HUMAN ROTAVIRUS A: 27 Adverse Event Reports & Safety Profile
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27
Total FAERS Reports
1 (3.7%)
Deaths Reported
5
Hospitalizations
27
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 20120221 · Latest Report: 20241230
What Are the Most Common HUMAN ROTAVIRUS A Side Effects?
#1 Most Reported
Foetal exposure during pregnancy
13 reports (48.1%)
#2 Most Reported
Transaminases increased
8 reports (29.6%)
#3 Most Reported
Liver injury
8 reports (29.6%)
All HUMAN ROTAVIRUS A Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Foetal exposure during pregnancy | 13 | 48.2% | 0 | 3 |
| Cholestasis | 8 | 29.6% | 0 | 0 |
| Hypovitaminosis | 8 | 29.6% | 0 | 0 |
| Liver injury | 8 | 29.6% | 0 | 0 |
| Transaminases increased | 8 | 29.6% | 0 | 0 |
| Diarrhoea | 5 | 18.5% | 0 | 3 |
| Pyrexia | 5 | 18.5% | 0 | 2 |
Who Reports HUMAN ROTAVIRUS A Side Effects? Age & Gender Data
Gender: 20.0% female, 80.0% male. Average age: 0.4 years. Most reports from: DE. View detailed demographics →
Is HUMAN ROTAVIRUS A Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 0 |
| 2014 | 1 | 0 | 0 |
| 2015 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2020 | 7 | 0 | 0 |
| 2021 | 7 | 0 | 2 |
| 2023 | 1 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
What Is HUMAN ROTAVIRUS A Used For?
| Indication | Reports |
|---|---|
| Prophylaxis | 12 |
| Product used for unknown indication | 7 |
Official FDA Label for HUMAN ROTAVIRUS A
Official prescribing information from the FDA-approved drug label.