Recombivax HB: side effects, ingredients & package insert

Recombivax HB 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.

Note: Aluminum salt is AAHS (chemically distinct from aluminum hydroxide used in Engerix-B).

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

Recombivax HB side effects: where the data is

Reported reactions for Recombivax HB and the other hepatitis B products are compiled on the hepatitis B 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

Recombivax HB lot number lookup

Recombivax HB vs Engerix-B vs Heplisav-B

All licensed hepatitis B 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 hepatitis B vaccine page.

Schedule and age range

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

Common questions about Recombivax HB

What are the side effects of Recombivax HB?

Common reactions listed in the Recombivax HB 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 hepatitis B vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in Recombivax HB?

Recombivax HB contains Hepatitis B surface antigen (HBsAg) as antigen; adjuvant: Amorphous aluminum hydroxyphosphate sulfate (AAHS); it is preservative-free. Excipients: Formaldehyde, Yeast protein. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Recombivax HB package insert?

The FDA-licensed prescribing information for Recombivax HB is published by Merck Sharp & Dohme LLC and the FDA; the source used for this page is https://www.fda.gov/vaccines-blood-biologics/vaccines/recombivax-hb. Formulations change, so re-verify the current insert before clinical use.

How does Recombivax HB compare with Engerix-B?

Recombivax HB (Merck Sharp & Dohme LLC) uses a recombinant protein platform with adjuvant Amorphous aluminum hydroxyphosphate sulfate (AAHS), given intramuscular; Engerix-B (GlaxoSmithKline Biologicals) uses recombinant protein with adjuvant Aluminum hydroxide. Both are licensed hepatitis B vaccines; the comparison table above lists every product.