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Drug

Amisulpride

360 flagged reaction(s) · 21,633 total co-reports · max PRR 100.4
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 Schizophrenia 339 100.4 106.4 signal
2 Akathisia 306 80.3 84.6 signal
3 Neuroleptic Malignant Syndrome 225 67.5 70.1 signal
4 Myocarditis 208 65.5 67.8 signal
5 Euphoric Mood 186 64.4 66.4 signal
6 Neutrophil Count Increased 162 56.1 57.6 signal
7 Salivary Hypersecretion 149 53.0 54.3 signal
8 Extrapyramidal Disorder 299 42.2 44.4 signal
9 Hallucination, Auditory 182 40.5 41.7 signal
10 Delusion 162 37.0 38.0 signal
11 Increased Appetite 178 33.5 34.5 signal
12 Parkinsonism 91 33.0 33.5 signal
13 Leukaemia 87 32.6 33.1 signal
14 Psychotic Disorder 233 27.8 28.9 signal
15 Electrocardiogram Qt Prolonged 276 27.1 28.3 signal
16 Obesity 119 26.3 26.8 signal
17 Mental Impairment 177 25.7 26.5 signal
18 Sedation 174 23.5 24.2 signal
19 White Blood Cell Count Increased 245 22.4 23.3 signal
20 Leukopenia 315 22.2 23.4 signal
21 Respiratory Depression 74 21.3 21.5 signal
22 Sopor 75 19.7 20.0 signal
23 Prescribed Overdose 108 19.6 20.0 signal
24 Dystonia 108 19.5 19.9 signal
25 Drug Level Increased 82 17.4 17.6 signal
26 Muscle Rigidity 59 17.4 17.5 signal
27 Sinus Tachycardia 69 17.1 17.3 signal
28 Cardiomyopathy 72 17.1 17.3 signal
29 Suicide Attempt 281 16.3 17.0 signal
30 Paranoia 80 16.2 16.4 signal
31 Intentional Self-injury 93 16.2 16.4 signal
32 Hallucination, Visual 95 15.9 16.2 signal
33 Blood Creatine Phosphokinase Increased 129 15.5 15.8 signal
34 Hepatic Cytolysis 52 15.0 15.1 signal
35 Neutrophil Count Decreased 172 14.9 15.3 signal
36 Leukocytosis 76 14.8 15.0 signal
37 Inappropriate Antidiuretic Hormone Secretion 40 13.8 13.9 signal
38 Aspiration 42 13.6 13.7 signal
39 Thinking Abnormal 68 12.8 12.9 signal
40 Platelet Count Increased 46 12.4 12.5 signal
41 Sexual Dysfunction 41 12.3 12.4 signal
42 Aggression 172 12.0 12.4 signal
43 Treatment Noncompliance 181 11.7 12.0 signal
44 Hyperthyroidism 48 11.7 11.7 signal
45 Apathy 48 11.6 11.7 signal
46 Therapeutic Product Effect Incomplete 220 10.9 11.3 signal
47 Drug Abuse 260 10.9 11.4 signal
48 Mania 51 10.9 11.0 signal
49 Poisoning Deliberate 28 10.6 10.6 signal
50 Lymphocyte Count Decreased 53 10.5 10.6 signal
51 Drug Interaction 464 10.3 11.0 signal
52 Neutropenia 394 10.2 10.9 signal
53 Type 2 Diabetes Mellitus 96 10.0 10.1 signal
54 Circulatory Collapse 48 9.9 9.9 signal
55 Agranulocytosis 51 9.7 9.8 signal
56 Orthostatic Hypotension 48 9.7 9.7 signal
57 Mydriasis 35 9.6 9.6 signal
58 C-reactive Protein Increased 99 9.6 9.7 signal
59 Rhabdomyolysis 113 9.5 9.7 signal
60 Sudden Death 29 9.5 9.6 signal
61 Tachycardia 227 9.0 9.3 signal
62 Poisoning 32 8.9 8.9 signal
63 Agitation 185 8.8 9.1 signal
64 Restlessness 92 8.8 8.9 signal
65 Tardive Dyskinesia 71 8.7 8.8 signal
66 Serotonin Syndrome 46 8.4 8.5 signal
67 Toxicity To Various Agents 400 8.4 8.9 signal
68 Myoclonus 28 8.2 8.3 signal
69 Mitral Valve Incompetence 26 8.1 8.1 signal
