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Drug

Bupivacaine Hydrochloride In Dextrose

346 flagged reaction(s) · 14,639 total co-reports · max PRR 26.2
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 Respiratory Depression 114 26.2 26.6 signal
2 Myoclonus 102 24.1 24.4 signal
3 No Therapeutic Response 91 20.7 20.9 signal
4 Premature Baby 200 18.6 19.1 signal
5 Premature Delivery 104 18.2 18.5 signal
6 Muscle Spasticity 76 17.2 17.4 signal
7 Device Failure 90 16.6 16.8 signal
8 Hypothermia 60 16.6 16.7 signal
9 Sedation 140 15.1 15.3 signal
10 Exposure During Pregnancy 327 14.7 15.4 signal
11 Paralysis 71 13.8 14.0 signal
12 Caesarean Section 54 12.9 12.9 signal
13 Post Procedural Complication 86 12.5 12.7 signal
14 Maternal Exposure During Pregnancy 374 11.9 12.4 signal
15 Unresponsive To Stimuli 103 11.2 11.4 signal
16 Incorrect Route Of Product Administration 67 11.2 11.3 signal
17 Generalised Tonic-clonic Seizure 64 10.9 11.0 signal
18 Mental Status Changes 104 10.5 10.6 signal
19 Bradycardia 193 10.2 10.4 signal
20 Urinary Retention 111 9.3 9.5 signal
21 Complication Associated With Device 42 8.9 8.9 signal
22 Drug Withdrawal Syndrome 281 8.9 9.2 signal
23 Motor Dysfunction 30 8.3 8.3 signal
24 Circulatory Collapse 49 8.0 8.1 signal
25 Foetal Exposure During Pregnancy 226 7.8 8.0 signal
26 Anaphylactic Shock 71 7.7 7.8 signal
27 Hypotonia 27 7.5 7.6 signal
28 Grand Mal Convulsion 25 7.5 7.5 signal
29 Hypotension 499 7.0 7.4 signal
30 Hypoxia 86 6.9 6.9 signal
31 Ventricular Fibrillation 27 6.8 6.8 signal
32 Neuralgia 57 6.6 6.6 signal
33 Nerve Injury 26 6.5 6.5 signal
34 Brain Injury 23 6.4 6.4 signal
35 Sinus Tachycardia 32 6.3 6.3 signal
36 Serotonin Syndrome 43 6.3 6.3 signal
37 Device Occlusion 31 6.2 6.2 signal
38 Neurotoxicity 38 6.1 6.1 signal
39 Cardiac Arrest 176 5.9 6.1 signal
40 Depressed Level Of Consciousness 81 5.7 5.8 signal
41 Ventricular Tachycardia 34 5.7 5.8 signal
42 Status Epilepticus 23 5.7 5.7 signal
43 Anaphylactic Reaction 111 5.6 5.7 signal
44 Joint Range Of Motion Decreased 27 5.6 5.7 signal
45 Diplopia 52 5.6 5.6 signal
46 Respiratory Arrest 54 5.4 5.5 signal
47 Muscle Rigidity 23 5.4 5.4 signal
48 Urinary Incontinence 55 5.2 5.2 signal
49 Drug Exposure During Pregnancy 63 5.1 5.1 signal
50 Subdural Haematoma 26 5.1 5.1 signal
51 Delirium 62 5.0 5.0 signal
52 Respiratory Distress 49 5.0 5.0 signal
53 Sinus Bradycardia 17 4.9 4.9 signal
54 Product Administration Error 35 4.9 4.9 signal
55 Muscular Weakness 197 4.8 4.9 signal
56 Hypoaesthesia 258 4.8 4.9 signal
57 Sensory Disturbance 27 4.7 4.7 signal
58 Withdrawal Syndrome 70 4.6 4.7 signal
59 Wound Infection 18 4.6 4.6 signal
60 Bronchospasm 23 4.5 4.5 signal
61 Therapy Non-responder 71 4.4 4.5 signal
62 Drug Toxicity 22 4.4 4.5 signal
63 Procedural Pain 44 4.4 4.5 signal
64 Ventricular Extrasystoles 16 4.3 4.3 signal
65 Acute Respiratory Failure 29 4.2 4.2 signal
66 Cyanosis 23 4.1 4.1 signal
