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U.S. Department of Health and Human Services


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RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) Oral Solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER) – June 2013


Summary View



  • FDA has approved required revisions to the Prescribing Information and Patient Information for RotaTeq as a result of the new safety data from this Mini-Sentinel PRISM study. 
  • New information was added to the Highlights, the existing intussusception subsection of the Warnings and Precautions section, and the Post-Marketing Experience section of the Full Prescribing Information, as well as to the Patient Information. 
  • The Mini-Sentinel PRISM study is the largest study of intussusception after rotavirus vaccines to date and identified an increased risk of intussusception in the 21 day time period after the first dose of RotaTeq, with most cases occurring in the first 7 days after vaccination.  No increased risk was found after the second or third doses.  These findings translate into 1 to 1.5 additional cases of intussusception per 100,000 first doses of RotaTeq.