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What the label lists and what reports show

Pentostatin side effects

Pentostatin's FDA label lists its adverse reactions in its own words. FAERS holds 1,048 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 pyrexia (74 reports).

  • No generic listed
  • In shortage
  • Boxed warning

Check it at the source: the pentostatin FDA label on DailyMed (effective July 1, 2026, Hospira, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most patients treated for hairy cell leukemia in the five NCI-sponsored Phase 2 studies and the Phase 3 SWOG study experienced an adverse event. The following table lists the most frequently occurring adverse events in patients treated with NIPENT (both frontline and IFN-refractory patients) compared with IFN (frontline only), regardless of drug association. The drug association of some adverse events is uncertain as they may be associated with the disease itself (e.g., infection, hematologic suppression), but other events, such as the gastrointestinal symptoms, rashes, and abnormal liver function tests, can in many cases be attributed to the drug. Most adverse events that were assessed for severity were either mild or moderate, and diminished in frequency with continued therapy.

Source: FDA drug label, Hospira, Inc., effective July 1, 2026 (SPL set 674e0e6d-46ed-4868-9196-04019d667716), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,048 reports list pentostatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 255 are coded as a death and 429 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, 14 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

  • Neutropenia (a use or a product term, not a reaction)76
  • Pyrexia74
  • Dyspnoea (named in the label)71
  • Diarrhoea (named in the label)62
  • Drug Ineffective (a use or a product term, not a reaction)62
  • Off Label Use (a use or a product term, not a reaction)59
  • Pneumonia (named in the label)58
  • Sepsis (named in the label)57
  • Nausea (named in the label)55
  • Anaemia (named in the label)54
  • Thrombocytopenia (a use or a product term, not a reaction)54
  • Febrile Neutropenia (named in the label)47
  • Hypotension (named in the label)47
  • Renal Failure (named in the label)47
  • Fatigue (named in the label)45
  • Neutrophil Count Decreased42
  • Chills (named in the label)38
  • Pancytopenia38
  • Vomiting (named in the label)37
  • Cough (named in the label)33
  • Bk Virus Infection32
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)32
  • Asthenia (named in the label)31
  • Dehydration31
  • Tumour Lysis Syndrome30

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

What next?

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