Proleukin Side Effects

Generic name: aldesleukin

Medically reviewed by Drugs.com. Last updated on Dec 5, 2023.

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

Applies to aldesleukin: intravenous powder for solution.

Serious side effects of Proleukin

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

• Anxiety
• black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• blue lips, fingernails, or skin
• blurred vision
• change in consciousness
• chest pain, discomfort, or tightness
• confusion
• coughing or vomiting blood
• decreased urine output
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fast, pounding, or irregular heartbeat or pulse
• fever or chills
• loss of appetite
• loss of consciousness
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• nausea
• no blood pressure or pulse
• numbness and tingling around the mouth, fingertips, or feet
• pain or discomfort in the arms, jaw, back, or neck
• painful or difficult urination
• pale skin
• palpitations
• persistent bleeding or oozing from puncture sites, mouth, or nose
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps
• stopping of the heart
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen glands
• tingling of the hands or feet
• tremor
• trouble breathing
• unconsciousness
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

Rare

• Agitation
• bloating
• burning, numbness, tingling, or painful sensations
• changes in skin color
• clumsiness
• constipation
• delusions of persecution, mistrust, suspiciousness, or combativeness
• depression
• dry, shriveled appearance of skin on the hands, lower legs, or feet
• heartburn
• heart murmur
• hostility
• indigestion
• irritability
• lethargy
• low body temperature
• muscle twitching
• pains in stomach, side, or abdomen, possibly radiating to the back
• severe stomach pain, cramping, or burning
• shivering
• slow or irregular heartbeat
• stupor
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• unsteadiness or awkwardness
• vomiting of blood or material that looks like coffee grounds
• weak or feeble pulse
• weakness in the arms, hands, legs, or feet
• yellow eyes or skin

Incidence not known

• Back pain
• blistering, peeling, or loosening of the skin
• dark urine
• difficulty swallowing
• hallucinations
• hives, itching skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nerve pain
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red irritated eyes
• red skin lesions, often with a purple center
• sensitivity to heat
• stiff neck
• stroke
• trouble sleeping
• upper right abdominal or stomach pain

Other side effects of Proleukin

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

• General feeling of discomfort or illness
• lack or loss of strength
• sneezing
• stuffy or runny nose
• swelling or inflammation of the mouth

Incidence not known

• Burning feeling in chest or stomach
• muscular tenderness or wasting
• tenderness in the stomach area

For Healthcare Professionals

Applies to aldesleukin: intravenous powder for injection.

Immunologic

Very common (10% or more): Anti-aldesleukin (the active ingredient contained in Proleukin) antibodies (74%)

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

Cardiovascular

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]

Gastrointestinal

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]

Renal

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]

Other

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]

Respiratory

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]

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]

Dermatologic

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]

Hepatic

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]

Hematologic

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]

Psychiatric

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]

Endocrine

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]

Metabolic

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]

General

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]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions

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

Musculoskeletal

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]

Ocular

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]

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.

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