ROCEPHINE: 89 Adverse Event Reports & Safety Profile
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89
Total FAERS Reports
13 (14.6%)
Deaths Reported
72
Hospitalizations
89
As Primary/Secondary Suspect
13
Life-Threatening
First Report: 20051222 · Latest Report: 20140521
What Are the Most Common ROCEPHINE Side Effects?
#1 Most Reported
Rash maculo-papular
11 reports (12.4%)
#2 Most Reported
Renal failure acute
9 reports (10.1%)
#3 Most Reported
Hepatocellular injury
9 reports (10.1%)
All ROCEPHINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Rash maculo-papular | 11 | 12.4% | 3 | 9 |
| Hepatocellular injury | 9 | 10.1% | 0 | 9 |
| Renal failure acute | 9 | 10.1% | 1 | 8 |
| Drug reaction with eosinophilia and systemic symptoms | 7 | 7.9% | 0 | 7 |
| Eosinophilia | 7 | 7.9% | 2 | 6 |
| Acute generalised exanthematous pustulosis | 6 | 6.7% | 0 | 6 |
| International normalised ratio increased | 6 | 6.7% | 2 | 4 |
| Clostridium difficile colitis | 5 | 5.6% | 0 | 5 |
| Dehydration | 5 | 5.6% | 1 | 4 |
| Purpura | 5 | 5.6% | 0 | 5 |
| Renal failure | 5 | 5.6% | 2 | 5 |
| Toxic epidermal necrolysis | 5 | 5.6% | 5 | 1 |
Who Reports ROCEPHINE Side Effects? Age & Gender Data
Average age: 70.3 years. Most reports from: FR. View detailed demographics →
Is ROCEPHINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 2 | 0 | 2 |
| 2008 | 1 | 0 | 1 |
| 2012 | 6 | 1 | 5 |
| 2013 | 40 | 6 | 35 |
| 2014 | 36 | 6 | 26 |
What Is ROCEPHINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 19 |
| Lung infection | 7 |
| Infection | 5 |
| Pneumonia | 5 |
| Sepsis | 5 |
Official FDA Label for ROCEPHINE
Official prescribing information from the FDA-approved drug label.