OLYSIO: 79 Adverse Event Reports & Safety Profile
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79
Total FAERS Reports
4 (5.1%)
Deaths Reported
21
Hospitalizations
79
As Primary/Secondary Suspect
3
Life-Threatening
2
Disabilities
First Report: 2014 · Latest Report: 20140625
What Are the Most Common OLYSIO Side Effects?
#1 Most Reported
Off label use
41 reports (51.9%)
#2 Most Reported
Blood bilirubin increased
7 reports (8.9%)
#3 Most Reported
Blood creatinine increased
6 reports (7.6%)
All OLYSIO Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 41 | 51.9% | 2 | 12 |
| Blood bilirubin increased | 7 | 8.9% | 0 | 1 |
| Blood creatinine increased | 6 | 7.6% | 0 | 0 |
| Dyspnoea | 5 | 6.3% | 0 | 2 |
| Headache | 5 | 6.3% | 0 | 0 |
Who Reports OLYSIO Side Effects? Age & Gender Data
Average age: 58.7 years. Most reports from: US. View detailed demographics →
Is OLYSIO Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 59 | 3 | 20 |
What Is OLYSIO Used For?
| Indication | Reports |
|---|---|
| Hepatitis c | 47 |
| Product used for unknown indication | 11 |
| Chronic hepatitis c | 7 |
Official FDA Label for OLYSIO
Official prescribing information from the FDA-approved drug label.