67 Device Dislocation 61 3.9 3.9 signal
68 Drug Ineffective For Unapproved Indication 77 3.9 3.9 signal
69 Respiratory Failure 98 3.7 3.8 signal
70 Sciatica 21 3.7 3.7 signal
71 Body Temperature Decreased 13 3.7 3.7 signal
72 Pulmonary Congestion 17 3.6 3.6 signal
73 Tachycardia 113 3.6 3.6 signal
74 Loss Of Consciousness 163 3.5 3.6 signal
75 Brain Oedema 16 3.5 3.5 signal
76 Encephalopathy 31 3.5 3.5 signal
77 Agitation 92 3.5 3.5 signal
78 Intraocular Pressure Increased 16 3.5 3.5 signal
79 Atelectasis 12 3.5 3.5 signal
80 Muscle Tightness 20 3.5 3.5 signal
81 Dystonia 24 3.4 3.4 signal
82 Blood Pressure Decreased 80 3.4 3.4 signal
83 Accidental Overdose 44 3.4 3.4 signal
84 Intervertebral Disc Degeneration 11 3.3 3.3 signal
85 Disorientation 46 3.2 3.2 signal
86 Hypercholesterolaemia 11 3.2 3.2 signal
87 Therapeutic Response Decreased 69 3.2 3.2 signal
88 Hyperhidrosis 145 3.1 3.2 signal
89 Medication Error 62 3.1 3.1 signal
90 Metabolic Acidosis 35 3.1 3.1 signal
91 Device Malfunction 74 3.1 3.1 signal
92 Cardio-respiratory Arrest 46 3.1 3.1 signal
93 Adrenal Insufficiency 13 3.0 3.0 signal
94 Helicobacter Infection 11 3.0 3.0 signal
95 Bursitis 13 3.0 3.0 signal
96 Incorrect Route Of Drug Administration 39 3.0 3.0 signal
97 Oxygen Saturation Decreased 60 3.0 3.0 signal
98 Pain 654 3.0 3.2 signal
99 Coma 50 2.9 2.9 signal
100 Myocardial Ischaemia 12 2.9 2.9 signal
101 Autoimmune Disorder 10 2.9 2.9 signal
102 Somnolence 208 2.9 2.9 signal
103 Tachypnoea 14 2.9 2.9 signal
104 Aspiration 11 2.8 2.8 signal
105 Mydriasis 13 2.8 2.8 signal
106 Pulmonary Oedema 45 2.8 2.8 signal
107 Aphonia 14 2.8 2.8 signal
108 Overdose 216 2.8 2.8 signal
109 Aphasia 30 2.8 2.8 signal
110 Personality Change 9 2.7 2.7 signal
111 Joint Dislocation 10 2.7 2.7 signal
112 Posterior Reversible Encephalopathy Syndrome 9 2.6 2.6 signal
113 Drug Interaction 150 2.6 2.7 signal
114 Lethargy 54 2.6 2.6 signal
115 Heart Rate Decreased 33 2.6 2.6 signal
116 Mass 13 2.6 2.6 signal
117 Nervous System Disorder 29 2.6 2.6 signal
118 Adverse Drug Reaction 82 2.6 2.6 signal
119 Musculoskeletal Pain 48 2.5 2.5 signal
120 Bladder Disorder 9 2.5 2.5 signal
121 Small Intestinal Obstruction 11 2.5 2.5 signal
122 Ileus 11 2.5 2.5 signal
123 Eyelid Ptosis 9 2.5 2.5 signal
124 Subarachnoid Haemorrhage 9 2.5 2.5 signal
125 Obesity 14 2.4 2.5 signal
126 Staphylococcal Infection 29 2.4 2.5 signal
127 Paraesthesia 138 2.4 2.5 signal
128 Scar 15 2.4 2.4 signal
129 Folliculitis 9 2.4 2.4 signal
130 Osteoarthritis 37 2.4 2.4 signal
131 Impaired Gastric Emptying 11 2.4 2.4 signal
132 Erythema Multiforme 8 2.4 2.4 signal
133 Hallucination, Visual 18 2.4 2.4 signal
134 Post Procedural Haemorrhage 10 2.4 2.4 signal
135 Eyelid Oedema 10 2.4 2.4 signal
136 Disseminated Intravascular Coagulation 12 2.4 2.4 signal
137 Incontinence 9 2.4 2.4 signal
138 Spinal Disorder 8 2.4 2.4 signal
139 Hand Deformity 11 2.3 2.3 signal
140 Ataxia 10 2.3 2.3 signal
141 Oedema 45 2.3 2.3 signal
