"Feb. 7, 2012 -- Despite studies showing that the rotavirus vaccine can reduce the number of children hospitalized for severe diarrhea, some U.S. doctors are slow to embrace it for fear that this vaccine may increase an infant's risk of a life-thr"...
Rotarix Patient Information Including Side Effects
Brand Names: Rotarix, RotaTeq
Generic Name: rotavirus vaccine, live (oral) (Pronunciation: ROE ta vye ris VAX een)
- What is rotavirus oral vaccine (Rotarix)?
- What are the possible side effects of rotavirus oral vaccine (Rotarix)?
- What is the most important information I should know about rotavirus oral vaccine (Rotarix)?
- What should I discuss with my health care provider before receiving rotavirus oral vaccine (Rotarix)?
- How is rotavirus oral vaccine given (Rotarix)?
- What happens if I miss a dose (Rotarix)?
- What happens if I overdose (Rotarix)?
- What should I avoid after receiving rotavirus oral vaccine (Rotarix)?
- What other drugs will affect rotavirus oral vaccine (Rotarix)?
- Where can I get more information?
What is rotavirus oral vaccine (Rotarix)?
Rotavirus oral vaccine contains up to five strains of rotavirus. It is made from both human and animal sources.
Infection with rotavirus can affect the digestive system of babies and young children, causing severe stomach or intestinal illness.
The rotavirus oral vaccine is used to help prevent this disease in children.
This vaccine works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Rotavirus oral vaccine is for use in children between the ages of 6 weeks and 32 weeks old.
Like any vaccine, the rotavirus oral vaccine may not provide protection from disease in every person.
What are the possible side effects of rotavirus oral vaccine (Rotarix)?
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects. Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
Call your doctor at once if the child has a serious side effect such as:
- seizure (black-out or convulsions);
- severe or ongoing diarrhea;
- dark red stools;
- fever, chills, cough with yellow or green mucus;
- stabbing chest pain, chest tightness, wheezing, feeling short of breath;
- stomach pain, weakness, loss of appetite, vomiting;
- ear pain, swelling, or drainage;
- runny or stuffy nose, sore throat;
- pain or burning when you urinate; or
- high fever, redness of the skin or eyes, swollen hands, peeling skin rash, chapped or cracked lips.
Other less serious side effects are more likely to occur, such as crying or mild irritability.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the Rotarix (rotavirus vaccine, live, oral suspension) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about rotavirus oral vaccine (Rotarix)?
Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to a rotavirus oral vaccine, or if the child has severe combined immunodeficiency disease (SCID). This vaccine should not be given if the child has a history of an intestinal problem called intussusception (in-tuh-suh-SEP-shun).
Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.
Before your child receives this vaccine, tell the doctor if your child has recently had a fever. Also tell the doctor if anyone living with or caring for the child has cancer or a weak immune system, or is receiving treatments that can weaken the immune system (such as radiation, chemotherapy, or steroids).
Always wash your hands after handling the diapers of a child who has been given the rotavirus oral vaccine. Small amounts of the virus may be passed in the child's stool and could possibly infect others who come into contact with the child's stool.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects.
Be sure your child receives all recommended doses of this vaccine. Your child may not be protected from rotavirus if the doses aren't given within 4 to 10 weeks of each other, or if the child does not receive the full series of vaccines.
Avoid receiving the doses of this vaccine in different clinics or from different doctors. Your child should receive the same brand of rotavirus oral vaccine for all doses given. Different brands of this vaccine may not have the same dosing or booster schedule.
Call your doctor as soon as possible if your child (after receiving a rotavirus oral vaccine) has stomach pain or bloating, vomiting (especially if it is golden-brown to green in color), bloody stools, grunting or excessive crying, and eventually weakness and shallow breathing.
Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Additional Rotarix Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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