ActHIB: side effects, ingredients & package insert

ActHIB 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: Unadjuvanted conjugate (unlike PedvaxHIB).

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

ActHIB side effects: where the data is

Reported reactions for ActHIB and the other Hib products are compiled on the Hib 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

ActHIB lot number lookup

ActHIB vs PedvaxHIB vs Hiberix

All licensed Hib 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 Hib vaccine page.

Schedule and age range

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

Common questions about ActHIB

What are the side effects of ActHIB?

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

What is in ActHIB?

ActHIB contains Haemophilus b capsular polysaccharide (PRP) conjugated to tetanus toxoid (PRP-T) as antigen; adjuvant: none; it is preservative-free. Excipients: Sucrose, Tris (trometamol), Sodium chloride diluent. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the ActHIB package insert?

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

How does ActHIB compare with PedvaxHIB?

ActHIB (Sanofi Pasteur) uses a conjugate platform with adjuvant none, given intramuscular; PedvaxHIB (Merck Sharp & Dohme LLC) uses conjugate with adjuvant Amorphous aluminum hydroxyphosphate sulfate. Both are licensed Hib vaccines; the comparison table above lists every product.