ORNITHINE ASPARTATE: 31 Adverse Event Reports & Safety Profile
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31
Total FAERS Reports
8 (25.8%)
Deaths Reported
17
Hospitalizations
31
As Primary/Secondary Suspect
5
Life-Threatening
4
Disabilities
First Report: 20011128 · Latest Report: 20230828
What Are the Most Common ORNITHINE ASPARTATE Side Effects?
#1 Most Reported
Stevens-johnson syndrome
13 reports (41.9%)
#2 Most Reported
Toxic epidermal necrolysis
12 reports (38.7%)
#3 Most Reported
Sepsis
12 reports (38.7%)
All ORNITHINE ASPARTATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Stevens-johnson syndrome | 13 | 41.9% | 0 | 13 |
| Sepsis | 12 | 38.7% | 0 | 12 |
| Toxic epidermal necrolysis | 12 | 38.7% | 0 | 12 |
| Acidosis | 5 | 16.1% | 5 | 0 |
| Blood pressure decreased | 5 | 16.1% | 5 | 0 |
| Central nervous system injury | 5 | 16.1% | 5 | 0 |
| Chromaturia | 5 | 16.1% | 5 | 0 |
| Heart rate increased | 5 | 16.1% | 5 | 0 |
| Hyperchloraemia | 5 | 16.1% | 5 | 0 |
| Hyperkalaemia | 5 | 16.1% | 5 | 0 |
| Hypoglycaemia | 5 | 16.1% | 5 | 0 |
| Hypoxia | 5 | 16.1% | 5 | 0 |
| Loss of consciousness | 5 | 16.1% | 5 | 0 |
| Tachyarrhythmia | 5 | 16.1% | 5 | 0 |
Who Reports ORNITHINE ASPARTATE Side Effects? Age & Gender Data
Gender: 58.6% female, 41.4% male. Average age: 41.0 years. Most reports from: DE. View detailed demographics →
Is ORNITHINE ASPARTATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 10 | 0 | 10 |
| 2017 | 2 | 2 | 2 |
| 2018 | 5 | 5 | 0 |
| 2019 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
What Is ORNITHINE ASPARTATE Used For?
| Indication | Reports |
|---|---|
| Liver disorder | 11 |
| Product used for unknown indication | 10 |
Official FDA Label for ORNITHINE ASPARTATE
Official prescribing information from the FDA-approved drug label.