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What the label lists and what reports show

Dexrazoxane side effects

Dexrazoxane's FDA label lists its adverse reactions in its own words. FAERS holds 928 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 (141 reports).

  • Generic listed

Check it at the source: the dexrazoxane FDA label on DailyMed (effective June 23, 2025, Gland Pharma Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

In clinical studies, dexrazoxane for injection was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving dexrazoxane for injection versus placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The adverse reaction profile described in this section was identified from randomized, placebo-controlled, double-blind studies in patients with metastatic breast cancer who received the combination of the FAC chemotherapy regimen with or without dexrazoxane for injection. …

Source: FDA drug label, Gland Pharma Limited, effective June 23, 2025 (SPL set c9c625fc-8852-4ed4-bcf2-63f46a706782), via openFDA; the full label on DailyMed

What do FAERS reports show?

928 reports list dexrazoxane among the medicines taken, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 407 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, 6 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 Neutropenia141
  • Off Label Use (a use or a product term, not a reaction)128
  • Neutropenia104
  • Product Use Issue (a use or a product term, not a reaction)55
  • Pyrexia54
  • Myelosuppression (named in the label)43
  • Nausea (named in the label)43
  • White Blood Cell Count Decreased39
  • Anaemia37
  • Vomiting (named in the label)37
  • Platelet Count Decreased36
  • Neutrophil Count Decreased35
  • Cardiotoxicity34
  • Decreased Appetite34
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)33
  • Sepsis (named in the label)31
  • Hypokalaemia30
  • Hypotension29
  • Drug Ineffective (a use or a product term, not a reaction)28
  • Thrombocytopenia (named in the label)28
  • Alanine Aminotransferase Increased26
  • Diarrhoea (named in the label)24
  • Aspartate Aminotransferase Increased23
  • Disease Progression (a use or a product term, not a reaction)23
  • Hepatic Function Abnormal23

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

What next?

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