TECELEUKIN: 73 Adverse Event Reports & Safety Profile
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73
Total FAERS Reports
19 (26.0%)
Deaths Reported
20
Hospitalizations
73
As Primary/Secondary Suspect
5
Life-Threatening
1
Disabilities
First Report: 20140418 · Latest Report: 20250430
What Are the Most Common TECELEUKIN Side Effects?
#1 Most Reported
Pyrexia
65 reports (89.0%)
#2 Most Reported
Aspartate aminotransferase increased
44 reports (60.3%)
#3 Most Reported
Hypoalbuminaemia
42 reports (57.5%)
All TECELEUKIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pyrexia | 65 | 89.0% | 19 | 16 |
| Aspartate aminotransferase increased | 44 | 60.3% | 8 | 11 |
| Hypoalbuminaemia | 42 | 57.5% | 7 | 11 |
| Alanine aminotransferase increased | 38 | 52.1% | 6 | 11 |
| Abdominal pain | 35 | 48.0% | 11 | 10 |
| Platelet count decreased | 30 | 41.1% | 6 | 9 |
| Gamma-glutamyltransferase increased | 25 | 34.3% | 6 | 7 |
| Anaemia | 24 | 32.9% | 5 | 6 |
| Vomiting | 24 | 32.9% | 4 | 6 |
| Neutrophil count decreased | 23 | 31.5% | 2 | 8 |
| Hypoxia | 22 | 30.1% | 2 | 5 |
| Neuroblastoma recurrent | 21 | 28.8% | 12 | 7 |
| Oedema | 21 | 28.8% | 5 | 5 |
| Pain | 21 | 28.8% | 1 | 5 |
| Pain in extremity | 19 | 26.0% | 7 | 5 |
| Malaise | 17 | 23.3% | 4 | 4 |
| C-reactive protein increased | 15 | 20.6% | 3 | 4 |
| Constipation | 15 | 20.6% | 1 | 3 |
| Face oedema | 15 | 20.6% | 0 | 2 |
| Diarrhoea | 14 | 19.2% | 4 | 1 |
Who Reports TECELEUKIN Side Effects? Age & Gender Data
Gender: 48.1% female, 51.9% male. Average age: 6.9 years. Most reports from: JP. View detailed demographics →
Is TECELEUKIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 7 | 0 | 1 |
| 2015 | 4 | 0 | 2 |
| 2017 | 2 | 0 | 1 |
| 2021 | 31 | 13 | 8 |
| 2022 | 18 | 5 | 4 |
| 2023 | 4 | 1 | 2 |
| 2024 | 3 | 0 | 1 |
| 2025 | 1 | 0 | 1 |
What Is TECELEUKIN Used For?
| Indication | Reports |
|---|---|
| Neuroblastoma | 53 |
| Neuroblastoma recurrent | 20 |
Official FDA Label for TECELEUKIN
Official prescribing information from the FDA-approved drug label.