Drug
Elotuzumab
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 | 564 | 59.7 | 67.0 | signal |
| 2 | Cytopenia | 35 | 12.0 | 12.1 | signal |
| 3 | Pneumocystis Jirovecii Pneumonia | 25 | 10.2 | 10.3 | signal |
| 4 | Malignant Neoplasm Progression | 254 | 10.2 | 10.7 | signal |
| 5 | Bacteraemia | 28 | 9.7 | 9.8 | signal |
| 6 | Lymphocyte Count Decreased | 40 | 9.2 | 9.3 | signal |
| 7 | Cytomegalovirus Infection | 37 | 9.1 | 9.2 | signal |
| 8 | Cytokine Release Syndrome | 39 | 8.4 | 8.4 | signal |
| 9 | Covid-19 Pneumonia | 24 | 8.3 | 8.3 | signal |
| 10 | Hypercalcaemia | 23 | 7.6 | 7.7 | signal |
| 11 | Therapy Partial Responder | 27 | 7.3 | 7.4 | signal |
| 12 | Myelodysplastic Syndrome | 25 | 7.1 | 7.1 | signal |
| 13 | Basal Cell Carcinoma | 26 | 6.8 | 6.8 | signal |
| 14 | Full Blood Count Decreased | 33 | 6.7 | 6.7 | signal |
| 15 | Neutrophil Count Decreased | 66 | 6.7 | 6.7 | signal |
| 16 | Acute Myeloid Leukaemia | 25 | 6.6 | 6.6 | signal |
| 17 | Febrile Neutropenia | 95 | 5.9 | 6.0 | signal |
| 18 | Neutropenia | 192 | 5.8 | 6.0 | signal |
| 19 | Clostridium Difficile Colitis | 15 | 5.8 | 5.8 | signal |
| 20 | Septic Shock | 57 | 5.4 | 5.4 | signal |
| 21 | Thrombocytopenia | 147 | 5.4 | 5.5 | signal |
| 22 | Lymphopenia | 18 | 5.2 | 5.2 | signal |
| 23 | Platelet Count Decreased | 134 | 5.1 | 5.3 | signal |
| 24 | Neuropathy Peripheral | 114 | 4.9 | 5.0 | signal |
| 25 | Urosepsis | 11 | 4.9 | 4.9 | signal |
| 26 | Acute Respiratory Failure | 22 | 4.7 | 4.7 | signal |
| 27 | Pneumonitis | 31 | 4.7 | 4.7 | signal |
| 28 | Malignant Melanoma | 15 | 4.6 | 4.6 | signal |
| 29 | Hypocalcaemia | 21 | 4.5 | 4.6 | signal |
| 30 | Sepsis | 124 | 4.5 | 4.6 | signal |
| 31 | Laboratory Test Abnormal | 32 | 4.4 | 4.5 | signal |
| 32 | Squamous Cell Carcinoma | 10 | 4.3 | 4.3 | signal |
| 33 | Pancytopenia | 55 | 4.0 | 4.1 | signal |
| 34 | Multiple Organ Dysfunction Syndrome | 27 | 4.0 | 4.0 | signal |
| 35 | Product Preparation Error | 20 | 3.9 | 4.0 | signal |
| 36 | Electrolyte Imbalance | 11 | 3.9 | 3.9 | signal |
| 37 | Lung Infection | 15 | 3.9 | 3.9 | signal |
| 38 | Pneumonia | 304 | 3.8 | 4.0 | signal |
| 39 | Infusion Related Reaction | 62 | 3.8 | 3.9 | signal |
| 40 | Anaemia | 173 | 3.7 | 3.8 | signal |
| 41 | White Blood Cell Count Decreased | 98 | 3.7 | 3.7 | signal |
| 42 | Deep Vein Thrombosis | 57 | 3.6 | 3.6 | signal |
| 43 | Colon Cancer | 13 | 3.6 | 3.6 | signal |
| 44 | Sudden Death | 9 | 3.4 | 3.4 | signal |
| 45 | Cholecystitis | 10 | 3.4 | 3.4 | signal |
| 46 | Atrial Fibrillation | 79 | 3.3 | 3.3 | signal |
| 47 | Fracture | 15 | 3.2 | 3.2 | signal |
| 48 | Skin Reaction | 11 | 3.2 | 3.2 | signal |
| 49 | Mucosal Inflammation | 20 | 3.1 | 3.1 | signal |
| 50 | Retinal Detachment | 7 | 3.1 | 3.1 | signal |
| 51 | Polyneuropathy | 9 | 3.1 | 3.1 | signal |
| 52 | Ileus | 9 | 3.0 | 3.0 | signal |
| 53 | Leukopenia | 36 | 2.9 | 3.0 | signal |
| 54 | Device Related Infection | 11 | 2.9 | 2.9 | signal |
| 55 | Pulmonary Embolism | 68 | 2.9 | 2.9 | signal |
| 56 | Myelosuppression | 24 | 2.9 | 2.9 | signal |
| 57 | Adverse Event | 65 | 2.9 | 2.9 | signal |
| 58 | Therapy Non-responder | 31 | 2.8 | 2.9 | signal |
| 59 | Osteonecrosis Of Jaw | 17 | 2.8 | 2.8 | signal |
| 60 | Femur Fracture | 21 | 2.8 | 2.8 | signal |
| 61 | Transfusion | 7 | 2.7 | 2.7 | signal |
| 62 | Cellulitis | 33 | 2.7 | 2.7 | signal |
| 63 | Upper Respiratory Tract Infection | 30 | 2.7 | 2.7 | signal |
| 64 | Disease Progression | 76 | 2.6 | 2.7 | signal |
| 65 | Pyrexia | 221 | 2.6 | 2.7 | signal |
| 66 | Rib Fracture | 13 | 2.6 | 2.6 | signal |
| 67 | Acute Kidney Injury | 95 | 2.5 | 2.6 | signal |
| 68 | Gastroenteritis | 9 | 2.5 | 2.5 | signal |
| 69 | Cerebral Infarction | 15 | 2.5 | 2.5 | signal |
| 70 | Cardiac Failure | 49 | 2.5 | 2.5 | signal |
| 71 | Incorrect Product Storage | 8 | 2.5 | 2.5 | signal |
| 72 | Red Blood Cell Count Decreased | 17 | 2.4 | 2.4 | signal |
| 73 | Infection | 85 | 2.4 | 2.4 | signal |
| 74 | Respiratory Tract Infection | 15 | 2.4 | 2.4 | signal |
| 75 | Interstitial Lung Disease | 27 | 2.3 | 2.3 | signal |
| 76 | Renal Disorder | 26 | 2.3 | 2.3 | signal |
| 77 | Electrocardiogram Qt Prolonged | 20 | 2.3 | 2.3 | signal |
| 78 | Hyperglycaemia | 20 | 2.2 | 2.3 | signal |
| 79 | Pulmonary Thrombosis | 6 | 2.2 | 2.2 | no signal |
| 80 | Diverticulitis | 15 | 2.2 | 2.2 | signal |
| 81 | Thrombosis | 43 | 2.2 | 2.2 | signal |
| 82 | Product Storage Error | 46 | 2.2 | 2.2 | signal |
| 83 | Sinus Bradycardia | 5 | 2.1 | 2.1 | no signal |
| 84 | Thrombotic Microangiopathy | 5 | 2.1 | 2.1 | no signal |
| 85 | Spinal Pain | 6 | 2.1 | 2.1 | no signal |
| 86 | Chills | 60 | 2.1 | 2.1 | signal |
| 87 | Cataract | 30 | 2.1 | 2.1 | signal |
| 88 | Hepatotoxicity | 11 | 2.0 | 2.0 | signal |
| 89 | Cardiogenic Shock | 7 | 2.0 | 2.0 | no signal |
| 90 | Bone Marrow Failure | 10 | 2.0 | 2.0 | no signal |
| 91 | Hyperbilirubinaemia | 5 | 2.0 | 2.0 | no signal |
| 92 | Hypoaesthesia Oral | 7 | 1.9 | 1.9 | no signal |
| 93 | Influenza | 51 | 1.9 | 1.9 | no signal |
| 94 | Immune System Disorder | 6 | 1.9 | 1.9 | no signal |
| 95 | Drug Eruption | 8 | 1.9 | 1.9 | no signal |
| 96 | Central Nervous System Lesion | 6 | 1.8 | 1.8 | no signal |
| 97 | Dementia | 12 | 1.8 | 1.8 | no signal |
| 98 | Appendicitis | 4 | 1.8 | 1.8 | no signal |
| 99 | Covid-19 | 76 | 1.8 | 1.8 | no signal |
| 100 | Subdural Haematoma | 6 | 1.7 | 1.7 | no signal |
| 101 | Tooth Disorder | 9 | 1.6 | 1.6 | no signal |
| 102 | Peritonitis | 8 | 1.6 | 1.6 | no signal |
| 103 | Pelvic Pain | 7 | 1.6 | 1.6 | no signal |
| 104 | Herpes Zoster | 22 | 1.6 | 1.6 | no signal |
| 105 | Bone Disorder | 7 | 1.6 | 1.6 | no signal |
| 106 | Dysgeusia | 28 | 1.5 | 1.5 | no signal |
| 107 | Aphonia | 5 | 1.5 | 1.5 | no signal |
| 108 | Hypertensive Crisis | 4 | 1.5 | 1.5 | no signal |
| 109 | Rebound Effect | 4 | 1.4 | 1.4 | no signal |
| 110 | Neoplasm | 4 | 1.4 | 1.4 | no signal |
| 111 | Death | 298 | 1.4 | 1.4 | no signal |
| 112 | Eosinophilia | 6 | 1.4 | 1.4 | no signal |
| 113 | Brain Neoplasm | 3 | 1.3 | 1.3 | no signal |
| 114 | Haematotoxicity | 3 | 1.3 | 1.3 | no signal |
| 115 | Leukaemia | 3 | 1.3 | 1.3 | no signal |
| 116 | Neurotoxicity | 5 | 1.2 | 1.2 | no signal |
| 117 | Skin Cancer | 6 | 1.1 | 1.1 | no signal |
| 118 | Myocarditis | 3 | 1.1 | 1.1 | no signal |
| 119 | Neoplasm Progression | 9 | 1.0 | 1.0 | no signal |
| 120 | Multiple Fractures | 4 | 1.0 | 1.0 | no signal |
| 121 | Gastric Cancer | 5 | 0.8 | 0.8 | no signal |
| 122 | Prostate Cancer | 11 | 0.6 | 0.6 | no signal |
| 123 | Hepatic Cancer | 3 | 0.5 | 0.5 | no signal |
| 124 | Pancreatic Carcinoma | 3 | 0.4 | 0.4 | no signal |
| 125 | Bladder Cancer | 3 | 0.2 | 0.2 | no signal |