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Proleukin Side Effects

Generic Name: aldesleukin

Note: This page contains side effects data for the generic drug aldesleukin. It is possible that some of the dosage forms included below may not apply to the brand name Proleukin.

Common side effects of Proleukin include supraventricular tachycardia, exfoliative dermatitis, infection, congestive heart failure, respiratory tract disease, pulmonary infiltrates, adult respiratory distress syndrome, pulmonary congestion, cardiac arrhythmia, edema, stomatitis, weight gain, dyspnea, fever, dizziness, skin rash, weakness, leukopenia, anxiety, thrombocytopenia, drowsiness, anemia, confusion, oliguria, pain, nausea, acidosis, vomiting, tachycardia, pulmonary disease, abdominal pain, increased serum creatinine, hypotension, rales, diarrhea, pruritus, enlargement of abdomen, cardiovascular disease, rhonchi, altered blood pressure, increased cough, hypocalcemia, asymptomatic ecg changes, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, hyperbilirubinemia, hypomagnesemia, rhinitis, peripheral edema, vasodilatation, anorexia, malaise, and chills. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to aldesleukin: intravenous powder for solution

As well as its needed effects, aldesleukin (the active ingredient contained in Proleukin) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking aldesleukin, check with your doctor or nurse immediately:

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 aldesleukin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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


Cardiovascular side effects from aldesleukin (the active ingredient contained in Proleukin) have been reported. Many of the adverse cardiovascular events from aldesleukin result from a capillary or vascular leak syndrome. Shifting of fluid into the interstitial spaces results in hypotension, tachycardia, and sometimes congestive heart failure, or myocardial infarction. Besides the vascular leak syndrome and hypotension, direct effects on the myocardium have been noted. These effects include hemodynamic changes as well as myocardial injury with creatine phosphokinase (CPK) elevations and myocarditis secondary to lymphocyte infiltration.[Ref]

Hypotension resulting from aldesleukin-induced capillary leak syndrome should be managed with careful fluid administration and institution of low-dose dopamine infusions.[Ref]


Respiratory side effects including respiratory distress resulting from fluid weight gain attributed to the vascular leak syndrome has been reported. Other respiratory effects reported include dyspnea, pulmonary congestion with rales and rhonchi, unspecified pulmonary changes with infiltrates on X-ray, increased cough, and rhinitis.[Ref]

Nervous system

Nervous system side effects including both acute and chronic neurologic and neuropsychiatric findings have been reported during aldesleukin (the active ingredient contained in Proleukin) administration. Patients receiving high-dose therapy have been reported to have become agitated, disoriented, and sometimes comatose. These effects have typically resolved upon discontinuation of the drug. Neuropsychiatric effects including a decrease in cognitive function and memory impairment have been reported in patients receiving continuous-infusion aldesleukin therapy.[Ref]


Renal damage attributed to aldesleukin (the active ingredient contained in Proleukin) results from the decrease in vascular resistance. Low-dose dopamine helps maintain adequate renal perfusion during aldesleukin therapy and may decrease the incidence of renal failure.[Ref]

Renal side effects including oliguria and anuria are the predominant adverse events that have been reported in the majority of patients. Acute kidney failure with an increase in creatinine has been reported in 1% of patients.[Ref]


Hepatic side effects reported with aldesleukin (the active ingredient contained in Proleukin) therapy include bilirubinemia, SGOT increase, and alkaline phosphatase increase and hepatosplenomegaly.[Ref]


Hematopoietic side effects which have been reported include anemia, thrombocytopenia, and leukopenia. Postmarketing reports have included lymphocytopenia.[Ref]


Antiemetics and antidiarrheals are helpful in treating the gastrointestinal side effects and H2-antagonists are often given for prophylaxis of gastrointestinal irritation and bleeding. Mucositis requires diligent oral care, including sodium bicarbonate mouthwashes and nystatin.[Ref]

Gastrointestinal side effects have included nausea, vomiting, diarrhea, and mucositis. Colon dilatation, perforation, and ischemic necrosis have also been reported but are uncommon.[Ref]


Dermatologic side effects such as erythema, pruritus, and generalized erythroderma have been reported with aldesleukin (the active ingredient contained in Proleukin) therapy. In patients with preexisting dermatologic conditions such as psoriasis, exacerbation of the underlying condition has been reported.[Ref]

Rashes have been treated with either hydroxyzine or diphenhydramine, which can be continued until resolution of the rash. Nonalcoholic-based creams and ointments as well as aloe vera gels may also be applied to skin conditions. Application may begin as early as 48 hours before treatment. Preparations containing steroids should be avoided.[Ref]


Meperidine may be helpful for the chills and rigors associated with this flu-like syndrome. Scheduled nonsteroidal anti-inflammatory drugs like acetaminophen and indomethacin can substantially relieve the other symptoms.[Ref]

General side effects including a flu-like syndrome have been reported in patients receiving aldesleukin. Symptoms include fever, chills, rigors, joint pain, myalgias, malaise, and anorexia.[Ref]


Other side effects including infection have been reported with aldesleukin (the active ingredient contained in Proleukin) treatment (which may be due to the initial drop in lymphocyte levels).[Ref]


Endocrine side effects including hypothyroidism and hyperthyroidism have been reported with aldesleukin (the active ingredient contained in Proleukin) therapy.[Ref]


Metabolic side effects seen with aldesleukin (the active ingredient contained in Proleukin) treatment have included acidosis, hypomagnesemia, hypocalcemia, and hyperuricemia.[Ref]


Immunologic side effects have included the formation of anti-aldesleukin (the active ingredient contained in Proleukin) antibodies (up to 74%).


1. Orucevic A, Lala PK "Role of nitric oxide in IL-2 therapy-induced capillary leak syndrome." Cancer Metastasis Rev 17 (1998): 127-42

2. "Product Information. Proleukin (aldesleukin)." Chiron Therapeutics, Emeryville, CA.

It is possible that some side effects of Proleukin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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.