Fluzone (Influenza Vaccine, trivalent): side effects, ingredients & package insert

Fluzone (Influenza Vaccine, trivalent) ingredients (FDA package insert, Section 11)

Per-dose composition as stated in the prescribing information; verified 2026-10-28. Click an ingredient for every vaccine that contains it.

Note: Trivalent egg-based split-virus vaccine; the US standard-dose Sanofi product that replaced Fluzone Quadrivalent from the 2024-2025 season. Antibiotics are not used in manufacture (no neomycin). No presentation is made with natural rubber latex. Sucrose is used in a density-gradient purification step but is not listed as an ingredient in Table 9. Check vial type: preservative status differs between prefilled syringe and multiple-dose vial.

Source: FDA package insert. Formulations change — re-verify before clinical use.

Fluzone (Influenza Vaccine, trivalent) side effects: where the data is

Reported reactions for Fluzone (Influenza Vaccine, trivalent) and the other influenza (flu) products are compiled on the influenza (flu) vaccine page: pre-licensure trial reactogenicity, VAERS report counts, and international databases (Canada Vigilance, EudraVigilance, Lareb, VigiAccess). Those counts are spontaneous reports with no denominator — a report does not establish that the vaccine caused the event.

• Pre-licensure clinical trial data
• Post-licensure surveillance (VAERS and international)
• Documented adverse events and causality assessment
• Vaccine Injury Table (VICP) — compensable injuries

Fluzone (Influenza Vaccine, trivalent) lot number lookup

Fluzone (Influenza Vaccine, trivalent) vs Fluzone Quadrivalent

All licensed influenza (flu) vaccine products side by side. Differences in platform, adjuvant and route are the usual reasons one is chosen over another; efficacy and safety comparisons belong to the trial and surveillance sections of the influenza (flu) vaccine page.

Schedule and age range

Licensed ages and the recommended series for influenza (flu) vaccines are on the influenza (flu) vaccine page; how 31 countries schedule it is on influenza (flu) schedule by country. Always confirm the product-specific age range in the current package insert.

Common questions about Fluzone (Influenza Vaccine, trivalent)

What are the side effects of Fluzone (Influenza Vaccine, trivalent)?

Common reactions listed in the Fluzone (Influenza Vaccine, trivalent) package insert are injection-site pain, redness or swelling and short-lived systemic symptoms such as fever, tiredness or irritability. Rarer events and the reported counts from VAERS and international databases are on the influenza (flu) vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in Fluzone (Influenza Vaccine, trivalent)?

Fluzone (Influenza Vaccine, trivalent) contains Influenza A (H1N1) hemagglutinin - A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus); Influenza A (H3N2) hemagglutinin - A/Michigan/105/2025 SAN-049A (A/Darwin/1454/2025-like virus); Influenza B (Victoria lineage) hemagglutinin - B/Tokyo/EIS13-175/2025 as antigen; adjuvant: none; it is Thimerosal. Excipients: Egg protein (residual from embryonated chicken egg propagation), Formaldehyde, Octylphenol ethoxylate (Triton X-100), Sodium phosphate-buffered isotonic sodium chloride solution. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-10-28).

Where is the Fluzone (Influenza Vaccine, trivalent) package insert?

The FDA-licensed prescribing information for Fluzone (Influenza Vaccine, trivalent) is published by Sanofi Vaccines US Inc. and the FDA; the source used for this page is https://www.fda.gov/media/170019/download. Formulations change, so re-verify the current insert before clinical use.

How does Fluzone (Influenza Vaccine, trivalent) compare with Fluzone Quadrivalent?

Fluzone (Influenza Vaccine, trivalent) (Sanofi Vaccines US Inc.) uses a inactivated platform with adjuvant none, given intramuscular; Fluzone Quadrivalent (Sanofi Pasteur) uses inactivated with adjuvant none. Both are licensed influenza (flu) vaccines; the comparison table above lists every product.