PROLINE: 25 Adverse Event Reports & Safety Profile
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25
Total FAERS Reports
1 (4.0%)
Deaths Reported
15
Hospitalizations
25
As Primary/Secondary Suspect
12
Life-Threatening
First Report: 20161118 · Latest Report: 20221101
What Are the Most Common PROLINE Side Effects?
#1 Most Reported
Vasoplegia syndrome
12 reports (48.0%)
#2 Most Reported
Rhabdomyolysis
12 reports (48.0%)
#3 Most Reported
Pulse absent
12 reports (48.0%)
All PROLINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Bradycardia | 12 | 48.0% | 0 | 12 |
| Cardiac arrest | 12 | 48.0% | 0 | 12 |
| Cardiogenic shock | 12 | 48.0% | 0 | 12 |
| Coma scale abnormal | 12 | 48.0% | 0 | 12 |
| Compartment syndrome | 12 | 48.0% | 0 | 12 |
| Condition aggravated | 12 | 48.0% | 0 | 12 |
| Hyperkalaemia | 12 | 48.0% | 0 | 12 |
| Hypotension | 12 | 48.0% | 0 | 12 |
| Ileus | 12 | 48.0% | 0 | 12 |
| Lactic acidosis | 12 | 48.0% | 0 | 12 |
| Overdose | 12 | 48.0% | 0 | 12 |
| Pulse absent | 12 | 48.0% | 0 | 12 |
| Rhabdomyolysis | 12 | 48.0% | 0 | 12 |
| Vasoplegia syndrome | 12 | 48.0% | 0 | 12 |
| Off label use | 9 | 36.0% | 0 | 8 |
Who Reports PROLINE Side Effects? Age & Gender Data
Gender: 47.8% female, 52.2% male. Average age: 56.2 years. Most reports from: CA. View detailed demographics →
Is PROLINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2016 | 1 | 0 | 0 |
| 2018 | 2 | 0 | 2 |
| 2019 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
What Is PROLINE Used For?
| Indication | Reports |
|---|---|
| Overdose | 11 |
| Product used for unknown indication | 5 |
Official FDA Label for PROLINE
Official prescribing information from the FDA-approved drug label.