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What the label lists and what reports show

Dactinomycin side effects

Dactinomycin's FDA label lists its adverse reactions in its own words. FAERS holds 2,189 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 (192 reports).

  • Generic listed

Check it at the source: the dactinomycin FDA label on DailyMed (effective June 18, 2024, Eugia US LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following serious adverse reactions are described elsewhere in the labeling: • Secondary Malignancy and Leukemia [see Warnings and Precautions (5.1) ] • Veno-occlusive Disease [see Warnings and Precautions (5.2) ] • Extravasation [see Warnings and Precautions (5.3) ] • Myelosuppression [see Warnings and Precautions (5.4) ] • Immunizations [see Warning and Precautions (5.5) ] • Severe Mucocutaneous Reactions [see Warnings and Precautions (5.6) ] • Renal Toxicity [see Warnings and Precautions (5.7) ] • Hepatotoxicity [see Warnings and Precautions (5.8) ] • Potentiation of Radiation Toxicity and Radiation Recall [see Warnings and Precautions (5.9) ] Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity. …

Source: FDA drug label, Eugia US LLC, effective June 18, 2024 (SPL set 5da55538-2602-4704-a9da-603c9f7ff7dc), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,189 reports list dactinomycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 386 are coded as a death and 679 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, 10 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)281
  • Febrile Neutropenia (named in the label)192
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)132
  • Neutropenia (named in the label)126
  • Drug Ineffective (a use or a product term, not a reaction)115
  • Vomiting (named in the label)104
  • Thrombocytopenia (named in the label)103
  • Pyrexia90
  • Anaemia (named in the label)86
  • Disease Progression (a use or a product term, not a reaction)85
  • Venoocclusive Liver Disease75
  • Stomatitis (named in the label)73
  • Venoocclusive Disease73
  • Nausea (named in the label)72
  • Acute Myeloid Leukaemia70
  • Mucosal Inflammation67
  • Drug Resistance61
  • Malignant Neoplasm Progression59
  • Ovarian Failure55
  • Toxicity To Various Agents54
  • Ascites (named in the label)51
  • Myelosuppression (named in the label)51
  • Product Use Issue (a use or a product term, not a reaction)50
  • Bone Marrow Failure48
  • Diarrhoea (named in the label)48

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

What next?

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