OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Esomeprazole Sodium

271 flagged reaction(s) · 7,775 total co-reports · max PRR 52.1
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 Malnutrition 66 52.1 53.6 signal
2 Eye Haemorrhage 54 35.4 36.2 signal
3 Thyroid Disorder 61 34.7 35.5 signal
4 Ocular Discomfort 35 28.2 28.6 signal
5 Body Temperature Decreased 31 27.3 27.7 signal
6 Sopor 41 26.8 27.3 signal
7 Motor Dysfunction 31 26.8 27.2 signal
8 Affect Lability 29 26.2 26.6 signal
9 Pericardial Effusion 68 25.9 26.6 signal
10 Sinus Congestion 31 20.0 20.3 signal
11 Head Discomfort 40 19.9 20.2 signal
12 Muscle Spasticity 28 19.7 20.0 signal
13 Coordination Abnormal 29 18.0 18.3 signal
14 Altered State Of Consciousness 44 17.8 18.2 signal
15 Ulcer 32 17.6 17.8 signal
16 Blood Calcium Decreased 22 17.0 17.2 signal
17 Skin Haemorrhage 28 17.0 17.2 signal
18 Angina Pectoris 55 16.7 17.0 signal
19 Respiratory Tract Congestion 30 16.5 16.7 signal
20 Hemiparesis 32 16.4 16.6 signal
21 Breast Pain 20 16.4 16.5 signal
22 Blood Pressure Systolic Increased 36 16.1 16.3 signal
23 Lymphocyte Count Decreased 31 15.3 15.5 signal
24 Ventricular Tachycardia 29 15.3 15.5 signal
25 Haematemesis 44 15.1 15.4 signal
26 Sinus Disorder 34 15.0 15.2 signal
27 Mass 24 15.0 15.1 signal
28 Ascites 46 13.7 13.9 signal
29 Supraventricular Tachycardia 14 12.8 12.9 signal
30 Arthritis 114 12.6 13.2 signal
31 Mitral Valve Incompetence 16 12.4 12.4 signal
32 Hypercalcaemia 17 12.0 12.1 signal
33 Vasculitis 16 12.0 12.1 signal
34 Neutrophil Count Increased 14 11.9 12.0 signal
35 Eating Disorder 29 11.9 12.0 signal
36 Sedation 35 11.7 11.9 signal
37 Haemorrhoids 26 11.6 11.7 signal
38 Blood Pressure Fluctuation 32 11.6 11.8 signal
39 Sneezing 29 11.3 11.5 signal
40 Pulmonary Oedema 57 11.1 11.4 signal
41 Hyperlipidaemia 15 10.9 11.0 signal
42 Intentional Self-injury 25 10.8 10.9 signal
43 Hypomagnesaemia 17 10.7 10.8 signal
44 Hand Deformity 16 10.7 10.7 signal
45 Hypokalaemia 56 10.7 10.9 signal
46 Drug Eruption 21 10.4 10.5 signal
47 Aphasia 36 10.4 10.5 signal
48 Bipolar Disorder 13 10.4 10.4 signal
49 Hepatic Cirrhosis 22 10.3 10.4 signal
50 Tachycardia 104 10.2 10.6 signal
51 Hypocalcaemia 22 10.2 10.3 signal
52 Neutrophil Count Decreased 47 10.1 10.3 signal
53 Hiatus Hernia 15 10.1 10.2 signal
54 Blindness 47 10.1 10.3 signal
55 Faeces Discoloured 25 10.1 10.2 signal
56 Generalised Oedema 14 9.9 10.0 signal
57 Cardiomegaly 14 9.9 9.9 signal
58 Nightmare 39 9.8 9.9 signal
59 Tooth Fracture 12 9.5 9.6 signal
60 Metastases To Liver 19 9.5 9.5 signal
61 Subarachnoid Haemorrhage 11 9.4 9.4 signal
62 Photophobia 20 9.4 9.4 signal
63 Poor Venous Access 11 9.3 9.3 signal
64 Spinal Disorder 10 9.2 9.2 signal
65 Cardio-respiratory Arrest 43 8.9 9.1 signal
