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Rasburicase Side Effects

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

For the Consumer

Applies to rasburicase: intravenous powder for solution

As well as its needed effects, rasburicase may cause unwanted side effects that require medical attention.

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

More common
  • Cracked lips
  • diarrhea
  • difficulty with swallowing
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
Less common
  • Abdominal or stomach pain
  • agitation
  • black or red, tarry, stools
  • bleeding gums
  • bluish color of the fingernails, lips, skin, palms, or nail beds
  • changes in skin color
  • changes in vision
  • chest pain or discomfort
  • chills
  • coma
  • confusion
  • convulsions (seizures)
  • cough
  • coughing that sometimes produces a pink, frothy sputum
  • coughing up blood
  • decreased urination
  • depression
  • dilated neck veins
  • dizziness
  • dry mouth
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • headache
  • hostility
  • increased menstrual flow or vaginal bleeding
  • increased sweating
  • increased thirst
  • irritability
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • lightheadedness
  • lower back or side pain
  • muscle twitching
  • nausea
  • no blood pressure or pulse
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • painful or difficult urination
  • pains in the chest, groin, or legs, especially calves of the legs
  • pale skin
  • paralysis
  • prolonged bleeding from cuts
  • red or dark brown urine
  • severe constipation
  • severe headaches of sudden onset
  • shortness of breath
  • skin rash
  • sneezing
  • sore throat
  • stopping of heart
  • stupor
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sunken eyes
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swollen glands
  • temporary blindness
  • thirst
  • tightness in the chest
  • troubled breathing
  • unconsciousness
  • unexplained or unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • wheezing
  • wrinkled skin
  • Back pain
  • hives
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • yellow eyes or skin

Some rasburicase 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:

Less common
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • feeling of warmth
  • feeling unusually cold
  • redness of the face, neck, arms, and occasionally, upper chest
  • shivering

For Healthcare Professionals

Applies to rasburicase: intravenous powder for injection


Immunologic side effects associated with the use of rasburicase in healthy volunteers have included reports of development of binding antibodies to rasburicase and neutralizing antibodies.[Ref]


Metabolic side effects including at least one case of hypocalcemia have been reported.[Ref]


Gastrointestinal (GI) side effects have been reported the most frequently. These have included vomiting, nausea, abdominal pain, constipation, and diarrhea. Ileus and intestinal obstruction have been reported in less than 1% patients included in studies (n = 703). At least one case of GI hemorrhage has also been reported.[Ref]


Respiratory side effects have included respiratory distress, pulmonary edema, pulmonary hypertension, and pneumonia.[Ref]


Cardiovascular side effects have been reported rarely. Less than 1% (n = 703) of patients have reported arrhythmia, cardiac failure, cardiac arrest, chest pain, and myocardial infarction.[Ref]


Renal side effects have been reported rarely. Acute renal failure has been reported in less than 1% of patients included in the studies (n = 703).[Ref]


Ocular side effects have included reports of retinal hemorrhage.[Ref]


A 50-year-old male who was admitted to the hospital for new onset seizure, diabetic ketoacidosis, respiratory failure, and acute renal failure experienced hemolytic anemia and methemoglobinemia coincident with rasburicase therapy. He was given one dose of intravenous rasburicase 22.5 mg for acute renal failure secondary to hyperuricemia. Routine arterial blood gas analysis performed after rasburicase was given revealed elevated methemoglobin concentrations, which peaked at 14.7%. Hemolytic anemia developed as evidenced by a reduction in blood hemoglobin from 14.8 to 5.3 g/dL. The patient made a complete recovery following aggressive fluid therapy, blood transfusions, and respiratory support.[Ref]

Hematologic side effects have included reports of neutropenia (2%), neutropenia with fever (4%), thrombosis, thrombophlebitis, and pancytopenia. At least two cases of methemoglobinemia have also been reported, in addition to a case of hemolytic anemia.[Ref]


Dermatologic side effects have included reports of rash (13%) and cellulitis (1% or less).[Ref]

Nervous system

Nervous system side effects have included headache (1.8%), cerebrovascular disorder, and convulsions.[Ref]


Musculoskeletal side effects including at least one case of arthralgia and one case of gout have been reported.[Ref]


Hypersensitivity side effects including allergic reactions have been reported in 0.7% of patients.


Hepatic side effects including increased serum glutamic pyruvate transaminase have been reported. At least 3 cases of increased liver enzymes have also been reported.[Ref]


A case report describes the lethal effect of a single dose of rasburicase in a preterm newborn infant with glucose-6-phosphate dehydrogenase (G6PD) deficiency who was treated for an increase in uric acid levels. It is suggested that G6PD testing be considered before rasburicase use.[Ref]

Other side effects including fever (1.4% to 5%) and rigors (1.1%) have been reported. A neonate with glucose-6-phosphate dehydrogenase (G6PD) deficiency died following a single dose of rasburicase.[Ref]


1. "Product Information. Elitek (rasburicase)." Sanofi Winthrop Pharmaceuticals, New York, NY.

2. Coiffier B, Mounier N, Bologna S, et al "Efficacy and safety of rasburicase (recombinant urate oxidase) for the prevention and treatment of hyperuricemia during induction chemotherapy of aggressive Non-Hodgkin's Lymphoma: results of the GRAAL1 (Groupe d'Etude des Lymphomes de l'Adulte Trial..." J Clin Oncol 21 (2003): 4402-6

3. Browning LA, Kruse JA "Hemolysis and methemoglobinemia secondary to rasburicase administration." Ann Pharmacother 39 (2005): 1932-5

4. Zaramella P, De Salvia A, Zaninotto M, et al. "Lethal effect of a single dose of rasburicase in a preterm newborn infant." Pediatrics 13 (2013): e309-12

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