ROVALCYTE: 19 Adverse Event Reports & Safety Profile
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19
Total FAERS Reports
3 (15.8%)
Deaths Reported
14
Hospitalizations
19
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 200409 · Latest Report: 20140426
What Are the Most Common ROVALCYTE Side Effects?
#1 Most Reported
Agranulocytosis
7 reports (36.8%)
#2 Most Reported
Neutropenia
6 reports (31.6%)
#3 Most Reported
Pancytopenia
3 reports (15.8%)
All ROVALCYTE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Agranulocytosis | 7 | 36.8% | 0 | 6 |
| Neutropenia | 6 | 31.6% | 0 | 5 |
Who Reports ROVALCYTE Side Effects? Age & Gender Data
Average age: 57.4 years. Most reports from: FR. View detailed demographics →
Is ROVALCYTE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 3 | 0 | 3 |
| 2012 | 1 | 1 | 0 |
| 2013 | 10 | 0 | 9 |
| 2014 | 5 | 2 | 2 |
What Is ROVALCYTE Used For?
| Indication | Reports |
|---|---|
| Cytomegalovirus infection | 6 |
Official FDA Label for ROVALCYTE
Official prescribing information from the FDA-approved drug label.