Aldesleukin side effects: what 1,231 FDA adverse event reports show
Drug class
Lymphocyte Growth Factor
Brand names
Proleukin
Who reports
1,231 reports · 93% serious · 207 with death outcome · 38% female
Used for
Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) The treatment of adults with metastatic melanoma. ( 1.2 ) 1.1 Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC). 1.2 Metastatic Melanoma Proleukin is indicated for the treatment of adults with metastatic melanoma.
What it is
Aldesleukin is a human interleukin-2 lymphocyte growth factor produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human interleukin-2 gene. It is a purified protein with a molecular weight of approximately 15,300 Da.
Boxed warning
CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 35 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 32 | 28.7 20.3–40.3ROR 29.4 · χ² 826 / p 6e-182 | 28.2 EB05 20.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Device related infection | 25 | 27.6 18.7–40.8ROR 28.2 · χ² 615 / p 5e-136 | 27.1 EB05 19.3 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 16.9 · 96% clinician | no trial data cached |
| Hypoxia (low oxygen) | 54 | 26.3 20.2–34.1ROR 27.4 · χ² 1,287 / p 3e-282 | 26.0 EB05 20.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 | no trial data cached |
| Myocarditis | 15 | 22.6 13.7–37.4ROR 22.9 · χ² 288 / p 7e-65 | 21.9 EB05 13.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.1 | no trial data cached |
| Lymphopenia | 18 | 21.8 13.8–34.5ROR 22.1 · χ² 337 / p 2e-75 | 21.3 EB05 14.1 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.6 | no trial data cached |
| Clostridium difficile colitis | 13 | 20.9 12.2–35.9ROR 21.1 · χ² 226 / p 2e-51 | 20.1 EB05 12.1 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.2 | no trial data cached |
| Metastases to lung | 13 | 19.2 11.2–33.0ROR 19.4 · χ² 206 / p 4e-47 | 18.4 EB05 10.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.1 | no trial data cached |
| Ejection fraction decreased | 16 | 17.5 10.8–28.5ROR 17.7 · χ² 233 / p 7e-53 | 16.9 EB05 10.6 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 11.2 | no trial data cached |
| Mental status changes | 28 | 17.2 11.9–24.8ROR 17.6 · χ² 411 / p 1e-91 | 16.9 EB05 12.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.8 | no trial data cached |
| Anorexia | 13 | 17.0 9.9–29.1ROR 17.1 · χ² 179 / p 3e-41 | 16.0 EB05 9.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Splenomegaly | 11 | 16.0 8.9–28.9ROR 16.2 · χ² 140 / p 1e-32 | 14.7 EB05 7.7 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.2 | no trial data cached |
| Metastases to central nervous system | 12 | 16.0 9.1–28.1ROR 16.1 · χ² 154 / p 1e-35 | 14.8 EB05 8.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.0 | no trial data cached |
| Sinus tachycardia | 13 | 15.6 9.1–26.9ROR 15.8 · χ² 164 / p 9e-38 | 14.6 EB05 8.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Pulmonary oedema | 40 | 15.2 11.2–20.6ROR 15.7 · χ² 518 / p 7e-115 | 15.0 EB05 11.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 92% clinician | no trial data cached |
| Acute respiratory failure | 17 | 15.1 9.4–24.3ROR 15.3 · χ² 211 / p 5e-48 | 14.4 EB05 9.0 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.4 | no trial data cached |
| Haemorrhage intracranial | 13 | 14.8 8.6–25.4ROR 14.9 · χ² 153 / p 2e-35 | 13.6 EB05 7.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 | no trial data cached |
| Cytopenia | 10 | 14.3 7.7–26.5ROR 14.4 · χ² 110 / p 4e-26 | 12.5 EB05 6.2 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Myelodysplastic syndrome | 12 | 14.1 8.0–24.8ROR 14.3 · χ² 134 / p 3e-31 | 12.7 EB05 6.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Malignant melanoma | 11 | 14.0 7.8–25.2ROR 14.1 · χ² 120 / p 3e-28 | 12.4 EB05 6.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 | no trial data cached |
| Blood bilirubin increased | 22 | 13.8 9.1–21.0ROR 14.1 · χ² 250 / p 2e-56 | 13.3 EB05 8.8 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 9.4 · 95% clinician | no trial data cached |
| Drug toxicity | 11 | 13.6 7.5–24.5ROR 13.7 · χ² 116 / p 3e-27 | 11.9 EB05 6.2 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 | no trial data cached |
| Febrile neutropenia | 51 | 13.1 10.0–17.2ROR 13.7 · χ² 561 / p 3e-124 | 12.9 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · ♀ 63% (drug 38%) · 100% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 83 | 12.7 10.3–15.6ROR 13.5 · χ² 886 / p 5e-195 | 12.5 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 92% clinician | no trial data cached |
| Quality of life decreased | 10 | 12.7 6.8–23.5ROR 12.8 · χ² 96 / p 5e-23 | 10.7 EB05 5.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Tachypnoea | 10 | 12.6 6.8–23.3ROR 12.7 · χ² 95 / p 8e-23 | 10.6 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 37 | 11.3 8.2–15.5ROR 11.6 · χ² 338 / p 7e-76 | 10.9 EB05 8.0 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 · ♀ 61% (drug 38%) | no trial data cached |
