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What the label lists and what reports show

Cytarabine side effects

Cytarabine's FDA label lists its adverse reactions in its own words. FAERS holds 59,731 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (7,662 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the cytarabine FDA label on DailyMed (effective April 7, 2025, Hospira, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Expected Reactions Because cytarabine is a bone marrow suppressant, anemia, leukopenia, thrombocytopenia, megaloblastosis and reduced reticulocytes can be expected as a result of administration with Cytarabine Injection. The severity of these reactions are dose and schedule dependent. Cellular changes in the morphology of bone marrow and peripheral smears can be expected. Following 5-day constant infusions or acute injections of 50 mg/m 2 to 600 mg/m 2 , white cell depression follows a biphasic course. Regardless of initial count, dosage level, or schedule, there is an initial fall starting the first 24 hours with a nadir at days 7-9. This is followed by a brief rise which peaks around the twelfth day. A second and deeper fall reaches nadir at days 15-24. Then there is a rapid rise to above baseline in the next 10 days. …

Source: FDA drug label, Hospira, Inc., effective April 7, 2025 (SPL set e3a8c0e9-19ed-49b7-8464-11e8806f47fd), via openFDA; the full label on DailyMed

What do FAERS reports show?

59,731 reports list cytarabine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13,675 are coded as a death and 24,381 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Febrile Neutropenia7,662
  • Off Label Use (a use or a product term, not a reaction)5,107
  • Pyrexia4,203
  • Neutropenia3,686
  • Drug Ineffective (a use or a product term, not a reaction)3,161
  • Thrombocytopenia (named in the label)2,966
  • Sepsis (named in the label)2,954
  • Disease Progression (a use or a product term, not a reaction)2,773
  • Pneumonia (named in the label)2,357
  • Myelosuppression2,263
  • Pancytopenia2,154
  • Death (an outcome recorded in the report)2,049
  • Septic Shock1,880
  • Anaemia (named in the label)1,870
  • Nausea (named in the label)1,868
  • Infection (named in the label)1,858
  • Mucosal Inflammation1,780
  • Diarrhoea (named in the label)1,778
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)1,775
  • Vomiting (named in the label)1,748
  • Platelet Count Decreased1,695
  • Hypotension1,476
  • Acute Myeloid Leukaemia1,325
  • White Blood Cell Count Decreased1,299
  • Respiratory Failure1,269

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Cytarabine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions