Drug
Lutetium Lu 177 Dotatate
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 | Ill-defined Disorder | 1,541 | 96.0 | 131.3 | signal |
| 2 | General Physical Health Deterioration | 1,200 | 38.9 | 49.1 | signal |
| 3 | Laboratory Test Abnormal | 172 | 21.6 | 22.3 | signal |
| 4 | Metastases To Liver | 101 | 21.4 | 21.7 | signal |
| 5 | Sars-cov-2 Test Positive | 64 | 17.8 | 18.0 | signal |
| 6 | Malignant Neoplasm Progression | 349 | 12.7 | 13.4 | signal |
| 7 | Metastases To Bone | 48 | 10.9 | 10.9 | signal |
| 8 | Lymphocyte Count Decreased | 46 | 9.6 | 9.7 | signal |
| 9 | Platelet Count Decreased | 229 | 7.9 | 8.2 | signal |
| 10 | Myelodysplastic Syndrome | 29 | 7.4 | 7.4 | signal |
| 11 | Ascites | 56 | 7.0 | 7.1 | signal |
| 12 | Lymphopenia | 24 | 6.3 | 6.3 | signal |
| 13 | Illness | 166 | 6.1 | 6.3 | signal |
| 14 | Acute Myeloid Leukaemia | 25 | 5.9 | 6.0 | signal |
| 15 | Glomerular Filtration Rate Decreased | 19 | 5.8 | 5.8 | signal |
| 16 | Haematotoxicity | 14 | 5.6 | 5.6 | signal |
| 17 | Disease Progression | 173 | 5.4 | 5.6 | signal |
| 18 | Full Blood Count Decreased | 28 | 5.1 | 5.1 | signal |
| 19 | Blood Urea Increased | 22 | 4.8 | 4.8 | signal |
| 20 | Small Intestinal Obstruction | 16 | 4.8 | 4.8 | signal |
| 21 | Disseminated Intravascular Coagulation | 18 | 4.7 | 4.7 | signal |
| 22 | Neutrophil Count Increased | 12 | 4.3 | 4.3 | signal |
| 23 | Leukaemia | 11 | 4.3 | 4.3 | signal |
| 24 | Thrombocytopenia | 128 | 4.2 | 4.3 | signal |
| 25 | Metastases To Lung | 13 | 4.2 | 4.2 | signal |
| 26 | Blood Pressure Systolic Increased | 22 | 4.1 | 4.2 | signal |
| 27 | Covid-19 | 198 | 4.1 | 4.2 | signal |
| 28 | Flank Pain | 10 | 3.9 | 4.0 | signal |
| 29 | Intestinal Obstruction | 40 | 3.9 | 4.0 | signal |
| 30 | Blood Test Abnormal | 14 | 3.7 | 3.7 | signal |
| 31 | Red Blood Cell Count Decreased | 28 | 3.6 | 3.6 | signal |
| 32 | Pancytopenia | 54 | 3.6 | 3.6 | signal |
| 33 | Hypoglycaemia | 47 | 3.6 | 3.6 | signal |
| 34 | Haematocrit Decreased | 19 | 3.5 | 3.5 | signal |
| 35 | Full Blood Count Abnormal | 10 | 3.5 | 3.5 | signal |
| 36 | Hepatomegaly | 9 | 3.4 | 3.4 | signal |
| 37 | Ileus | 11 | 3.3 | 3.3 | signal |
| 38 | Hepatic Failure | 27 | 3.3 | 3.3 | signal |
| 39 | Cytopenia | 10 | 3.1 | 3.1 | signal |
| 40 | Neoplasm Progression | 29 | 3.0 | 3.1 | signal |
| 41 | Generalised Oedema | 10 | 3.0 | 3.0 | signal |
| 42 | Myelosuppression | 27 | 2.9 | 2.9 | signal |
| 43 | Neutrophil Count Decreased | 32 | 2.9 | 2.9 | signal |
| 44 | Blood Alkaline Phosphatase Increased | 19 | 2.8 | 2.8 | signal |
| 45 | Hepatic Encephalopathy | 7 | 2.8 | 2.8 | signal |
| 46 | Body Temperature Decreased | 7 | 2.6 | 2.6 | signal |