142 Accidental Underdose 12 2.3 2.3 signal
143 Drug Effect Decreased 45 2.3 2.3 signal
144 Impaired Healing 27 2.3 2.3 signal
145 Muscle Twitching 19 2.3 2.3 signal
146 Toxicity To Various Agents 137 2.3 2.3 signal
147 Discomfort 49 2.3 2.3 signal
148 Haematoma 21 2.3 2.3 signal
149 Off Label Use 691 2.2 2.3 signal
150 Seizure 91 2.2 2.2 signal
151 Road Traffic Accident 33 2.2 2.2 signal
152 Inappropriate Antidiuretic Hormone Secretion 8 2.2 2.2 signal
153 Coordination Abnormal 11 2.2 2.2 signal
154 Restlessness 28 2.1 2.1 signal
155 Pneumothorax 12 2.1 2.1 signal
156 Neuroleptic Malignant Syndrome 9 2.1 2.1 signal
157 Device Leakage 32 2.1 2.1 signal
158 Flank Pain 7 2.1 2.1 no signal
159 Movement Disorder 24 2.1 2.1 signal
160 Pemphigus 9 2.0 2.0 no signal
161 Prescribed Overdose 14 2.0 2.0 signal
162 Back Pain 168 2.0 2.0 signal
163 Confusional State 117 2.0 2.0 signal
164 Red Blood Cell Sedimentation Rate Increased 8 2.0 2.0 no signal
165 Abasia 18 2.0 2.0 signal
166 Dyskinesia 29 2.0 2.0 no signal
167 Acute Myocardial Infarction 21 2.0 2.0 no signal
168 Muscle Spasms 130 2.0 2.0 no signal
169 Burning Sensation 49 1.9 2.0 no signal
170 Drug-induced Liver Injury 21 1.9 1.9 no signal
171 Device Issue 59 1.9 1.9 no signal
172 Drug Administration Error 21 1.9 1.9 no signal
173 Convulsion 39 1.9 1.9 no signal
174 Dysarthria 25 1.9 1.9 no signal
175 Hypoaesthesia Oral 10 1.9 1.9 no signal
176 Clostridium Difficile Colitis 7 1.8 1.8 no signal
177 Hip Arthroplasty 10 1.8 1.8 no signal
178 Shock 15 1.8 1.8 no signal
179 Irritable Bowel Syndrome 14 1.8 1.8 no signal
180 Tinnitus 30 1.8 1.8 no signal
181 End Stage Renal Disease 12 1.8 1.8 no signal
182 Nerve Compression 6 1.8 1.8 no signal
183 Urosepsis 6 1.8 1.8 no signal
184 Device Related Infection 10 1.8 1.8 no signal
185 Unevaluable Event 49 1.8 1.8 no signal
186 Cognitive Disorder 30 1.8 1.8 no signal
187 Respiratory Disorder 19 1.8 1.8 no signal
188 Lower Limb Fracture 12 1.8 1.8 no signal
189 Hallucination, Auditory 10 1.8 1.8 no signal
190 Sleep Apnoea Syndrome 12 1.8 1.8 no signal
191 Visual Acuity Reduced 21 1.7 1.8 no signal
192 Blood Pressure Fluctuation 15 1.7 1.7 no signal
193 Synovitis 11 1.7 1.7 no signal
194 Electrolyte Imbalance 7 1.7 1.7 no signal
195 Leukocytosis 11 1.7 1.7 no signal
196 Heart Rate Increased 60 1.7 1.7 no signal
197 Pericarditis 10 1.7 1.7 no signal
198 Spinal Pain 7 1.7 1.7 no signal
199 Intervertebral Disc Protrusion 13 1.7 1.7 no signal
200 Blood Pressure Increased 90 1.6 1.6 no signal
201 Feeling Hot 36 1.6 1.6 no signal
202 Pallor 16 1.6 1.6 no signal
203 Euphoric Mood 6 1.6 1.6 no signal
204 Delusion 9 1.6 1.6 no signal
205 Spinal Operation 7 1.6 1.6 no signal
206 Respiratory Tract Infection 15 1.6 1.6 no signal
207 Mental Impairment 14 1.6 1.6 no signal
208 Underdose 42 1.6 1.6 no signal
209 Gait Inability 19 1.6 1.6 no signal
210 Neck Pain 32 1.6 1.6 no signal
211 Cold Sweat 10 1.6 1.6 no signal
212 Acute Respiratory Distress Syndrome 10 1.6 1.6 no signal
