Aldesleukin: Side Effects, Uses & Monitoring
Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).
- Data source
- FDA labeling via NIH DailyMed (label 4e2b687e…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Hypotension | 71% |
| Diarrhea | 67% |
| Oliguria | 63% |
| Chills | 52% |
| Vomiting | 50% |
| Hemic and lymphatic | 42% |
| Thrombocytopenia | 37% |
| Nausea | 35% |
| Vasodilation | 34% |
| Fever | 33% |
| Anemia | 29% |
| Malaise | 28% |
| Asthenia | 23% |
| Tachycardia | 23% |
| Supraventricular tachycardia | 22% |
| Stomatitis | 22% |
| Anorexia | 20% |
| Nausea and vomiting | 19% |
| Infection | 16% |
| Leukopenia | 16% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC). Proleukin is indicated for the treatment of adults with metastatic melanoma. Careful patient selection is mandatory prior to the administration of Proleukin. See “ CONTRAINDICATIONS ”, “ WARNINGS ” and “ PRECAUTIONS ” sections regarding patient screening, including recommended cardiac and pulmonary function tests and laboratory tests. Evaluation of clinical studies to date reveals that patients with more favorable ECOG performance status (ECOG PS 0) at treatment initiation respond better to Proleukin, with a higher response rate and lower toxicity (See “ CLINICAL PHARMACOLOGY ” section, “ CLINICAL STUDIES ” section and “ ADVERSE REACTIONS ” section). Therefore, selection of patients for treatment should include assessment of performance status. Experience in patients with ECOG PS >1 is extremely limited.
Conditions associated with Aldesleukin in labeling
Frequently Asked Questions
What is Aldesleukin used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Aldesleukin?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Aldesleukin. Individual risk varies.
Does Aldesleukin require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Aldesleukin.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.