Gardasil 9: side effects, ingredients & package insert

Gardasil 9 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.

Gardasil 9 side effects: where the data is

Reported reactions for Gardasil 9 and the other HPV products are compiled on the HPV 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

Gardasil 9 lot number lookup

Schedule and age range

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

Common questions about Gardasil 9

What are the side effects of Gardasil 9?

Common reactions listed in the Gardasil 9 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 HPV vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in Gardasil 9?

Gardasil 9 contains HPV Type 6 L1 protein; HPV Type 11 L1 protein; HPV Type 16 L1 protein; HPV Type 18 L1 protein; HPV Type 31 L1 protein; HPV Type 33 L1 protein; HPV Type 45 L1 protein; HPV Type 52 L1 protein; HPV Type 58 L1 protein as antigen; adjuvant: Amorphous aluminum hydroxyphosphate sulfate (AAHS); it is preservative-free. Excipients: Sodium chloride, L-histidine, Polysorbate 80, Sodium borate, Yeast protein, 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 Gardasil 9 package insert?

The FDA-licensed prescribing information for Gardasil 9 is published by Merck Sharp & Dohme LLC and the FDA; the source used for this page is https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9. Formulations change, so re-verify the current insert before clinical use.