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Aldesleukin Side Effects

Medically reviewed by Last updated on Jun 12, 2024.

Applies to aldesleukin: intravenous powder for solution.


Intravenous route (Powder for Solution)

Warning: Capillary Leak Syndrome (CLS), Neurologic Toxicities and Serious InfectionsCapillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with aldesleukin. Do not administer aldesleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment. Administer aldesleukin in a hospital setting with an intensive care facility. Withhold or discontinue aldesleukin as recommended.Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with aldesleukin. Withhold or discontinue aldesleukin as recommended.Serious infections including sepsis and bacterial endocarditis have occurred in patients treated with aldesleukin. Treat pre-existing bacterial infections prior to initiation of aldesleukin therapy and withhold aldesleukin as recommended.

Serious side effects of Aldesleukin

Along with its needed effects, aldesleukin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking aldesleukin:

More common


Incidence not known

Other side effects of Aldesleukin

Some side effects of aldesleukin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

For Healthcare Professionals

Applies to aldesleukin: intravenous powder for injection.


Very common (10% or more): Anti-aldesleukin antibodies (74%)

Common (1% to 10%): Neutralizing antibodies[Ref]


Very common (10% or more): Hypotension (71%), tachycardia (23%), vasodilation (13%), supraventricular tachycardia (12%), cardiovascular disorder (11%), arrhythmia (10%), chest pain

Common (1% to 10%): Myocardial infarction, ventricular tachycardia, cardiac arrest, cyanosis, transient ECG changes, myocardial ischemia, palpitations, phlebitis, hypertension

Uncommon (0.1% to 1%): Hemorrhage (including subdural, subarachnoid, cerebral, retroperitoneal), myocarditis, cardiomyopathy, pericardial effusion, thrombosis, thrombophlebitis

Rare (less than 0.1%): Ventricular hypokinesia

Frequency not reported: Capillary leak syndrome (CLS), hypoperfusion, bradycardia, ventricular extrasystoles, atrial arrhythmia, second degree AV block, endocarditis, coronary artery disorder, transient ischemic attacks, pericarditis, shock

Postmarketing reports: Cardiac tamponade[Ref]


Very common (10% or more): Diarrhea (67%), vomiting (50%), nausea (35%), stomatitis (22%), nausea with vomiting (19%), abdominal pain (11%), enlarged abdomen (10%)

Common (1% to 10%): Dysphagia, dyspepsia, constipation, GI bleeding (including rectal hemorrhage), hematemesis, ascites, cheilitis, gastritis

Uncommon (0.1% to 1%): Pancreatitis, intestinal obstruction, GI perforation (including necrosis/gangrene)

Rare (less than 0.1%): Activation of quiescent Crohn's disease

Frequency not reported: GI hemorrhage, bloody diarrhea, GI disorder, intestinal perforation, duodenal ulceration, bowel necrosis, bowel perforation/infarction

Postmarketing reports: Colitis[Ref]


Very common (10% or more): Oliguria (63%), increased serum creatinine (33%), increased serum urea

Common (1% to 10%): Anuria, hematuria, renal failure

Frequency not reported: Increased blood urea nitrogen, crescentic IgA glomerulonephritis, acute tubular necrosis, allergic interstitial nephritis

Postmarketing reports: Increased hyperuricemia non-protein nitrogen[Ref]


Very common (10% or more): Chills (52%), fever (29%), peripheral edema (28%), malaise (27%), asthenia/fatigue (23%), edema (15%), infection (13%), pain (12%), injection site reactions, injection site necrosis, injection site pain, injection site inflammation

Common (1% to 10%): Sepsis, mucositis, injection site nodule, hypothermia

Frequency not reported: Peripheral gangrene, atypical reactions to iodinated contrast media, catheter site infections, bacterial infections, malignant hyperthermia[Ref]


Lung disorder includes physical findings associated with pulmonary congestion, rales, and rhonchi. Respiratory disorder includes acute respiratory distress syndrome (ARDS), chest x-ray infiltrates, respiratory failure, intubation, and unspecified pulmonary changes.[Ref]

Very common (10% or more): Dyspnea (43%), lung disorder (24%), respiratory disorder (11%), increased cough (11%), rhinitis (10%)

Common (1% to 10%): Apnea, respiratory tract infection, lung/pulmonary edema, pleural effusion, hypoxia, hemoptysis, epistaxis, nasal congestion, rhinitis

