Fluzone Highdose

Last updated on RxList: 12/9/2020
Fluzone Highdose Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Fluzone High-Dose?

Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2016-2017 Formula 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, approved for use in persons 65 years of age and older.

What Are Side Effects of Fluzone High-Dose?

Common side effects of Fluzone High-Dose include:

Dosage for Fluzone High-Dose

The dose of Fluzone High-Dose is a single 0.5 mL dose for intramuscular injection in adults 65 years of age and older.

What Drugs, Substances, or Supplements Interact with Fluzone High-Dose?

Fluzone High-Dose may interact with other drugs or vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Fluzone High-Dose During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before receiving Fluzone High-Dose; it is unknown if it would affect a fetus. It is unknown if Fluzone High-Dose passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2016-2017 Formula 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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Fluzone Highdose 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 Fluzone Highdose (Flu Vaccine)


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Fluzone Highdose Professional Information


Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice. One clinical study has evaluated the safety of Fluzone High-Dose Quadrivalent.

Study 1 (NCT03282240, see https://clinicaltrials.gov) was a randomized, active-controlled, modified double-blind pre-licensure trial conducted in the U.S. The study compared the safety and immunogenicity of Fluzone High-Dose Quadrivalent to those of Fluzone High- Dose (trivalent formulation). The safety analysis set included 1777 Fluzone High-Dose Quadrivalent recipients, 443 Fluzone High-Dose recipients, and 450 investigational Fluzone High-Dose containing the alternate B influenza strain recipients.

The most common reactions occurring after Fluzone High-Dose Quadrivalent administration were injection-site pain (41.3%), myalgia (22.7%), headache (14.4%), and malaise (13.2%). Onset usually occurred within the first 3 days after vaccination. The majority of solicited reactions resolved within three days of vaccination.

Table 1 displays solicited adverse reactions for Fluzone High-Dose Quadrivalent compared to Fluzone High-Dose reported within 7 days after vaccination and collected using standardized diary cards.

Table 1: Study 1*: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events within 7 Days after Vaccination with Fluzone High-Dose Quadrivalent or Fluzone High-Dose, Adults 65 Years of Age and Older

Fluzone High-Dose Quadrivalent
(N =1761-1768)
Fluzone High-Dose
(N =885-889)
AnyGrade 3AnyGrade 3
Local Reactions
Injection Site Pain§41.30.736.40.2
Injection Site Erythema6.
Injection Site Swelling4.
Injection Site Induration3.
Injection Site Bruising1.
Systemic Reactions
* NCT03282240
N is the number of vaccinated participants with available data for the events listed
Safety results for the Fluzone High-Dose and investigational Fluzone High-Dose containing the alternate B influenza strain recipients were pooled for the analysis.
§ Grade 3: A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Grade 3: > 100 mm
# Grade 3: ≥ 102.1°F (39.0°C)

Based on data from Fluzone High-Dose, solicited injection site reactions and systemic adverse reactions were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.

Unsolicited non-serious adverse events were reported in 279 (15.7%) recipients in the Fluzone High-Dose Quadrivalent group and 140 (15.7%) recipients in the Fluzone High-Dose group. The most commonly reported unsolicited adverse event was cough.

Within 180 days post-vaccination, 80 (4.5%) Fluzone High-Dose Quadrivalent recipients and 48 (5.4%) Fluzone High-Dose recipients experienced a serious adverse event (SAE). None of the SAEs were assessed as related to the study vaccines.

Postmarketing Experience

The following additional adverse events have been spontaneously reported during the postmarketing use of Fluzone High-Dose, Fluzone, or Fluzone Quadrivalent and may occur in people receiving Fluzone High-Dose Quadrivalent. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone High-Dose, Fluzone, or Fluzone Quadrivalent.

  • Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
  • Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema) Eye Disorders: Ocular hyperemia
  • Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
  • Vascular Disorders: Vasculitis, vasodilatation
  • Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, cough, wheezing, throat tightness, oropharyngeal pain, and rhinorrhea
  • Gastrointestinal Disorders: Vomiting
  • Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
  • General Disorders and Administration Site Conditions: pruritus, asthenia/fatigue, chest pain, chills

Read the entire FDA prescribing information for Fluzone Highdose (Flu Vaccine)

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

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