70 Epilepsy 70 8.0 8.1 signal
71 Erectile Dysfunction 59 8.0 8.1 signal
72 Haematocrit Decreased 45 7.9 8.0 signal
73 White Blood Cell Count Decreased 241 7.8 8.1 signal
74 Bedridden 29 7.7 7.8 signal
75 Supraventricular Tachycardia 21 7.7 7.7 signal
76 Mental Disorder 94 7.6 7.7 signal
77 Drug Resistance 55 7.5 7.6 signal
78 Suicidal Ideation 194 7.4 7.6 signal
79 Amenorrhoea 35 7.4 7.4 signal
80 Hypothermia 21 7.3 7.3 signal
81 Pneumonia Aspiration 51 7.2 7.2 signal
82 Psychomotor Hyperactivity 34 7.2 7.2 signal
83 Synovitis 36 7.0 7.0 signal
84 Hypotonia 20 7.0 7.0 signal
85 Therapy Partial Responder 30 7.0 7.0 signal
86 Weight Increased 443 7.0 7.5 signal
87 Hypercholesterolaemia 19 7.0 7.0 signal
88 Abnormal Behaviour 79 6.9 7.0 signal
89 Coma 94 6.9 7.0 signal
90 Eating Disorder 42 6.9 6.9 signal
91 Encephalopathy 47 6.7 6.8 signal
92 Gamma-glutamyltransferase Increased 42 6.6 6.7 signal
93 Motor Dysfunction 19 6.6 6.6 signal
94 Cognitive Disorder 81 6.1 6.2 signal
95 Metabolic Acidosis 55 6.1 6.1 signal
96 Altered State Of Consciousness 37 6.0 6.1 signal
97 Ventricular Fibrillation 19 6.0 6.0 signal
98 Lower Respiratory Tract Infection 77 6.0 6.0 signal
99 Blood Alkaline Phosphatase Increased 42 5.9 6.0 signal
100 Ataxia 20 5.9 5.9 signal
101 Depressed Mood 87 5.8 5.9 signal
102 Urinary Incontinence 48 5.7 5.7 signal
103 Incontinence 17 5.6 5.6 signal
104 Depressed Level Of Consciousness 63 5.6 5.6 signal
105 Emphysema 16 5.5 5.6 signal
106 Liver Function Test Abnormal 46 5.5 5.5 signal
107 Delirium 54 5.5 5.5 signal
108 Disorientation 62 5.5 5.5 signal
109 Bipolar Disorder 17 5.4 5.5 signal
110 Libido Decreased 19 5.4 5.4 signal
111 Generalised Tonic-clonic Seizure 25 5.4 5.4 signal
112 Hyperglycaemia 55 5.3 5.3 signal
113 Confusional State 245 5.3 5.5 signal
114 Hypersomnia 43 5.3 5.3 signal
115 Grand Mal Convulsion 14 5.2 5.2 signal
116 Irritability 90 5.2 5.3 signal
117 Intentional Overdose 95 5.2 5.3 signal
118 Lymphoma 23 5.2 5.2 signal
119 Hallucination 111 5.2 5.3 signal
120 Affect Lability 14 5.1 5.1 signal
121 Sinus Bradycardia 14 5.1 5.1 signal
122 Sleep Apnoea Syndrome 27 4.9 5.0 signal
123 Hepatic Steatosis 26 4.9 4.9 signal
124 Speech Disorder 73 4.9 4.9 signal
125 Hypokinesia 20 4.8 4.8 signal
126 Drug Level Decreased 14 4.8 4.8 signal
127 Somnolence 275 4.8 5.0 signal
128 Ejection Fraction Decreased 21 4.7 4.7 signal
129 Choking 26 4.7 4.7 signal
130 Hyponatraemia 75 4.7 4.7 signal
131 Withdrawal Syndrome 56 4.6 4.7 signal
132 Status Epilepticus 15 4.6 4.7 signal
133 Dyskinesia 53 4.6 4.6 signal
134 Drug Toxicity 18 4.6 4.6 signal
135 Pulmonary Congestion 17 4.5 4.5 signal
136 Unresponsive To Stimuli 33 4.5 4.5 signal
137 Loss Of Consciousness 160 4.4 4.5 signal
138 Blood Triglycerides Increased 22 4.3 4.4 signal
139 Body Temperature Increased 25 4.3 4.3 signal
140 Pancreatitis Acute 27 4.2 4.3 signal
141 Iron Deficiency Anaemia 11 4.2 4.2 signal
142 Haemoglobin Decreased 123 4.2 4.3 signal
143 Contraindicated Product Administered 36 4.2 4.2 signal
144 Transaminases Increased 26 4.1 4.1 signal
