Drug

Daunorubicin Hydrochloride

77 flagged reaction(s) · 2,298 total co-reports · max PRR 138.9

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	Clostridium Difficile Colitis	110	138.9	149.2	signal
2	Bacterial Infection	154	111.0	122.8	signal
3	Myelosuppression	161	63.1	70.1	signal
4	Lymphopenia	59	55.9	58.0	signal
5	Bone Marrow Failure	61	39.7	41.2	signal
6	Febrile Neutropenia	194	39.0	44.3	signal
7	Fungal Infection	87	34.8	36.7	signal
8	Viral Infection	86	34.4	36.3	signal
9	Hyperbilirubinaemia	21	27.1	27.5	signal
10	Posterior Reversible Encephalopathy Syndrome	19	26.5	26.9	signal
11	Acute Myeloid Leukaemia	31	26.5	27.0	signal
12	Bacteraemia	20	22.6	22.9	signal
13	Pancytopenia	92	21.9	23.2	signal
14	Lymphadenopathy	48	18.0	18.5	signal
15	Disseminated Intravascular Coagulation	19	17.9	18.1	signal
16	Oral Herpes	26	17.8	18.0	signal
17	Electrolyte Imbalance	15	17.3	17.5	signal
18	Device Related Infection	20	17.2	17.4	signal
19	Coagulopathy	21	16.8	17.0	signal
20	Polyneuropathy	15	16.8	16.9	signal
21	Mucosal Inflammation	32	16.3	16.6	signal
22	Premature Delivery	19	15.8	16.0	signal
23	Hepatotoxicity	25	15.0	15.2	signal
24	Septic Shock	48	14.8	15.2	signal
25	Cytomegalovirus Infection	18	14.4	14.5	signal
26	Incorrect Route Of Product Administration	18	14.2	14.4	signal
27	Cellulitis	54	14.2	14.7	signal
28	Tooth Infection	14	14.1	14.2	signal
29	Ileus	13	14.0	14.1	signal
30	Myelodysplastic Syndrome	15	13.8	13.9	signal
31	Drug Resistance	23	11.9	12.1	signal
32	Neutrophil Count Decreased	36	11.8	12.1	signal
33	Acute Respiratory Distress Syndrome	15	11.3	11.4	signal
34	Multiple Organ Dysfunction Syndrome	23	10.9	11.1	signal
35	Circulatory Collapse	14	10.9	11.0	signal
36	Blood Bilirubin Increased	22	10.8	10.9	signal
37	Cystitis	25	10.4	10.5	signal
38	Agranulocytosis	14	10.1	10.1	signal
39	Cardiomyopathy	11	9.9	9.9	signal
40	Colitis	27	9.5	9.7	signal
41	Neoplasm Progression	25	9.5	9.6	signal
42	Musculoskeletal Chest Pain	11	9.4	9.5	signal
43	Blood Lactate Dehydrogenase Increased	11	9.2	9.2	signal
44	Pancreatitis Acute	15	8.9	9.0	signal
45	Cytopenia	8	8.9	8.9	signal
46	Adrenal Insufficiency	8	8.9	8.9	signal
47	Clostridium Difficile Infection	14	8.6	8.6	signal
48	Ejection Fraction Decreased	10	8.5	8.6	signal
49	Premature Baby	19	8.4	8.4	signal
50	Temperature Intolerance	6	7.8	7.8	signal
51	Respiratory Failure	42	7.6	7.8	signal
52	Ventricular Tachycardia	9	7.2	7.2	signal
53	Platelet Count Decreased	55	6.9	7.1	signal
54	Multi-organ Failure	9	6.8	6.8	signal
55	Neutropenia	69	6.8	7.0	signal
56	White Blood Cell Count Decreased	53	6.5	6.7	signal
57	Hepatic Function Abnormal	18	6.4	6.5	signal
58	Shock	11	6.4	6.4	signal
59	Thrombocytopenia	52	6.2	6.4	signal
60	Haematotoxicity	4	5.7	5.7	signal
61	Hepatic Encephalopathy	4	5.7	5.7	signal
62	Grand Mal Convulsion	4	5.7	5.7	signal
63	Thrombotic Microangiopathy	4	5.5	5.5	signal
64	Inappropriate Antidiuretic Hormone Secretion	4	5.2	5.2	signal
65	Lung Infection	6	5.1	5.1	signal
66	Face Oedema	6	4.7	4.7	signal
67	Exposure During Pregnancy	22	4.7	4.7	signal
68	Status Epilepticus	4	4.7	4.7	signal
69	Myocarditis	4	4.7	4.7	signal
70	Pneumocystis Jirovecii Pneumonia	3	4.0	4.0	signal
71	Neurotoxicity	5	3.8	3.8	signal
72	Hepatocellular Injury	4	3.7	3.7	signal
73	Nephropathy Toxic	3	3.6	3.6	no signal
74	Haemorrhage Intracranial	4	3.5	3.5	signal
75	Malignant Neoplasm Progression	24	3.1	3.2	signal
76	Foetal Exposure During Pregnancy	18	2.9	3.0	signal
77	Drug Reaction With Eosinophilia And Systemic Symptoms	5	2.6	2.6	no signal