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Drug

Edoxaban Tosylate

308 flagged reaction(s) · 10,373 total co-reports · max PRR 34.4
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 Cerebral Infarction 262 34.4 35.8 signal
2 Mitral Valve Incompetence 53 15.0 15.1 signal
3 Melaena 96 13.9 14.1 signal
4 Haematuria 147 13.7 14.0 signal
5 Renal Impairment 286 10.9 11.4 signal
6 Brain Oedema 42 10.6 10.7 signal
7 Cardiac Failure 260 10.3 10.7 signal
8 Pneumonia Aspiration 75 9.6 9.7 signal
9 Joint Dislocation 30 9.1 9.1 signal
10 Glomerular Filtration Rate Decreased 34 9.0 9.0 signal
11 Subdural Haematoma 40 8.9 8.9 signal
12 Subarachnoid Haemorrhage 28 8.7 8.8 signal
13 Metastases To Central Nervous System 34 8.5 8.5 signal
14 Upper Gastrointestinal Haemorrhage 44 8.3 8.4 signal
15 Pulmonary Hypertension 54 8.2 8.3 signal
16 Cerebral Haemorrhage 90 8.0 8.1 signal
17 Interstitial Lung Disease 120 7.9 8.0 signal
18 Myelodysplastic Syndrome 35 7.7 7.7 signal
19 Iron Deficiency Anaemia 22 7.6 7.7 signal
20 Gastrointestinal Haemorrhage 195 7.4 7.6 signal
21 Cardiogenic Shock 32 7.1 7.2 signal
22 Hiatus Hernia 29 7.1 7.2 signal
23 Presyncope 53 7.0 7.0 signal
24 Atrial Fibrillation 210 6.9 7.1 signal
25 Candida Infection 35 6.7 6.7 signal
26 Ischaemic Stroke 37 6.6 6.6 signal
27 Cardiomegaly 25 6.4 6.4 signal
28 Polyneuropathy 23 6.2 6.2 signal
29 Faeces Discoloured 40 5.9 5.9 signal
30 Osteopenia 28 5.8 5.9 signal
31 Gingival Bleeding 25 5.8 5.8 signal
32 C-reactive Protein Increased 66 5.8 5.8 signal
33 Sopor 24 5.7 5.7 signal
34 Skin Fissures 33 5.6 5.6 signal
35 Post Procedural Haemorrhage 20 5.5 5.5 signal
36 Drug Eruption 30 5.4 5.4 signal
37 Epistaxis 127 5.4 5.5 signal
38 Haematoma 44 5.4 5.4 signal
39 Eructation 32 5.4 5.4 signal
40 Anaemia 313 5.2 5.4 signal
41 Disseminated Intravascular Coagulation 23 5.2 5.2 signal
42 Altered State Of Consciousness 35 5.2 5.2 signal
43 Sudden Death 17 5.1 5.1 signal
44 Hepatic Function Abnormal 58 5.0 5.0 signal
45 Pleural Effusion 95 5.0 5.0 signal
46 Hyponatraemia 86 4.9 4.9 signal
47 Ventricular Fibrillation 17 4.9 4.9 signal
48 Transfusion 15 4.5 4.6 signal
49 Blood Urine Present 27 4.5 4.5 signal
50 Rectal Haemorrhage 61 4.5 4.5 signal
51 Myocarditis 16 4.5 4.5 signal
52 Cardiovascular Disorder 36 4.5 4.5 signal
53 Hyperkalaemia 49 4.5 4.5 signal
54 Metastases To Liver 23 4.2 4.2 signal
55 Gastric Haemorrhage 15 4.1 4.1 signal
56 Urinary Retention 43 4.1 4.1 signal
57 Haemoptysis 36 4.1 4.1 signal
58 Restlessness 47 4.1 4.1 signal
59 Blood Lactate Dehydrogenase Increased 20 4.0 4.0 signal
60 Acute Kidney Injury 189 4.0 4.0 signal
