Drug

Dactinomycin

81 flagged reaction(s) · 2,143 total co-reports · max PRR 43.2

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Acute Myeloid Leukaemia	70	43.2	44.6	signal
2	Febrile Neutropenia	192	27.8	30.4	signal
3	Mucosal Inflammation	67	24.7	25.4	signal
4	Haematotoxicity	23	23.8	24.1	signal
5	Drug Resistance	61	22.8	23.4	signal
6	Bone Marrow Failure	48	22.5	23.0	signal
7	Metastases To Lung	24	19.9	20.2	signal
8	Hepatomegaly	20	19.4	19.6	signal
9	Neurotoxicity	34	18.8	19.0	signal
10	Drug Toxicity	25	17.4	17.5	signal
11	Disseminated Intravascular Coagulation	25	17.0	17.2	signal
12	Hyperbilirubinaemia	18	16.8	16.9	signal
13	Ascites	51	16.6	17.0	signal
14	Myelodysplastic Syndrome	24	15.9	16.1	signal
15	Myelosuppression	51	14.4	14.7	signal
16	Thyroid Cancer	15	11.9	11.9	signal
17	Tubulointerstitial Nephritis	23	11.8	11.9	signal
18	Ileus	15	11.7	11.8	signal
19	Stomatitis	73	11.5	11.9	signal
20	Pneumocystis Jirovecii Pneumonia	12	11.5	11.6	signal
21	Acute Respiratory Distress Syndrome	21	11.4	11.5	signal
22	Metastases To Central Nervous System	15	11.2	11.3	signal
23	Neoplasm Progression	37	10.1	10.3	signal
24	Metastases To Liver	18	9.8	9.9	signal
25	Neutrophil Count Decreased	40	9.5	9.6	signal
26	Neutropenia	126	8.9	9.4	signal
27	Thrombocytopenia	103	8.9	9.2	signal
28	Lymphocyte Count Decreased	16	8.7	8.7	signal
29	Septic Shock	38	8.4	8.6	signal
30	Hypophagia	22	8.3	8.4	signal
31	Osteopenia	13	8.2	8.2	signal
32	Nephropathy Toxic	9	7.7	7.8	signal
33	Leukopenia	40	7.7	7.8	signal
34	Eyelid Ptosis	8	7.5	7.6	signal
35	Encephalopathy	19	7.4	7.5	signal
36	Respiratory Distress	21	7.3	7.3	signal
37	Polyneuropathy	9	7.2	7.3	signal
38	Premature Baby	22	7.0	7.0	signal
39	Thrombotic Microangiopathy	7	6.9	6.9	signal
40	Coagulopathy	12	6.9	7.0	signal
41	Disease Progression	85	6.9	7.1	signal
42	Pneumothorax	11	6.6	6.7	signal
43	Deafness	18	6.6	6.6	signal
44	Clostridium Difficile Colitis	7	6.3	6.3	signal
45	Hepatic Cytolysis	8	6.3	6.3	signal
46	Leukaemia	6	6.1	6.1	signal
47	Cardiomyopathy	9	5.8	5.8	signal
48	Amenorrhoea	10	5.7	5.8	signal
49	Therapy Partial Responder	9	5.7	5.7	signal
50	Agranulocytosis	11	5.7	5.7	signal
51	Pancytopenia	33	5.7	5.7	signal
52	Inappropriate Antidiuretic Hormone Secretion	6	5.6	5.7	signal
53	Malignant Neoplasm Progression	59	5.5	5.7	signal
54	Small Intestinal Obstruction	7	5.5	5.5	signal
55	Oesophagitis	6	5.3	5.3	signal
56	Product Use In Unapproved Indication	132	5.2	5.4	signal
57	Multiple Organ Dysfunction Syndrome	15	5.1	5.2	signal
58	Hepatic Encephalopathy	5	5.1	5.1	signal
59	Nephropathy	5	5.1	5.1	signal
60	Pneumonitis	14	5.0	5.0	signal
61	Hepatic Function Abnormal	19	4.9	4.9	signal
62	Lymphopenia	7	4.8	4.8	signal
63	Proteinuria	9	4.6	4.6	signal
64	Hepatic Failure	14	4.4	4.5	signal
65	Hemiparesis	7	3.9	3.9	signal
66	Hepatotoxicity	9	3.9	3.9	signal
67	No Therapeutic Response	5	3.9	3.9	signal
68	Tuberculosis	5	3.7	3.7	signal
69	Nervous System Disorder	12	3.7	3.7	signal
70	Maternal Exposure During Pregnancy	33	3.6	3.6	signal
71	Acute Hepatic Failure	5	3.5	3.5	signal
72	Caesarean Section	4	3.3	3.3	signal
73	Cytopenia	4	3.2	3.2	signal
74	Toxicity To Various Agents	54	3.1	3.1	signal
75	Premature Delivery	5	3.0	3.0	signal
76	Metastases To Bone	5	2.9	2.9	signal
77	Pulmonary Arterial Hypertension	4	2.6	2.6	no signal
78	Pregnancy	5	2.4	2.4	no signal
79	Cytomegalovirus Infection	4	2.3	2.3	no signal
80	Device Failure	3	1.9	1.9	no signal
81	Vaginal Haemorrhage	7	1.6	1.6	no signal