Rotarix

Rotarix is a vaccine used to prevent rotavirus in your baby. It comes in liquid form and is administered by a healthcare professional.

Rotarix comes in liquid form to be administered orally (by mouth) by a healthcare professional. It is administered using a prefilled applicator.

Common side effects include cough, runny nose, and fussiness.

Rotarix is a vaccine used for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. Rotarix is approved for use in infants 6 weeks to 24 weeks of age.

Use Rotarix exactly as prescribed by your doctor. 

The vaccination series consists of two 1-ml doses administered orally. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose. The 2-dose series should be completed by 24 weeks of age.

In the event that your baby spits out of regurgitates most of the vaccine dose, a single replacement dose may be considered at the same vaccination visit.

Serious side effects have been reported with Rotarix including the following:

• bad vomiting
• bad diarrhea
• bloody bowel movement
• high fever
• severe stomach pain (if your baby brings his/her knees to his/her chest while crying or screaming)
• intussusception (a type of bowel blockage)

Do not give your baby Rotarix if he/she:

• has had an allergic reaction after getting a dose of Rotarix
• has an abnormal digestive system
• has a history of a serious problem called intussusception that happens when a part of the intestine gets blocked or twisted
• has Severe Combined Immunodeficiency Disease (SCID), a severe problem with the immune system
• is allergic to any of the ingredients of this vaccine

Serious side effects have been reported with Rotarix. See the "Rotarix Precautions" section.

Common side effects of Rotarix include the following:

• crying
• fussiness
• cough
• runny nose
• fever
• loss of appetite
• vomiting

This is not a complete list of Rotarix side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if your baby has any side effect that bothers him/her or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to VAERS at 1-800-822-7967.

Tell your baby's doctor about all the medicines he/she takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if your baby takes:

• other vaccines
• medicines that suppress the immune system

This is not a complete list of Rotarix drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Rotarix falls into category C. No studies have been conducted in animals, and no well-controlled studies have been done in pregnant women. Rotarix should only be given to a pregnant woman if clearly needed.

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if Rotarix crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using Rotarix.