61 Hemiparesis 21 3.9 3.9 signal
62 General Physical Health Deterioration 141 3.9 4.0 signal
63 Arrhythmia 58 3.9 3.9 signal
64 Impaired Healing 40 3.9 3.9 signal
65 Pulmonary Congestion 16 3.8 3.9 signal
66 Urosepsis 11 3.8 3.8 signal
67 Bacteraemia 14 3.8 3.8 signal
68 Coronary Artery Disease 36 3.8 3.8 signal
69 Haematochezia 65 3.8 3.8 signal
70 Blood Sodium Decreased 22 3.7 3.7 signal
71 Adrenal Insufficiency 14 3.7 3.7 signal
72 Drug-induced Liver Injury 36 3.7 3.7 signal
73 Pulmonary Arterial Hypertension 17 3.7 3.7 signal
74 Blood Pressure Decreased 77 3.7 3.7 signal
75 Gastric Ulcer 22 3.7 3.7 signal
76 Prescribed Underdose 23 3.7 3.7 signal
77 Acute Myocardial Infarction 34 3.7 3.7 signal
78 Colon Cancer 17 3.6 3.6 signal
79 Haemorrhage Intracranial 17 3.6 3.6 signal
80 Dermatitis Allergic 14 3.6 3.6 signal
81 Tubulointerstitial Nephritis 21 3.6 3.6 signal
82 Circulatory Collapse 19 3.5 3.5 signal
83 Neutrophil Count Decreased 45 3.5 3.6 signal
84 Bradycardia 59 3.5 3.6 signal
85 Device Related Infection 17 3.5 3.5 signal
86 Cholecystitis 13 3.5 3.5 signal
87 Ascites 32 3.5 3.5 signal
88 Inappropriate Antidiuretic Hormone Secretion 11 3.4 3.4 signal
89 Multiple Organ Dysfunction Syndrome 30 3.4 3.4 signal
90 Hypokalaemia 49 3.4 3.4 signal
91 Febrile Neutropenia 70 3.4 3.4 signal
92 Cytokine Release Syndrome 20 3.3 3.3 signal
93 Internal Haemorrhage 12 3.3 3.3 signal
94 Metastases To Bone 17 3.3 3.3 signal
95 Dyspnoea Exertional 39 3.3 3.3 signal
96 Lymphocyte Count Decreased 18 3.2 3.2 signal
97 International Normalised Ratio Increased 29 3.2 3.2 signal
98 Toxic Skin Eruption 10 3.2 3.2 signal
99 Hypertensive Crisis 11 3.1 3.1 signal
100 Haematemesis 25 3.1 3.1 signal
101 Palmar-plantar Erythrodysaesthesia Syndrome 23 3.1 3.1 signal
102 Dehydration 131 3.1 3.2 signal
103 Oedema Peripheral 120 3.1 3.2 signal
104 Blood Creatinine Increased 64 3.1 3.1 signal
105 Flank Pain 9 3.1 3.1 signal
106 Haemorrhage 100 3.0 3.1 signal
107 Full Blood Count Abnormal 10 3.0 3.0 signal
108 Hypothyroidism 30 3.0 3.0 signal
109 Syncope 94 3.0 3.0 signal
110 Covid-19 Pneumonia 11 2.9 2.9 signal
111 Blood Creatine Phosphokinase Increased 27 2.9 2.9 signal
112 Agranulocytosis 17 2.9 2.9 signal
113 Eczema 46 2.9 2.9 signal
114 Drug Interaction 145 2.9 3.0 signal
115 Angina Pectoris 26 2.9 2.9 signal
116 Gastroenteritis 13 2.8 2.8 signal
117 Transient Ischaemic Attack 30 2.8 2.8 signal
118 Acute Hepatic Failure 12 2.8 2.8 signal
119 Hyperbilirubinaemia 9 2.8 2.8 signal
120 Red Blood Cell Count Decreased 25 2.8 2.8 signal
121 Pneumonitis 23 2.7 2.7 signal
122 Incontinence 9 2.7 2.7 signal
123 Hypocalcaemia 16 2.7 2.7 signal
