Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine
*GARDASIL® is not indicated for the treatment of genital warts or to address the consequences of genital warts.
Genital warts are usually flesh-coloured growths that are caused by certain types of HPV. The types of HPV that can cause genital warts (HPV types 6 and 11) are different from the types that can cause cervical cancer. Even after seeing pictures of genital warts, you may not be able to recognize them. That’s because genital warts don’t always look the same. They can be raised or flat, small or large, and alone or in clusters. Not to mention, some warts can grow inside, such as in a woman's vagina, or on the cervix, or the anus, rectum or urethra in both men and women, making them hard to see.
In girls and women ages 9 to 45, GARDASIL® helps prevent infection caused by HPV types 6, 11, 16 and 18 and the following diseases associated with the HPV types included in the vaccine: cervical, vaginal, and vulvar cancers caused by HPV types 16 and 18; abnormal and precancerous vaginal and vulvar lesions, abnormal and precancerous cervical lesions as found in Pap tests, caused by types 6, 11, 16 and 18; and genital warts caused by types 6 and 11.
In girls and women ages 9 to 26, GARDASIL® also helps protect against anal cancer caused by HPV types 16 and 18, and abnormal and precancerous anal lesions caused by types 6, 11, 16 and 18.
In boys and men ages 9 to 26, GARDASIL® helps protect against infection caused by HPV types 6, 11, 16 and 18 and the following diseases associated with the HPV types included in the vaccine: anal cancer caused by HPV types 16 and 18, genital warts caused by types 6 and 11, and abnormal and precancerous anal lesions caused by types 6, 11, 16 and 18.
GARDASIL® helps prevent these diseases, but it does not treat them. And just like all vaccines, GARDASIL® may not fully protect everyone who gets it. GARDASIL® does not protect against all types of HPV. Duration of protection continues to be studied. GARDASIL® does not protect against other sexually transmitted infections.
Even if vaccinated with GARDASIL®, it is still important for women to continue having regular Pap tests. Recipients of GARDASIL® should not discontinue anal cancer screening if it has been recommended by a healthcare provider. Vaccination with GARDASIL® is not recommended during pregnancy.
Like all vaccines, GARDASIL® may cause some side effects. GARDASIL® has been shown to be generally well tolerated in adults and children as young as age 9. The most commonly reported side effects included pain, swelling, itching, bruising and redness where the shot was given, fever, nausea, dizziness, headache, vomiting and pain in extremity.
Fainting has been reported. Fainting can occur after vaccination, most commonly among adolescents and young adults. Although fainting episodes are uncommon, vaccinees should be observed for 15 minutes after they receive GARDASIL®.
Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives, and rash have been reported.
These were not all the side effects reported. If you notice any unusual or severe symptoms after receiving GARDASIL®, contact your healthcare professional as soon as possible.
Information about GARDASIL® is provided in the
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VACC-1158121-0000 FE 2017