145 Dysarthria 44 4.1 4.1 signal
146 Gastroenteritis 17 4.1 4.1 signal
147 Cardio-respiratory Arrest 49 4.1 4.1 signal
148 Amnesia 75 4.0 4.1 signal
149 Rebound Effect 13 4.0 4.0 signal
150 Product Prescribing Issue 23 4.0 4.0 signal
151 Disturbance In Attention 61 4.0 4.0 signal
152 Hepatocellular Injury 16 3.9 4.0 signal
153 Alanine Aminotransferase Increased 69 3.9 4.0 signal
154 Jaundice 30 3.9 3.9 signal
155 Therapy Non-responder 49 3.9 3.9 signal
156 Restless Legs Syndrome 20 3.8 3.9 signal
157 Panic Attack 40 3.8 3.9 signal
158 Hyperlipidaemia 13 3.8 3.8 signal
159 Red Blood Cell Count Decreased 31 3.8 3.8 signal
160 Initial Insomnia 11 3.8 3.8 signal
161 Nephropathy Toxic 12 3.8 3.8 signal
162 Arrhythmia 51 3.8 3.8 signal
163 Fear 29 3.7 3.8 signal
164 Thirst 19 3.7 3.7 signal
165 Gynaecomastia 33 3.7 3.7 signal
166 Cardiogenic Shock 15 3.7 3.7 signal
167 Myocardial Ischaemia 12 3.7 3.7 signal
168 Pericardial Effusion 24 3.7 3.7 signal
169 Overdose 225 3.6 3.7 signal
170 Vitamin D Deficiency 10 3.6 3.6 signal
171 Splenomegaly 12 3.6 3.6 signal
172 Head Injury 32 3.6 3.6 signal
173 Hemiparesis 17 3.5 3.5 signal
174 Hepatitis C 12 3.4 3.4 signal
175 Chronic Obstructive Pulmonary Disease 51 3.4 3.4 signal
176 Eosinophilia 17 3.4 3.4 signal
177 Ventricular Extrasystoles 10 3.4 3.4 signal
178 Vertigo 57 3.3 3.3 signal
179 Constipation 198 3.2 3.3 signal
180 Platelet Count Decreased 97 3.2 3.2 signal
181 Tremor 150 3.2 3.2 signal
182 Brain Injury 9 3.1 3.1 signal
183 Cardiomegaly 11 3.1 3.1 signal
184 Sleep Disorder 62 3.1 3.1 signal
185 Product Use In Unapproved Indication 216 3.1 3.2 signal
186 Intestinal Obstruction 33 3.1 3.1 signal
187 Respiratory Failure 64 3.1 3.1 signal
188 Intentional Product Misuse 76 3.1 3.1 signal
189 Hypertension 185 3.1 3.1 signal
190 Conjunctivitis 16 3.1 3.1 signal
191 Joint Dislocation 9 3.0 3.0 signal
192 Diarrhoea Haemorrhagic 8 3.0 3.0 signal
193 Hypotension 171 3.0 3.0 signal
194 Arteriosclerosis 8 3.0 3.0 signal
195 Cardiac Arrest 70 3.0 3.0 signal
196 Shock 19 2.9 2.9 signal
197 Liver Injury 20 2.9 2.9 signal
198 Muscle Twitching 19 2.9 2.9 signal
199 Cardiovascular Disorder 21 2.9 2.9 signal
200 Treatment Failure 67 2.9 2.9 signal
201 Blood Lactate Dehydrogenase Increased 13 2.9 2.9 signal
202 Skin Ulcer 21 2.8 2.9 signal
203 Pulmonary Oedema 36 2.8 2.8 signal
204 Central Nervous System Lesion 11 2.8 2.8 signal
205 Blood Cholesterol Increased 37 2.8 2.8 signal
206 Seizure 91 2.8 2.8 signal
207 Drug Reaction With Eosinophilia And Systemic Symptoms 20 2.7 2.7 signal
208 Hepatic Enzyme Increased 53 2.7 2.7 signal
209 Pelvic Pain 14 2.7 2.7 signal
210 Lethargy 44 2.7 2.7 signal
211 Therapeutic Response Decreased 46 2.7 2.7 signal
212 Gastrointestinal Carcinoma 7 2.7 2.7 signal
213 Inflammation 39 2.7 2.7 signal
214 Medication Error 42 2.7 2.7 signal
215 Breast Pain 8 2.6 2.6 signal
216 Hepatic Cirrhosis 14 2.6 2.6 signal
217 Poor Quality Sleep 16 2.6 2.6 signal
218 Hypocalcaemia 14 2.6 2.6 signal
219 Hepatic Failure 22 2.5 2.6 signal