124 Ejection Fraction Decreased 13 2.7 2.7 signal
125 Dizziness Postural 8 2.7 2.7 signal
126 Septic Shock 36 2.7 2.7 signal
127 Ileus 10 2.6 2.6 signal
128 Pneumocystis Jirovecii Pneumonia 8 2.5 2.5 signal
129 Deep Vein Thrombosis 52 2.5 2.5 signal
130 Proteinuria 15 2.5 2.5 signal
131 Thrombosis 64 2.5 2.5 signal
132 Aphasia 24 2.5 2.5 signal
133 Acute Respiratory Distress Syndrome 14 2.5 2.5 signal
134 Haemoglobin Decreased 81 2.5 2.5 signal
135 Rib Fracture 16 2.5 2.5 signal
136 Platelet Count Decreased 83 2.5 2.5 signal
137 Blood Urea Increased 13 2.5 2.5 signal
138 Pancytopenia 43 2.5 2.5 signal
139 Basal Cell Carcinoma 12 2.4 2.4 signal
140 Haemorrhoids 15 2.4 2.4 signal
141 Skin Haemorrhage 11 2.4 2.4 signal
142 Erythema Multiforme 7 2.4 2.4 signal
143 Hepatic Encephalopathy 7 2.4 2.4 signal
144 Hepatic Cirrhosis 14 2.4 2.4 signal
145 Eye Haemorrhage 10 2.4 2.4 signal
146 Cerebrovascular Accident 127 2.4 2.4 signal
147 Gastric Cancer 19 2.4 2.4 signal
148 Decreased Appetite 170 2.3 2.4 signal
149 Toxic Epidermal Necrolysis 11 2.3 2.3 signal
150 Prescribed Overdose 14 2.3 2.3 signal
151 Sinus Bradycardia 7 2.3 2.3 no signal
152 Liver Disorder 32 2.3 2.3 signal
153 Osteonecrosis Of Jaw 18 2.3 2.3 signal
154 Hypomagnesaemia 10 2.3 2.3 signal
155 Product Prescribing Error 17 2.3 2.3 signal
156 Hypotension 143 2.3 2.3 signal
157 Respiratory Failure 52 2.3 2.3 signal
158 Haematocrit Decreased 14 2.2 2.2 signal
159 Bacterial Infection 13 2.2 2.2 signal
160 Loss Of Consciousness 89 2.2 2.2 signal
161 Delirium 24 2.2 2.2 signal
162 Pneumothorax 11 2.2 2.2 signal
163 Vertigo 42 2.2 2.2 signal
164 Vasculitis 8 2.2 2.2 signal
165 Tooth Abscess 7 2.2 2.2 no signal
166 Oedema 37 2.2 2.2 signal
167 Aspartate Aminotransferase Increased 36 2.2 2.2 signal
168 Gamma-glutamyltransferase Increased 15 2.2 2.2 signal
169 Pallor 18 2.1 2.1 signal
170 Pneumonia 212 2.1 2.1 signal
171 Breast Cancer Metastatic 7 2.1 2.1 no signal
172 Pericardial Effusion 15 2.1 2.1 signal
173 Malignant Neoplasm Progression 66 2.1 2.1 signal
174 Ovarian Cancer 6 2.1 2.1 no signal
175 Device Occlusion 9 2.1 2.1 no signal
176 Femur Fracture 20 2.0 2.1 signal
177 Stomatitis 39 2.0 2.1 signal
178 Hyperthyroidism 9 2.0 2.0 no signal
179 Fall 206 2.0 2.0 no signal
180 Osteoarthritis 26 1.9 2.0 no signal
181 Myocardial Ischaemia 7 1.9 1.9 no signal
182 Gastritis 16 1.9 1.9 no signal
183 Ventricular Tachycardia 10 1.9 1.9 no signal
184 Contusion 58 1.9 1.9 no signal
185 Underdose 44 1.9 1.9 no signal
186 Coagulopathy 10 1.9 1.9 no signal
187 Taste Disorder 12 1.9 1.9 no signal
188 Pulmonary Embolism 57 1.9 1.9 no signal
189 Emphysema 6 1.9 1.9 no signal
