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What the label lists and what reports show

Etoposide side effects

Etoposide's FDA label lists its adverse reactions in its own words. FAERS holds 74,560 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 (7,774 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the etoposide FDA label on DailyMed (effective September 14, 2023, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following data on adverse reactions are based on intravenous administration of etoposide as a single agent, using several different dose schedules for treatment of a wide variety of malignancies. Hematologic Toxicity Myelosuppression is dose-related and dose-limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported. The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with etoposide in association with other antineoplastic agents. …

Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective September 14, 2023 (SPL set 6dfedeff-a807-4405-a482-2f7109ad31c9), via openFDA; the full label on DailyMed

What do FAERS reports show?

74,560 reports list etoposide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18,069 are coded as a death and 25,309 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, 9 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

  • Off Label Use (a use or a product term, not a reaction)8,421
  • Febrile Neutropenia7,774
  • Neutropenia5,107
  • Drug Ineffective (a use or a product term, not a reaction)4,778
  • Disease Progression (a use or a product term, not a reaction)4,643
  • Thrombocytopenia (named in the label)4,168
  • Pyrexia3,495
  • Anaemia (named in the label)3,407
  • Sepsis3,074
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)3,068
  • Death (an outcome recorded in the report)2,892
  • Pancytopenia2,813
  • Pneumonia2,540
  • Nausea (named in the label)2,505
  • Mucosal Inflammation2,326
  • Diarrhoea (named in the label)2,324
  • Vomiting (named in the label)2,176
  • Malignant Neoplasm Progression2,056
  • Infection (named in the label)2,051
  • Myelosuppression (named in the label)1,998
  • Septic Shock1,602
  • Dyspnoea (named in the label)1,574
  • Fatigue (named in the label)1,508
  • Acute Myeloid Leukaemia1,460
  • Platelet Count Decreased1,457

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

What next?

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