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Rotarix Side Effects

Fussiness or irritability, fever, and loss of appetite are some of the most common side effects reported with Rotarix. In most cases, the vaccine's side effects are mild and easy to treat. However, certain side effects are potentially serious and should be reported to a healthcare provider immediately, such as seizures or high fever.

An Introduction to Rotarix Side Effects

As with all vaccines, side effects are possible with Rotarix® (rotavirus vaccine). However, not everyone who receives the vaccine will have problems. In fact, most children tolerate it quite well. If side effects do occur, in most cases, they are minor and either require no treatment or can easily be treated by you or your healthcare provider.
(This article covers many, but not all, of the possible side effects with Rotarix. Your healthcare provider can discuss a more complete list of Rotarix side effects with you.)
In March 2010, the United States Food and Drug Administration (FDA) recommended that this vaccine should not be used, at least temporarily, since DNA from porcine circovirus type 1 (PCV1) has been found in the vaccine. This means that DNA from a virus found in pigs has been found in the vaccine. However, in May 2010, the FDA announced that it is safe to begin using Rotarix again, since PCV1 poses no known health risks to humans.

Common Side Effects of Rotarix

Rotarix has been studied thoroughly in clinical trials. In these studies, the side effects that occurred in a group of children given Rotavirus were documented and compared to side effects that occurred in a similar group of children given a placebo (with no active ingredient). This way, it is possible to see what side effects occurred, how often they appeared, and how they compare to the placebo group.
In these studies, the most common Rotarix side effects included:
  • Fussiness or irritability -- in up to 52 percent of children
  • Cough and runny nose -- up to 31 percent
  • Fever -- up to 28 percent
  • Loss of appetite -- up to 25 percent
  • Vomiting -- up to 13 percent
  • Diarrhea -- up to 4 percent.
It is important to note that almost all of these common side effects (with the exception of vomiting and diarrhea) actually occurred just as frequently or more frequently with the placebo than with Rotarix, suggesting that these may not be true side effects.
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Rotarix Vaccine Information

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