🇺🇸 Rotavirus vaccine in United States

93 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Foetal Exposure During Pregnancy — 22 reports (23.66%)
  2. Incorrect Dose Administered — 9 reports (9.68%)
  3. Atrial Septal Defect — 8 reports (8.6%)
  4. Cholestasis — 8 reports (8.6%)
  5. Exposure Via Breast Milk — 8 reports (8.6%)
  6. Hypovitaminosis — 8 reports (8.6%)
  7. Liver Injury — 8 reports (8.6%)
  8. Transaminases Increased — 8 reports (8.6%)
  9. Diarrhoea — 7 reports (7.53%)
  10. Low Birth Weight Baby — 7 reports (7.53%)

Source database →

Rotavirus vaccine in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology / Infectious Disease approved in United States

Frequently asked questions

Is Rotavirus vaccine approved in United States?

Rotavirus vaccine does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Rotavirus vaccine in United States?

PATH is the originator. The local marketing authorisation holder may differ — check the official source linked above.