ZELITREX: 84 Adverse Event Reports & Safety Profile
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84
Total FAERS Reports
8 (9.5%)
Deaths Reported
70
Hospitalizations
84
As Primary/Secondary Suspect
4
Life-Threatening
1
Disabilities
First Report: 200409 · Latest Report: 20140510
What Are the Most Common ZELITREX Side Effects?
#1 Most Reported
Renal failure acute
18 reports (21.4%)
#2 Most Reported
Pyrexia
13 reports (15.5%)
#3 Most Reported
Drug reaction with eosinophilia and systemic symptoms
10 reports (11.9%)
All ZELITREX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Renal failure acute | 18 | 21.4% | 1 | 16 |
| Pyrexia | 13 | 15.5% | 1 | 13 |
| Drug reaction with eosinophilia and systemic symptoms | 10 | 11.9% | 0 | 10 |
| Eosinophilia | 7 | 8.3% | 0 | 7 |
| Hepatocellular injury | 6 | 7.1% | 0 | 6 |
| Rash maculo-papular | 6 | 7.1% | 0 | 6 |
| Thrombocytopenia | 6 | 7.1% | 0 | 6 |
| Toxic epidermal necrolysis | 6 | 7.1% | 6 | 2 |
| Agranulocytosis | 5 | 6.0% | 0 | 5 |
| Cholestasis | 5 | 6.0% | 0 | 5 |
| Confusional state | 5 | 6.0% | 1 | 5 |
| Hepatitis | 5 | 6.0% | 0 | 5 |
| Neutropenia | 5 | 6.0% | 0 | 5 |
| Renal tubular necrosis | 5 | 6.0% | 0 | 5 |
Who Reports ZELITREX Side Effects? Age & Gender Data
Average age: 60.2 years. Most reports from: FR. View detailed demographics →
Is ZELITREX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 4 | 0 | 4 |
| 2005 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 0 |
| 2012 | 4 | 0 | 3 |
| 2013 | 35 | 1 | 31 |
| 2014 | 37 | 7 | 31 |
What Is ZELITREX Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 28 |
| Prophylaxis | 6 |
| Oral herpes | 5 |
Official FDA Label for ZELITREX
Official prescribing information from the FDA-approved drug label.