OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Isatuximab

154 flagged reaction(s) · 7,080 total co-reports · max PRR 37.9
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 Plasma Cell Myeloma 388 37.9 40.6 signal
2 Thrombotic Microangiopathy 70 27.5 27.8 signal
3 Covid-19 Pneumonia 78 24.9 25.3 signal
4 Lymphopenia 74 20.0 20.2 signal
5 Cytopenia 51 16.2 16.3 signal
6 Infusion Related Reaction 253 14.5 15.2 signal
7 Neutropenia 515 14.4 15.8 signal
8 Polyneuropathy 42 13.4 13.5 signal
9 Neutrophil Count Decreased 119 11.1 11.3 signal
10 Cytokine Release Syndrome 55 10.9 11.0 signal
11 Thrombocytopenia 321 10.9 11.5 signal
12 Hepatic Cytolysis 34 10.5 10.6 signal
13 Respiratory Tract Infection 70 10.2 10.3 signal
14 Pneumocystis Jirovecii Pneumonia 26 9.8 9.9 signal
15 Bacteraemia 29 9.3 9.4 signal
16 Basal Cell Carcinoma 37 9.0 9.0 signal
17 Hypercalcaemia 29 8.9 8.9 signal
18 Therapy Partial Responder 34 8.5 8.6 signal
19 Febrile Neutropenia 149 8.5 8.7 signal
20 Hypocalcaemia 42 8.4 8.5 signal
21 Hypertensive Crisis 24 8.1 8.2 signal
22 Haematotoxicity 19 7.8 7.8 signal
23 Myelodysplastic Syndrome 28 7.3 7.4 signal
24 Gastroenteritis 26 6.7 6.8 signal
25 Covid-19 297 6.3 6.7 signal
26 Toxic Skin Eruption 15 5.6 5.6 signal
27 Anaemia 278 5.5 5.7 signal
28 Leukopenia 70 5.3 5.4 signal
29 Mitral Valve Incompetence 15 5.0 5.0 signal
30 Spinal Pain 15 4.8 4.9 signal
31 Septic Shock 52 4.5 4.6 signal
32 Pulmonary Embolism 114 4.5 4.6 signal
33 Urosepsis 11 4.5 4.5 signal
34 Bronchospasm 17 4.5 4.5 signal
35 Flank Pain 11 4.4 4.5 signal
36 Pneumonia 379 4.4 4.7 signal
37 Squamous Cell Carcinoma 11 4.4 4.4 signal
38 Disease Progression 137 4.4 4.5 signal
39 Platelet Count Decreased 123 4.4 4.4 signal
40 Pancytopenia 64 4.3 4.4 signal
41 Cytomegalovirus Infection 19 4.3 4.3 signal
42 Hepatotoxicity 25 4.3 4.3 signal
43 Cardiac Failure 90 4.2 4.3 signal
44 Hypokalaemia 51 4.2 4.2 signal
45 Bronchitis 80 4.1 4.1 signal
46 Sepsis 118 4.0 4.1 signal
47 Acute Respiratory Failure 20 3.9 4.0 signal
48 Pharyngitis 13 3.9 4.0 signal
49 Acute Kidney Injury 151 3.7 3.8 signal
50 Infection 142 3.7 3.8 signal
51 Pulmonary Hypertension 20 3.6 3.6 signal
52 Pneumonitis 25 3.5 3.5 signal
53 Pulmonary Arterial Hypertension 13 3.4 3.4 signal
54 Tuberculosis 11 3.2 3.2 signal
55 Splenomegaly 10 3.2 3.2 signal
56 Arteriosclerosis 8 3.2 3.2 signal
57 Device Related Infection 13 3.2 3.2 signal
58 Presyncope 20 3.1 3.1 signal
59 Upper Respiratory Tract Infection 38 3.1 3.1 signal
60 Malignant Melanoma 11 3.1 3.1 signal
61 Pyrexia 281 3.1 3.2 signal
62 Haemorrhage Intracranial 12 3.0 3.0 signal
63 Respiratory Distress 22 3.0 3.0 signal
64 Neuropathy Peripheral 74 3.0 3.0 signal
65 Bone Marrow Failure 16 3.0 3.0 signal
66 Atrial Fibrillation 76 2.9 3.0 signal
67 General Physical Health Deterioration 89 2.9 3.0 signal
68 Oral Candidiasis 10 2.9 2.9 signal
69 Lung Disorder 37 2.9 2.9 signal
70 Bacterial Infection 14 2.8 2.9 signal
71 Lower Respiratory Tract Infection 34 2.8 2.8 signal
72 Hypoxia 26 2.8 2.8 signal
73 Tachypnoea 10 2.8 2.8 signal
74 Multiple Organ Dysfunction Syndrome 20 2.7 2.7 signal
75 Bone Pain 42 2.7 2.7 signal
76 Myocarditis 8 2.7 2.7 signal
77 Hemiparesis 12 2.7 2.7 signal
78 Skin Haemorrhage 10 2.6 2.6 signal