220 Thrombocytopenia 81 2.5 2.6 signal
221 Ventricular Tachycardia 12 2.5 2.5 signal
222 Condition Aggravated 216 2.5 2.6 signal
223 Blood Urea Increased 12 2.5 2.5 signal
224 Aspartate Aminotransferase Increased 37 2.4 2.4 signal
225 Ovarian Cyst 7 2.4 2.4 signal
226 Angina Pectoris 20 2.4 2.4 signal
227 Blood Sodium Decreased 13 2.4 2.4 signal
228 Lactic Acidosis 22 2.4 2.4 signal
229 Cardiac Disorder 63 2.3 2.4 signal
230 Hyperhidrosis 86 2.3 2.4 signal
231 Pallor 18 2.3 2.3 signal
232 Hypothyroidism 21 2.3 2.3 signal
233 Deep Vein Thrombosis 43 2.3 2.3 signal
234 Drug Ineffective 863 2.3 2.5 signal
235 Coronary Artery Disease 20 2.3 2.3 signal
236 Cholelithiasis 21 2.2 2.2 signal
237 Hypoglycaemia 31 2.2 2.2 signal
238 Insomnia 169 2.2 2.3 signal
239 Cholestasis 12 2.2 2.2 signal
240 Dizziness Postural 6 2.2 2.2 no signal
241 Hiatus Hernia 8 2.2 2.2 no signal
242 Drug-induced Liver Injury 19 2.2 2.2 signal
243 Pulmonary Embolism 58 2.1 2.1 signal
244 Disability 12 2.1 2.1 signal
245 Diabetes Mellitus 46 2.1 2.1 signal
246 Cardiac Failure 48 2.1 2.1 signal
247 Sluggishness 6 2.1 2.1 no signal
248 Acute Hepatic Failure 8 2.1 2.1 no signal
249 Hepatitis 15 2.1 2.1 signal
250 Cytopenia 7 2.1 2.1 no signal
251 Hypoacusis 25 2.0 2.0 signal
252 Respiratory Tract Infection 15 2.0 2.0 signal
253 Menstruation Delayed 6 2.0 2.0 no signal
254 Drug Withdrawal Syndrome 51 2.0 2.0 signal
255 Blood Pressure Decreased 37 2.0 2.0 no signal
256 Anxiety 159 2.0 2.0 no signal
257 Glycosylated Haemoglobin Increased 14 1.9 1.9 no signal
258 Blood Bilirubin Increased 15 1.9 1.9 no signal
259 Hypophagia 14 1.9 1.9 no signal
260 Anosmia 8 1.9 1.9 no signal
261 Oesophagitis 6 1.9 1.9 no signal
262 Infusion Site Pain 7 1.9 1.9 no signal
263 Emotional Disorder 17 1.9 1.9 no signal
264 Balance Disorder 47 1.9 1.9 no signal
265 Diabetic Ketoacidosis 13 1.9 1.9 no signal
266 Pericarditis 9 1.9 1.9 no signal
267 Skin Infection 6 1.9 1.9 no signal
268 Incorrect Route Of Product Administration 9 1.9 1.9 no signal
269 Convulsion 31 1.9 1.9 no signal
270 Gastritis 14 1.9 1.9 no signal
271 Blood Calcium Decreased 6 1.9 1.9 no signal
272 Face Oedema 9 1.9 1.9 no signal
273 Stress 38 1.9 1.9 no signal
274 Malaise 232 1.8 1.9 no signal
275 Disease Recurrence 25 1.8 1.8 no signal
276 Quality Of Life Decreased 7 1.8 1.8 no signal
277 Crying 19 1.8 1.8 no signal
278 Fall 172 1.8 1.8 no signal
279 Tachypnoea 7 1.8 1.8 no signal
280 Tendonitis 8 1.8 1.8 no signal
281 Haematemesis 13 1.8 1.8 no signal
282 Renal Failure Acute 22 1.8 1.8 no signal
283 Head Discomfort 9 1.8 1.8 no signal
284 Caesarean Section 6 1.8 1.8 no signal
285 Influenza 57 1.8 1.8 no signal
286 Product Prescribing Error 12 1.8 1.8 no signal
287 Hypomagnesaemia 7 1.8 1.8 no signal
288 Musculoskeletal Stiffness 44 1.8 1.8 no signal
289 Multiple Organ Dysfunction Syndrome 14 1.8 1.8 no signal
290 Blood Test Abnormal 7 1.7 1.7 no signal
291 Nocturia 6 1.7 1.7 no signal
292 Glomerular Filtration Rate Decreased 6 1.7 1.7 no signal
293 Muscle Tightness 8 1.7 1.7 no signal