66 Coma 48 8.8 9.0 signal
67 Diplopia 26 8.7 8.8 signal
68 Hypertensive Crisis 11 8.6 8.6 signal
69 Cystitis 31 8.5 8.6 signal
70 Frequent Bowel Movements 26 8.4 8.5 signal
71 Ejection Fraction Decreased 15 8.4 8.5 signal
72 Chills 113 8.4 8.8 signal
73 Dysarthria 36 8.4 8.5 signal
74 Productive Cough 45 8.3 8.4 signal
75 Neuropathy Peripheral 89 8.2 8.5 signal
76 Chest Discomfort 96 8.2 8.5 signal
77 Pallor 25 8.0 8.1 signal
78 Liver Injury 22 7.9 8.0 signal
79 Gout 16 7.8 7.8 signal
80 Diverticulitis 24 7.6 7.7 signal
81 Movement Disorder 28 7.6 7.7 signal
82 Impaired Gastric Emptying 11 7.5 7.6 signal
83 Tenderness 9 7.5 7.6 signal
84 Flank Pain 8 7.5 7.5 signal
85 Cholelithiasis 28 7.5 7.5 signal
86 Hypoglycaemia 41 7.4 7.5 signal
87 Covid-19 Pneumonia 10 7.3 7.4 signal
88 Body Height Decreased 9 7.3 7.3 signal
89 Anosmia 12 7.2 7.3 signal
90 Fibromyalgia 20 7.2 7.2 signal
91 Heart Rate Increased 81 7.1 7.4 signal
92 Haematuria 28 7.1 7.2 signal
93 Eye Pain 45 7.1 7.2 signal
94 Gamma-glutamyltransferase Increased 18 7.1 7.1 signal
95 Drug Intolerance 78 7.1 7.3 signal
96 Cataract 48 7.1 7.2 signal
97 Skin Lesion 22 7.1 7.1 signal
98 Night Sweats 26 7.1 7.1 signal
99 Hepatic Steatosis 15 7.0 7.1 signal
100 Needle Issue 23 7.0 7.1 signal
101 Ovarian Cyst 8 6.9 7.0 signal
102 Inappropriate Antidiuretic Hormone Secretion 8 6.9 6.9 signal
103 Tinnitus 36 6.8 6.9 signal
104 Pericarditis 13 6.8 6.8 signal
105 Fear 21 6.8 6.8 signal
106 Upper Gastrointestinal Haemorrhage 13 6.7 6.8 signal
107 Hepatotoxicity 17 6.7 6.7 signal
108 Alanine Aminotransferase Increased 47 6.7 6.8 signal
109 Hyponatraemia 43 6.7 6.8 signal
110 Rheumatoid Arthritis 85 6.6 6.8 signal
111 Orthostatic Hypotension 13 6.5 6.5 signal
112 Palpitations 87 6.5 6.7 signal
113 Platelet Count Decreased 79 6.5 6.7 signal
114 Abdominal Pain Upper 151 6.4 6.8 signal
115 Cardiac Failure Congestive 59 6.4 6.5 signal
116 Gastritis 19 6.3 6.4 signal
117 Drug-induced Liver Injury 22 6.2 6.3 signal
118 Gastrointestinal Disorder 63 6.2 6.4 signal
119 Rash Papular 16 6.2 6.3 signal
120 Blood Pressure Decreased 47 6.2 6.3 signal
121 Upper Limb Fracture 14 6.1 6.1 signal
122 Blood Pressure Increased 107 6.1 6.3 signal
123 Intestinal Obstruction 26 6.1 6.1 signal
124 Arrhythmia 33 6.1 6.1 signal
125 Upper Respiratory Tract Infection 32 6.1 6.1 signal
126 Tooth Abscess 7 6.0 6.0 signal
127 Type 2 Diabetes Mellitus 23 5.9 6.0 signal
128 Cold Sweat 12 5.9 6.0 signal
129 Myelosuppression 23 5.9 5.9 signal
130 Bursitis 8 5.8 5.8 signal
131 Sepsis 73 5.7 5.9 signal
132 Conjunctivitis 12 5.7 5.7 signal
133 Muscle Twitching 15 5.7 5.7 signal
134 Hepatic Function Abnormal 24 5.7 5.7 signal
135 Drug Abuse 54 5.6 5.7 signal
136 Rhinorrhoea 41 5.6 5.6 signal
137 Nerve Injury 7 5.5 5.5 signal
