GARDASIL

The safety of a vaccine is an important part of its story. That’s why Merck and the Centers for Disease Control and Prevention (CDC) are committed to monitoring the safety of GARDASIL on an ongoing basis.

What are the possible GARDASIL side effects?
The most common GARDASIL side effects are:

• pain, swelling, itching, bruising, and redness at the injection site
• headache
• fever
• nausea
• dizziness
• vomiting
• fainting

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

Tell your health care professional if any of the following problems occur because these may be signs of an allergic reaction:

• difficulty breathing
• wheezing (bronchospasm)
• hives
• rash

Tell your health care professional about:

• swollen glands (neck, armpit, or groin)
• joint pain
• unusual tiredness, weakness, or confusion
• chills
• generally feeling unwell
• leg pain
• shortness of breath
• chest pain
• aching muscles
• muscle weakness
• seizure
• bad stomach ache
• bleeding or bruising more easily than normal

Contact your health care professional right away if any of these symptoms concern you, even several months after getting the vaccine.

For a more complete list of GARDASIL side effects, ask a doctor or health care professional.

Is it possible to get HPV or any disease caused by HPV from GARDASIL?
No. It is not possible to get HPV or any disease caused by HPV from GARDASIL. That’s because there is no live virus in the vaccine.

Instead, GARDASIL contains a protein that helps the body’s immune system produce antibodies against HPV—without causing an infection.

For more information on GARDASIL, talk to a doctor or health care professional.

Who should not get GARDASIL?
People should not get GARDASIL if they have, or have had:

• an allergic reaction after getting a dose of GARDASIL.
• a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate 80.

What should my health care professional know before giving GARDASIL?
Tell your health care provider if you:

• are pregnant or planning to get pregnant. GARDASIL is not recommended for use in pregnant women.
• have immune problems, like HIV infection, cancer, or you take medicines that affect your immune system.
• have a fever over 100°F (37.8°C).
• had an allergic reaction to another dose of GARDASIL.
• take any medicines, even those you can buy over the counter.

Your doctor or health care professional will help you decide if you or your child should get the vaccine.

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INFORMATION ABOUT GARDASIL

GARDASIL is the only human papillomavirus (HPV) vaccine that helps protect against 4 types of HPV. In girls and young women ages 9 to 26, GARDASIL helps protect against 2 types of HPV that cause about 75% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. In boys and young men ages 9 to 26, GARDASIL helps protect against 90% of genital warts cases.

GARDASIL also helps protect girls and young women ages 9 to 26 against 70% of vaginal cancer cases and up to 50% of vulvar cancer cases.

GARDASIL may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL does not prevent all types of cervical cancer, so it’s important for women to continue routine cervical cancer screenings. GARDASIL does not treat cancer or genital warts. GARDASIL is given as 3 injections over 6 months.

IMPORTANT SAFETY INFORMATION

Anyone who is allergic to the ingredients of GARDASIL, including those severely allergic to yeast, should not receive the vaccine. GARDASIL is not for women who are pregnant.

The side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Fainting can happen after getting GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask you to sit or lie down for 15 minutes after you get GARDASIL. Some people who faint might shake or become stiff. This may require evaluation or treatment by your health care professional.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch By clicking on this link, you will be leaving this siteThis link will take you to a site outside of Merck & Co., Inc. Merck does not review or control the content of any non-Merck site. Merck does not endorse and is not responsible for the accuracy, content, practices, or standards of any non-Merck site.
Proceed or call 1-800-FDA-1088.

Read the Patient Product Information or the Prescribing Information for GARDASIL.