Cytosar-U Side Effects

Generic Name: cytarabine

Please note - some side effects for Cytosar-U may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

Hematologic

Hematologic side effects including myelosuppression have been the most universal and dose limiting effect of cytarabine. Leukopenia and thrombocytopenia have been reported commonly. Anemia has been reported occasionally.

Myelosuppression has generally been reported to occur four to twelve days after therapy with recovery generally by day twenty eight. It is recommended that the patient's blood counts be monitored throughout therapy and at any clinical sign of thrombocytopenia, fever, or anemia, and before subsequent courses of therapy.

Respiratory

Respiratory side effects including adult respiratory distress syndrome (5% to 32%), sore throat, esophageal ulceration, esophagitis, and shortness of breath have been reported. One case of pulmonary edema has also been reported.

Nervous system

One study has reported 8 of 49 patients treated with high dose cytarabine developed cerebellar and cerebral toxicity. In another study 4 out of 24 patients developed treated with high dose cytarabine were reported to have developed cerebellar degeneration during treatment. Acute cerebellar toxicity after high dose cytarabine has been associated with CNS accumulation of its metabolite, uracil arabinoside.

Nervous system side effects have been reported in up to 10% of patients and have included neuritis, neural toxicity, cerebellar toxicity, lethargy, confusion, and headache.

Gastrointestinal

Gastrointestinal side effects including oral and anal inflammation or ulceration, anorexia, nausea, vomiting, and diarrhea have been reported frequently. Bowel necrosis, stomatitis, and pancreatitis have also been reported.

Nausea and vomiting have been reported most frequently following rapid intravenous injection.

Hepatic

Hepatic side effects including hepatic dysfunction have been reported frequently. Jaundice has also been reported.

General

General side effects including fever have been reported frequently. Chest pain, abdominal pain, and dizziness have also been reported.

Dermatologic

Dermatologic side effects including rash have been reported frequently. Skin ulceration, freckling, alopecia, pruritus, and urticaria have also been reported.

Cardiovascular

Cardiovascular side effects including thrombophlebitis and bleeding have been reported frequently. Pericarditis has also been reported.

Immunologic

Immunologic side effects including sepsis and pneumonia have been reported.

Local

Local side effects including cellulitis at the injection site have been reported.

Genitourinary

Genitourinary side effects including urinary retention and renal dysfunction have been reported.

Ocular

Ocular side effects including conjunctivitis have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and allergic edema have been reported.

Other

Other side effects have included a syndrome of fever, conjunctival suffusion, and maculopapular rash which has been reported primarily in children who received large cumulative doses of cytarabine.

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