| Unresponsive to stimuli | 17 | 11.3 7.0–18.1ROR 11.4 · χ² 149 / p 1e-34 | 10.1 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Encephalopathy | 16 | 11.1 6.8–18.1ROR 11.3 · χ² 138 / p 4e-32 | 9.9 EB05 6.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Pleural effusion | 39 | 10.9 8.0–14.9ROR 11.2 · χ² 342 / p 1e-76 | 10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Blood lactate dehydrogenase increased | 10 | 10.7 5.8–19.8ROR 10.8 · χ² 78 / p 4e-19 | 8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.1 | no trial data cached |
| Bacterial infection | 11 | 10.1 5.6–18.2ROR 10.2 · χ² 81 / p 1e-19 | 8.2 EB05 4.5 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.2 | no trial data cached |
| Rash maculo-papular | 13 | 10.0 5.8–17.2ROR 10.1 · χ² 97 / p 4e-23 | 8.4 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Renal failure acute | 25 | 9.9 6.7–14.6ROR 10.1 · χ² 191 / p 8e-44 | 9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 100% clinician | no trial data cached |
| Hypotension (low blood pressure) | 111 | 9.4 7.9–11.3ROR 10.3 · χ² 837 / p 2e-184 | 9.3 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.6 · 96% clinician | no trial data cached |
| Blood creatinine increased | 36 | 9.4 6.8–12.9ROR 9.6 · χ² 262 / p 3e-59 | 8.8 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 94% clinician | no trial data cached |
| Respiratory failure | 39 | 9.1 6.7–12.4ROR 9.4 · χ² 274 / p 7e-62 | 8.6 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 62% (drug 38%) · 91% clinician | no trial data cached |
| Cerebral infarction | 13 | 9.1 5.3–15.6ROR 9.1 · χ² 85 / p 1e-20 | 7.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 | no trial data cached |
| Chills | 62 | 9.0 7.1–11.5ROR 9.4 · χ² 435 / p 6e-97 | 8.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Multiple organ dysfunction syndrome | 14 | 8.5 5.1–14.4ROR 8.6 · χ² 86 / p 9e-21 | 7.1 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Disease progression | 52 | 7.5 5.8–9.8ROR 7.8 · χ² 289 / p 5e-65 | 7.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 94% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypotension (low blood pressure) | 111 | 9.4 7.9–11.3ROR 10.3 · χ² 837 / p 2e-184 | 9.3 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.6 · 96% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 83 | 12.7 10.3–15.6ROR 13.5 · χ² 886 / p 5e-195 | 12.5 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 92% clinician | no trial data cached |
| Chills | 62 | 9.0 7.1–11.5ROR 9.4 · χ² 435 / p 6e-97 | 8.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Hypoxia (low oxygen) | 54 | 26.3 20.2–34.1ROR 27.4 · χ² 1,287 / p 3e-282 | 26.0 EB05 20.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 | no trial data cached |
| Disease progression | 52 | 7.5 5.8–9.8ROR 7.8 · χ² 289 / p 5e-65 | 7.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 94% clinician | no trial data cached |
| Febrile neutropenia | 51 | 13.1 10.0–17.2ROR 13.7 · χ² 561 / p 3e-124 | 12.9 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · ♀ 63% (drug 38%) · 100% clinician | no trial data cached |
| Malignant neoplasm progression | 42 | 7.0 5.2–9.5ROR 7.2 · χ² 212 / p 2e-48 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 92% clinician | no trial data cached |
| Pulmonary oedema | 40 | 15.2 11.2–20.6ROR 15.7 · χ² 518 / p 7e-115 | 15.0 EB05 11.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 92% clinician | no trial data cached |
| Respiratory failure | 39 | 9.1 6.7–12.4ROR 9.4 · χ² 274 / p 7e-62 | 8.6 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 62% (drug 38%) · 91% clinician | no trial data cached |
| Pleural effusion | 39 | 10.9 8.0–14.9ROR 11.2 · χ² 342 / p 1e-76 | 10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 37 | 11.3 8.2–15.5ROR 11.6 · χ² 338 / p 7e-76 | 10.9 EB05 8.0 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 · ♀ 61% (drug 38%) | no trial data cached |
| Blood creatinine increased | 36 | 9.4 6.8–12.9ROR 9.6 · χ² 262 / p 3e-59 | 8.8 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 94% clinician | no trial data cached |
| Cytokine release syndrome | 32 | 28.7 20.3–40.3ROR 29.4 · χ² 826 / p 6e-182 | 28.2 EB05 20.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Mental status changes | 28 | 17.2 11.9–24.8ROR 17.6 · χ² 411 / p 1e-91 | 16.9 EB05 12.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.8 | no trial data cached |
| Renal failure acute | 25 | 9.9 6.7–14.6ROR 10.1 · χ² 191 / p 8e-44 | 9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 100% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Cytokine release syndrome — n=32, PRR 28.7
- Pleural effusion — n=39, PRR 10.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Aldesleukin?
In FDA FAERS, the most frequently co-reported reaction terms for Aldesleukin are hypotension, thrombocytopenia, chills, hypoxia, febrile neutropenia, pulmonary oedema. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Aldesleukin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment.
Do FAERS signals prove that Aldesleukin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f3c516ad-d405-4fbe-af6a-962080dbfa7d, effective 20241220; matched on
openfda.generic_name.exact:"ALDESLEUKIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 75 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.