| 47 | Palmar-plantar Erythrodysaesthesia Syndrome | 16 | 2.5 | 2.5 | signal |
| 48 | Cholecystitis | 8 | 2.5 | 2.5 | signal |
| 49 | Blood Bilirubin Increased | 18 | 2.5 | 2.5 | signal |
| 50 | Renal Impairment | 52 | 2.3 | 2.3 | signal |
| 51 | Mouth Ulceration | 13 | 2.3 | 2.3 | signal |
| 52 | Liver Disorder | 27 | 2.2 | 2.3 | signal |
| 53 | Abdominal Pain | 137 | 2.2 | 2.2 | signal |
| 54 | Musculoskeletal Chest Pain | 9 | 2.1 | 2.1 | signal |
| 55 | White Blood Cell Count Decreased | 62 | 2.1 | 2.1 | signal |
| 56 | Flushing | 58 | 2.1 | 2.1 | signal |
| 57 | Incontinence | 6 | 2.1 | 2.1 | no signal |
| 58 | Jaundice | 15 | 2.1 | 2.1 | signal |
| 59 | Blood Creatinine Increased | 36 | 2.0 | 2.0 | signal |
| 60 | Oesophagitis | 6 | 2.0 | 2.0 | no signal |
| 61 | Haemoglobin Decreased | 56 | 2.0 | 2.0 | signal |
| 62 | Leukopenia | 27 | 2.0 | 2.0 | no signal |
| 63 | Hepatic Function Abnormal | 20 | 2.0 | 2.0 | no signal |
| 64 | Platelet Count Increased | 7 | 2.0 | 2.0 | no signal |
| 65 | Intestinal Perforation | 6 | 2.0 | 2.0 | no signal |
| 66 | Quality Of Life Decreased | 7 | 1.9 | 1.9 | no signal |
| 67 | Device Related Infection | 8 | 1.9 | 1.9 | no signal |
| 68 | Death | 439 | 1.9 | 2.0 | no signal |
| 69 | Lethargy | 29 | 1.9 | 1.9 | no signal |
| 70 | Therapy Partial Responder | 7 | 1.7 | 1.7 | no signal |
| 71 | Faeces Discoloured | 10 | 1.7 | 1.7 | no signal |
| 72 | Feeding Disorder | 9 | 1.7 | 1.7 | no signal |
| 73 | Nephropathy Toxic | 5 | 1.7 | 1.7 | no signal |
| 74 | Lacrimation Increased | 12 | 1.5 | 1.5 | no signal |
| 75 | Bone Marrow Failure | 8 | 1.4 | 1.4 | no signal |
| 76 | Eructation | 7 | 1.4 | 1.4 | no signal |
| 77 | Cholestasis | 7 | 1.4 | 1.4 | no signal |
| 78 | Neutropenia | 48 | 1.3 | 1.3 | no signal |
| 79 | Hip Fracture | 11 | 1.3 | 1.3 | no signal |
| 80 | Inappropriate Schedule Of Product Administration | 60 | 1.3 | 1.3 | no signal |
| 81 | Peritonitis | 7 | 1.2 | 1.2 | no signal |
| 82 | Mood Altered | 9 | 1.2 | 1.2 | no signal |
| 83 | Gastrointestinal Carcinoma | 3 | 1.2 | 1.2 | no signal |
| 84 | Brain Neoplasm | 3 | 1.2 | 1.2 | no signal |
| 85 | Blood Glucose Abnormal | 6 | 1.2 | 1.2 | no signal |
| 86 | Metastases To Central Nervous System | 4 | 1.2 | 1.2 | no signal |
| 87 | Toxic Skin Eruption | 3 | 1.1 | 1.1 | no signal |
| 88 | Pelvic Pain | 5 | 1.0 | 1.0 | no signal |
| 89 | Blood Glucose Decreased | 11 | 0.8 | 0.8 | no signal |
| 90 | Plasma Cell Myeloma | 7 | 0.7 | 0.7 | no signal |
| 91 | Needle Issue | 5 | 0.6 | 0.6 | no signal |
| 92 | Pancreatic Carcinoma | 5 | 0.6 | 0.6 | no signal |
| 93 | Injection Site Mass | 5 | 0.5 | 0.5 | no signal |
| 94 | Drug Dependence | 13 | 0.3 | 0.3 | no signal |
| 95 | Prostate Cancer | 6 | 0.3 | 0.3 | no signal |