Safety Information for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)





























To Report Side Effects 1-800-FDA-1088

Information on RotaTeq for health care professionals

RotaTeq is a vaccine that can help protect babies against common types of rotavirus.
Rotavirus is the most common cause of severe diarrhea in infants.

RotaTeq is not a shot; the vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later, and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.

Important Selected Safety Information

RotaTeq may not fully protect all children who get the vaccine.

RotaTeq should not be given to infants who are allergic to any part of the vaccine.

Your child should not get RotaTeq if he or she has Severe Combined Immunodeficiency Disease (SCID).

Your child should not get RotaTeq if he or she has ever had intussusception, a form of blockage of the intestines.

The most common side effects reported after taking RotaTeq were diarrhea, vomiting, fever, runny nose, sore throat, wheezing or coughing, and ear infection.

Other reported side effects include: hives; Kawasaki disease (a serious condition that can affect the heart, symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet, and if untreated, can be life threatening).

Call your child's doctor or go to the emergency department right away if, following any dose of RotaTeq, your child has vomiting, diarrhea, severe stomach pain, blood in their stool or change in bowel movements. These may be signs of a serious and life-threatening problem called intussusception. Intussusception can happen even when no vaccine has been given and the cause is usually unknown. Contact your doctor or go to the emergency department right away if your child has any symptoms of intussusception, even if it has been several weeks since the last vaccine dose.

There are some important things your doctor needs to know about your baby. Tell your doctor if your baby:
– Is sick with fever, diarrhea, or vomiting
– Is not growing or gaining weight as expected
– Has a weakened immune system from a disease (such as cancer, HIV/AIDS or a blood disorder) or from medicine (such as steroids)
– Has received a blood transfusion or blood products recently
– Was born with gastrointestinal problems, had a blockage, or had abdominal surgery

The spread of vaccine virus to non-vaccinated contacts has been reported. Tell your doctor if you have someone in your household who has a weak immune system, cancer or is taking medications that can weaken the immune system so that your doctor can provide further advice.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Patient Product Information and discuss it with your doctor. Also available is the physician Prescribing Information.


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PDVA-1002759-0042 08/11

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