Gardasil (generic: human papillomavirus quadrivalent (types 6, 11, 16, and 18)) is a vaccine used to prevent genital warts and cervical, vaginal, and anal cancers caused by certain types of human papillomavirus in girls and women age 9 through 26 years. It may also be used to prevent genital warts in boys and men age 9 through 26 years.
This vaccine comes in an injectable form and is given in a series of 3 injections, usually in the arm muscle.
Common side effects of Gardasil include pain, swelling, itching, bruising, and redness at the injection site, headache, and fever.
Gardasil does not contain thimerosal.
Gardasil is a vaccine (injection/shot) that is used for girls and women 9 through 26 years of age to help protect against the following diseases caused by Human Papillomavirus (HPV):
- Cervical cancer
- Vulvar and vaginal cancers
- Anal cancer
- Genital warts
- Precancerous cervical, vaginal, vulvar, and anal lesions
- Anal cancer
- Genital warts
- Precancerous anal lesions
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
The most common side effects with Gardasil are:
- pain, swelling, itching, bruising, and redness at the injection site
Tell your health care provider if you have any of the following problems because these may be signs of an allergic reaction:
- difficulty breathing
- wheezing (bronchospasm)
- Tell your health care provider if you have:
- swollen glands (neck, armpit, or groin)
- joint pain
- unusual tiredness, weakness, or confusion
- generally feeling unwell
- leg pain
- shortness of breath
- chest pain
- aching muscles
- muscle weakness
- bad stomach ache
- bleeding or bruising more easily than normal
- skin infection
Contact your health care provider right away if you get any symptoms that concern you, even several months after getting the vaccine.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
You should not get Gardasil if you 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
You should continue to get routine cervical cancer screening. Gardasil may not fully protect everyone who gets the vaccine. Gardasil will not protect against HPV types that you already have.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Gardasil there are no specific foods that you must exclude from your diet when receiving 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.
Tell your doctor if you are pregnant or planning to become pregnant. Gardasil is not recommended for use in pregnant women.
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Gardasil is excreted in human breast milk or if it will harm your nursing baby.
Gardasil is a shot that is usually given in the arm muscle. You will need 3 shots given on the following schedule:
- Dose 1: at a date you and your health care provider choose.
- Dose 2: 2 months after Dose 1.
- Dose 3: 6 months after Dose 1.
Fainting can happen after getting Gardasil. Sometimes people who faint can fall and hurt themselves. For this reason, your health care provider 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 provider.
Make sure that you get all 3 doses on time so that you get the best protection. If you miss a dose, talk to your health care provider.
Gardasil can be given at the same time as RECOMBIVAX HB®1 [hepatitis B vaccine (recombinant)] or Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)].
Gardasil should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months. For intramuscular use only.
An overdose of Gardasil is unlikely to occur, however, if overdose is suspected, contact your doctor or local Poison Control Center.
All presentations for Gardasil contain a suspension of 120 mcg L1 protein from HPV types 6, 11, 16, and 18 in a 0.5-mL dose. Gardasil is supplied in vials and syringes.
The ingredients are proteins of HPV Types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.
Store refrigerated at 2 to 8°C (36 to 46°F). Do not freeze. Protect from light.
Gardasil should be administered as soon as possible after being removed from refrigeration.
Gardasil can be out of refrigeration (at temperatures at or below 25°C/77°F), for a total time of not more than 72 hours.