BUPIVACAINE

Bupivacaine Adverse Events Reported to the FDA Over Time

How are Bupivacaine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Bupivacaine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Bupivacaine is flagged as the suspect drug causing the adverse event.

Most Common Bupivacaine Adverse Events Reported to the FDA

What are the most common Bupivacaine adverse events reported to the FDA?

Musculoskeletal Pain	427 (4.09%)
Chondrolysis	390 (3.74%)
Joint Injury	236 (2.26%)
Anaesthetic Complication	218 (2.09%)
Drug Ineffective	201 (1.93%)
Hypotension	195 (1.87%)
Joint Range Of Motion Decreased	140 (1.34%)
Musculoskeletal Discomfort	127 (1.22%)
Drug Exposure During Pregnancy	121 (1.16%)
Pain	114 (1.09%)
Activities Of Daily Living Impaired	106 (1.02%)
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Musculoskeletal Disorder	99 (.95%)
Cardiac Arrest	98 (.94%)
Post Procedural Complication	90 (.86%)
Loss Of Consciousness	87 (.83%)
Convulsion	80 (.77%)
Hypoaesthesia	76 (.73%)
Bradycardia	75 (.72%)
Osteoarthritis	72 (.69%)
Asthenia	71 (.68%)
Headache	67 (.64%)
Nausea	67 (.64%)
Dyspnoea	62 (.59%)
Muscular Weakness	62 (.59%)
Vomiting	60 (.57%)
Blood Pressure Decreased	59 (.57%)
Cauda Equina Syndrome	54 (.52%)
Arthropathy	53 (.51%)
Dizziness	52 (.5%)
Drug Toxicity	49 (.47%)
Movement Disorder	49 (.47%)
Musculoskeletal Stiffness	49 (.47%)
Arthralgia	46 (.44%)
Incorrect Route Of Drug Administrat...	46 (.44%)
Drug Effect Decreased	44 (.42%)
Oxygen Saturation Decreased	44 (.42%)
Paraplegia	44 (.42%)
Pain In Extremity	43 (.41%)
Paraesthesia	43 (.41%)
Fall	42 (.4%)
Tachycardia	42 (.4%)
Medication Error	41 (.39%)
Death	40 (.38%)
Synovitis	40 (.38%)
Anaphylactic Shock	38 (.36%)
Procedural Complication	38 (.36%)
Rotator Cuff Syndrome	37 (.35%)
Conjunctival Oedema	36 (.34%)
Disseminated Intravascular Coagulat...	36 (.34%)
Sensory Disturbance	36 (.34%)
Caesarean Section	35 (.34%)
Myoclonus	35 (.34%)
Respiratory Distress	35 (.34%)
Anaphylactic Reaction	34 (.33%)
Pyrexia	34 (.33%)
Sensory Loss	34 (.33%)
Grand Mal Convulsion	33 (.32%)
Exophthalmos	32 (.31%)
Hypertension	32 (.31%)
Parophthalmia	32 (.31%)
Respiratory Arrest	32 (.31%)
Respiratory Failure	32 (.31%)
Apnoea	31 (.3%)
Erythema	31 (.3%)
Unresponsive To Stimuli	31 (.3%)
Agitation	29 (.28%)
Coma	29 (.28%)
Disorientation	29 (.28%)
Overdose	29 (.28%)
Chondromalacia	28 (.27%)
Insomnia	28 (.27%)
Hypoxia	27 (.26%)
Neuropathy Peripheral	27 (.26%)
Back Pain	26 (.25%)
Somnolence	26 (.25%)
Hypersensitivity	25 (.24%)
Procedural Hypotension	25 (.24%)
Pulmonary Oedema	25 (.24%)
Respiratory Depression	25 (.24%)
Drug Hypersensitivity	24 (.23%)
Urinary Incontinence	24 (.23%)
Visual Acuity Reduced	24 (.23%)
Circulatory Collapse	23 (.22%)
Confusional State	23 (.22%)
Depressed Level Of Consciousness	23 (.22%)
Drug Interaction	23 (.22%)
Injection Site Pain	23 (.22%)
Medical Device Complication	23 (.22%)
Procedural Pain	23 (.22%)
Restlessness	23 (.22%)
Ventricular Fibrillation	23 (.22%)
Bursitis	22 (.21%)
Hearing Impaired	22 (.21%)
Heart Rate Increased	22 (.21%)
Injury	22 (.21%)
Spinal Cord Infarction	22 (.21%)
Staphylococcal Infection	22 (.21%)
Tremor	22 (.21%)
Urinary Retention	22 (.21%)
Abdominal Pain	21 (.2%)
Flushing	21 (.2%)

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This graph shows the top adverse events submitted to the FDA for Bupivacaine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Bupivacaine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Bupivacaine

What are the most common Bupivacaine adverse events reported to the FDA?

