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Cytosar Side Effects

Generic Name: cytarabine

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

For the Consumer

Applies to cytarabine: parenteral conventional cytarabine injection, parenteral conventional cytarabine powder for injection, parenteral liposomal cytarabine injection

Side effects include:

IV, sub-Q, or IM administration of conventional cytarabine (the active ingredient contained in Cytosar) Myelosuppression, anorexia, nausea, vomiting, diarrhea, oral and anal inflammation or ulceration, hepatic dysfunction, fever, rash, thrombophlebitis, bleeding (all sites).

Intrathecal administration of conventional cytarabine: Nausea, vomiting, fever, transient headaches.

Intrathecal administration of liposomal cytarabine: Chemical arachnoiditis (neck rigidity, neck pain, meningism, nausea, vomiting, headache, fever, back pain, and/or CSF pleocytosis), asthenia, pain, confusion, somnolence.

For Healthcare Professionals

Applies to cytarabine: injectable powder for injection, injectable solution

Ocular

Very common (10% or more): Hemorrhagic conjunctivitis, corneal disorder

Common (1% to 10%): Photophobia, burning, visual disturbance, increased lacrimation, keratitis

Uncommon (0.1% to 1%): Conjunctivitis

Frequency not reported: Blindness[Ref]

Nervous system

Very common (10% or more): Somnolence

Common (1% to 10%): Decreased level of consciousness, dysarthria, nystagmus

Uncommon (0.1% to 1%): Neurotoxicity, neuritis, dizziness, headache, peripheral neuropathy, paraplegia (with intrathecal administration)

Frequency not reported: Dizziness, neurotoxicity rash, coma, convulsion, peripheral sensory neuropathy, ataxia, tremor, coma, convulsions[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Chest pain

Very rare (less than 0.01%): Arrhythmia

Frequency not reported: Pericarditis, cardiomyopathy[Ref]

Hematologic

Very common (10% or more): Bone marrow failure, thrombocytopenia, anemia, megaloblastic anemia, leukopenia, reticulocyte count decreased

Common (1% to 10%): Bleeding (all sites), thrombophlebitis

Frequency not reported: Reticulocytopenia, neutropenia, febrile neutropenia[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, allergic edema[Ref]

Immunologic

Very common (10% or more): Sepsis, infection

Frequency not reported: Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body (sometimes fatal)[Ref]

Local

Uncommon (0.1% to 1%): Injection site cellulitis, injection site thrombophlebitis

Frequency not reported: Injection site pain, injection site inflammation, injection site irritation, injection site sepsis[Ref]

Musculoskeletal

Very common (10% or more): Cytarabine (the active ingredient contained in Cytosar) syndrome (e.g., fever, myalgia, bone pain, occasionally chest pain, exanthema, maculopapular rash, conjunctivitis, nausea, malaise)

Uncommon (0.1% to 1%): Myalgia, joint pain[Ref]

Metabolic

Common (1% to 10%): Anorexia, hyperuricemia[Ref]

Psychiatric

Frequency not reported: Personality change, confusion[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention

Frequency not reported: Amenorrhea, azoospermia[Ref]

Hepatic

Very common (10% or more): Hepatic function abnormal

Common (1% to 10%): Liver enzymes increased

Uncommon (0.1% to 1%): Jaundice

Frequency not reported: Liver abscess, hyperbilirubinemia, hepatomegaly, Budd-Chiari-syndrome (hepatic venous thrombosis)[Ref]

Respiratory

Very common (10% or more): Pneumonia, acute respiratory distress syndrome, pulmonary edema

Uncommon (0.1% to 1%): Shortness of breath[Ref]

Other

Very common (10% or more): Pyrexia[Ref]

Renal

Uncommon (0.1% to 1%): Renal dysfunction[Ref]

Dermatologic

Very common (10% or more): Alopecia, rash

Common (1% to 10%): Skin ulceration, erythema, bullous dermatitis, vasculitis

Uncommon (0.1% to 1%): Lentigo, palmar-plantar erythrodysesthesia syndrome, urticaria, pruritus, freckling, burning pain of palms and soles

Very rare (less than 0.01%): Neutrophilic eccrine hidradenitis

Frequency not reported: Skin bleeding[Ref]

Gastrointestinal

Very common (10% or more): Stomatitis, mouth ulceration, anal ulcer, anal inflammation, diarrhea, vomiting, nausea, abdominal pain

Common (1% to 10%): Necrotizing colitis

Uncommon (0.1% to 1%): Sore throat, esophagitis, esophageal ulceration, bowel necrosis

Frequency not reported: Pancreatitis, bowel necrosis, GI ulcer, pneumatosis intestinalis, peritonitis, mucosal bleeding[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Cytarabine (cytarabine)." Hospira Inc, Lake Forest, IL.

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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