Heplisav-B: side effects, ingredients & package insert

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

Heplisav-B side effects: where the data is

Reported reactions for Heplisav-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

Heplisav-B lot number lookup

Heplisav-B vs Engerix-B vs Recombivax HB

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 Heplisav-B

What are the side effects of Heplisav-B?

Common reactions listed in the Heplisav-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 Heplisav-B?

Heplisav-B contains Hepatitis B surface antigen (HBsAg) as antigen; adjuvant: CpG 1018; it is preservative-free. Excipients: Sodium chloride, Sodium phosphate, dibasic dodecahydrate, Sodium phosphate, monobasic dihydrate, Polysorbate 80, Yeast protein, Yeast DNA, Deoxycholate. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Heplisav-B package insert?

The FDA-licensed prescribing information for Heplisav-B is published by Dynavax Technologies and the FDA; the source used for this page is https://www.fda.gov/media/108745/download. Formulations change, so re-verify the current insert before clinical use.

How does Heplisav-B compare with Engerix-B?

Heplisav-B (Dynavax Technologies) uses a recombinant protein platform with adjuvant CpG 1018, 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.