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Aldesleukin Side Effects

The most commonly reported side effects of aldesleukin include pyrexia, off label use, and pyrexia, based on 1,354 FDA adverse event reports from 2004 to 2025. 3.5% of reports found the drug to be ineffective.

Aldesleukin side effects

Percentages show how often each reaction appears relative to total reports for aldesleukin.

1
Pyrexia6.7%91
2
Off Label Use6.4%86
3
Pyrexia4.9%66
4
Hypotension4.4%60
5
Thrombocytopenia4.2%57
6
Hypotension4.1%56
7
Diarrhoea3.7%50
8
Drug Ineffective3.5%47
9
Nausea3.4%46
10
Acute Kidney Injury3.4%46
11
Pain3.4%46
12
Vomiting3.2%44
13
Hypoxia3.2%44
14
Diarrhoea3.0%40
15
Fatigue2.7%37

These are voluntary reports and do not establish that aldesleukin caused these reactions.

Report severity

93.9%Serious1,272 reports
54.6%Hospitalizations739 reports
16.2%Fatal219 reports

Seriousness is determined by the reporter, not by OpenClaim.

Aldesleukin drug interactions

Other drugs that appear in adverse event reports alongside aldesleukin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Cyclophosphamide24.3%329
2
Fludarabine-phosphate23.1%313
3
Nivolumab10.6%144
4
Pembrolizumab6.1%83
5
Dinutuximab4.2%57
6
Interferon3.8%51
7
Fluorouracil3.5%48
8
Bevacizumab3.5%47
9
Isotretinoin3.4%46
10
Sargramostim3.0%41
11
Ropeginterferon-alfa-2b-njft2.5%34
12
Cisplatin2.4%32
13
Ipilimumab2.1%29
14
Etoposide1.9%26
15
Peginterferon1.8%24

Taken alongside

1
Acetaminophen14.5%196
2
Ondansetron7.5%102
3
Acyclovir6.9%93
4
Filgrastim5.6%76
5
Fluconazole5.4%73
6
Lorazepam5.3%72
7
Furosemide5.2%71
8
Amlodipine5.2%71
9
Sulfamethoxazole5.0%68
10
Levothyroxine-sodium4.9%67
11
Pantoprazole-sodium4.7%64
12
Oxycodone4.6%62
13
Famotidine4.6%62
14
Trimethoprim4.4%60
15
Diphenhydramine4.4%59

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports aldesleukin side effects

28.1% of aldesleukin adverse event reports involve female patients and 51.8% involve male patients. The largest age group is adult at 63%. These figures reflect who reports side effects, not underlying risk.

Sex

Female28.1%
Male51.8%
Unknown20.0%

Age group

< 21.6%
2–117.4%
12–170.8%
18–6463.0%
65+27.3%

What is aldesleukin used for

Conditions and purposes for which patients were taking aldesleukin when the adverse event was reported.

Acral Lentiginous MelanomaAcute Febrile Neutrophilic DermatosisAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAdenocarcinomaAdenosquamous Carcinoma Of The CervixAmyotrophic Lateral SclerosisAngiosarcomaAcral Lentiginous MelanomaAcral Lentiginous Melanoma Stage IiiAcute Febrile Neutrophilic DermatosisAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma MetastaticAdenocarcinoma Of The Cervix

Showing 15 of 201 indications

Aldesleukin brand names and reporting trend

Aldesleukin is sold under the brand name Proleukin.

Brand names

Proleukin747

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking aldesleukin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.