Drug
Aldesleukin
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Cytokine Release Syndrome | 32 | 28.7 | 29.4 | signal |
| 2 | Device Related Infection | 25 | 27.6 | 28.2 | signal |
| 3 | Hypoxia | 54 | 26.3 | 27.4 | signal |
| 4 | Myocarditis | 15 | 22.6 | 22.9 | signal |
| 5 | Lymphopenia | 18 | 21.8 | 22.1 | signal |
| 6 | Clostridium Difficile Colitis | 13 | 20.9 | 21.1 | signal |
| 7 | Metastases To Lung | 13 | 19.2 | 19.4 | signal |
| 8 | Ejection Fraction Decreased | 16 | 17.5 | 17.7 | signal |
| 9 | Mental Status Changes | 28 | 17.2 | 17.6 | signal |
| 10 | Anorexia | 13 | 17.0 | 17.1 | signal |
| 11 | Splenomegaly | 11 | 16.0 | 16.2 | signal |
| 12 | Metastases To Central Nervous System | 12 | 16.0 | 16.1 | signal |
| 13 | Sinus Tachycardia | 13 | 15.6 | 15.8 | signal |
| 14 | Pulmonary Oedema | 40 | 15.2 | 15.7 | signal |
| 15 | Acute Respiratory Failure | 17 | 15.1 | 15.3 | signal |
| 16 | Haemorrhage Intracranial | 13 | 14.8 | 14.9 | signal |
| 17 | Cytopenia | 10 | 14.3 | 14.4 | signal |
| 18 | Myelodysplastic Syndrome | 12 | 14.1 | 14.3 | signal |
| 19 | Malignant Melanoma | 11 | 14.0 | 14.1 | signal |
| 20 | Blood Bilirubin Increased | 22 | 13.8 | 14.1 | signal |
| 21 | Drug Toxicity | 11 | 13.6 | 13.7 | signal |
| 22 | Febrile Neutropenia | 51 | 13.1 | 13.7 | signal |
| 23 | Thrombocytopenia | 83 | 12.7 | 13.5 | signal |
| 24 | Quality Of Life Decreased | 10 | 12.7 | 12.8 | signal |
| 25 | Tachypnoea | 10 | 12.6 | 12.7 | signal |
| 26 | Pancytopenia | 37 | 11.3 | 11.6 | signal |
| 27 | Unresponsive To Stimuli | 17 | 11.3 | 11.4 | signal |
| 28 | Encephalopathy | 16 | 11.1 | 11.3 | signal |
| 29 | Hypomagnesaemia | 9 | 11.1 | 11.1 | signal |
| 30 | Hypercalcaemia | 8 | 11.1 | 11.1 | signal |
| 31 | Pleural Effusion | 39 | 10.9 | 11.2 | signal |
| 32 | Supraventricular Tachycardia | 6 | 10.7 | 10.7 | signal |
| 33 | Blood Lactate Dehydrogenase Increased | 10 | 10.7 | 10.8 | signal |
| 34 | Electrolyte Imbalance | 7 | 10.4 | 10.4 | signal |
| 35 | Bacterial Infection | 11 | 10.1 | 10.2 | signal |
| 36 | Rash Maculo-papular | 13 | 10.0 | 10.1 | signal |
| 37 | Renal Failure Acute | 25 | 9.9 | 10.1 | signal |
| 38 | Hypotension | 111 | 9.4 | 10.3 | signal |
| 39 | Blood Creatinine Increased | 36 | 9.4 | 9.6 | signal |
| 40 | Respiratory Failure | 39 | 9.1 | 9.4 | signal |
| 41 | Cerebral Infarction | 13 | 9.1 | 9.1 | signal |
| 42 | Chills | 62 | 9.0 | 9.4 | signal |
| 43 | Posterior Reversible Encephalopathy Syndrome | 5 | 9.0 | 9.0 | signal |
| 44 | Uveitis | 7 | 8.8 | 8.9 | signal |
| 45 | Multi-organ Failure | 9 | 8.7 | 8.8 | signal |
| 46 | Multiple Organ Dysfunction Syndrome | 14 | 8.5 | 8.6 | signal |
| 47 | Hypotonia | 5 | 8.5 | 8.5 | signal |
| 48 | Generalised Tonic-clonic Seizure | 8 | 8.3 | 8.4 | signal |
| 49 | Hyperbilirubinaemia | 5 | 8.3 | 8.3 | signal |
| 50 | Hypocalcaemia | 9 | 8.1 | 8.2 | signal |
| 51 | Brain Oedema | 6 | 8.1 | 8.1 | signal |
| 52 | Acute Myeloid Leukaemia | 7 | 7.7 | 7.7 | signal |
| 53 | Disease Progression | 52 | 7.5 | 7.8 | signal |
| 54 | Eyelid Oedema | 5 | 7.3 | 7.3 | signal |
| 55 | Disseminated Intravascular Coagulation | 6 | 7.2 | 7.3 | signal |
| 56 | Cardiogenic Shock | 6 | 7.2 | 7.2 | signal |
| 57 | Thrombotic Microangiopathy | 4 | 7.0 | 7.1 | signal |
| 58 | Malignant Neoplasm Progression | 42 | 7.0 | 7.2 | signal |
| 59 | Neurotoxicity | 7 | 6.9 | 6.9 | signal |
| 60 | Tooth Extraction | 5 | 6.8 | 6.9 | signal |
| 61 | Eosinophilia | 7 | 6.8 | 6.9 | signal |
| 62 | Shock | 9 | 6.7 | 6.8 | signal |
| 63 | Neoplasm Progression | 13 | 6.3 | 6.4 | signal |
| 64 | Neutrophil Count Decreased | 15 | 6.3 | 6.4 | signal |
| 65 | Hyperthyroidism | 5 | 5.9 | 5.9 | signal |
| 66 | Metastases To Liver | 6 | 5.8 | 5.9 | signal |
| 67 | Bone Marrow Failure | 7 | 5.8 | 5.9 | signal |
| 68 | Fluid Overload | 5 | 5.8 | 5.8 | signal |
| 69 | Inappropriate Antidiuretic Hormone Secretion | 3 | 5.0 | 5.0 | signal |
| 70 | Injection Site Discomfort | 3 | 5.0 | 5.0 | signal |
| 71 | Status Epilepticus | 3 | 4.5 | 4.5 | signal |
| 72 | Diabetic Ketoacidosis | 6 | 4.3 | 4.3 | signal |
| 73 | Osteonecrosis | 7 | 3.6 | 3.6 | signal |
| 74 | Myelosuppression | 7 | 3.5 | 3.5 | signal |
| 75 | Injection Site Erythema | 15 | 2.1 | 2.1 | signal |