Drug
Amikacin Sulfate
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 | Drug Resistance | 62 | 29.6 | 30.7 | signal |
| 2 | Disseminated Intravascular Coagulation | 33 | 28.7 | 29.2 | signal |
| 3 | Nephropathy Toxic | 21 | 23.1 | 23.4 | signal |
| 4 | Blood Alkaline Phosphatase Increased | 43 | 21.2 | 21.7 | signal |
| 5 | Blood Urea Increased | 29 | 21.1 | 21.5 | signal |
| 6 | Toxic Skin Eruption | 17 | 20.6 | 20.8 | signal |
| 7 | Eosinophilia | 28 | 19.7 | 20.0 | signal |
| 8 | Gamma-glutamyltransferase Increased | 35 | 19.4 | 19.7 | signal |
| 9 | Ventricular Fibrillation | 17 | 18.7 | 18.9 | signal |
| 10 | Blood Lactate Dehydrogenase Increased | 23 | 17.7 | 17.9 | signal |
| 11 | Candida Infection | 22 | 16.2 | 16.4 | signal |
| 12 | Vasculitis | 15 | 15.8 | 15.9 | signal |
| 13 | Drug Reaction With Eosinophilia And Systemic Symptoms | 32 | 15.4 | 15.6 | signal |
| 14 | Electrocardiogram Qt Prolonged | 44 | 15.0 | 15.4 | signal |
| 15 | Multiple Organ Dysfunction Syndrome | 34 | 14.9 | 15.2 | signal |
| 16 | Septic Shock | 52 | 14.8 | 15.2 | signal |
| 17 | Hepatic Function Abnormal | 41 | 13.6 | 13.9 | signal |
| 18 | C-reactive Protein Increased | 40 | 13.5 | 13.8 | signal |
| 19 | Status Epilepticus | 12 | 13.0 | 13.1 | signal |
| 20 | Deafness | 27 | 12.6 | 12.8 | signal |
| 21 | Brain Oedema | 13 | 12.6 | 12.7 | signal |
| 22 | Rash Maculo-papular | 21 | 11.6 | 11.7 | signal |
| 23 | Febrile Neutropenia | 61 | 11.3 | 11.7 | signal |
| 24 | Hepatomegaly | 9 | 11.2 | 11.2 | signal |
| 25 | Hepatotoxicity | 20 | 11.1 | 11.2 | signal |
| 26 | Hypothermia | 9 | 10.9 | 10.9 | signal |
| 27 | Bone Marrow Failure | 18 | 10.8 | 10.9 | signal |
| 28 | Cardiovascular Disorder | 22 | 10.5 | 10.7 | signal |
| 29 | Acute Respiratory Distress Syndrome | 15 | 10.4 | 10.5 | signal |
| 30 | Atelectasis | 8 | 10.1 | 10.2 | signal |
| 31 | Hypokalaemia | 37 | 9.9 | 10.1 | signal |
| 32 | Generalised Tonic-clonic Seizure | 13 | 9.7 | 9.8 | signal |
| 33 | Neutrophil Count Decreased | 32 | 9.7 | 9.8 | signal |
| 34 | Lymphopenia | 11 | 9.6 | 9.6 | signal |
| 35 | Drug-induced Liver Injury | 24 | 9.5 | 9.7 | signal |
| 36 | Hyperbilirubinaemia | 8 | 9.5 | 9.6 | signal |
| 37 | Leukocytosis | 14 | 9.5 | 9.6 | signal |
| 38 | Acute Myeloid Leukaemia | 12 | 9.4 | 9.5 | signal |
| 39 | Oral Candidiasis | 10 | 9.4 | 9.5 | signal |
| 40 | Impaired Work Ability | 16 | 9.1 | 9.2 | signal |
| 41 | Sepsis | 83 | 9.1 | 9.5 | signal |
| 42 | Multi-organ Failure | 13 | 9.1 | 9.1 | signal |
| 43 | Aspiration | 8 | 9.0 | 9.1 | signal |
| 44 | Thrombotic Microangiopathy | 7 | 8.9 | 8.9 | signal |
| 45 | Malnutrition | 8 | 8.8 | 8.9 | signal |
| 46 | Pancreatitis Acute | 16 | 8.8 | 8.9 | signal |
| 47 | Alanine Aminotransferase Increased | 44 | 8.8 | 9.0 | signal |
| 48 | Aspartate Aminotransferase Increased | 38 | 8.8 | 8.9 | signal |
| 49 | Agranulocytosis | 13 | 8.6 | 8.7 | signal |
| 50 | Altered State Of Consciousness | 15 | 8.5 | 8.6 | signal |
| 51 | Peritonitis Bacterial | 7 | 8.5 | 8.6 | signal |
| 52 | Bacterial Infection | 12 | 7.9 | 8.0 | signal |
