OpenClaim

Dactinomycin Side Effects

The most commonly reported side effects of dactinomycin include off label use, febrile neutropenia, and product use in unapproved indication, based on 2,816 FDA adverse event reports from 2004 to 2025. 4.1% of reports found the drug to be ineffective.

Dactinomycin side effects

Percentages show how often each reaction appears relative to total reports for dactinomycin.

1
Off Label Use11.2%316
2
Febrile Neutropenia8.4%237
3
Product Use In Unapproved Indication5.3%150
4
Neutropenia5.0%140
5
Drug Ineffective4.1%116
6
Vomiting3.7%103
7
Thrombocytopenia3.3%93
8
Disease Progression3.2%91
9
Anaemia3.1%88
10
Stomatitis3.1%87
11
Acute Myeloid Leukaemia2.9%81
12
Mucosal Inflammation2.7%76
13
Pyrexia2.7%75
14
Drug Resistance2.6%72
15
Nausea2.3%66

These are voluntary reports and do not establish that dactinomycin caused these reactions.

Report severity

97.8%Serious2,753 reports
31.7%Hospitalizations893 reports
17.8%Fatal500 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dactinomycin drug interactions

Other drugs that appear in adverse event reports alongside dactinomycin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Vincristine-sulfate71.8%2,022
2
Cyclophosphamide47.5%1,337
3
Etoposide37.3%1,051
4
Doxorubicin-hydrochloride32.3%910
5
Ifosfamide26.2%739
6
Methotrexate20.8%586
7
Cisplatin12.5%352
8
Irinotecan-hydrochloride11.9%335
9
Carboplatin9.4%265
10
Temsirolimus8.0%226
11
Melphalan4.0%114
12
Vinorelbine-tartrate3.4%95
13
Bleomycin-sulfate3.1%88
14
Mesna3.1%88
15
Paclitaxel2.8%79

Taken alongside

1
Vincristine-sulfate7.1%199
2
Ondansetron5.5%154
3
Cyclophosphamide4.0%114
4
Dexamethasone3.4%96
5
Acetaminophen3.3%94
6
Etoposide3.1%87
7
Doxorubicin-hydrochloride3.0%85
8
Sulfamethoxazole3.0%85
9
Trimethoprim2.7%76
10
Mesna2.3%65
11
Ifosfamide2.1%59
12
Heparin2.0%57
13
Irinotecan-hydrochloride1.7%47
14
Methotrexate1.6%46
15
Filgrastim1.6%45

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dactinomycin side effects

47.8% of dactinomycin adverse event reports involve female patients and 32.4% involve male patients. The largest age group is child at 35%. These figures reflect who reports side effects, not underlying risk.

Sex

Female47.8%
Male32.4%
Unknown19.9%

Age group

< 213.9%
2–1134.5%
12–1718.1%
18–6430.6%
65+2.9%

What is dactinomycin used for

Conditions and purposes for which patients were taking dactinomycin when the adverse event was reported.

Acral Lentiginous MelanomaAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RecurrentAdenocarcinomaAesthesioneuroblastomaAlveolar RhabdomyosarcomaAngiosarcomaArthritisAstrocytomaAstrocytoma, Low GradeAtypical Teratoid/rhabdoid Tumour Of CnsAcute Lymphocytic LeukaemiaAesthesioneuroblastomaAlveolar Rhabdomyosarcoma

Showing 15 of 245 indications

Dactinomycin brand names and reporting trend

Dactinomycin is sold under the brand name Dactinomycin.

Brand names

Dactinomycin2,650

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dactinomycin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.