190 Blindness 24 1.9 1.9 no signal
191 Drug Reaction With Eosinophilia And Systemic Symptoms 15 1.9 1.9 no signal
192 Nocturia 7 1.8 1.8 no signal
193 Ventricular Extrasystoles 6 1.8 1.8 no signal
194 Schizophrenia 7 1.8 1.8 no signal
195 Bronchospasm 8 1.8 1.8 no signal
196 Muscle Atrophy 7 1.8 1.8 no signal
197 Cardiac Failure Congestive 45 1.8 1.8 no signal
198 Blood Potassium Increased 9 1.8 1.8 no signal
199 Renal Failure 74 1.8 1.8 no signal
200 Wound Infection 6 1.8 1.8 no signal
201 Liver Function Test Abnormal 16 1.7 1.7 no signal
202 Skin Ulcer 14 1.7 1.7 no signal
203 Skin Disorder 18 1.7 1.7 no signal
204 Stevens-johnson Syndrome 12 1.7 1.7 no signal
205 Urinary Tract Infection 90 1.7 1.7 no signal
206 Pollakiuria 22 1.7 1.7 no signal
207 Electrocardiogram Qt Prolonged 19 1.7 1.7 no signal
208 Orthostatic Hypotension 9 1.6 1.6 no signal
209 Pulmonary Oedema 23 1.6 1.6 no signal
210 Blood Iron Decreased 6 1.6 1.6 no signal
211 Peripheral Coldness 7 1.6 1.6 no signal
212 Metabolic Acidosis 16 1.6 1.6 no signal
213 Wound 14 1.6 1.6 no signal
214 Cardio-respiratory Arrest 21 1.6 1.6 no signal
215 Hypotonia 5 1.6 1.6 no signal
216 Blood Test Abnormal 7 1.6 1.6 no signal
217 Generalised Tonic-clonic Seizure 8 1.6 1.6 no signal
218 Paralysis 7 1.5 1.6 no signal
219 Chromaturia 11 1.5 1.6 no signal
220 Depressed Level Of Consciousness 19 1.5 1.5 no signal
221 Leukopenia 24 1.5 1.5 no signal
222 Covid-19 85 1.5 1.5 no signal
223 Colitis 18 1.5 1.5 no signal
224 Head Injury 15 1.5 1.5 no signal
225 Face Oedema 8 1.5 1.5 no signal
226 Renal Disorder 22 1.5 1.5 no signal
227 Blood Pressure Systolic Increased 9 1.5 1.5 no signal
228 Platelet Count Increased 6 1.5 1.5 no signal
229 Bedridden 6 1.5 1.5 no signal
230 Diabetes Mellitus Inadequate Control 8 1.4 1.4 no signal
231 Acute Myeloid Leukaemia 7 1.4 1.4 no signal
232 Quality Of Life Decreased 6 1.4 1.4 no signal
233 Intestinal Perforation 5 1.4 1.4 no signal
234 Shock 10 1.4 1.4 no signal
235 Palpitations 51 1.4 1.4 no signal
236 Cardiac Arrest 36 1.4 1.4 no signal
237 Diverticulitis 12 1.4 1.4 no signal
238 Hypoglycaemia 21 1.4 1.4 no signal
239 Contraindicated Product Administered 13 1.4 1.4 no signal
240 Appendicitis 4 1.4 1.4 no signal
241 Hepatic Failure 13 1.4 1.4 no signal
242 Anaphylactic Shock 11 1.4 1.4 no signal
243 Hallucination, Visual 9 1.4 1.4 no signal
244 Diarrhoea Haemorrhagic 4 1.4 1.4 no signal
245 Blindness Unilateral 6 1.4 1.4 no signal
246 Epilepsy 13 1.4 1.4 no signal
247 Fracture 8 1.3 1.3 no signal
248 Pericarditis 7 1.3 1.3 no signal
249 Accident 5 1.3 1.3 no signal
250 Feeling Jittery 8 1.3 1.3 no signal
