SEROPLEX: 68 Adverse Event Reports & Safety Profile
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68
Total FAERS Reports
4 (5.9%)
Deaths Reported
53
Hospitalizations
68
As Primary/Secondary Suspect
16
Life-Threatening
First Report: 20070715 · Latest Report: 20140523
What Are the Most Common SEROPLEX Side Effects?
#1 Most Reported
Coma
16 reports (23.5%)
#2 Most Reported
Hyponatraemia
10 reports (14.7%)
#3 Most Reported
Intentional overdose
6 reports (8.8%)
All SEROPLEX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Coma | 16 | 23.5% | 2 | 9 |
| Hyponatraemia | 10 | 14.7% | 0 | 10 |
| Bradycardia | 6 | 8.8% | 0 | 6 |
| Disturbance in attention | 6 | 8.8% | 0 | 2 |
| Intentional overdose | 6 | 8.8% | 0 | 5 |
| Agitation | 5 | 7.4% | 0 | 5 |
| Circulatory collapse | 5 | 7.4% | 0 | 1 |
| Confusional state | 5 | 7.4% | 0 | 5 |
| Electrocardiogram qt prolonged | 5 | 7.4% | 0 | 3 |
| Fall | 5 | 7.4% | 0 | 5 |
| Hypothermia | 5 | 7.4% | 0 | 1 |
| Pancreatitis acute | 5 | 7.4% | 0 | 5 |
| Somnolence | 5 | 7.4% | 0 | 5 |
| Thrombocytopenia | 5 | 7.4% | 1 | 2 |
Who Reports SEROPLEX Side Effects? Age & Gender Data
Average age: 64.6 years. Most reports from: FR. View detailed demographics →
Is SEROPLEX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 1 |
| 2013 | 28 | 4 | 18 |
| 2014 | 35 | 0 | 33 |
What Is SEROPLEX Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 25 |
| Depression | 7 |
Official FDA Label for SEROPLEX
Official prescribing information from the FDA-approved drug label.