Overall, 94% of subjects who received GARDASIL judged their
injection-site adverse experience to be mild or moderate
in intensity. In addition, common postmarketing reports include
vomiting and syncope.
GARDASIL is not recommended for use in pregnant women;
GARDASIL is designated Pregnancy Category B
GARDASIL is a vaccine indicated in girls and women 9 to 26 years of age for the
prevention of cervical cancer, precancerous or dysplastic lesions, and genital
warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18.
Select Safety Information
GARDASIL is contraindicated in individuals who are hypersensitive to the active
substances or to any of the excipients of the vaccine.
GARDASIL does not substitute for routine cervical cancer screening, and women
who receive GARDASIL should continue to undergo screening per standard of care.
GARDASIL is not recommended for use in pregnant women.
Vaccination with GARDASIL may not result in protection in all vaccine recipients.
GARDASIL is not intended to be used for treatment of active genital warts,
cervical cancer, cervical intraepithelial neoplasia, vulvar intraepithelial
neoplasia, or vaginal intraepithelial neoplasia.
GARDASIL has not been shown to protect against diseases due to non-vaccine
HPV types.
The vaccine-related adverse experiences that were observed among recipients
of GARDASIL at a frequency of at least 1.0% and greater than placebo were pain,
swelling, erythema, fever, nausea, pruritus, and dizziness. In addition, common
postmarketing reports include vomiting and syncope.
GARDASIL should be administered in 3 separate intramuscular injections in
the deltoid region of the upper arm or in the higher anterolateral area of
the thigh over a 6-month period with the first dose at an elected date, the
second dose 2 months after the first dose, and the third dose 6 months after
the first dose.
Before administering GARDASIL, please read the Prescribing
Information and Patient
Product Information.
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AEs=adverse experiences. |
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Study
Design: Four placebo-controlled clinical studies evaluated the
safety of GARDASIL using vaccination report card (VRC)–aided surveillance
for 14 days after each injection of GARDASIL (n=5,088) or placebo (n=3,790). |
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