Licensed vaccine product
Havrix: side effects, ingredients & package insert
GlaxoSmithKline Biologicals · hepatitis A vaccine · inactivated · intramuscular · 0.5 mL pediatric / 1 mL adult
Havrix 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.
| Role | Ingredient | Amount per dose |
|---|---|---|
| Antigen | Hepatitis A virus, inactivated | 720 EL.U. pediatric / 1440 EL.U. adult |
| Adjuvant | Aluminum hydroxide | |
| Preservative | None (preservative-free) | Single-dose presentation; label states no preservative. |
| stabilizer | Amino acid supplement | label quantity |
| buffer | Phosphate-buffered saline components | label quantity |
| surfactant | Polysorbate 20 | label quantity |
| inactivating_agent_residual | Formaldehyde | ≤0.1 mg residual |
| antibiotic_residual | Neomycin sulfate | ≤40 ng residual |
Source: FDA package insert. Formulations change — re-verify before clinical use.
Havrix side effects: where the data is
Reported reactions for Havrix and the other hepatitis A products are compiled on the hepatitis A 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.
Havrix lot number lookup
VAERS report counts are available by lot for Hepatitis A vaccines. Use the hepatitis A lot number lookup or search any lot directly in the lot explorer. Lot numbers are printed on the vaccination record card and the vial label.
Havrix vs Vaqta
All licensed hepatitis A 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 A vaccine page.
| Product | Manufacturer | Platform | Adjuvant | Route | |
|---|---|---|---|---|---|
| Havrix | GlaxoSmithKline Biologicals | inactivated | Aluminum hydroxide | intramuscular | |
| Vaqta | Merck Sharp & Dohme LLC | inactivated | Amorphous aluminum hydroxyphosphate sulfate | intramuscular | page |
Schedule and age range
Licensed ages and the recommended series for hepatitis A vaccines are on the hepatitis A vaccine page; how 31 countries schedule it is on hepatitis A schedule by country. Always confirm the product-specific age range in the current package insert.
Common questions about Havrix
What are the side effects of Havrix?
Common reactions listed in the Havrix 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 A vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.
What is in Havrix?
Havrix contains Hepatitis A virus, inactivated as antigen; adjuvant: Aluminum hydroxide; it is preservative-free. Excipients: Amino acid supplement, Phosphate-buffered saline components, Polysorbate 20, Formaldehyde, Neomycin sulfate. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).
Where is the Havrix package insert?
The FDA-licensed prescribing information for Havrix is published by GlaxoSmithKline Biologicals and the FDA; the source used for this page is https://www.fda.gov/vaccines-blood-biologics/vaccines/havrix. Formulations change, so re-verify the current insert before clinical use.
How does Havrix compare with Vaqta?
Havrix (GlaxoSmithKline Biologicals) uses a inactivated platform with adjuvant Aluminum hydroxide, given intramuscular; Vaqta (Merck Sharp & Dohme LLC) uses inactivated with adjuvant Amorphous aluminum hydroxyphosphate sulfate. Both are licensed hepatitis A vaccines; the comparison table above lists every product.
Reviewed 2026-10-08 · Matthew Thomas J Halma, Founder, Open Source Medicine Foundation. Informational, not medical advice.