Rare (less than 0.1%): Pulmonary embolism

Frequency not reported: Respiratory acidosis, asthma, hyperventilation, hypoventilation, pneumothorax, trachea-esophageal fistula, respiratory arrest

Postmarketing reports: Pneumonia (bacterial, fungal, viral)[Ref]


Very common (10% or more): Erythema and rash (42%), pruritus (24%), exfoliative dermatitis (18%), sweating

Common (1% to 10%): Urticaria, alopecia

Uncommon (0.1% to 1%): Quincke's edema, vitiligo

Rare (less than 0.1%): Vesiculobullous rash, Stevens-Johnson syndrome

Frequency not reported: Bullous pemphigoid, cutaneous and leukocytoclastic hypersensitivity vasculitis

Postmarketing reports: Cellulitis[Ref]


Very common (10% or more): Bilirubinemia (40%), increased SGOT (23%)

Common (1% to 10%): Acute kidney failure, elevation of hepatic transaminases

Uncommon (0.1% to 1%): Hyperbilirubinemia, hepatomegaly/hepatosplenomegaly

Rare (less than 0.1%): Cholecystitis, liver failure

Frequency not reported: Abnormal liver function tests, abnormal kidney function

Postmarketing reports: Hepatitis[Ref]


Very common (10% or more): Thrombocytopenia (37%), anemia (29%), leukopenia (16%)

Common (1% to 10%): Coagulopathy (including disseminated intravascular coagulation), eosinophilia

Uncommon (0.1% to 1%): Neutropenia

Rare (less than 0.1%): Agranulocytosis, aplastic anemia, hemolytic anemia, neutropenic fever

Frequency not reported: Leukocytosis, lymphocytosis

Postmarketing reports: Lymphocytopenia[Ref]


Very common (10% or more): Confusion (34%), anxiety (12%), depression, insomnia

Common (1% to 10%): Psychosis, irritability, agitation, hallucinations

Frequency not reported: Paranoid reaction, delirium, suicide[Ref]


Very common (10% or more): Hypothyroidism

Common (1% to 10%): Hyperthyroidism, hyperglycemia

Uncommon (0.1% to 1%): Hypoglycemia

Rare (less than 0.1%): Diabetes mellitus

Frequency not reported: Thyroiditis[Ref]


Very common (10% or more): Anorexia (20%), weight gain (16%), acidosis (12%), hypomagnesemia (12%), hypocalcemia (11%), increased alkaline phosphatase (10%), weight loss

Common (1% to 10%): Hypercalcemia, hyperkalemia, dehydration, elevated lactic dehydrogenase[Ref]

Nervous system

Very common (10% or more): Somnolence (22%), dizziness (11%), headache, paresthesia

Common (1% to 10%): Coma, stupor, neuropathy, syncope, speech disorders, taste loss, lethargy

Uncommon (0.1% to 1%): Convulsions, paralysis

Rare (less than 0.1%): Leukoencephalopathy

Frequency not reported: Grand mal convulsion, meningitis, cerebral edema, mental status changes, ataxia (limb or gait), cortical lesion, cerebral vasculitis, obtundation, cerebrovascular accident, stroke, cerebral vasculitis

Postmarketing reports: Cerebral lesions, extrapyramidal syndrome, neuralgia, neuritis, demyelinating neuropathy[Ref]


Most adverse reactions were self-limited and usually reversed or improved within 1 to 3 days of therapy cessation; however, some adverse reactions (e.g., myocardial infarction, bowl perforation/infarction, gangrene) have permanent sequelae.[Ref]


Uncommon (0.1% to 1%): Hypersensitivity reactions

Rare (less than 0.1%): Anaphylaxis[Ref]


Common (1% to 10%): Myalgia, arthralgia

Uncommon (0.1% to 1%): Myasthenia, myopathy, myositis

Frequency not reported: Scleroderma, inflammatory arthritis, oculobulbar myasthenia gravis

Postmarketing reports: Rhabdomyolysis[Ref]


Common (1% to 10%): Conjunctivitis

Rare (less than 0.1%): Optic nerve disorder (including optic neuritis)

Frequency not reported: Cortical blindness, mydriasis, pupillary disorder, blindness (permanent and transient)[Ref]


1. (2001) "Product Information. Proleukin (aldesleukin)." Chiron Therapeutics

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.