Drug

Defibrotide Sodium

77 flagged reaction(s) · 4,552 total co-reports · max PRR 73.6

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	Multiple Organ Dysfunction Syndrome	343	73.6	81.4	signal
2	Thrombotic Microangiopathy	53	32.5	33.0	signal
3	Acute Myeloid Leukaemia	54	20.6	20.9	signal
4	Acute Respiratory Distress Syndrome	61	20.5	20.8	signal
5	Posterior Reversible Encephalopathy Syndrome	24	14.9	15.0	signal
6	Septic Shock	104	14.3	14.7	signal
7	Melaena	50	13.4	13.6	signal
8	Intentional Product Use Issue	198	13.3	14.1	signal
9	Cytomegalovirus Infection	33	11.8	11.9	signal
10	Haematuria	64	11.1	11.2	signal
11	Bacteraemia	20	10.1	10.1	signal
12	Myelodysplastic Syndrome	24	9.8	9.9	signal
13	Blood Bilirubin Increased	42	9.2	9.3	signal
14	Upper Gastrointestinal Haemorrhage	26	9.1	9.2	signal
15	Haemorrhage	155	8.8	9.1	signal
16	Gastrointestinal Haemorrhage	123	8.7	8.9	signal
17	Off Label Use	1,236	8.4	12.4	signal
18	Hepatic Encephalopathy	13	8.2	8.3	signal
19	Subarachnoid Haemorrhage	14	8.1	8.1	signal
20	Hepatic Failure	40	7.8	7.9	signal
21	Subdural Haematoma	19	7.8	7.9	signal
22	Lymphoma	20	7.6	7.7	signal
23	Interstitial Lung Disease	62	7.6	7.7	signal
24	Ascites	37	7.4	7.5	signal
25	Incorrect Product Administration Duration	25	7.3	7.3	signal
26	Cerebral Haemorrhage	44	7.3	7.4	signal
27	Altered State Of Consciousness	25	6.9	6.9	signal
28	Petechiae	12	6.8	6.8	signal
29	Clostridium Difficile Colitis	12	6.7	6.7	signal
30	Gastric Haemorrhage	13	6.6	6.7	signal
31	Hepatomegaly	11	6.6	6.6	signal
32	Sepsis	121	6.4	6.6	signal
33	Coagulopathy	17	6.1	6.1	signal
34	Nephropathy Toxic	11	5.8	5.9	signal
35	Respiratory Distress	25	5.4	5.4	signal
36	Candida Infection	15	5.3	5.3	signal
37	Epistaxis	64	5.1	5.1	signal
38	Respiratory Failure	62	5.0	5.1	signal
39	Disease Progression	98	4.9	5.0	signal
40	Haematemesis	21	4.9	4.9	signal
41	Hypotension	159	4.7	4.9	signal
42	Pericardial Effusion	18	4.6	4.6	signal
43	Disseminated Intravascular Coagulation	11	4.6	4.6	signal
44	Renal Failure	103	4.6	4.7	signal
45	Staphylococcal Infection	25	4.5	4.5	signal
46	Oesophagitis	8	4.3	4.3	signal
47	Febrile Neutropenia	46	4.1	4.2	signal
48	Post Procedural Haemorrhage	8	4.1	4.1	signal
49	Encephalopathy	16	3.9	3.9	signal
50	Haemoptysis	18	3.8	3.8	signal
51	Hepatocellular Injury	9	3.7	3.8	signal
52	Mucosal Inflammation	16	3.6	3.6	signal
53	Haemorrhage Intracranial	9	3.5	3.6	signal
54	Thrombocytopenia	66	3.5	3.5	signal
55	Bone Marrow Failure	11	3.2	3.2	signal
56	Death	458	3.1	3.5	signal
57	Clostridium Difficile Infection	11	3.0	3.0	signal
58	Anaphylactic Shock	13	3.0	3.0	signal
59	Drug Ineffective For Unapproved Indication	28	3.0	3.0	signal
60	Cholestasis	9	2.8	2.8	signal
61	Circulatory Collapse	8	2.8	2.8	signal
62	Drug Level Increased	7	2.5	2.5	signal
63	Haematochezia	23	2.5	2.5	signal
64	Hyperbilirubinaemia	4	2.3	2.3	no signal
65	Status Epilepticus	4	2.1	2.1	no signal
66	Peritonitis	7	2.0	2.0	no signal
67	Hepatic Cytolysis	4	1.9	1.9	no signal
68	Diarrhoea Haemorrhagic	3	1.9	1.9	no signal
69	Leukaemia	3	1.9	1.9	no signal
70	Incorrect Drug Administration Duration	9	1.9	1.9	no signal
71	Underdose	23	1.9	1.9	no signal
72	Drug Resistance	8	1.8	1.8	no signal
73	Myocarditis	3	1.6	1.6	no signal
74	Internal Haemorrhage	3	1.5	1.6	no signal
75	Cytopenia	3	1.5	1.5	no signal
76	Genital Haemorrhage	3	1.4	1.4	no signal
77	Metrorrhagia	4	1.4	1.4	no signal