Afluria

Name: Afluria

Manufacturer

  • CSL Limited

Afluria Precautions

Serious side effects have been reported with Afluria including the following:

  • Hives or a bad rash
  • Trouble breathing
  • Swelling of the face, tongue, or throat
  • Guillain-Barre Syndrome
  • Brief fainting spells can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting and injuries caused by a fall. Tell the person giving you the vaccine if you feel dizzy, or have vision changes or ringing in the ears.
  • Severe shoulder pain and reduced range of motion in the arm where the shot was given can happen, very rarely, after a vaccination.
  • Severe allergic reactions from a vaccine are very rare. If one were to occur, it would usually be within a few minutes to a few hours after the vaccination.
  • Young children who get the flu vaccine and the pneumococcal vaccine at the same time may be at increased risk for seizures caused by fever. Ask your doctor for more information.
  • As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

Do not get Afluria if you:

  • have known severe allergic reactions (anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine
  • ever had Guillain-Barre Syndrome (a severe, paralyzing illness, also called GBS). Some people with a history of GBS should not get this vaccine.
  • are not feeling well. It is usually okay to get flu vaccine when you have a mild illness, but you might be advised to wait until you feel better. 

Some inactivated flu vaccines contain a very small amount of a mercury-based preservative called thimerosal. Studies have not shown thimerosal in vaccines to be harmful, but flu vaccines that do not contain thimerosal are available.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • A burning, numbness, or tingling feeling that is not normal.
  • Not able to move face muscles as much.
  • Trouble controlling body movements.
  • Very bad dizziness or passing out.
  • Muscle weakness.
  • Seizures.
  • Very bad headache.
  • Change in eyesight.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Afluria Description

Afluria, Influenza Virus Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. Afluria is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using a continuous flow zonal centrifuge. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a "split virion". The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.

Afluria is standardized according to USPHS requirements for the 2010-2011 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2010-2011 Northern Hemisphere influenza season: A/California/7/2009, NYMC X-181 (H1N1), A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like strain), and B/Brisbane/60/2008. A 0.25 mL dose contains 7.5 mcg HA of each of the same three influenza strains.

Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; therefore these products contain no preservative. The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

A single 0.5 mL dose of Afluria contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone (< 25 nanograms). A single 0.25 mL dose of Afluria contains half of these quantities.

The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex.

Clinical Studies

Immunogenicity in the Adult and Geriatric Populations

Three randomized, controlled clinical studies of Afluria have evaluated the immune responses by measuring HI antibody titers to each virus strain in the vaccine. In these studies, post-vaccination immunogenicity was evaluated on sera obtained 21 days after administration of Afluria. No controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Afluria have been performed.

The US study (Study 1) was a randomized, double-blinded, placebo-controlled, multicenter study in healthy subjects ages 18 to less than 65 years. A total of 1,357 subjects were vaccinated (1,089 subjects with Afluria and 268 with a thimerosal-containing placebo). Subjects receiving Afluria were vaccinated using either a single-dose (preservative-free) or multi-dose (one of three lots) formulation. The evaluable efficacy population consisted of 1,341 subjects (1,077 in the Afluria group and 264 in the placebo group) with complete serological data who had not received any contraindicated medications before the post-vaccination immunogenicity assessment. Among the evaluable efficacy population receiving Afluria, 37.5% were men and 62.5% were women. The mean age of the entire evaluable population receiving Afluria was 38 years; 73% were ages 18 to less than 50 years and 27% were ages 50 to less than 65 years. Additionally, 81% of Afluria recipients were White, 12% Black, and 6% Asian.

In Study 1, the following co-primary immunogenicity endpoints were assessed: 1) the lower bounds of the 2-sided 95% confidence intervals (CI) for the proportion of subjects with HI antibody titers of 1:40 or greater after vaccination, which should exceed 70% for each vaccine antigen strain; and 2) the lower bounds of the 2-sided 95% CI for rates of seroconversion (defined as a 4-fold increase in post-vaccination HI antibody titers from pre-vaccination titers of 1:10 or greater, or an increase in titers from less than 1:10 to 1:40 or greater), which should exceed 40% for each vaccine antigen strain.

In subjects ages 18 to less than 65 years, serum HI antibody responses to Afluria met the pre-specified co-primary endpoint criteria for all three virus strains (Table 6). Clinical lot-to-lot consistency was demonstrated for the single-dose (preservative-free) and multi-dose formulations of Afluria, showing that these formulations elicited similar immune responses.

