Fluzone is a vaccine given to prevent the flu. It is recommended to get vaccinated as soon as the flu vaccine becomes available.

Fluzone Overview

Reviewed: August 29, 2015

Fluzone is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.

This medication comes as a shot and is injected into the muscle each year. 

Common side effects of Fluzone vaccine include soreness, pain, and swelling at the injection site.

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Fluzone Cautionary Labels


Uses of Fluzone

Fluzone is a vaccine that helps protect against influenza illness (flu).

Fluzone vaccine is for people who are 6 months of age and older. Vaccination with Fluzone vaccine may not protect all people who receive the vaccine.

This vaccine may be prescribed for other uses. Ask your doctor or pharmacist for more information.


Side Effects of Fluzone

Serious side effects have been reported with Fluzone. See the “Fluzone Precautions” section.

The most common side effects of Fluzone vaccine are:

  • pain
  • redness 
  • swelling
  • bruising
  • hardness where you got the shot
  • muscle aches
  • tiredness
  • headache
  • fever

These are not all of the possible side effects of Fluzone vaccine.

You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals.

Call your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967.

Fluzone Interactions

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Fluzone Precautions

Serious side effects have been reported with Fluzone, including the following:

  • Guillain-Barré Syndrome (GBS). Tell your healthcare provider immediately if you have a history of GBS or any neurologic disorder including seizures. If Guillain-Barré syndrome has occurred within 6 weeks of receiving an influenza vaccine in the past, your doctor will determine if you should receive Fluzone. Some people with a history of GBS should not get this vaccine. This should be discussed with your doctor.

Do not receive Fluzone vaccine if you:

  • ever had a severe allergic reaction to eggs or egg products.
  • ever had a severe allergic reaction after getting any flu vaccine
  • are younger than 6 months of age.

Fluzone Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fluzone, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before taking Fluzone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • have any severe, life-threatening allergies. If you ever had a life-threatening allergic reaction after a dose of flu vaccine, or have a severe allergy to any part of this vaccine, including (for example) an allergy to gelatin, antibiotics, or eggs, you may be advised not to get vaccinated. Most, but not all, types of flu vaccine contain a small amount of egg protein.
  • ever had Guillain-Barre Syndrome (a severe paralyzing illness, also called GBS)
  • problems with your immune system as the immune response may be diminished.
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you 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. You should come back when you are better.


Fluzone and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fluzone falls into category C. No studies have been done in animals. 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.

Fluzone and Lactation

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

Fluzone Usage

This medication is available in an injectable form to be given directly into the muscle (IM) by a healthcare professional.

In infants 6 months through 11 months of age, the vaccine will be injected into the thigh.

In persons ≥12 months through 35 months of age, the vaccine will be injected into the thigh or into the deltoid muscle if muscle mass is adequate. 

In persons ≥36 months of age, the vaccine will be injected into the deltoid muscle.

Fluzone Dosage

The recommened dose for Fluzone is:

  • 6 months through 8 years: One or two doses of Fluzone. If 2 doses are required, they will be given at least 1 month apart. (1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines)
  • 9 years and older: One dose of Fluzone

Fluzone Overdose

Fluzone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.