Drug · FAERS side-effect profile with label screen
Dactinomycin side effects: what 2,189 FDA adverse event reports show
Drug class
Actinomycin
FDA label (Established Pharmacologic Class)
Who reports
2,189 reports · 98% serious · 386 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dactinomycin for injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. ( 1.1 ) adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen.
FDA label, Indications and Usage
What it is
Dactinomycin is an actinomycin. Dactinomycin is produced by Streptomyces parvullus .
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 10Labeled (related wording) 3Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 24
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 41 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Acute myeloid leukaemia | 70 | 43.2 34.3–54.5ROR 44.6 · χ² 2,835 / p <1e-300 | 42.6 EB05 34.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 · 95% clinician | no trial data cached |
| Febrile neutropenia | 192 | 27.8 24.3–31.9ROR 30.4 · χ² 4,942 / p <1e-300 | 27.7 EB05 24.6 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.3 · 98% clinician | no trial data cached |
| Mucosal inflammation | 67 | 24.7 19.5–31.2ROR 25.4 · χ² 1,496 / p <1e-300 | 24.5 EB05 19.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.2 · 97% clinician | no trial data cached |
| Haematotoxicity | 23 | 23.8 15.8–35.8ROR 24.1 · χ² 479 / p 2e-106 | 23.3 EB05 16.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · 100% clinician | no trial data cached |
| Drug resistance | 61 | 22.8 17.8–29.2ROR 23.4 · χ² 1,248 / p 1e-273 | 22.6 EB05 18.2 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 · 95% clinician | no trial data cached |
| Bone marrow failure | 48 | 22.5 17.0–29.8ROR 23.0 · χ² 964 / p 6e-212 | 22.3 EB05 17.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · 100% clinician | no trial data cached |
| Metastases to lung | 24 | 19.9 13.4–29.7ROR 20.2 · χ² 413 / p 5e-92 | 19.6 EB05 13.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · 100% clinician | no trial data cached |
| Hepatomegaly | 20 | 19.4 12.6–30.1ROR 19.6 · χ² 331 / p 3e-74 | 19.0 EB05 12.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.8 | no trial data cached |
| Neurotoxicity | 34 | 18.8 13.4–26.2ROR 19.0 · χ² 554 / p 1e-122 | 18.5 EB05 13.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · 100% clinician | no trial data cached |
| Drug toxicity | 25 | 17.4 11.8–25.6ROR 17.5 · χ² 369 / p 2e-82 | 17.0 EB05 11.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.2 | no trial data cached |
| Disseminated intravascular coagulation | 25 | 17.0 11.5–25.1ROR 17.2 · χ² 360 / p 2e-80 | 16.6 EB05 11.7 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · 100% clinician | no trial data cached |
| Hyperbilirubinaemia | 18 | 16.8 10.6–26.6ROR 16.9 · χ² 251 / p 9e-57 | 16.2 EB05 10.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Ascites | 51 | 16.6 12.7–21.8ROR 17.0 · χ² 733 / p 9e-162 | 16.5 EB05 13.0 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · 98% clinician | no trial data cached |
| Myelodysplastic syndrome | 24 | 15.9 10.7–23.7ROR 16.1 · χ² 320 / p 7e-72 | 15.5 EB05 10.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 23% (drug 60%) · 95% clinician | no trial data cached |
| Myelosuppression | 51 | 14.4 11.0–18.9ROR 14.7 · χ² 621 / p 2e-137 | 14.2 EB05 11.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · 92% clinician | no trial data cached |
| Thyroid cancer | 15 | 11.9 7.2–19.7ROR 11.9 · χ² 139 / p 3e-32 | 10.6 EB05 6.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Tubulointerstitial nephritis | 23 | 11.8 7.8–17.7ROR 11.9 · χ² 216 / p 3e-49 | 11.0 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · ♀ 10% (drug 60%) · 100% clinician | no trial data cached |
| Ileus | 15 | 11.7 7.1–19.4ROR 11.8 · χ² 136 / p 1e-31 | 10.4 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Stomatitis (mouth sores) | 73 | 11.5 9.2–14.5ROR 11.9 · χ² 693 / p 5e-153 | 11.3 EB05 9.2 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · ♀ 35% (drug 60%) · 97% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 12 | 11.5 6.5–20.2ROR 11.6 · χ² 105 / p 7e-25 | 9.8 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Acute respiratory distress syndrome | 21 | 11.4 7.4–17.4ROR 11.5 · χ² 188 / p 3e-43 | 10.5 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 90% (drug 60%) | no trial data cached |
| Metastases to central nervous system | 15 | 11.2 6.8–18.6ROR 11.3 · χ² 130 / p 3e-30 | 9.9 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Neoplasm progression | 37 | 10.1 7.3–13.9ROR 10.3 · χ² 295 / p 3e-66 | 9.6 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 38% (drug 60%) · 100% clinician | no trial data cached |
| Metastases to liver | 18 | 9.8 6.2–15.6ROR 9.9 · χ² 134 / p 3e-31 | 8.7 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Neutrophil count decreased | 40 | 9.5 7.0–12.9ROR 9.6 · χ² 295 / p 2e-66 | 8.9 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · ♀ 38% (drug 60%) · 97% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 126 | 8.9 7.5–10.6ROR 9.4 · χ² 882 / p 4e-194 | 8.7 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 98% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 103 | 8.9 7.3–10.7ROR 9.2 · χ² 713 / p 3e-157 | 8.6 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 99% clinician | no trial data cached |
