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Proleukin Side Effects

Generic Name: aldesleukin

Note: This document contains side effect information about aldesleukin. Some of the dosage forms listed on this page may not apply to the brand name Proleukin.

For the Consumer

Applies to aldesleukin: intravenous powder for solution

Along with its needed effects, aldesleukin (the active ingredient contained in Proleukin) 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
  • Agitation
  • confusion
  • diarrhea
  • dizziness
  • drowsiness
  • fever or chills
  • mental depression
  • nausea and vomiting
  • shortness of breath
  • sores in the mouth and on lips
  • tingling of the hands or feet
  • unusual decrease in urination
  • unusual tiredness or weakness
  • weight gain of 5 to 10 pounds or more
Less common
  • Bloating and stomach pain
  • blurred or double vision
  • faintness
  • fast or irregular heartbeat
  • loss of taste
  • rapid breathing
  • redness, swelling, and soreness of the tongue
  • trouble with speaking
  • yellow eyes and skin
  • Changes in menstrual periods
  • clumsiness
  • coldness
  • convulsions (seizures)
  • listlessness
  • muscle aches
  • pain or redness at injection site
  • sudden inability to move
  • swelling in the front of the neck
  • swelling of the feet or lower legs
  • weakness
Less common
  • Black, tarry stools
  • blisters on the skin
  • blood in the urine
  • bloody vomit
  • chest pain
  • cough or hoarseness
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on the skin
  • stomach pain (severe)
  • unusual bleeding or bruising

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
  • Dry skin
  • loss of appetite
  • skin rash or redness with burning or itching, followed by peeling
  • unusual feeling of discomfort or illness
Less common
  • Constipation
  • headache
  • joint pain
  • muscle pain

For Healthcare Professionals

Applies to aldesleukin: intravenous powder for injection


-Very common (10% or more): Anti-aldesleukin (the active ingredient contained in Proleukin) antibodies (up to 74%)
-Common (1% to 10%): Neutralizing antibodies[Ref]


-Very common (10% or more): Hypotension (up to 71%), tachycardia (up to 23%), vasodilation (up to 13%), supraventricular tachycardia (up to 12%), cardiovascular disorder (up to 11%), arrhythmia (up to 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, hypoperfusion, bradycardia, ventricular extrasystoles, atrial arrhythmia, second degree AV block, endocarditis, coronary artery disorder, transient ischemic attacks, pericarditis, shock
-Postmarketing reports: Cardiac tamponade[Ref]

Cardiovascular disorder includes fluctuations in blood pressure, asymptomatic ECG changes, cardiac failure, and congestive heart failure.[Ref]


-Very common (10% or more): Diarrhea (up to 67%), vomiting (up to 50%), nausea (up to 35%), stomatitis (up to 22%), nausea with vomiting (up to 19%), abdominal pain (up to 11%), enlarged abdomen (up to 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 (up to 63%), increased serum creatinine (up to 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 (up to 52%), fever (up to 29%), peripheral edema (up to 28%), malaise (up to 27%), asthenia/fatigue (up to 23%), edema (up to 15%), infection (up to 13%), pain (up to 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 (up to 43%), lung disorder (up to 24%), respiratory disorder (up to 11%), increased cough (up to 11%), rhinitis (up to 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 (up to 42%), pruritus (up to 24%), exfoliative dermatitis (up to 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 leukocytoplastic hypersensitivity vasculitis
-Postmarketing reports: Cellulitis[Ref]


-Very common (10% or more): Bilirubinemia (up to 40%), increased SGOT (up to 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 (up to 37%), anemia (up to 29%), leukopenia (up to 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 (up to 34%), anxiety (up to 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 (up to 20%), weight gain (up to 16%), acidosis (up to 12%), hypomagnesemia (up to 12%), hypocalcemia (up to 11%), increased alkaline phosphatase (up to 10%), weight loss
-Common (1% to 10%): Hypercalcemia, hyperkalemia, dehydration, elevated lactic dehydrogenase[Ref]

Nervous system

-Very common (10% or more): Somnolence (up to 22%), dizziness (up to 11%), headache, paraesthesia
-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. "Product Information. Proleukin (aldesleukin)." Chiron Therapeutics, Emeryville, CA.

Some side effects of Proleukin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.