May 29, 2017
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Included as part of the PRECAUTIONS section.


Guillain-Barre Syndrome

The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barre syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.1 If GBS has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone should be based on careful consideration of the potential benefits and risks.

Preventing And Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Altered Immunocompetence

If Fluzone is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.

Limitations Of Vaccine Effectiveness

Vaccination with Fluzone may not protect all recipients.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION).

  • Inform the patient or guardian that Fluzone contains killed viruses and cannot cause influenza.
  • Fluzone stimulates the immune system to produce antibodies that help protect against influenza, but does not prevent other respiratory infections.
  • Annual influenza vaccination is recommended.
  • Instruct vaccine recipients and guardians to report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Fluzone has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.

Use In Specific Populations


Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone. It is also not known whether Fluzone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Fluzone is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Fluzone in children below the age of 6 months have not been established. Safety and immunogenicity of Fluzone were evaluated in children 6 months through 8 years of age. [See ADVERSE REACTIONS and Clinical Studies] Efficacy of Fluzone was evaluated in children 6 through 24 months of age. [See Clinical Studies]

Geriatric Use

Safety and immunogenicity of Fluzone were evaluated in adults 65 years of age and older. [See ADVERSE REACTIONS and Clinical Studies] Antibody responses to Fluzone are lower in persons ≥ 65 years of age than in younger adults.


1 Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barre syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998;339:1797-802.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/3/2015


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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