| 53 | Blood Bilirubin Increased | 17 | 7.7 | 7.8 | signal |
| 54 | Liver Injury | 15 | 7.6 | 7.7 | signal |
| 55 | Electrolyte Imbalance | 7 | 7.5 | 7.5 | signal |
| 56 | Coagulopathy | 10 | 7.4 | 7.4 | signal |
| 57 | Cytomegalovirus Infection | 10 | 7.4 | 7.4 | signal |
| 58 | Face Oedema | 10 | 7.2 | 7.3 | signal |
| 59 | Device Related Infection | 9 | 7.1 | 7.2 | signal |
| 60 | Peritonitis | 12 | 7.1 | 7.1 | signal |
| 61 | Shock | 13 | 7.0 | 7.0 | signal |
| 62 | Metabolic Acidosis | 18 | 7.0 | 7.0 | signal |
| 63 | Drug Eruption | 10 | 7.0 | 7.0 | signal |
| 64 | Blood Creatinine Increased | 37 | 6.9 | 7.1 | signal |
| 65 | Liver Disorder | 25 | 6.9 | 7.0 | signal |
| 66 | Platelet Count Decreased | 60 | 6.9 | 7.1 | signal |
| 67 | Thrombocytopenia | 62 | 6.8 | 7.0 | signal |
| 68 | Staphylococcal Infection | 18 | 6.7 | 6.7 | signal |
| 69 | Transaminases Increased | 12 | 6.6 | 6.7 | signal |
| 70 | Pulmonary Mass | 8 | 6.6 | 6.6 | signal |
| 71 | Intestinal Perforation | 6 | 6.5 | 6.6 | signal |
| 72 | Toxic Epidermal Necrolysis | 8 | 6.5 | 6.5 | signal |
| 73 | Hypocalcaemia | 10 | 6.5 | 6.5 | signal |
| 74 | Cholestasis | 10 | 6.4 | 6.4 | signal |
| 75 | Pancytopenia | 29 | 6.4 | 6.5 | signal |
| 76 | Renal Failure Acute | 22 | 6.3 | 6.3 | signal |
| 77 | Depressed Level Of Consciousness | 20 | 6.2 | 6.3 | signal |
| 78 | Cardiogenic Shock | 7 | 6.0 | 6.0 | signal |
| 79 | Skin Lesion | 13 | 5.9 | 5.9 | signal |
| 80 | Circulatory Collapse | 8 | 5.7 | 5.8 | signal |
| 81 | Tuberculosis | 6 | 5.7 | 5.7 | signal |
| 82 | Tinnitus | 21 | 5.6 | 5.6 | signal |
| 83 | International Normalised Ratio Increased | 13 | 5.5 | 5.6 | signal |
| 84 | Leukopenia | 22 | 5.4 | 5.5 | signal |
| 85 | Erythema Multiforme | 4 | 5.3 | 5.3 | signal |
| 86 | Hepatic Encephalopathy | 4 | 5.2 | 5.3 | signal |
| 87 | Sputum Discoloured | 4 | 5.2 | 5.2 | signal |
| 88 | Hepatocellular Injury | 6 | 5.2 | 5.2 | signal |
| 89 | Hepatic Failure | 12 | 4.9 | 4.9 | signal |
| 90 | Inappropriate Antidiuretic Hormone Secretion | 4 | 4.8 | 4.8 | signal |
| 91 | White Blood Cell Count Decreased | 42 | 4.7 | 4.8 | signal |
| 92 | Neutropenia | 52 | 4.7 | 4.8 | signal |
| 93 | Anorexia | 5 | 4.7 | 4.7 | signal |
| 94 | Obstructive Airways Disorder | 4 | 4.4 | 4.4 | signal |
| 95 | Myocarditis | 4 | 4.3 | 4.3 | signal |
| 96 | Myelodysplastic Syndrome | 5 | 4.2 | 4.2 | signal |
| 97 | Cytopenia | 4 | 4.1 | 4.1 | signal |
| 98 | Myelosuppression | 11 | 4.0 | 4.0 | signal |
| 99 | Lymphoma | 5 | 4.0 | 4.0 | signal |
| 100 | Lung Infection | 5 | 3.9 | 3.9 | signal |
| 101 | Hypoacusis | 13 | 3.7 | 3.7 | signal |
| 102 | Drug Level Decreased | 3 | 3.6 | 3.6 | no signal |
| 103 | Haemorrhage Intracranial | 4 | 3.3 | 3.3 | signal |
| 104 | Fistula | 3 | 3.3 | 3.3 | no signal |
| 105 | Gastric Haemorrhage | 3 | 3.2 | 3.2 | no signal |
| 106 | Diabetic Ketoacidosis | 6 | 3.1 | 3.1 | signal |
| 107 | Hepatic Cytolysis | 3 | 3.0 | 3.0 | no signal |
| 108 | Incorrect Product Administration Duration | 4 | 2.4 | 2.4 | no signal |