INCIVO: 667 Adverse Event Reports & Safety Profile
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667
Total FAERS Reports
43 (6.4%)
Deaths Reported
250
Hospitalizations
667
As Primary/Secondary Suspect
18
Life-Threatening
3
Disabilities
First Report: 201102 · Latest Report: 20140618
What Are the Most Common INCIVO Side Effects?
#1 Most Reported
Anaemia
185 reports (27.7%)
#2 Most Reported
Rash
161 reports (24.1%)
#3 Most Reported
Off label use
76 reports (11.4%)
All INCIVO Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaemia | 185 | 27.7% | 8 | 89 |
| Rash | 161 | 24.1% | 7 | 57 |
| Off label use | 76 | 11.4% | 11 | 29 |
| Pruritus | 71 | 10.6% | 1 | 19 |
| Nausea | 56 | 8.4% | 0 | 24 |
| Pyrexia | 55 | 8.3% | 5 | 32 |
| Thrombocytopenia | 48 | 7.2% | 5 | 18 |
| Neutropenia | 45 | 6.8% | 2 | 9 |
| Asthenia | 43 | 6.5% | 4 | 24 |
| Leukopenia | 35 | 5.3% | 1 | 13 |
| Vomiting | 31 | 4.7% | 0 | 20 |
| Haemoglobin decreased | 30 | 4.5% | 4 | 11 |
| Diarrhoea | 29 | 4.4% | 2 | 14 |
| Depression | 25 | 3.8% | 1 | 8 |
| Fatigue | 25 | 3.8% | 0 | 6 |
| Malaise | 25 | 3.8% | 1 | 13 |
| Decreased appetite | 23 | 3.5% | 1 | 10 |
| Urinary tract infection | 23 | 3.5% | 4 | 15 |
| Headache | 22 | 3.3% | 0 | 10 |
| Drug reaction with eosinophilia and systemic symptoms | 19 | 2.9% | 1 | 13 |
Who Reports INCIVO Side Effects? Age & Gender Data
Average age: 54.0 years. Most reports from: ES. View detailed demographics →
Is INCIVO Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 8 | 0 | 5 |
| 2012 | 58 | 2 | 39 |
| 2013 | 191 | 5 | 97 |
| 2014 | 136 | 9 | 42 |
What Is INCIVO Used For?
| Indication | Reports |
|---|---|
| Hepatitis c | 447 |
| Chronic hepatitis c | 162 |
| Product used for unknown indication | 60 |
| Hepatic cirrhosis | 12 |
INCIVO vs Alternatives: Which Is Safer?
INCIVO vs INCLISIRAN
INCIVO vs INCOBOTULINUMTOXINA
INCIVO vs INDACATEROL
INCIVO vs INDAPAMIDE
INCIVO vs INDAPAMIDE\PERINDOPRIL
INCIVO vs INDAPAMIDE\PERINDOPRIL ARGININE
INCIVO vs INDAPAMIDE\PERINDOPRIL ERBUMINE
INCIVO vs INDINAVIR
INCIVO vs INDOMETHACIN
INCIVO vs INDOMETHACIN\INDOMETHACIN
Official FDA Label for INCIVO
Official prescribing information from the FDA-approved drug label.