251 Cholestasis 8 1.3 1.3 no signal
252 Rhabdomyolysis 17 1.3 1.3 no signal
253 Rash Maculo-papular 9 1.3 1.3 no signal
254 White Blood Cell Count Decreased 44 1.3 1.3 no signal
255 Bladder Disorder 4 1.3 1.3 no signal
256 Intestinal Obstruction 15 1.3 1.3 no signal
257 Neoplasm Progression 14 1.3 1.3 no signal
258 Heart Rate Irregular 9 1.3 1.3 no signal
259 Drug Level Decreased 4 1.2 1.2 no signal
260 Flatulence 22 1.2 1.2 no signal
261 Poor Venous Access 4 1.2 1.2 no signal
262 Tendonitis 6 1.2 1.2 no signal
263 Herpes Zoster 22 1.2 1.2 no signal
264 Blood Glucose Abnormal 7 1.2 1.2 no signal
265 Abscess 6 1.2 1.2 no signal
266 Systemic Lupus Erythematosus 13 1.2 1.2 no signal
267 Psychomotor Hyperactivity 6 1.1 1.1 no signal
268 Myocardial Infarction 63 1.1 1.1 no signal
269 Neutropenia 48 1.1 1.1 no signal
270 Vaginal Haemorrhage 15 1.1 1.1 no signal
271 Hepatocellular Injury 5 1.1 1.1 no signal
272 Paranoia 6 1.1 1.1 no signal
273 Incorrect Product Administration Duration 7 1.1 1.1 no signal
274 Pancreatic Carcinoma 10 1.1 1.1 no signal
275 Neoplasm Malignant 22 1.0 1.0 no signal
276 Hip Arthroplasty 5 1.0 1.0 no signal
277 Dementia 9 1.0 1.0 no signal
278 Posterior Reversible Encephalopathy Syndrome 3 1.0 1.0 no signal
279 Erectile Dysfunction 8 1.0 1.0 no signal
280 Thrombotic Microangiopathy 3 1.0 1.0 no signal
281 Inability To Afford Medication 3 1.0 1.0 no signal
282 Drug Level Increased 5 1.0 1.0 no signal
283 Sars-cov-2 Test Positive 4 1.0 1.0 no signal
284 Malignant Melanoma 4 0.9 0.9 no signal
285 Wrong Technique In Product Usage Process 60 0.9 0.9 no signal
286 Lung Neoplasm Malignant 12 0.9 0.9 no signal
287 Peritonitis 6 0.9 0.9 no signal
288 Prostatic Specific Antigen Increased 4 0.9 0.9 no signal
289 Lactic Acidosis 9 0.9 0.9 no signal
290 No Adverse Event 47 0.8 0.8 no signal
291 Metastases To Lung 3 0.8 0.8 no signal
292 Incorrect Dose Administered 57 0.8 0.8 no signal
293 Diabetic Ketoacidosis 6 0.8 0.8 no signal
294 Skin Cancer 5 0.7 0.7 no signal
295 Plasma Cell Myeloma 9 0.7 0.7 no signal
296 Neurotoxicity 4 0.7 0.7 no signal
297 Product Dispensing Error 5 0.7 0.7 no signal
298 Complication Associated With Device 3 0.7 0.7 no signal
299 Prostate Cancer 17 0.7 0.7 no signal
300 Myelosuppression 7 0.7 0.7 no signal
301 Colitis Ulcerative 9 0.6 0.6 no signal
302 Glycosylated Haemoglobin Increased 5 0.6 0.6 no signal
303 Drug Prescribing Error 3 0.5 0.5 no signal
304 Oesophageal Carcinoma 4 0.4 0.4 no signal
305 Bladder Cancer 7 0.4 0.4 no signal
306 Device Dislocation 5 0.4 0.4 no signal
307 Intentional Overdose 7 0.3 0.3 no signal
308 Breast Cancer 9 0.3 0.3 no signal