61% 55% 68%
Erythema 24% 23% 17%
Swelling 18% 17% 13%
Systemic
Headache 17% 10% 27%
* Malaise or feeling generally unwell 16% 8% 17%
Any Fever 13% 6% 5%
  Fever ≥ 102.2°F 2% 2% 1%
General Muscle Ache (Myalgia) 12% 8% 20%
* Nausea/vomiting 7% 3% 5%
Vomiting/Diarrhea† 5% 6% -
* Diarrhea 4% 2% 5%
Irritability 3% 3% -
Loss of appetite 1% 1% -
*These preferred terms were used to describe Solicited Adverse Events in Study 2.
†These preferred terms were used to describe Solicited Adverse Events in Study 3.

In Study 1, unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 5 years to less than 9 years following the first or second dose included cough (15%) and pyrexia (9%). Unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 9 years to less than 18 years following the first dose included cough (7%), oropharyngeal pain (7%), headache (7%) and nasal congestion (6%).

In Studies 2 and 3, unsolicited adverse events that occurred in ≥ 5% subjects ages 5 years to less than 9 years after the first or second dose included the following: upper respiratory tract infection (13%), cough (10%), rhinorrhoea (7%), headache (5%), nasopharyngitis (5%) and pyrexia (5%). Unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 9 years to less than 18 years following the first dose included upper respiratory tract infection (9%) and headache (8%).

Adults

In clinical studies, a single dose of AFLURIA was administered to, and safety information collected for, 11,104 subjects ages 18 to less than 65 years and 836 subjects ages 65 years and older. Clinical safety data for AFLURIA in adults are presented from three clinical studies (Studies 4 through 6). In all adult studies, there were no vaccine-related deaths or vaccine-related serious adverse events reported.

Study 4 included 1,357 subjects for safety analysis, ages 18 to less than 65 years, randomized to receive AFLURIA (1,089 subjects) or placebo (268 subjects) (see Clinical Studies).

Study 5 included 15,020 subjects for safety analysis, ages 18 to less than 65 years, randomized to receive AFLURIA (10,015 subjects) or placebo (5,005 subjects) (see Clinical Studies).

Study 6 included 1,266 subjects for safety analysis, ages 65 years and older, randomized to receive AFLURIA (630 subjects) or another U.S.-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur SA) as an active control (636 subjects) (see Clinical Studies).

The safety assessment was identical for the three adult studies. Local (injection-site) and systemic adverse events were solicited for 5 days post-vaccination (Table 4). Unsolicited adverse events were collected for 21 days post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.

Table 4: Proportion of Subjects 18 Years of Age and Older with Solicited Local or Systemic Adverse Events within 5 Days after Administration of AFLURIA or Placebo, Irrespective of Causality (Studies 4, 5 and 6)

Solicited Adverse Event Study 4 Subjects ≥ 18 to < 65 years Study 5 Subjects ≥ 18 to < 65 years Study 6 Subjects ≥ 65 years
AFLURIA
N=1089
Placebo
N=268
AFLURIA
N=10,015
Placebo
N=5005
AFLURIA
N=630
Comparator
N=636
Local
Tenderness (Pain on touching) 60% 18% 69% 17% 36% 31%
Pain (without touching) 40% 9% 48% 11% 15% 14%
Redness 16% 8% 4% < 1% 3% 1%
Swelling 9% 1% 4% < 1% 7% 8%
Bruising 5% 1% 1% < 1% 1% 1%
Systemic
Headache 26% 26% 25% 23% 9% 10%
Malaise 20% 19% 29% 26% 7% 6%
Muscle aches 13% 9% 21% 12% 9% 8%
Nausea 6% 9% 7% 6% 2% 1%
Chills/Shivering 3% 2% 5% 4% 2% 2%
Fever 1% 1% 3% 2% 0% 0%

In Study 4, headache was the only unsolicited adverse event that occurred in ≥ 5% of subjects who received AFLURIA or placebo (8% versus 6%, respectively).

In Study 5, headache was the only unsolicited adverse event that occurred in ≥ 5% of subjects who received AFLURIA or placebo (12% versus 11%, respectively).

In Study 6, unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA included headache (8%), nasal congestion (7%), cough (5%), rhinorrea (5%), and pharyngolaryngeal pain (5%).

Postmarketing Experience

Because postmarketing reporting of adverse reactions 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 reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently. These adverse reactions reflect experience in both children and adults and include those identified during post-approval use of AFLURIA outside the US since 1985.

Blood and lymphatic system disorders

Transient thrombocytopenia

Immune system disorders

Allergic reactions including anaphylactic shock and serum sickness

Nervous system disorders

Neuralgia, paresthesia, convulsions (including febrile seizures), encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS

Vascular disorders

Vasculitis with transient renal involvement

Skin and subcutaneous tissue disorders

Pruritus, urticaria, and rash

General disorders and administration site conditions

Cellulitis and large injection site swelling

Adverse Reactions Associated With Influenza Vaccination

Anaphylaxis has been reported after administration of AFLURIA. Egg protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, asthma, and systemic anaphylaxis (see CONTRAINDICATIONS).

Neurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported.

Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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