| Lymphocyte count decreased | 16 | 8.7 5.3–14.1ROR 8.7 · χ² 101 / p 5e-24 | 7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Septic shock | 38 | 8.4 6.1–11.5ROR 8.6 · χ² 242 / p 9e-55 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 100% clinician | no trial data cached |
| Hypophagia | 22 | 8.3 5.5–12.6ROR 8.4 · χ² 134 / p 2e-31 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 38% (drug 60%) | no trial data cached |
| Osteopenia | 13 | 8.2 4.7–14.0ROR 8.2 · χ² 75 / p 3e-18 | 6.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Leukopenia (low white blood cells) | 40 | 7.7 5.7–10.4ROR 7.8 · χ² 226 / p 2e-51 | 7.2 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 100% clinician | no trial data cached |
| Encephalopathy | 19 | 7.4 4.7–11.6ROR 7.5 · χ² 99 / p 1e-23 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Respiratory distress | 21 | 7.3 4.8–11.2ROR 7.3 · χ² 108 / p 2e-25 | 6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Premature baby | 22 | 7.0 4.6–10.6ROR 7.0 · χ² 107 / p 2e-25 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 100% clinician | no trial data cached |
| Coagulopathy | 12 | 6.9 3.9–12.2ROR 7.0 · χ² 55 / p 6e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Disease progression | 85 | 6.9 5.6–8.5ROR 7.1 · χ² 425 / p 8e-95 | 6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 96% clinician | no trial data cached |
| Pneumothorax | 11 | 6.6 3.7–12.0ROR 6.7 · χ² 47 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Deafness | 18 | 6.6 4.2–10.4ROR 6.6 · χ² 80 / p 2e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Amenorrhoea (missed periods) | 10 | 5.7 3.1–10.7ROR 5.8 · χ² 35 / p 2e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 192 | 27.8 24.3–31.9ROR 30.4 · χ² 4,942 / p <1e-300 | 27.7 EB05 24.6 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.3 · 98% clinician | no trial data cached |
| Product use in unapproved indication | 132 | 5.2 4.4–6.1ROR 5.4 · χ² 446 / p 3e-99 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · ♀ 84% (drug 60%) · 97% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 126 | 8.9 7.5–10.6ROR 9.4 · χ² 882 / p 4e-194 | 8.7 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 98% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 103 | 8.9 7.3–10.7ROR 9.2 · χ² 713 / p 3e-157 | 8.6 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 99% clinician | no trial data cached |
| Disease progression | 85 | 6.9 5.6–8.5ROR 7.1 · χ² 425 / p 8e-95 | 6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 96% clinician | no trial data cached |
| Stomatitis (mouth sores) | 73 | 11.5 9.2–14.5ROR 11.9 · χ² 693 / p 5e-153 | 11.3 EB05 9.2 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · ♀ 35% (drug 60%) · 97% clinician | no trial data cached |
| Acute myeloid leukaemia | 70 | 43.2 34.3–54.5ROR 44.6 · χ² 2,835 / p <1e-300 | 42.6 EB05 34.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 · 95% clinician | no trial data cached |
| Mucosal inflammation | 67 | 24.7 19.5–31.2ROR 25.4 · χ² 1,496 / p <1e-300 | 24.5 EB05 19.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.2 · 97% clinician | no trial data cached |
| Drug resistance | 61 | 22.8 17.8–29.2ROR 23.4 · χ² 1,248 / p 1e-273 | 22.6 EB05 18.2 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.8 · 95% clinician | no trial data cached |
| Malignant neoplasm progression | 59 | 5.5 4.3–7.1ROR 5.7 · χ² 216 / p 3e-49 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 98% clinician | no trial data cached |
| Toxicity to various agents | 54 | 3.1 2.4–4.0ROR 3.1 · χ² 74 / p 3e-18 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 · 100% clinician | no trial data cached |
| Myelosuppression | 51 | 14.4 11.0–18.9ROR 14.7 · χ² 621 / p 2e-137 | 14.2 EB05 11.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · 92% clinician | no trial data cached |
| Ascites | 51 | 16.6 12.7–21.8ROR 17.0 · χ² 733 / p 9e-162 | 16.5 EB05 13.0 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · 98% clinician | no trial data cached |
| Bone marrow failure | 48 | 22.5 17.0–29.8ROR 23.0 · χ² 964 / p 6e-212 | 22.3 EB05 17.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · 100% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 40 | 7.7 5.7–10.4ROR 7.8 · χ² 226 / p 2e-51 | 7.2 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 100% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Acute myeloid leukaemia — n=70, PRR 43.2
- Haematotoxicity — n=23, PRR 23.8
- Bone marrow failure — n=48, PRR 22.5
- Metastases to lung — n=24, PRR 19.9
- Neurotoxicity — n=34, PRR 18.8
- Myelodysplastic syndrome — n=24, PRR 15.9
- Tubulointerstitial nephritis — n=23, PRR 11.8
- Acute respiratory distress syndrome — n=21, PRR 11.4
- Neoplasm progression — n=37, PRR 10.1
- Septic shock — n=38, PRR 8.4
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Dactinomycin?
In FDA FAERS, the most frequently co-reported reaction terms for Dactinomycin are febrile neutropenia, neutropenia, thrombocytopenia, stomatitis, acute myeloid leukaemia, mucosal inflammation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Dactinomycin have an FDA boxed warning?
No. The FDA label retrieved for Dactinomycin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dactinomycin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 95d5c152-aa00-41e6-83e8-8df374a56447, effective 20240508; matched on
openfda.generic_name.exact:"DACTINOMYCIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 81 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.