138 Heart Rate Decreased 22 5.4 5.5 signal
139 Nephrolithiasis 28 5.3 5.4 signal
140 Musculoskeletal Pain 32 5.3 5.3 signal
141 Aspartate Aminotransferase Increased 32 5.3 5.3 signal
142 Feeding Disorder 12 5.3 5.3 signal
143 Clostridium Difficile Infection 13 5.2 5.3 signal
144 Eyelid Oedema 7 5.2 5.2 signal
145 Hypothermia 6 5.2 5.2 signal
146 Tachypnoea 8 5.2 5.2 signal
147 International Normalised Ratio Increased 17 5.2 5.2 signal
148 Coronary Artery Disease 18 5.1 5.2 signal
149 Melaena 13 5.1 5.2 signal
150 Temperature Intolerance 6 5.1 5.1 signal
151 Treatment Failure 48 5.1 5.2 signal
152 Musculoskeletal Chest Pain 9 5.1 5.1 signal
153 White Blood Cell Count Decreased 63 5.1 5.2 signal
154 Peripheral Coldness 8 5.1 5.1 signal
155 Presyncope 14 5.1 5.1 signal
156 C-reactive Protein Increased 21 5.0 5.1 signal
157 Abdominal Pain 134 5.0 5.3 signal
158 Pulmonary Fibrosis 11 5.0 5.0 signal
159 Infusion Related Reaction 38 5.0 5.1 signal
160 Acute Myocardial Infarction 17 5.0 5.0 signal
161 Heart Rate Irregular 13 5.0 5.0 signal
162 Angioedema 25 4.9 5.0 signal
163 Irritable Bowel Syndrome 12 4.9 4.9 signal
164 Hyperhidrosis 72 4.9 5.0 signal
165 Blood Cholesterol Increased 26 4.9 4.9 signal
166 Electrocardiogram Qt Prolonged 20 4.9 4.9 signal
167 Brain Oedema 7 4.8 4.9 signal
168 Blood Creatinine Increased 36 4.8 4.9 signal
169 Dysstasia 16 4.8 4.8 signal
170 Inflammation 28 4.8 4.8 signal
171 Anaemia 104 4.8 4.9 signal
172 Skin Ulcer 14 4.7 4.8 signal
173 Nodule 7 4.7 4.7 signal
174 Transient Ischaemic Attack 18 4.6 4.7 signal
175 Nasopharyngitis 98 4.6 4.8 signal
176 Sinusitis 54 4.6 4.7 signal
177 Gastric Ulcer 10 4.6 4.6 signal
178 Cytokine Release Syndrome 10 4.6 4.6 signal
179 Myalgia 89 4.6 4.7 signal
180 Rash Pruritic 28 4.5 4.6 signal
181 Gastric Disorder 18 4.5 4.5 signal
182 Syncope 51 4.4 4.5 signal
183 Haemoglobin Decreased 52 4.4 4.5 signal
184 Lethargy 29 4.4 4.4 signal
185 Blood Lactate Dehydrogenase Increased 8 4.4 4.4 signal
186 Interstitial Lung Disease 24 4.3 4.4 signal
187 Injection Site Reaction 34 4.3 4.4 signal
188 Cognitive Disorder 23 4.3 4.3 signal
189 Hepatocellular Injury 7 4.3 4.3 signal
190 Paralysis 7 4.3 4.3 signal
191 Petechiae 5 4.2 4.2 signal
192 Intentional Product Use Issue 42 4.2 4.2 signal
193 Cerebral Haemorrhage 17 4.1 4.2 signal
194 Agitation 35 4.1 4.2 signal
195 Stress 34 4.1 4.2 signal
196 Cough 132 4.1 4.3 signal
197 Bradycardia 25 4.1 4.1 signal
198 Pruritus 177 4.1 4.3 signal
199 Joint Swelling 56 4.1 4.1 signal
200 Toxic Epidermal Necrolysis 7 4.1 4.1 signal
201 Leukopenia 23 4.0 4.1 signal
202 Kidney Infection 9 4.0 4.0 signal
203 Hyperkalaemia 16 4.0 4.0 signal
204 Injection Site Nodule 5 4.0 4.0 signal
205 Lip Swelling 15 3.9 4.0 signal
206 Red Blood Cell Sedimentation Rate Increased 5 3.9 3.9 signal