213 Chills 66 1.6 1.6 no signal
214 Cardiogenic Shock 8 1.6 1.6 no signal
215 Altered State Of Consciousness 12 1.6 1.6 no signal
216 Muscle Atrophy 7 1.6 1.6 no signal
217 Paraesthesia Oral 8 1.6 1.6 no signal
218 Back Injury 6 1.5 1.5 no signal
219 Speech Disorder 29 1.5 1.5 no signal
220 Osteomyelitis 10 1.5 1.5 no signal
221 Blood Creatine Phosphokinase Increased 16 1.5 1.5 no signal
222 Pregnancy 11 1.5 1.5 no signal
223 Wound 15 1.5 1.5 no signal
224 Obstructive Airways Disorder 6 1.5 1.5 no signal
225 Musculoskeletal Stiffness 47 1.5 1.5 no signal
226 Haemorrhage 56 1.5 1.5 no signal
227 Hallucination 40 1.5 1.5 no signal
228 Bedridden 7 1.5 1.5 no signal
229 Pharmaceutical Product Complaint 14 1.5 1.5 no signal
230 Contraindicated Product Administered 16 1.5 1.5 no signal
231 Hemiparesis 9 1.5 1.5 no signal
232 Abnormal Behaviour 21 1.5 1.5 no signal
233 Treatment Failure 43 1.5 1.5 no signal
234 Dysgeusia 39 1.5 1.5 no signal
235 Peripheral Coldness 7 1.4 1.4 no signal
236 Type 2 Diabetes Mellitus 17 1.4 1.4 no signal
237 Liver Injury 12 1.4 1.4 no signal
238 Joint Stiffness 13 1.4 1.4 no signal
239 Fibromyalgia 12 1.4 1.4 no signal
240 Neutrophil Count Increased 5 1.4 1.4 no signal
241 Brain Fog 7 1.3 1.3 no signal
242 Swollen Tongue 15 1.3 1.3 no signal
243 Tremor 79 1.3 1.3 no signal
244 Balance Disorder 41 1.3 1.3 no signal
245 Musculoskeletal Disorder 9 1.3 1.3 no signal
246 Infusion Site Pain 6 1.3 1.3 no signal
247 Hepatitis 12 1.3 1.3 no signal
248 Rotator Cuff Syndrome 6 1.3 1.3 no signal
249 Paranoia 8 1.3 1.3 no signal
250 Intestinal Obstruction 17 1.3 1.3 no signal
251 Injury 32 1.3 1.3 no signal
252 Local Swelling 8 1.3 1.3 no signal
253 Drug Dispensing Error 7 1.3 1.3 no signal
254 Ejection Fraction Decreased 7 1.3 1.3 no signal
255 Drug Ineffective 589 1.2 1.3 no signal
256 Glossodynia 10 1.2 1.2 no signal
257 Mobility Decreased 32 1.2 1.2 no signal
258 Amnesia 29 1.2 1.2 no signal
259 Akathisia 6 1.2 1.2 no signal
260 Increased Tendency To Bruise 4 1.2 1.2 no signal
261 Carpal Tunnel Syndrome 6 1.2 1.2 no signal
262 Deformity 4 1.2 1.2 no signal
263 Epilepsy 13 1.2 1.2 no signal
264 Eye Inflammation 4 1.2 1.2 no signal
265 Drug Level Increased 7 1.2 1.2 no signal
266 Limb Discomfort 13 1.2 1.2 no signal
267 Laceration 4 1.2 1.2 no signal
268 Therapy Change 4 1.2 1.2 no signal
269 Affect Lability 4 1.2 1.2 no signal
270 Product Use Issue 77 1.1 1.2 no signal
271 Libido Decreased 5 1.1 1.1 no signal
272 Extrapyramidal Disorder 10 1.1 1.1 no signal
273 Activities Of Daily Living Impaired 8 1.1 1.1 no signal
274 Incorrect Dose Administered By Device 10 1.1 1.1 no signal
275 Initial Insomnia 4 1.1 1.1 no signal
276 Economic Problem 6 1.1 1.1 no signal
277 Rhabdomyolysis 16 1.1 1.1 no signal
278 Panic Attack 14 1.1 1.1 no signal
279 Platelet Count Increased 5 1.1 1.1 no signal
280 Immune System Disorder 5 1.1 1.1 no signal
281 Fear 10 1.0 1.0 no signal
