Ixiaro: side effects, ingredients & package insert

Ixiaro ingredients (FDA package insert, Section 11)

Per-dose composition as stated in the prescribing information; verified 2026-07-09. Click an ingredient for every vaccine that contains it.

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

Ixiaro side effects: where the data is

Reported reactions for Ixiaro and the other Japanese encephalitis products are compiled on the Japanese encephalitis 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

Ixiaro lot number lookup

Schedule and age range

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

Common questions about Ixiaro

What are the side effects of Ixiaro?

Common reactions listed in the Ixiaro 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 Japanese encephalitis vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in Ixiaro?

Ixiaro contains Japanese encephalitis virus proteins, purified inactivated as antigen; adjuvant: Aluminum hydroxide; it is preservative-free. Excipients: Phosphate-buffered saline, Formaldehyde, Bovine serum albumin, Host cell DNA, Sodium metabisulphite, Protamine sulfate. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Ixiaro package insert?

The FDA-licensed prescribing information for Ixiaro is published by Valneva Austria GmbH and the FDA; the source used for this page is https://www.fda.gov/vaccines-blood-biologics/vaccines/ixiaro. Formulations change, so re-verify the current insert before clinical use.