Table 6: Study 1 – Serum HI Antibody Responses in Subjects ≥ 18 to < 65 Years Receiving Afluria
Treatment Arm Number Enrolled/Evaluable Vaccine Strain Seroconversion Rate*
(95% CI)
HI Titer ≥ 1:40†
(95% CI)
* Seroconversion rate is defined as a 4-fold increase in post-vaccination HI antibody titer from pre-vaccination titer ≥ 1:10, or an increase in titer from < 1:10 to ≥ 1:40. Lower bound of 95% CI for seroconversion should be > 40% for the study population. † HI titer ≥ 1:40 is defined as the proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40. Lower bound of 95% CI for HI antibody titer ≥ 1:40 should be > 70% for the study population. ‡ Active formulations include aggregated results for the single-dose (preservative-free) and multi-dose formulations of Afluria.
All active Afluria influenza vaccine formulations‡ 1089/1077 H1N1 48.7%
(45.6, 51.7)
97.8%
(96.7, 98.6)
H3N2 71.5%
(68.7, 74.2)
99.9%
(99.5, 100.0)
B 69.7%
(66.9, 72.5)
94.2%
(92.7, 95.6)
Placebo 270/264 H1N1 2.3%
(0.8, 4.9)
74.6%
(68.9, 79.8)
H3N2 0.0%
(N/A)
72.0%
(66.1, 77.3)
B 0.4%
(< 0.1, 2.1)
47.0%
(40.8, 53.2)

The UK study (Study 2) was a randomized, controlled study that enrolled 275 healthy subjects ages 65 years and older. This study compared Afluria with a European-licensed trivalent inactivated influenza vaccine as an active control. The evaluable efficacy population consisted of 274 subjects (206 in the Afluria group and 68 in the control group). Among these subjects, 50% were men and 50% were women, with a mean age of 72 years (range: 65 to 93 years).

The co-primary immunogenicity endpoints for the seroconversion rate and the proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40 are presented in Table 7.

Table 7: Study 2 – Serum HI Antibody Responses in Subjects ≥ 65 Years Receiving Afluria
Number of Subjects Vaccine Strain Seroconversion Rate*
(95% CI)
HI Titer ≥ 1:40†
(95% CI)
* Seroconversion rate is defined as a 4-fold increase in post-vaccination HI antibody titer from pre-vaccination titer ≥ 1:10, or an increase in titer from < 1:10 to ≥ 1:40. Lower bound of 95% CI for seroconversion should be > 30% for the study population. † HI titer ≥ 1:40 is defined as the proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40. Lower bound of 95% CI for HI antibody titer ≥ 1:40 should be > 60% for the study population.
206 H1N1 34.0% (27.5, 40.9) 85.0% (79.3, 89.5)
H3N2 44.2% (37.3, 51.2) 99.5% (97.3, 100.0)
B 45.6% (38.7, 52.7) 77.7% (71.4, 83.2)

A second UK study (Study 3) was a randomized, controlled study that enrolled 406 healthy subjects ages 18 years and older (stratified by age from 18 to less than 60 years and 60 years and older). This study compared Afluria with a European-licensed trivalent inactivated influenza vaccine as an active control. In a post-hoc analysis of different age ranges, among subjects ages 18 to less than 65 years receiving Afluria (146 subjects), 47% were men and 53% were women, with a mean age of 48 years for all subjects. Among subjects ages 65 years and older receiving Afluria (60 subjects), 53% were men and 47% were women, with a mean age of 71 years.

Analysis of serum HI antibody responses showed that the lower bound of the 95% CI for subjects with HI antibody titers of 1:40 or greater after vaccination exceeded 70% for each strain. HI antibody responses were lower in subjects, ages 65 years and older after administration of Afluria. Serum HI antibody responses to the active control were similar to those for Afluria in both age groups.

Immunogenicity in a Pediatric Population

An open-label, uncontrolled, multi-center study (Study 4) to evaluate the safety, tolerability and immunogenicity of Afluria in children 6 months to 9 years of age was conducted in Australia. The study subjects were subdivided into two groups dependent upon age at time of enrollment. A total of 298 subjects were enrolled, including 151 subjects, 6 months to less than 3 years (mean age 1.7 years with 51.0% females) and 147 subjects, 3 years to less than 9 years (mean age 5 years with 55.1% females).

Two doses of Afluria were administered to all subjects, with a 30 day interval between each dose. Children ages 6 months to less than 3 years received two 0.25 mL doses of Afluria. Children ages 3 years to less than 9 years were administered two 0.5 mL doses of Afluria. Sera for immunological assessment were taken 30 days (± 3) following each vaccination. Immunogenicity endpoints were the seroconversion rate and the proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40. The results for each dose are presented in Table 8.

For both age groups, the vaccine met FDA acceptance criteria for immunogenicity developed for healthy adults for all three influenza strains following two doses. These criteria are: 1) that the lower bound of the 2-sided 95% CI for the seroconversion rate should be at least 40%; and 2) the lower bound of the 2-sided 95% CI for the proportion of subjects with a post-vaccination HI titer of ≥ 1:40 should be at least 70%.