294 Hospitalisation 75 1.7 1.7 no signal
295 Depression 112 1.7 1.7 no signal
296 Temperature Intolerance 5 1.7 1.7 no signal
297 Small Intestinal Obstruction 6 1.7 1.7 no signal
298 Heart Rate Increased 48 1.7 1.7 no signal
299 Dry Eye 23 1.7 1.7 no signal
300 Full Blood Count Abnormal 5 1.7 1.7 no signal
301 Transient Ischaemic Attack 16 1.7 1.7 no signal
302 Pancytopenia 26 1.6 1.6 no signal
303 Blood Pressure Fluctuation 11 1.6 1.6 no signal
304 Multi-organ Failure 8 1.6 1.6 no signal
305 Therapy Cessation 23 1.6 1.6 no signal
306 Respiratory Tract Congestion 7 1.5 1.5 no signal
307 Lung Neoplasm Malignant 18 1.5 1.5 no signal
308 Blood Thyroid Stimulating Hormone Increased 4 1.5 1.5 no signal
309 Nightmare 15 1.5 1.5 no signal
310 Oral Discomfort 6 1.5 1.5 no signal
311 Aphonia 6 1.5 1.5 no signal
312 Adverse Drug Reaction 38 1.5 1.5 no signal
313 Sputum Discoloured 4 1.5 1.5 no signal
314 Oropharyngeal Pain 39 1.5 1.5 no signal
315 Completed Suicide 35 1.5 1.5 no signal
316 Drug Effect Incomplete 15 1.4 1.4 no signal
317 Movement Disorder 13 1.4 1.4 no signal
318 Ageusia 10 1.4 1.4 no signal
319 Abnormal Dreams 11 1.4 1.4 no signal
320 Myocardial Infarction 69 1.4 1.4 no signal
321 Subarachnoid Haemorrhage 4 1.4 1.4 no signal
322 Limb Discomfort 12 1.4 1.4 no signal
323 Circumstance Or Information Capable Of Leading To Medication Error 13 1.4 1.4 no signal
324 Drug Dispensing Error 6 1.4 1.4 no signal
325 Emotional Distress 47 1.4 1.4 no signal
326 Anhedonia 10 1.3 1.3 no signal
327 Mood Altered 10 1.3 1.3 no signal
328 Multiple Fractures 6 1.3 1.3 no signal
329 Lymphopenia 5 1.2 1.2 no signal
330 Drug Effect Less Than Expected 5 1.2 1.2 no signal
331 Drug Administration Error 11 1.2 1.2 no signal
332 Vasculitis 4 1.2 1.2 no signal
333 Drug Effective For Unapproved Indication 10 1.2 1.2 no signal
334 Drug Withdrawal Syndrome Neonatal 5 1.2 1.2 no signal
335 Toxic Epidermal Necrolysis 5 1.2 1.2 no signal
336 Drug Dependence 53 1.1 1.1 no signal
337 Abnormal Weight Gain 4 1.1 1.1 no signal
338 Feeling Jittery 6 1.1 1.1 no signal
339 Accidental Overdose 11 1.1 1.1 no signal
340 Peritonitis Bacterial 3 1.0 1.0 no signal
341 Therapy Interrupted 20 1.0 1.0 no signal
342 Exposure During Pregnancy 18 1.0 1.0 no signal
343 Breast Cancer Metastatic 3 1.0 1.0 no signal
344 Pulmonary Thrombosis 3 1.0 1.0 no signal
345 Eye Irritation 15 0.9 0.9 no signal
346 Fistula 3 0.9 0.9 no signal
347 Product Dose Omission In Error 7 0.9 0.9 no signal
348 Foetal Exposure During Pregnancy 20 0.9 0.9 no signal
349 Metastases To Bone 4 0.9 0.9 no signal
350 Tuberculosis 3 0.8 0.8 no signal
351 Premature Baby 7 0.8 0.8 no signal
352 Blood Glucose Increased 42 0.8 0.8 no signal
353 Psoriasis 29 0.8 0.8 no signal
354 Drug Effect Decreased 11 0.7 0.7 no signal
355 Acne 12 0.6 0.6 no signal
356 Skin Burning Sensation 10 0.5 0.5 no signal
357 Accidental Exposure To Product 11 0.4 0.4 no signal
358 Breast Cancer 10 0.4 0.4 no signal
359 Oesophageal Carcinoma 3 0.3 0.3 no signal
360 Dependence 3 0.2 0.2 no signal