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Generic Name: Rotavirus Oral Vaccine (ROE ta VI russ)
Brand Name: RotaTeq

Uses of RotaTeq:

  • It is used to prevent very bad stomach problems caused by rotavirus infection.

What do I need to tell my doctor BEFORE I take RotaTeq?

  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: Birth defect of the stomach or bowel (like Meckel diverticulum) that has not been fixed by surgery, loose stools (diarrhea) or is throwing up, or severe combined immunodeficiency disease (SCID).
  • If your child has ever had a very bad type of bowel blockage or twisting (intussusception).

This medicine may interact with other drugs or health problems.

Tell the doctor and pharmacist about all of your child's drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take RotaTeq (rotavirus oral vaccine) with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while I take RotaTeq?

For all patients taking this medicine:

  • Tell all of your child's health care providers that your child is taking RotaTeq. This includes your child's doctors, nurses, pharmacists, and dentists.
  • If your child has a latex allergy, talk with the doctor.
  • This medicine may not protect all people who use it. Talk with the doctor.
  • Tell the doctor if your child will be in close contact with people who have a weak immune system. This includes people with cancer, immune system problems, or who take drugs that weaken the immune system. There is a chance of spreading the vaccine virus to these people.

If your child is pregnant or breast-feeding a baby:

  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
  • Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.

How is this medicine (RotaTeq) best taken?

Give this medicine as ordered by your child's doctor. Read all information given to you. Follow all instructions closely.

  • It is given by mouth only.

What do I do if I miss a dose?

  • Call your child's doctor to find out what to do.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Wheezing or coughing.
  • Ear pain.
  • The chance of a very bad type of bowel blockage or twisting may be raised in infants and children after taking RotaTeq. Most of the time, this has happened within 7 days after the first dose. Sometimes, this can happen up to many weeks after the last dose. Call the doctor right away if your child has blood in the stools; high fever; or very bad loose stools (diarrhea), throwing up, or stomach pain.
  • Rarely, a very bad health problem called Kawasaki disease has happened with this medicine. This health problem can affect the heart and can be deadly if left untreated. Call the doctor right away if your child has high fever, rash, red eyes or mouth, swollen glands, or swelling in the arms or legs.

What are some other side effects of RotaTeq?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

  • Feeling fussy.
  • Runny nose.
  • Fever.
  • Not hungry.
  • Throwing up.
  • Crying that is not normal.
  • Loose stools (diarrhea).
  • Sore throat.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at

Side Effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out RotaTeq?

  • If you need to store RotaTeq at home, talk with your child's doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

  • If your child's symptoms or health problems do not get better or if they become worse, call your child's doctor.
  • Do not share your child's drug with others and do not give anyone else's drug to your child.
  • Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
  • Talk with your child's doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take RotaTeq or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to RotaTeq. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: December 6, 2017