Daptacel: side effects, ingredients & package insert

Daptacel 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.

Daptacel side effects: where the data is

Reported reactions for Daptacel and the other DTaP/Tdap products are compiled on the DTaP/Tdap 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

Daptacel lot number lookup

Daptacel vs Infanrix

All licensed DTaP/Tdap 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 DTaP/Tdap vaccine page.

Schedule and age range

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

Common questions about Daptacel

What are the side effects of Daptacel?

Common reactions listed in the Daptacel 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 DTaP/Tdap vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in Daptacel?

Daptacel contains Diphtheria toxoid; Tetanus toxoid; Pertussis toxin (detoxified); Filamentous hemagglutinin (FHA); Pertactin (PRN); Fimbriae types 2 and 3 (FIM) as antigen; adjuvant: Aluminum phosphate; it is preservative-free. Excipients: 2-Phenoxyethanol, Formaldehyde, Glutaraldehyde, Water for injection. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the Daptacel package insert?

The FDA-licensed prescribing information for Daptacel is published by Sanofi Pasteur and the FDA; the source used for this page is https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=06f34d0f-4e72-41d3-967f-8abf3f2005c1. Formulations change, so re-verify the current insert before clinical use.

How does Daptacel compare with Infanrix?

Daptacel (Sanofi Pasteur) uses a combination platform with adjuvant Aluminum phosphate, given intramuscular; Infanrix (GlaxoSmithKline Biologicals) uses combination with adjuvant Aluminum hydroxide. Both are licensed DTaP/Tdap vaccines; the comparison table above lists every product.