What the label lists and what reports show
Aldesleukin side effects
Aldesleukin's FDA label: “Most common (≥ 30%) adverse reactions including laboratory abnormalities are hypotension, hyperbilirubinemia, dyspnea, rash, diarrhea, oliguria, chills, vomiting, thrombocytopenia, nausea, confusional state and increased creatinine.” FAERS holds 1,231 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (148 reports).
- No generic listed
- Boxed warning
Check it at the source: the aldesleukin FDA label on DailyMed (effective December 20, 2024, Iovance Biotherapeutics, Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common (≥ 30%) adverse reactions including laboratory abnormalities are hypotension, hyperbilirubinemia, dyspnea, rash, diarrhea, oliguria, chills, vomiting, thrombocytopenia, nausea, confusional state and increased creatinine.
Table 4: Adverse Reactions (≥10% all grades or ≥1% Grade 4) in Patients with Metastatic Renal Cell Carcinoma or Metastatic Melanoma (n=525) receiving Proleukin
| Reaction | Adverse Reaction All Grades (%) | Proleukin N = 525 Grade 4 (%) |
|---|---|---|
| Chills | 52 | 0 |
| Pyrexia | 29 | 1 |
| Edema peripheral | 28 | 0 |
| Malaise | 27 | 0 |
| Asthenia | 23 | 0 |
| Edema | 15 | 0 |
| Pain | 12 | 0 |
| Hypotension | 71 | 3 |
| Tachycardia | 23 | 0 |
| Dilated veins | 13 | 0 |
| Supraventricular tachycardia | 12 | 1 |
| Ventricular tachycardia | <10 | 1 |
| Cardiovascular disorder Cardiovascular disorder: Electrocardiogram abnormal, cardiac… | 11 | 0 |
| Myocardial infarction | <10 | 1 |
| Arrhythmia | 10 | 0 |
| Cardiac arrest | <10 | 1 |
| Diarrhea | 67 | 2 |
| Vomiting | 50 | 0 |
| Nausea | 35 | 0 |
| Stomatitis | 22 | <1 |
| Decreased appetite | 20 | 0 |
| Abdominal pain | 11 | 0 |
| Abdominal distention | 10 | 0 |
| Thrombocytopenia | 37 | 1 |
| Anemia | 29 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Capillary Leak Syndrome [see Warnings and Precautions (5.1) ]. Neurotoxicity [see Warnings and Precautions (5.2) ]. Serious Infections Including Sepsis [see Warnings and Precautions (5.3) ]. Renal Toxicity [see Warnings and Precautions (5.4) ]. Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.5) ]. Serious Manifestations of Eosinophilia [see Warnings and Precautions (5.7) ]. Severe Hypersensitivity Reactions [see Warnings and Precautions (5.9) ]. Infusion-Related Reactions [see Warnings and Precautions (5.10) ]. Most common (≥ 30%) adverse reactions including laboratory abnormalities are hypotension, hyperbilirubinemia, dyspnea, rash, diarrhea, oliguria, chills, vomiting, thrombocytopenia, nausea, confusional state and increased creatinine. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Iovance Biotherapeutics Manufacturing LLC. at 1 844-845-IOVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, BLA103293 (Chiron), as published by Iovance Biotherapeutics, Inc, effective December 20, 2024 (SPL set f3c516ad-d405-4fbe-af6a-962080dbfa7d), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,231 reports list aldesleukin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 207 are coded as a death and 602 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Aldesleukin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions