Engerix-B: side effects, ingredients & package insert

Engerix-B 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: DailyMed. Formulations change — re-verify before clinical use.

Engerix-B side effects: where the data is

Reported reactions for Engerix-B 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

Engerix-B lot number lookup

Engerix-B vs Recombivax HB 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 Engerix-B

What are the side effects of Engerix-B?

Common reactions listed in the Engerix-B 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 Engerix-B?

Engerix-B contains Hepatitis B surface antigen (HBsAg) as antigen; adjuvant: Aluminum hydroxide; it is preservative-free. Excipients: Sodium chloride, Disodium phosphate dihydrate, Sodium dihydrogen phosphate dihydrate, 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 Engerix-B package insert?

The FDA-licensed prescribing information for Engerix-B is published by GlaxoSmithKline Biologicals and the FDA; the source used for this page is https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4d930f24-4ddb-488d-9e79-3f495972733b. Formulations change, so re-verify the current insert before clinical use.

How does Engerix-B compare with Recombivax HB?

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