282 Surgery 21 1.0 1.0 no signal
283 Psychomotor Hyperactivity 6 1.0 1.0 no signal
284 Blindness Unilateral 5 1.0 1.0 no signal
285 Disability 7 1.0 1.0 no signal
286 Hepatocellular Injury 5 1.0 1.0 no signal
287 Impaired Driving Ability 4 1.0 1.0 no signal
288 Disturbance In Attention 19 1.0 1.0 no signal
289 Prescribed Underdose 7 1.0 1.0 no signal
290 Hypoacusis 15 1.0 1.0 no signal
291 Hospitalisation 53 1.0 1.0 no signal
292 Impaired Quality Of Life 5 1.0 1.0 no signal
293 Hyperthyroidism 5 1.0 1.0 no signal
294 Apathy 5 1.0 1.0 no signal
295 Product Quality Issue 46 1.0 1.0 no signal
296 Angioedema 15 0.9 0.9 no signal
297 Psychotic Disorder 10 0.9 0.9 no signal
298 Therapeutic Product Effect Decreased 15 0.9 0.9 no signal
299 Knee Arthroplasty 7 0.9 0.9 no signal
300 Brain Neoplasm 3 0.9 0.9 no signal
301 Extra Dose Administered 13 0.9 0.9 no signal
302 Complication Of Device Insertion 6 0.9 0.9 no signal
303 Injection Site Discolouration 4 0.9 0.9 no signal
304 Thinking Abnormal 6 0.9 0.9 no signal
305 Nightmare 11 0.9 0.9 no signal
306 Irritability 19 0.9 0.9 no signal
307 Feeling Jittery 6 0.9 0.9 no signal
308 Anorexia 4 0.9 0.9 no signal
309 Device Breakage 12 0.9 0.9 no signal
310 No Adverse Event 54 0.8 0.8 no signal
311 Central Nervous System Lesion 4 0.8 0.8 no signal
312 Cardiac Disorder 27 0.8 0.8 no signal
313 Tooth Loss 6 0.8 0.8 no signal
314 Drug Effect Less Than Expected 4 0.8 0.8 no signal
315 Cardiovascular Disorder 7 0.8 0.8 no signal
316 Psoriatic Arthropathy 11 0.8 0.8 no signal
317 Drug Resistance 7 0.8 0.8 no signal
318 Haemorrhage Intracranial 4 0.7 0.7 no signal
319 Metastases To Lung 3 0.7 0.7 no signal
320 Sexual Dysfunction 3 0.7 0.7 no signal
321 Therapeutic Response Shortened 8 0.7 0.7 no signal
322 Mood Swings 8 0.7 0.7 no signal
323 Suicidal Ideation 22 0.7 0.7 no signal
324 Poisoning 3 0.7 0.7 no signal
325 Incorrect Dose Administered 53 0.7 0.7 no signal
326 Product Administered At Inappropriate Site 4 0.6 0.6 no signal
327 Pelvic Pain 4 0.6 0.6 no signal
328 Diabetic Ketoacidosis 5 0.6 0.6 no signal
329 Intentional Overdose 13 0.6 0.6 no signal
330 Osteonecrosis Of Jaw 5 0.6 0.6 no signal
331 Injury Associated With Device 4 0.6 0.6 no signal
332 Intentional Self-injury 4 0.6 0.6 no signal
333 Drug Reaction With Eosinophilia And Systemic Symptoms 5 0.5 0.5 no signal
334 Product Preparation Error 4 0.5 0.5 no signal
335 Drug Abuse 14 0.5 0.5 no signal
336 Drug Dependence 27 0.5 0.5 no signal
337 Vaginal Haemorrhage 7 0.5 0.5 no signal
338 Drug Effect Incomplete 6 0.5 0.5 no signal
339 Injection Site Mass 6 0.5 0.5 no signal
340 Multiple Sclerosis Relapse 10 0.4 0.4 no signal
341 Pancreatic Carcinoma 4 0.4 0.4 no signal
342 Drug Effective For Unapproved Indication 4 0.4 0.4 no signal
343 Wrong Technique In Drug Usage Process 5 0.4 0.4 no signal
344 Completed Suicide 11 0.4 0.4 no signal
345 Multiple Sclerosis 6 0.3 0.3 no signal
346 Accidental Exposure To Product 11 0.3 0.3 no signal