SOVRIAD: 63 Adverse Event Reports & Safety Profile
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63
Total FAERS Reports
8 (12.7%)
Deaths Reported
23
Hospitalizations
63
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
First Report: 20131210 · Latest Report: 20140515
What Are the Most Common SOVRIAD Side Effects?
#1 Most Reported
Platelet count decreased
12 reports (19.0%)
#2 Most Reported
Neutrophil count decreased
10 reports (15.9%)
#3 Most Reported
White blood cell count decreased
9 reports (14.3%)
All SOVRIAD Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Platelet count decreased | 12 | 19.1% | 4 | 5 |
| Neutrophil count decreased | 10 | 15.9% | 0 | 0 |
| Haemoglobin decreased | 9 | 14.3% | 0 | 2 |
| White blood cell count decreased | 9 | 14.3% | 0 | 3 |
| Alanine aminotransferase increased | 8 | 12.7% | 4 | 5 |
| Off label use | 8 | 12.7% | 0 | 3 |
| Aspartate aminotransferase increased | 7 | 11.1% | 4 | 4 |
| Blood bilirubin increased | 7 | 11.1% | 0 | 1 |
| Hyperbilirubinaemia | 6 | 9.5% | 3 | 3 |
| Pyrexia | 6 | 9.5% | 3 | 4 |
| Anaemia | 5 | 7.9% | 0 | 2 |
| Disseminated intravascular coagulation | 5 | 7.9% | 5 | 4 |
Who Reports SOVRIAD Side Effects? Age & Gender Data
Average age: 63.7 years. Most reports from: JP. View detailed demographics →
Is SOVRIAD Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 1 | 0 | 1 |
| 2014 | 54 | 7 | 20 |
What Is SOVRIAD Used For?
| Indication | Reports |
|---|---|
| Chronic hepatitis c | 49 |
| Product used for unknown indication | 14 |
Official FDA Label for SOVRIAD
Official prescribing information from the FDA-approved drug label.