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HPV Vaccine, Quadrivalent


Trade/other name(s): Gardasil; human papillomavirus quadrivalent (Types 6, 11, 16, and 18) vaccine, recombinant

Why would this drug be used?

This vaccine is given to children and young people to help prevent problems caused by infection with certain types of human papillomavirus (HPV). These types of HPV cause most cervical cancers and pre-cancers, as well as many cancers and pre-cancers of the anus, vagina and vulva. It also helps protect against the 2 types of HPV that cause most cases of genital warts. This vaccine helps prevent:

  • Anal, cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11
  • It is approved for use in those aged 9 to 26 years old.

How does this drug work?

The HPV vaccine is made from virus-like particles that the immune system reacts to as if they were real viruses. In response to the vaccine, the immune system makes antibodies against 4 types of HPV. If the body is exposed to any of these types of HPV later on, these antibodies help prevent infection from taking hold. This protects against the illnesses, such as cancer and genital warts, which are caused by these HPV types.

The vaccine can not prevent illness (cancer or warts) caused by an HPV infection that was already present at the time you got the vaccine. It also does not prevent cancer or warts that are caused by different types of HPV than the 4 the vaccine includes. About 7 in 10 cervical cancers are caused by HPV types 16 and 18, which the vaccine helps prevent. About 9 in 10 cases of genital warts are caused by HPV types 6 and 11.

The vaccine is not made of virus so it cannot cause HPV infection.

Before taking this medicine

Tell your doctor…

  • if you are allergic to anything, including yeast, medicines, dyes, additives, or foods. Also, if you have had an allergic reaction to a previous dose of the HPV vaccine.
  • if you are pregnant or trying to get pregnant. Even though no bad outcomes have been linked to the vaccine, it has not been studied carefully in pregnant women. (Women who are breast feeding may safely get the vaccine.)
  • about any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Medicines or treatments that suppress the immune system, such as cancer chemotherapy, radiation, and steroid drugs, may reduce the effectiveness of the vaccine.

Check with your doctor, nurse, or pharmacist about all of your medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time.

How is this drug taken or given?

The HPV vaccine is given as a series of 3 shots (injections) over a 6-month period. The injection is given in the muscle of the upper arm or the outer thigh. After the first dose, the second is given 2 months later. The third dose is given 6 months after the first (4 months after the second one).


Tell your doctor or nurse right away if you feel dizzy, have trouble breathing, notice thickness or swelling in the mouth or throat, fast heart beat, or other new sensations after the injection is given. These can be signs of a serious allergic reaction, which can be treated with medicines from your doctor. It is also important to call your doctor or nurse right away if you have itching, hives, or other symptoms after you get home.

Fainting can happen after injections, and is more common in pre-teens and teens. Falls that happen when someone faints can cause serious injuries. To help prevent injuries, anyone getting the vaccine should rest (sit or lie down) for 15 minutes after the injection is given. Tell the doctor or nurse right away if you notice ringing in your ears, sweating, nausea, dizziness, or changes in your vision. These can be signals that you are about to faint. It is also important to know that some people can have muscle jerks or lose control of their bladders, almost like they are having a seizure, as they are fainting. This is not a seizure, and symptoms get better quickly after the person lies down.

If you have a serious problem after you get the vaccine, ask your doctor or health department to complete a Vaccine Adverse Event Report System (VAERS) form to report it. Or you can report it through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967.

This vaccine has not been tested in pregnant women. Any woman who finds out that she was pregnant when she got the vaccine is encouraged to call 1-800-986-8999 and register before the baby is born. Information from this registry will help doctors learn how pregnant women respond to the vaccine. Pregnant women who have started the vaccine series should complete the series after their baby is born.

This vaccine does not protect against all types of HPV that can cause cervical cancer. Women who get this vaccine should still get Pap tests on the same schedule as women who don't get the vaccine.

At this time, it is not known when women who get the 3-dose series of vaccine will need another dose later, but immunity is not likely to last a lifetime. The body's ability to fight HPV is expected to wane over time, which would require a "booster" to keep up immunity.

No vaccine works 100% of the time. There is still a chance that a person who gets the full series will still get cancer or warts if they are exposed to one of the types of HPV that the vaccine is designed to prevent.

This vaccine does not work against any of the viruses you were already exposed to before being vaccinated. It works best when given to people who have not yet had sex or had the chance to contract any type of HPV.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.


  • pain at the injection site
  • headache

Less common

  • swelling or redness at the injection site
  • itching at the injection site
  • nausea
  • vomiting
  • fainting in the first few minutes after injection, sometimes with jerking muscles or loss of bladder control so that it looks something like a seizure*


  • fever
  • allergic reaction*

*See "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2006

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 02/09/2010
Last Revised: 12/23/2010