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Information About GARDASIL 9 and GARDASIL

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in females, anal cancer, certain head and neck cancers, such as throat and back of mouth cancers and genital warts in both males and females.

GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] helps protect individuals ages 9 to 26 against the following diseases caused by 4 types of HPV: cervical, vaginal, and vulvar cancers in females, anal cancer and genital warts in both males and females.

GARDASIL 9 and GARDASIL may not fully protect everyone, nor will they protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL 9 and GARDASIL do not prevent all types of cervical, vulvar, vaginal, or anal cancers. GARDASIL 9 does not prevent all types of head and neck cancers. Vaccination does not remove the need for recommended screenings for these cancers, and it’s important for girls to get routine cervical cancer screenings later in life and for women to continue routine cervical cancer screenings. GARDASIL 9 and GARDASIL do not treat cancer or genital warts.

GARDASIL 9 is a shot that is usually given in the arm muscle. GARDASIL 9 may be given as 2 or 3 shots.

  • For persons 9 through 14 years of age, GARDASIL 9 can be given using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second shot should be given 6–12 months after the first shot. If the second shot is given less than 5 months after the first shot, a third shot should be given at least 4 months after the second shot. For the 3-dose schedule, the second shot should be given 2 months after the first shot and the third shot should be given 6 months after the first shot.
  • For persons 15 through 45 years of age, GARDASIL 9 is given using a 3-dose schedule; the second shot should be given 2 months after the first shot and the third shot should be given 6 months after the first shot.

The appropriate dosing schedule will be determined by your child’s or your health care professional.

GARDASIL was a shot that was usually given in the arm muscle. GARDASIL was given as 3 shots over 6 months.

Important Safety Information for GARDASIL 9 and GARDASIL

Anyone who is allergic to the ingredients of GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant],c including those severely allergic to yeast, should not receive the vaccine. GARDASIL 9 was not studied in women who knew they were pregnant. GARDASIL is not recommended for pregnant women.

The side effects for GARDASIL 9 include pain, swelling, redness, itching, bruising, bleeding, and a lump where you got the shot; headache; fever; nausea; and dizziness.

The side effects for GARDASIL include pain, swelling, itching, bruising, and redness where you got the shot; headache; fever; nausea; dizziness; vomiting; and fainting.

Fainting can happen after getting GARDASIL 9 and GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask your child or you to sit or lie down for 15 minutes after your child or you get GARDASIL 9 or GARDASIL. Some people who faint might shake or become stiff.

Only a doctor or health care professional can decide if GARDASIL 9 is right for your child or you.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the Patient Information for GARDASIL 9, and discuss it with your doctor. The physician Prescribing Information also is available.

Please also read the Patient Information for GARDASIL, and discuss it with your doctor. The physician Prescribing Information also is available.

cGARDASIL is no longer marketed in the United States.