79 Mucosal Inflammation 18 2.6 2.6 signal
80 Tachycardia 61 2.6 2.6 signal
81 White Blood Cell Count Decreased 74 2.6 2.6 signal
82 Rash Maculo-papular 15 2.6 2.6 signal
83 Ischaemic Stroke 12 2.5 2.5 signal
84 Drug Reaction With Eosinophilia And Systemic Symptoms 17 2.5 2.5 signal
85 Anaphylactic Reaction 36 2.5 2.5 signal
86 Influenza 73 2.5 2.5 signal
87 Appendicitis 6 2.4 2.4 no signal
88 Deep Vein Thrombosis 42 2.4 2.4 signal
89 Ejection Fraction Decreased 10 2.4 2.4 signal
90 Transaminases Increased 14 2.4 2.4 signal
91 Drug Eruption 11 2.4 2.4 signal
92 Haematoma 16 2.3 2.3 signal
93 Chills 71 2.3 2.3 signal
94 Sars-cov-2 Test Positive 8 2.3 2.3 signal
95 Subarachnoid Haemorrhage 6 2.2 2.2 no signal
96 Therapy Non-responder 26 2.2 2.2 signal
97 Acute Myeloid Leukaemia 9 2.2 2.2 signal
98 Renal Failure 77 2.2 2.2 signal
99 Ileus 7 2.1 2.2 no signal
100 Hepatic Function Abnormal 21 2.1 2.1 signal
101 Acute Respiratory Distress Syndrome 10 2.1 2.1 signal
102 Laryngitis 6 2.1 2.1 no signal
103 Cardio-respiratory Arrest 23 2.1 2.1 signal
104 Anaphylactic Shock 14 2.1 2.1 signal
105 Ventricular Tachycardia 9 2.1 2.1 no signal
106 Pancreatitis Acute 12 2.0 2.0 signal
107 Cerebral Haemorrhage 19 2.0 2.0 signal
108 Colitis 20 2.0 2.0 signal
109 Epistaxis 39 2.0 2.0 no signal
110 Angina Pectoris 15 2.0 2.0 no signal
111 Nervous System Disorder 16 1.9 1.9 no signal
112 Hyperglycaemia 18 1.9 1.9 no signal
113 Subdural Haematoma 7 1.8 1.8 no signal
114 Dermatitis Allergic 6 1.8 1.8 no signal
115 Petechiae 5 1.8 1.8 no signal
116 Fracture 9 1.8 1.8 no signal
117 Diverticulitis 13 1.8 1.8 no signal
118 Sudden Death 5 1.8 1.8 no signal
119 Chest Discomfort 47 1.7 1.7 no signal
120 Epilepsy 14 1.7 1.7 no signal
121 Femur Fracture 14 1.7 1.7 no signal
122 Osteonecrosis Of Jaw 11 1.7 1.7 no signal
123 Acute Myocardial Infarction 13 1.7 1.7 no signal
124 Diarrhoea Haemorrhagic 4 1.6 1.6 no signal
125 Malignant Neoplasm Progression 43 1.6 1.6 no signal
126 Interstitial Lung Disease 20 1.6 1.6 no signal
127 Cerebral Infarction 10 1.5 1.5 no signal
128 Hospice Care 4 1.5 1.5 no signal
129 Chronic Obstructive Pulmonary Disease 21 1.5 1.5 no signal
130 Ageusia 10 1.5 1.5 no signal
131 Drug Resistance 10 1.5 1.5 no signal
132 Transient Ischaemic Attack 13 1.4 1.5 no signal
133 Eye Haemorrhage 5 1.4 1.4 no signal
134 Blood Glucose Fluctuation 4 1.4 1.4 no signal
135 Influenza Like Illness 30 1.4 1.4 no signal
136 Myelosuppression 12 1.3 1.3 no signal
137 Rebound Effect 4 1.3 1.3 no signal
138 Intentional Dose Omission 9 1.2 1.2 no signal
139 Skin Cancer 7 1.2 1.2 no signal
140 Blindness 13 1.2 1.2 no signal
141 Posterior Reversible Encephalopathy Syndrome 3 1.2 1.2 no signal
142 Adverse Event 28 1.1 1.1 no signal
143 Neurotoxicity 5 1.1 1.1 no signal
144 Cardiovascular Disorder 7 1.0 1.0 no signal
145 Nephropathy Toxic 3 1.0 1.0 no signal
146 Pancreatic Carcinoma 6 0.8 0.8 no signal
147 Neoplasm Progression 7 0.8 0.8 no signal
148 Lung Neoplasm Malignant 7 0.6 0.6 no signal
149 Hepatic Cancer 4 0.6 0.6 no signal
150 Prostate Cancer 10 0.5 0.5 no signal
151 Gastric Cancer 3 0.4 0.4 no signal
152 Breast Cancer Female 3 0.4 0.4 no signal
153 Bladder Cancer 4 0.3 0.3 no signal
154 Colorectal Cancer 3 0.2 0.2 no signal