207 Ischaemic Stroke 8 3.9 3.9 signal
208 Metabolic Acidosis 14 3.9 3.9 signal
209 Flatulence 25 3.9 3.9 signal
210 Flushing 45 3.8 3.9 signal
211 Bone Marrow Failure 9 3.8 3.9 signal
212 Extrapyramidal Disorder 11 3.8 3.8 signal
213 Skin Exfoliation 36 3.8 3.8 signal
214 Dyskinesia 17 3.7 3.7 signal
215 Pharyngeal Swelling 4 3.6 3.7 signal
216 Hyperthyroidism 6 3.6 3.6 signal
217 Blood Glucose Increased 78 3.6 3.7 signal
218 Influenza Like Illness 34 3.6 3.6 signal
219 Influenza 46 3.6 3.6 signal
220 Hepatic Cytolysis 5 3.6 3.6 signal
221 Toxic Skin Eruption 4 3.5 3.5 signal
222 Systemic Lupus Erythematosus 14 3.5 3.5 signal
223 Helicobacter Infection 4 3.4 3.4 signal
224 Synovitis 7 3.4 3.4 signal
225 Basal Cell Carcinoma 6 3.4 3.4 signal
226 Plasma Cell Myeloma 15 3.3 3.4 signal
227 Dysmenorrhoea 5 3.3 3.3 signal
228 Ill-defined Disorder 23 3.3 3.3 signal
229 Therapeutic Response Shortened 12 3.3 3.3 signal
230 Inappropriate Schedule Of Product Administration 66 3.3 3.3 signal
231 Breast Cancer Metastatic 4 3.3 3.3 signal
232 Mental Impairment 9 3.2 3.2 signal
233 Pain Of Skin 10 3.2 3.2 signal
234 Uveitis 5 3.2 3.2 signal
235 Pneumonitis 10 3.2 3.2 signal
236 Cholestasis 7 3.2 3.2 signal
237 Therapeutic Product Effect Decreased 16 3.1 3.2 signal
238 Oral Herpes 7 3.1 3.1 signal
239 Psychomotor Hyperactivity 6 3.1 3.1 signal
240 Stevens-johnson Syndrome 8 3.1 3.1 signal
241 Fistula 4 3.1 3.1 no signal
242 Malignant Neoplasm Progression 34 2.9 2.9 signal
243 Hot Flush 25 2.9 2.9 signal
244 Blood Thyroid Stimulating Hormone Increased 3 2.8 2.8 no signal
245 Injection Site Extravasation 4 2.8 2.8 no signal
246 Cerebrovascular Accident 53 2.7 2.8 signal
247 Ankylosing Spondylitis 4 2.7 2.7 no signal
248 Psoriasis 40 2.7 2.7 signal
249 Eye Pruritus 10 2.6 2.7 signal
250 Drug Level Increased 5 2.6 2.6 no signal
251 Underdose 22 2.6 2.6 signal
252 Cytomegalovirus Infection 5 2.6 2.6 no signal
253 Mood Altered 8 2.6 2.6 signal
254 Drug Level Decreased 3 2.6 2.6 no signal
255 Injection Site Swelling 21 2.4 2.4 signal
256 Breast Cancer 26 2.4 2.4 signal
257 Status Epilepticus 3 2.3 2.3 no signal
258 Diabetic Ketoacidosis 6 2.2 2.2 no signal
259 Psoriatic Arthropathy 10 2.2 2.2 signal
260 Poisoning 3 2.1 2.1 no signal
261 Injection Site Erythema 29 2.1 2.1 signal
262 Drug Reaction With Eosinophilia And Systemic Symptoms 6 2.0 2.1 no signal
263 Neurotoxicity 4 2.0 2.0 no signal
264 Dystonia 4 1.8 1.8 no signal
265 Injection Site Warmth 4 1.7 1.7 no signal
266 Injection Site Bruising 13 1.4 1.4 no signal
267 Suicide Attempt 10 1.4 1.4 no signal
268 Injection Site Pruritus 8 1.0 1.0 no signal
269 Injection Site Pain 35 1.0 1.0 no signal
270 Completed Suicide 9 0.9 0.9 no signal
271 Oesophageal Carcinoma 3 0.9 0.9 no signal