OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Inotuzumab Ozogamicin

97 flagged reaction(s) · 3,520 total co-reports · max PRR 50.2
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 Cytokine Release Syndrome 133 50.2 52.5 signal
2 Cytopenia 57 34.2 34.9 signal
3 Neoplasm Progression 155 31.7 33.4 signal
4 Febrile Neutropenia 265 28.7 31.4 signal
5 Thrombotic Microangiopathy 31 22.9 23.2 signal
6 Neurotoxicity 55 22.7 23.1 signal
7 Blood Bilirubin Increased 82 21.7 22.3 signal
8 Hyperbilirubinaemia 30 20.8 21.1 signal
9 Multiple Organ Dysfunction Syndrome 81 20.8 21.3 signal
10 Subdural Haematoma 31 15.4 15.6 signal
11 Hepatotoxicity 47 15.2 15.4 signal
12 Ascites 62 15.1 15.4 signal
13 Bacteraemia 23 14.0 14.1 signal
14 Lymphocyte Count Decreased 34 13.7 13.9 signal
15 Mucosal Inflammation 47 12.9 13.1 signal
16 Hepatomegaly 17 12.3 12.4 signal
17 Encephalopathy 38 11.1 11.2 signal
18 Myelosuppression 50 10.5 10.7 signal
19 Bone Marrow Failure 29 10.1 10.2 signal
20 Haematotoxicity 13 10.0 10.1 signal
21 Neutrophil Count Decreased 55 9.7 9.9 signal
22 Thrombocytopenia 148 9.5 9.9 signal
23 Blood Lactate Dehydrogenase Increased 20 9.0 9.0 signal
24 Liver Function Test Increased 26 8.7 8.8 signal
25 Sepsis 136 8.7 9.1 signal
26 Hyperglycaemia 44 8.7 8.8 signal
27 Lymphopenia 16 8.1 8.2 signal
28 Platelet Count Decreased 121 8.1 8.4 signal
29 Acute Hepatic Failure 15 7.9 7.9 signal
30 Hepatic Failure 33 7.8 7.9 signal
31 Aspartate Aminotransferase Increased 57 7.7 7.8 signal
32 Cytomegalovirus Infection 17 7.3 7.3 signal
33 Covid-19 Pneumonia 12 7.2 7.2 signal
34 Transaminases Increased 22 7.1 7.1 signal
35 Myelodysplastic Syndrome 14 6.9 6.9 signal
36 Hyponatraemia 54 6.9 7.0 signal
37 Pancytopenia 53 6.8 6.9 signal
38 Septic Shock 39 6.4 6.5 signal
39 Alanine Aminotransferase Increased 54 6.3 6.4 signal
40 Neutropenia 118 6.2 6.4 signal
41 Clostridium Difficile Colitis 9 6.1 6.1 signal
42 Blood Alkaline Phosphatase Increased 21 6.0 6.1 signal
43 Device Related Infection 13 6.0 6.0 signal
44 Therapy Non-responder 37 5.9 6.0 signal
45 Mental Status Changes 23 5.9 6.0 signal
46 Gamma-glutamyltransferase Increased 18 5.8 5.8 signal
47 Acute Myeloid Leukaemia 12 5.5 5.5 signal
48 Acute Respiratory Distress Syndrome 13 5.2 5.3 signal
49 Generalised Tonic-clonic Seizure 12 5.2 5.3 signal
50 Ileus 9 5.2 5.2 signal
51 Therapy Partial Responder 11 5.2 5.2 signal
52 Nephropathy Toxic 8 5.1 5.1 signal
53 Pneumocystis Jirovecii Pneumonia 7 5.0 5.0 signal
54 Lung Infection 11 5.0 5.0 signal
55 Hypokalaemia 31 4.8 4.9 signal
56 White Blood Cell Count Decreased 73 4.8 4.9 signal
57 Adrenal Insufficiency 8 4.8 4.8 signal
58 Lower Respiratory Tract Infection 30 4.7 4.8 signal
59 Upper Gastrointestinal Haemorrhage 11 4.7 4.7 signal
60 Hypomagnesaemia 9 4.6 4.6 signal
61 Infection 93 4.6 4.7 signal
62 Hepatic Encephalopathy 6 4.6 4.6 signal
63 Hepatic Cirrhosis 12 4.6 4.6 signal
64 Oesophagitis 7 4.6 4.6 signal
65 Disseminated Intravascular Coagulation 9 4.6 4.6 signal
66 Hepatic Function Abnormal 23 4.4 4.5 signal
67 Shock 14 4.4 4.4 signal
68 Liver Disorder 27 4.4 4.4 signal
69 Staphylococcal Infection 20 4.3 4.3 signal
70 Haemorrhage Intracranial 9 4.3 4.3 signal
71 Drug Resistance 15 4.2 4.2 signal
72 Drug-induced Liver Injury 17 3.9 4.0 signal
73 Urosepsis 5 3.9 3.9 signal
74 Skin Infection 6 3.8 3.8 signal
75 Body Temperature Increased 11 3.8 3.8 signal
76 Pancreatitis 28 3.8 3.8 signal
77 Posterior Reversible Encephalopathy Syndrome 5 3.8 3.8 signal
78 Cholestasis 10 3.7 3.7 signal
79 Hepatocellular Injury 7 3.5 3.5 signal
80 Hepatic Cytolysis 6 3.5 3.5 signal
81 Euphoric Mood 5 3.5 3.5 signal
82 Coagulopathy 8 3.4 3.4 signal
83 Hypocalcaemia 9 3.4 3.4 signal
84 Full Blood Count Abnormal 5 3.4 3.4 signal
85 Full Blood Count Decreased 9 3.2 3.2 signal
86 Gingival Bleeding 6 3.1 3.1 signal
87 Eyelid Oedema 5 3.1 3.1 signal
88 Leukopenia 20 2.9 2.9 signal
89 Death 343 2.8 3.1 signal
90 Disease Recurrence 17 2.5 2.6 signal
91 Neoplasm 4 2.5 2.5 no signal
92 Blood Count Abnormal 5 2.3 2.3 no signal
93 Leukaemia 3 2.3 2.3 no signal
94 Malignant Neoplasm Progression 32 2.2 2.3 signal
95 Lactic Acidosis 9 2.0 2.0 no signal
96 Drug Effective For Unapproved Indication 7 1.7 1.7 no signal
97 Extrapyramidal Disorder 3 0.9 0.9 no signal