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Gardasil is used to prevent genital warts and cervical/vaginal/anal cancers caused by human papillomavirus (HPV) types 6, 11, 16, and 18 in girls and young women ages 9 through 26. Gardasil is also used to prevent genital warts caused by HPV types 6 and 11 in boys and young men ages 9 through 26. Human papillomavirus (HPV) can cause genital warts, cancer of the cervix, and various cancers of the vulva or vagina.

The quadrivalent form of HPV vaccine (Gardasil) is used in both females and males. Another form of HPV vaccine (Cervarix) is used only in females. This medication guide provides information only for Gardasil.

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all girls ages 11 or 12 years old. The vaccine is also recommended in girls and women ages 13 through 26 years old who have not already received the vaccine or have not completed all booster shots.

You may receive Gardasil even if you have already had genital warts, or had a positive HPV test or abnormal pap smear in the past. However, Gardasil will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection.

Important information

You should not receive a booster Gardasil vaccine if you have had a life-threatening allergic reaction after the first shot.

Before receiving Gardasil, tell your doctor if you have a high fever or signs of infection, a weak immune system, a bleeding disorder such as hemophilia, or if you are taking a blood thinner such as warfarin (Coumadin).

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all girls ages 11 or 12 years old. The vaccine is also recommended in girls and women ages 13 through 26 years old who have not already received the vaccine or have not completed all booster shots.

Gardasil should not be used in place of having a routine pelvic exam and Pap smear to screen for cervical cancer. You may receive Gardasil even if you have already had genital warts, or had a positive HPV test or abnormal pap smear in the past. However, Gardasil will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection. You may feel faint after receiving Gardasil. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, Gardasil can cause side effects but the risk of serious side effects is extremely low.

Gardasil will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

Before receiving Gardasil

Before receiving Gardasil, tell your doctor if you have:

  • high fever, or signs of infection;

  • a weak immune system;

  • a bleeding or blood-clotting disorder, such as hemophilia; or

  • if you are taking a blood thinner such as warfarin (Coumadin).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. However, you should not receive Gardasil without telling your doctor if you are pregnant or plan to become pregnant before you have received all doses of Gardasil. It is not known whether HPV vaccine passes into breast milk or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

Gardasil will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

Gardasil will not prevent diseases caused by HPV types other than types 6, 11, 16, and 18. There are over 100 different types of HPV.

How is Gardasil given?

Gardasil is given as an injection (shot) into a muscle in your upper arm or thigh. You will receive this injection in a doctor"s office or other clinic setting.

Gardasil is given in a series of 3 shots. You may have the first shot at any time as long as you are between the ages of 9 and 26 years old. Then you will need to receive a second dose 2 months after your first shot, and a third dose 6 months after your first shot.

Be sure to receive all doses of Gardasil recommended by your healthcare provider or your state"s health department. You may not be fully protected if you do not receive the full series.

Gardasil should not be used in place of having a routine pelvic exam and Pap smear to screen for cervical cancer.

What happens if I miss a dose?

Contact your doctor if you will miss an Gardasil booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of Gardasil. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid?

There may be certain other vaccines that should not be given at the same time as the Gardasil. Until you have completed the series of 3 Gardasils, do not receive any other vaccine (including a flu shot) without first asking your doctor.

Gardasil side effects

You should not receive a Gardasil booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, Gardasil can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction to Gardasil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. You may feel faint after receiving Gardasil. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain;

  • swollen glands;

  • easy bruising or bleeding, confusion, unusual weakness;

  • fever, chills, body aches, general ill feeling;

  • chest pain; or

  • feeling short of breath.

Less serious Gardasil side effects may include:

  • pain, swelling, redness, bruising, or itching where the shot was given;

  • mild fever, headache, dizziness, tired feeling;

  • nausea, vomiting, diarrhea;

  • sleep problems (insomnia);

  • runny or stuffy nose, sore throat, cough; or

  • tooth pain, joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

See also: Side effects (in more detail)

What other drugs will affect Gardasil?

Before receiving the Gardasil, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;

  • chemotherapy or radiation;

  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can interact with Gardasil. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.


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