Arexvy: side effects, ingredients & package insert

Arexvy 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.

Arexvy side effects: where the data is

Reported reactions for Arexvy and the other RSV products are compiled on the RSV 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

Arexvy lot number lookup

Arexvy vs Abrysvo

All licensed RSV 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 RSV vaccine page.

Schedule and age range

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

Common questions about Arexvy

What are the side effects of Arexvy?

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

What is in Arexvy?

Arexvy contains Recombinant RSV prefusion F glycoprotein (RSVPreF3) as antigen; adjuvant: AS01E; it is preservative-free. Excipients: Trehalose, Sodium chloride, Potassium dihydrogen phosphate, Dipotassium phosphate, Polysorbate 80, Disodium phosphate anhydrous. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Arexvy package insert?

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

How does Arexvy compare with Abrysvo?

Arexvy (GlaxoSmithKline Biologicals) uses a recombinant protein platform with adjuvant AS01E, given intramuscular; Abrysvo (Pfizer Inc.) uses recombinant protein with adjuvant none. Both are licensed RSV vaccines; the comparison table above lists every product.