Worldwide

Worldwide
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)
Click here to view
Prescribing Information
and
Patient Product Information .

Models

Information for Parents and Family
 
 What Is Rotavirus?
 How to Help Protect Your Baby From Rotavirus
 Talking With Your Child's Doctor
 Recommendations
 Patient Product Information
 Prescribing Information
 Important Selected Safety Information
 Questions to Ask Your Child's Doctor
 More Help
 To Report Side Effects
1-800-FDA-1088

Find Out More About How RotaTeq Can Help
Information for Health Care Professionals
 
The information on this site is intended for health care professionals in the United States and is not intended for the general public.
Click here if you are a health care professional.
Health care professionals in Canada, click here.
 
   

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 the age.

   

During your child's first well visits, ask your doctor about RotaTeq.

 
   

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 your child has any of the following problems after getting RotaTeq, even if it has been several weeks since the last dose, because these may be signs of a serious problem called intussusception:

  • bad vomiting
  • bad diarrhea
  • severe stomach pain
  • blood in the stool.

Intussusception happens when a part of the intestine gets blocked or twisted. Since FDA approval, reports of infants with intussusception following RotaTeq have been received by the Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some infants needed hospitalization, surgery on their intestines, or a special enema to treat this problem. Death due to intussusception has occurred. A study conducted after approval of RotaTeq showed an increased risk of intussusception in the 21 days after the first dose of RotaTeq, but especially in the first 7 days.

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. The physician Prescribing Information also is available.

PRIVACY POLICY TERMS OF USE COPYRIGHT © 2006-2011 MERCK SHARP & DOHME CORP., A SUBSIDIARY OF MERCK & CO., INC. MERCK & CO., INC. (USA)
         
Validate TRUSTe privacy certification
TRUSTe European Safe Harbor certification

SITE MAP PRIVACY POLICY TERMS OF USE COPYRIGHT © 2006-2013 MERCK SHARP & DOHME CORP., A SUBSIDIARY OF MERCK & CO., INC. MERCK & CO., INC. (USA)
Validate TRUSTe privacy certification
TRUSTe European Safe Harbor certification