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Marcaine (Bupivacaine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Marcaine (Bupivacaine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (46)
Death (2)
Life Threatening Events (16)
Disability (8)

Reports by Reaction Type

Cardiac Arrest (8)Anaesthetic Complication (6)Respiratory Distress (5)Brain Oedema (4)Hypoxic-Ischaemic Encephalopathy (4)Drug Ineffective (3)Anaphylactic Reaction (3)Pain (3)Anaphylactic Shock (3)Oedema Peripheral (3)Product Contamination (2)Anaphylactoid Reaction (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Marcaine (Bupivacaine). For a complete list or a specific selection of reports, please use the links above.

Possible Marcaine side effects in

Reported by a physician from Japan on 2012-08-24

Patient:

Reactions: Cauda Equina Syndrome

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in

Reported by a physician from Japan on 2012-08-24

Patient:

Reactions: Cauda Equina Syndrome

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in 22 year old male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-19

Patient: 22 year old male

Reactions: Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Midazolam HCL; Sodium Chloride



Possible Marcaine side effects in 50 year old female

Reported by a physician from Russian Federation on 2012-06-12

Patient: 50 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Pneumonia, Postresuscitation Encephalopathy, Pulmonary Embolism, Coma, Macular Ischaemia, Cardiomyopathy, Respiratory Distress, Hypoxic-Ischaemic Encephalopathy, Drug-Induced Liver Injury, Brain Oedema, Bronchitis, Cardiac Arrest

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Dexamethasone; Fragmin; Midazolam; Gamma-Hydroxybutyric Acid; Sodium Oxybate; Perftoran; Hemohes; Ceraxon (Citicoline); Dofamine; Omez; Adrenalin IN OIL INJ; Cytoflavin (Inosine + Nicotinamide + Riboflavin Mononucleotide + Succi



Possible Marcaine side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-05

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Dilaudid
    Dosage: unk

Rocephin
    Dosage: unk

Marcaine
    Dosage: unk

Ibuprofen (Advil)
    Dosage: unk

Axil
    Dosage: unk



Possible Marcaine side effects in 30 year old female

Reported by a physician from Japan on 2012-05-21

Patient: 30 year old female

Reactions: Hyperaesthesia, Hypoaesthesia, Intentional Drug Misuse

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in 68 year old female

Reported by a physician from Japan on 2012-05-03

Patient: 68 year old female

Reactions: Pharyngeal Oedema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine
    Dosage: dose unknown
    Indication: Local Anaesthesia

Marcaine
    Dosage: dose unknown

Neurotropin
    Dosage: dose unknown

Marcaine
    Dosage: dose unknown
    Indication: Epidural Anaesthesia

Elcitonin
    Dosage: dose unknown
    Indication: Local Anaesthesia

Marcaine
    Dosage: dose unknown

Neurotropin
    Dosage: dose unknown
    Indication: Local Anaesthesia

Neurotropin
    Dosage: dose unknown

Neurotropin
    Dosage: dose unknown
    Indication: Epidural Anaesthesia

Marcaine
    Dosage: dose unknown

Marcaine
    Dosage: dose unknown

Adant
    Dosage: dose unknown
    Indication: Local Anaesthesia



Possible Marcaine side effects in 28 year old female

Reported by a physician from Russian Federation on 2012-04-30

Patient: 28 year old female

Reactions: Off Label Use, Overdose, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine
    Indication: Spinal Anaesthesia

Methylergobrevin

Diazepam



Possible Marcaine side effects in 68 year old female

Reported by a physician from Japan on 2012-04-25

Patient: 68 year old female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Neurotropin
    Dosage: dose unknown

Marcaine
    Dosage: dose unknown

Adant
    Dosage: dose unknown
    Indication: Local Anaesthesia

Marcaine
    Dosage: dose unknown
    Indication: Local Anaesthesia

Marcaine
    Dosage: dose unknown

Neurotropin
    Dosage: dose unknown
    Indication: Local Anaesthesia

Elcitonin
    Dosage: dose unknown
    Indication: Local Anaesthesia



Possible Marcaine side effects in 56 year old male

Reported by a physician from Norway on 2012-04-04

Patient: 56 year old male

Reactions: Neuropathy Peripheral, Eyelid Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Xylocaine W / Epinephrene
    Dosage: 1-3 ml in the skin area to be treated with light
    Indication: Local Anaesthesia
    Start date: 2008-05-28
    End date: 2008-05-28

Marcaine
    Start date: 2008-05-28
    End date: 2008-05-28



Possible Marcaine side effects in 49 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-26

Patient: 49 year old male

Reactions: Pruritus Generalised, Flushing

Drug(s) suspected as cause:
Gentamicin Sulfate
    Dosage: 160 mg milligram(s), intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-08
    End date: 2012-02-09

Ceftriaxone
    Dosage: 2 g gram(s), intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-08
    End date: 2012-02-09

Marcaine
    Dosage: 13 mg milligram(s), epidural
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-08
    End date: 2012-02-08



Possible Marcaine side effects in 56 year old male

Reported by a physician from Norway on 2012-03-20

Patient: 56 year old male

Reactions: Neuropathy Peripheral, Eyelid Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Xylocaine
    Indication: Local Anaesthesia
    Start date: 2008-05-28
    End date: 2008-05-28