Table 8: Study 4 – Serum HI Antibody Responses in Subjects ≥ 6 months to < 9 Years Receiving Afluria
Vaccine Strain Vaccine Dose Seroconversion Rate*
(lower 95% CI)
HI Titer ≥ 1:40†
(lower 95% CI)
* Seroconversion rate is defined as a 4-fold increase in post-vaccination HI antibody titer from pre-vaccination titer ≥ 1:10, or an increase in titer from < 1:10 to ≥ 1:40. The lower 95% confidence limits were determined. Lower bound of 95% CI for seroconversion was taken as > 40% for the study population (as applied to adults 18 to 64 years of age). † HI titer ≥ 1:40 is defined as the proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40. The lower 95% confidence limits were determined. Lower bound of 95% CI for HI antibody titer ≥ 1:40 was taken as > 70% for the study population (as applied to adults 18 to 64 years of age). ‡ Evaluable population post-dose 1. § Evaluable population post-dose 2.
Subjects
≥ 6 months to
< 3 years
n=143‡
n=139§
H1N1 Dose 1 16.1% (> 11.3) 16.1% (> 11.3)
Dose 2 95.0% (> 90.8) 95.7% (> 91.7)
H3N2 Dose 1 86.0% (> 80.3) 97.9% (> 94.7)
Dose 2 90.6% (> 85.6) 100.0% (> 97.9)
B Dose 1 20.3% (> 14.9) 21.0% (> 15.5)
Dose 2 94.2% (> 89.9) 95.7% (> 91.7)
Subjects
≥ 3 years to
< 9 years
n=144‡
n=132§
H1N1 Dose 1 24.3% (> 18.5) 25.7% (> 19.8)
Dose 2 93.9% (> 89.3) 95.5% (> 91.2)
H3N2 Dose 1 68.1% (> 61.1) 98.6% (> 95.7)
Dose 2 70.5% (> 63.2) 100.0% (> 97.8)
B Dose 1 32.6% (> 26.2) 34.0% (> 27.5)
Dose 2 93.2% (> 88.4) 94.7% (> 90.3)

Patient Counseling Information

  • Inform the patient that Afluria is an inactivated vaccine that cannot cause influenza but stimulates the immune system to produce antibodies that protect against influenza. The full effect of the vaccine is generally achieved approximately 3 weeks after vaccination. Annual revaccination is recommended.
  • Instruct the patient to report any severe or unusual adverse reactions to their healthcare provider.

Manufactured by:
CSL Limited
Parkville, Victoria, 3052, Australia
US License No. 1764

Distributed by:
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Afluria is a registered trademark of CSL Limited.
CSL Biotherapies is a division of CSL Limited.

Principal Display Panel - 5 mL Vial Carton

NDC 33332–110–10

Influenza Virus
Vaccine
Afluria®

2010 – 2011 Formula

No Latex
For use in persons 6 months
and older

5 mL Multi-dose Vial

Rx only

CSL Biotherapies

Principal Display Panel - 10 Pre-Filled Syringe Carton

NDC 33332–010–01

Influenza Virus Vaccine
Afluria®

2010 – 2011 Formula

No Preservative
No Latex

For use in persons 36 months and older

Rx only

10 Pre-Filled Syringes
each containing a single 0.5 mL dose

Store between 2 – 8°C (36 – 46°F).
Refrigerate. Do not freeze.
Protect from light. SHAKE WELL.

No Preservative

CSL Biotherapies

Afluria 
influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated), influenza b virus b/brisbane/60/2008 antigen (propiolactone inactivated), and influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:33332-110
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
THIMEROSAL 24.5 ug  in 0.5 mL
SODIUM CHLORIDE 4.1 mg  in 0.5 mL
SODIUM PHOSPHATE, MONOBASIC 80 ug  in 0.5 mL
SODIUM PHOSPHATE, DIBASIC 300 ug  in 0.5 mL
POTASSIUM PHOSPHATE, MONOBASIC 20 ug  in 0.5 mL
POTASSIUM CHLORIDE 20 ug  in 0.5 mL
CALCIUM CHLORIDE 1.5 ug  in 0.5 mL
SODIUM TAURODEOXYCHOLATE  
OVALBUMIN  
NEOMYCIN SULFATE  
POLYMYXIN B  
PROPIOLACTONE  
Packaging
# Item Code Package Description
1 NDC:33332-110-10 1 VIAL, MULTI-DOSE (VIAL) in 1 CARTON
1 5 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125254 07/30/2010 06/30/2011
Afluria 
influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated), influenza b virus b/brisbane/60/2008 antigen (propiolactone inactivated), and influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:33332-010
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 2.05 mg  in 0.25 mL
SODIUM PHOSPHATE, MONOBASIC 40 ug  in 0.25 mL
SODIUM PHOSPHATE, DIBASIC 150 ug  in 0.25 mL
POTASSIUM PHOSPHATE, MONOBASIC 10 ug  in 0.25 mL
POTASSIUM CHLORIDE 10 ug  in 0.25 mL
CALCIUM CHLORIDE 0.75 ug  in 0.25 mL
SODIUM TAURODEOXYCHOLATE  
OVALBUMIN  
NEOMYCIN SULFATE  
POLYMYXIN B  
PROPIOLACTONE  
Packaging
# Item Code Package Description
1 NDC:33332-010-01 10 SYRINGE, GLASS (SYRINGE) in 1 CARTON
1 0.50 mL in 1 SYRINGE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125254 07/30/2010 06/30/2011
Labeler - CSL Limited (753243823)
Establishment
Name Address ID/FEI Operations
CSL Behring GmbH 326530474 MANUFACTURE
Establishment
Name Address ID/FEI Operations
CSL Limited 753243823 MANUFACTURE
Establishment
Name Address ID/FEI Operations
CSL Behring LLC 931896963 MANUFACTURE
Revised: 08/2010   CSL Limited
  • Cold, Flu, Allergy Treatments
  • Flu (Influenza)
  • Vaccination and Immunization Safety Information

