Rotarix: side effects, ingredients & package insert

Rotarix 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.

Rotarix side effects: where the data is

Reported reactions for Rotarix and the other rotavirus products are compiled on the rotavirus 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

Rotarix lot number lookup

Rotarix vs RotaTeq

All licensed rotavirus 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 rotavirus vaccine page.

Schedule and age range

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

Common questions about Rotarix

What are the side effects of Rotarix?

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

What is in Rotarix?

Rotarix contains Live attenuated human rotavirus RIX4414 (G1P[8]) as antigen; adjuvant: none; it is preservative-free. Excipients: Sucrose, Dulbecco's Modified Eagle Medium components, Amino acids / salts. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Rotarix package insert?

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

How does Rotarix compare with RotaTeq?

Rotarix (GlaxoSmithKline Biologicals) uses a live attenuated platform with adjuvant none, given oral; RotaTeq (Merck Sharp & Dohme LLC) uses live attenuated with adjuvant none. Both are licensed rotavirus vaccines; the comparison table above lists every product.