🇺🇸 RotaTeq in United States
104 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.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 104
Most-reported reactions
- Pyrexia — 20 reports (19.23%)
- No Adverse Event — 17 reports (16.35%)
- Product Storage Error — 14 reports (13.46%)
- Diarrhoea — 11 reports (10.58%)
- Decreased Appetite — 8 reports (7.69%)
- Acute Pulmonary Oedema — 7 reports (6.73%)
- Cardio-Respiratory Arrest — 7 reports (6.73%)
- Pain In Extremity — 7 reports (6.73%)
- Sudden Death — 7 reports (6.73%)
- Dyspnoea — 6 reports (5.77%)
Other Immunology / Infectious Disease approved in United States
Frequently asked questions
Is RotaTeq approved in United States?
RotaTeq does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for RotaTeq in United States?
National Institute of Pediatrics, Mexico is the originator. The local marketing authorisation holder may differ — check the official source linked above.