For Healthcare Professionals

Applies to influenza virus vaccine, inactivated: intradermal suspension, intramuscular solution, intramuscular suspension, nasal spray

General

The most common adverse events were local reactions, myalgia, and headache.[Ref]

Local

Very common (10% or more): Tenderness (89%), erythema/redness (76.4%), pain (73.8%), induration (58.4%), swelling (56.8%), injection-site pruritus (46.9%), itching (28%), bruising (18%), injection-site ecchymosis (14.9%), mass (11%)
Common (1% to 10%): Reaction, hemorrhage
Postmarketing reports: Cellulitis, injection site inflammation, injection site sterile abscess[Ref]

Other

Very common (10% or more): Crying abnormal (41.2%), malaise (38%), fever (16%)
Common (1% to 10%): Chest tightness
Rare (less than 0.1%): Death
Postmarketing reports: Hot flashes/flushes[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (40%)
Common (1% to 10%): Chills/shivering, back pain
Postmarketing reports: Muscle weakness, arthritis, arthralgia, myasthenia[Ref]

Nervous system

Very common (10% or more): Headache (40%), drowsiness (37.7%), lethargy (14%)
Common (1% to 10%): Migraine
Postmarketing reports: Neuralgia, paresthesia, convulsions (including febrile seizures), encephalopathy, neuritis or neuropathy, transverse myelitis, Guillain-Barre syndrome, abnormal gait, dizziness, hypoesthesia, hypokinesia, tremor, somnolence, syncope, facial or cranial nerve paralysis, encephalopathy, limb paralysis, confusion, paralysis (including Bell's Palsy), vertigo, exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome), meningitis, eosinophilic meningitis, vaccine-associated encephalitis[Ref]

Respiratory

Very common (10% or more): Runny nose/nasal congestion (58%), cough (15%), upper respiratory tract infection (13%)
Common (1% to 10%): Sore throat, cough, oropharyngeal pain, rhinorrhea, wheezing, pharyngolaryngeal pain, nasopharyngitis
Postmarketing reports: Rhinitis, laryngitis, dyspnea, dysphonia, bronchospasm, throat tightness, pharyngitis, epistaxis[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (15%), nausea (14.9%) diarrhea (13%)
Postmarketing reports: Dysphagia, abdominal pain, swelling of the mouth, throat, and/or tongue[Ref]

Metabolic

Very common (10% or more): Loss of appetite (33.3%), decreased appetite (21%)[Ref]

Psychiatric

Very common (10% or more): Irritability (54%)
Postmarketing reports: Insomnia[Ref]

Hypersensitivity

Postmarketing reports: Allergic reactions including anaphylactic shock, serum sickness, and death; Stevens-Johnson syndrome[Ref]

Immunologic

Common (1% to 10%): Infection, influenza-like illness
Postmarketing reports: Cellulitis[Ref]

Dermatologic

Common (1% to 10%): Facial swelling
Postmarketing reports: Pruritus, urticaria, rash, angioedema, sweating, flushing, pallor, rash, erythema multiforme[Ref]

Ocular

Common (1% to 10%): Reddened eyes
Postmarketing reports: Eye pain, photophobia, conjunctivitis, eye irritation, eye swelling, eyelid swelling, ocular hyperemia[Ref]

Hematologic

Postmarketing reports: Transient thrombocytopenia, lymphadenopathy[Ref]

Cardiovascular

Frequency not reported: Pleuropericarditis with effusions
Postmarketing reports: Tachycardia, pericarditis, vasculitis, vasodilation/flushing[Ref]

Renal

Postmarketing reports: Vasculitis with transient renal involvement[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea[Ref]

Some side effects of Afluria may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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