Marcaine
    Indication: Local Anaesthesia
    Start date: 2008-05-28
    End date: 2008-05-28



Possible Marcaine side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-19

Patient: 48 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Anaphylactoid Reaction

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Diazepam; Droperidol



Possible Marcaine side effects in 35 year old female

Reported by a physician from Turkey on 2012-03-13

Patient: 35 year old female, weighing 90.0 kg (198.0 pounds)

Reactions: Anaphylactic Reaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine
    Dosage: once
    Indication: Spinal Anaesthesia

Ampicillin
    Dosage: once
    Indication: Endocarditis



Possible Marcaine side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: female, weighing 88.4 kg (194.6 pounds)

Reactions: Pain

Drug(s) suspected as cause:
Flector
    Dosage: unk
    Indication: Gout
    Start date: 2012-02-27

Marcaine
    Dosage: unk
    Indication: Gout
    Start date: 2012-02-27
    End date: 2012-02-27

Other drugs received by patient: Fluoxetine; Anastrozole; Bystolic; Multi-Vitamins; Mesalamine; Vitamin B Complex CAP; Losartan



Possible Marcaine side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-01

Patient: 76 year old female, weighing 88.5 kg (194.6 pounds)

Reactions: NO Therapeutic Response, Abasia, Anaphylactic Reaction, Atrial Fibrillation, Unevaluable Event, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Marcaine

Traumeel
    Dosage: 2.2ml, once 014 1 dose
    Indication: Contusion

Traumeel
    Dosage: 2.2ml, once 014 1 dose
    Indication: Pain



Possible Marcaine side effects in 50 year old female

Reported by a physician from Russian Federation on 2012-02-28

Patient: 50 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Hypoxic-Ischaemic Encephalopathy, Brain Oedema, Respiratory Distress, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Sodium Oxibatum; Dopamine HCL; Epinephrine; Perftoran; Hemohes; Fragmin; Midazolam; Gamma-Hydroxybutyric Acid; Ceraxone; Dexamethasone; Cytoflavine; Omes



Possible Marcaine side effects in 23 year old female

Reported by a physician from Russian Federation on 2012-02-27

Patient: 23 year old female, weighing 96.0 kg (211.2 pounds)

Reactions: Dyspnoea, Renal Disorder, Maternal Exposure During Pregnancy, Adverse Event, Blood Pressure Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in 26 year old female

Reported by a physician from Russian Federation on 2012-02-27

Patient: 26 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Hypotension, Anaphylactic Shock, Pulmonary Oedema, Bradycardia, Cardiac Arrest, Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Premedication Drugs (Not Specified); Stabisol GAK; Dimedrole; Pentoxifylline; Saline



Possible Marcaine side effects in 51 year old male

Reported by a physician from Russian Federation on 2012-02-27

Patient: 51 year old male

Reactions: Urticaria, Bronchospasm, Anaphylactic Shock, Rash

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Novocain



Possible Marcaine side effects in

Reported by a physician from Russian Federation on 2012-02-27

Patient:

Reactions: Foetal Hypokinesia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in 22 year old female

Reported by a physician from Russian Federation on 2012-02-27

Patient: 22 year old female

Reactions: Vomiting, Nausea, Headache, Nephritis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Ketorolac Tromethamine; Dextrose; Metoclopramide; Reopolyglucine; Rheopolyglukin; Diazepam



Possible Marcaine side effects in 29 year old female

Reported by a physician from Russian Federation on 2012-02-27

Patient: 29 year old female

Reactions: Paresis, Quadriplegia, Respiratory Distress

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Sodium Cefotaxime; Neohemodes; Atropine Sulfate; Acesole; Dithylin; Tractrium; Corglycard; Sodium Chloride; Propofol; Promedole; Drotaverine; Dimedrole; Reamberine; Fentanyl; Penzital; Spasgan; Almagel; Metoclopramide; Ranitidine; Quamatel



Possible Marcaine side effects in female

Reported by a pharmacist from United States on 2012-02-23

Patient: female

Reactions: Anaesthetic Complication

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in female

Reported by a pharmacist from United States on 2012-02-23

Patient: female

Reactions: Anaesthetic Complication, Treatment Failure

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in female

Reported by a pharmacist from United States on 2012-02-23

Patient: female, weighing 147.9 kg (325.3 pounds)

Reactions: Drug Ineffective, Anaesthetic Complication

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in 49 year old female

Reported by a physician from United States on 2012-02-22

Patient: 49 year old female

Reactions: Skin Atrophy

Drug(s) suspected as cause:
Kenalog
    Start date: 2010-07-07

Marcaine
    Start date: 2010-07-07



Possible Marcaine side effects in 44 year old female

Reported by a physician from Russian Federation on 2012-02-21

Patient: 44 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Apparent Death, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in 70 year old male

Reported by a physician from Romania on 2012-02-16

Patient: 70 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Drug Effect Decreased, Drug Effect Delayed

Drug(s) suspected as cause:
Marcaine



Possible Marcaine side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-15

Patient: 48 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Anaphylactoid Reaction

Drug(s) suspected as cause:
Marcaine

Other drugs received by patient: Droperidol; Diazepam

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