Musculoskeletal And Connective Tiss...	815 (7.81%)
Neurological	764 (7.32%)
Procedural And Device Related Injur...	590 (5.65%)
Joint	496 (4.75%)
Tendon, Ligament And Cartilage	434 (4.16%)
Cardiac Arrhythmias	409 (3.92%)
Therapeutic And Nontherapeutic Effe...	369 (3.54%)
Respiratory	347 (3.33%)
Bone And Joint Injuries	278 (2.66%)
Decreased And Nonspecific Blood Pre...	246 (2.36%)
Movement Disorders	240 (2.3%)
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Injuries	214 (2.05%)
Medication Errors	208 (1.99%)
Gastrointestinal Signs	198 (1.9%)
Cardiac And Vascular Investigations	197 (1.89%)
Chemical Injury And Poisoning	196 (1.88%)
Spinal Cord And Nerve Root	155 (1.49%)
Epidermal And Dermal Conditions	148 (1.42%)
Muscle	143 (1.37%)
Administration Site Reactions	142 (1.36%)
Infections - Pathogen Unspecified	133 (1.27%)
Lifestyle Issues	133 (1.27%)
Allergic Conditions	132 (1.26%)
Seizures	132 (1.26%)
Ocular Infections, Irritations And ...	112 (1.07%)
Peripheral Neuropathies	77 (.74%)
Vision	76 (.73%)
Anxiety Disorders	73 (.7%)
Headaches	68 (.65%)
Metabolic, Nutritional And Blood Ga...	65 (.62%)
Synovial And Bursal	64 (.61%)
Deliria	62 (.59%)
Urinary Tract Signs	61 (.58%)
Bacterial Infectious	60 (.57%)
Body Temperature Conditions	56 (.54%)
Ocular Neuromuscular	55 (.53%)
Lower Respiratory Tract Disorders	54 (.52%)
Hepatic And Hepatobiliary	53 (.51%)
Tissue	49 (.47%)
Fatal Outcomes	48 (.46%)
Physical Examination Topics	47 (.45%)
Bone Disorders	46 (.44%)
Obstetric And Gynecological Therape...	44 (.42%)
Hepatobiliary	43 (.41%)
Ocular Structural Change, Deposit A...	43 (.41%)
Product Quality Issues	40 (.38%)
Vascular	40 (.38%)
Central Nervous System Vascular	39 (.37%)
Eye	39 (.37%)
Neurological, Special Senses And Ps...	39 (.37%)
Therapeutic Procedures And Supporti...	39 (.37%)
Cardiac Disorder Signs	38 (.36%)
Coagulopathies And Bleeding Diathes...	38 (.36%)
Sleep Disorders	38 (.36%)
Coronary Artery	36 (.34%)
Hearing	36 (.34%)
Skin Appendage Conditions	36 (.34%)
Hematology Investigations	32 (.31%)
Neuromuscular	32 (.31%)
Vascular Hypertensive	32 (.31%)
Bronchial Disorders	30 (.29%)
Gastrointestinal Motility And Defec...	28 (.27%)
Heart Failures	28 (.27%)
Changes In Physical Activity	26 (.25%)
Oral Soft Tissue Conditions	25 (.24%)
Vascular Hemorrhagic	25 (.24%)
Musculoskeletal And Connective Tiss...	24 (.23%)
Upper Respiratory Tract Disorders	24 (.23%)
Mood Disorders	23 (.22%)
Pulmonary Vascular	23 (.22%)
Angiedema And Urticaria	22 (.21%)
Disturbances In Thinking	20 (.19%)
Maternal Complications Of Pregnancy	19 (.18%)
Nervous System Neoplasms Malignant ...	19 (.18%)
Central Nervous System Infections A...	18 (.17%)
Tongue Conditions	18 (.17%)
Arteriosclerosis, Stenosis, Vascula...	17 (.16%)
Viral Infectious	17 (.16%)
Cranial Nerve Disorders	16 (.15%)
Increased Intracranial Pressure And...	16 (.15%)
Psychiatric	15 (.14%)
Renal Disorders	15 (.14%)
Electrolyte And Fluid Balance Condi...	14 (.13%)
Investigations, Imaging And Histopa...	14 (.13%)
Mental Impairment	14 (.13%)
Bone And Joint Therapeutic Procedur...	13 (.12%)
Depressed Mood Disorders	13 (.12%)
Embolism And Thrombosis	13 (.12%)
Gastrointestinal Conditions	13 (.12%)
Retina, Choroid And Vitreous Hemorr...	13 (.12%)
Maternal Complications Of Labour An...	12 (.11%)
Neonatal Respiratory	12 (.11%)
Pregnancy, Labour, Delivery And Pos...	12 (.11%)
Anal And Rectal Conditions	11 (.11%)
Bladder And Bladder Neck Disorders	11 (.11%)
Glucose Metabolism Disorders	11 (.11%)
Anterior Eye Structural Change, Dep...	10 (.1%)
Bone, Calcium, Magnesium And Phosph...	10 (.1%)
Ocular Sensory Symptoms	10 (.1%)
Skin Vascular Abnormalities	10 (.1%)
Metastases	9 (.09%)

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This graph shows the top categories of adverse events submitted to the FDA for Bupivacaine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Bupivacaine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.