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Rotavirus infection can have serious consequences1

Although rotavirus infection is usually self-limiting and not life-threatening, symptoms can range from mild diarrhea to severe diarrhea with vomiting and fever.1

In more severe cases, these symptoms can result in dehydration with shock, or on rare occasions, even death.1

Rotavirus infection can cause2,3:

Up to 20 Episodes of Diarrhea per Day, Up to 8 Days of GI Symptoms, Potentially Life-Threatening DiarrheaUp to 20 Episodes of Diarrhea per Day, Up to 8 Days of GI Symptoms, Potentially Life-Threatening Diarrhea

Based on the most recent national survey4:

~1 Out of 4 Children in the US Has Not Been Vaccinated for Rotavirus~1 Out of 4 Children in the US Has Not Been Vaccinated for Rotavirus

GI, gastrointestinal.

National Immunization Survey-Child, United States, 2022-2024. Children born between 2021-2022 (N=27,392).

References

  1. Baker JM, Tate JE, Gautam R, et al. Manual for the surveillance of vaccine-preventable diseases. Centers for Disease Control and Prevention (CDC) and Department of Health and Human Services; last updated January 8, 2025. Accessed May 30, 2025. https://www.cdc.gov/surv-manual/php/table-of-contents/ chapter-13-rotavirus.html CDC_AAref_Val=https://www.cdc.gov/vaccines/pubs/surv-manual/chpt13-rotavirus.html
  2. Yen C, Cortese MM. Rotaviruses. In Long SS, Prober CG, Fischer M. Principles and Practice of Pediatric Infectious Diseases. Elsevier Inc. 2022:1141 -1144.
  3. Centers for Disease Control and Prevention (CDC). About Rotavirus. United States, last updated April 22, 2024. Accessed April 10, 2026. https://www.cdc.gov/rotavirus/about/index.html
  4. Hill HA, Yankey D, Elam-Evans LD, et al. Vaccination Coverage by Age 24 Months Among Children Born in 2021 and 2022 — National Immunization Survey-Child, United States, 2022–2024. MMWR Morb Mortal Wkly Rep 2026;75:146–155. DOI: http://dx.doi.org/10.15585/mmwr.mm7511a2
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Indications and Usage

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age.

The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.

Selected Safety Information

RotaTeq is contraindicated in infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine.

RotaTeq is contraindicated in infants with Severe Combined Immunodeficiency Disease (SCID). These infants should not receive RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.

RotaTeq is contraindicated in infants with a history of intussusception. These infants should not receive RotaTeq.

No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised.

In a post-marketing observational study in the US, cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.

No safety or efficacy data are available for administration of RotaTeq to infants with a history of gastrointestinal disorders.

Vaccine virus transmission from vaccine recipient to nonvaccinated contacts has been reported. Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.

In clinical trials, the most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.

In post-marketing experience, intussusception (including death) and Kawasaki disease have been reported in infants who have received RotaTeq.

RotaTeq may not protect all vaccine recipients against rotavirus.

Before administering RotaTeq, please read the accompanying Prescribing Information. The Patient Product Information also is available.

Indications and Usage
Selected Safety Information

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age.

The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.

Selected Safety Information

RotaTeq is contraindicated in infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine.

RotaTeq is contraindicated in infants with Severe Combined Immunodeficiency Disease (SCID). These infants should not receive RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.

RotaTeq is contraindicated in infants with a history of intussusception. These infants should not receive RotaTeq.

No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised.

In a post-marketing observational study in the US, cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.

No safety or efficacy data are available for administration of RotaTeq to infants with a history of gastrointestinal disorders.

Vaccine virus transmission from vaccine recipient to nonvaccinated contacts has been reported. Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.

In clinical trials, the most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.

In post-marketing experience, intussusception (including death) and Kawasaki disease have been reported in infants who have received RotaTeq.

RotaTeq may not protect all vaccine recipients against rotavirus.

Before administering RotaTeq, please read the accompanying Prescribing Information. The Patient Product Information also is available.