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Baclofen (Baclofen) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (64)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Baclofen life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 64   Next >>

Possible Baclofen side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-07-25

Patient: 23 year old female

Reactions: Electrocardiogram QT Prolonged, Pneumonia Aspiration, Blood Creatine Phosphokinase Increased, Rhabdomyolysis, Psychomotor Retardation, Atrioventricular Block Complete, Hypercapnia, Ventricular Arrhythmia, Coma, Hypokalaemia, Speech Disorder, Balance Disorder, Multiple Drug Overdose Intentional, Depression, Arrhythmia Supraventricular, Vomiting, Hypotension, Encephalopathy, Ataxia, Conduction Disorder, Hyponatraemia, Status Epilepticus, Body Temperature Decreased, Heart Rate Decreased, Respiratory Failure, Ventricular Tachycardia, Areflexia, Suicide Attempt, Pulse Absent, Ventricular Fibrillation, Memory Impairment

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lamotrigine
    Dosage: 10, 000 - 20, 000mg, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Baclofen
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Baclofen side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-09

Patient: 52 year old male

Reactions: Pancreatitis Acute, Circulatory Collapse, Respiratory Distress

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Diprivan
    Indication: Anaesthesia
    Start date: 2012-02-27
    End date: 2012-02-27

Pipamperone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Aspirin
    Administration route: Oral
    Indication: Cerebrovascular Accident

Baclofen
    Indication: Cerebrovascular Accident

Depakote
    Administration route: Oral
    Indication: Epilepsy
    End date: 2012-02-28



Possible Baclofen side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-06-29

Patient: 23 year old female

Reactions: Arrhythmia Supraventricular, Rhabdomyolysis, Encephalopathy, Conduction Disorder, Hyponatraemia, Ventricular Arrhythmia, Toxicity To Various Agents, Convulsion, Hypokalaemia, Loss of Consciousness, Respiratory Failure, Ventricular Tachycardia, Pulse Absent, Suicide Attempt, Atrioventricular Block, Ventricular Fibrillation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: unknown amount
    Administration route: Oral
    Indication: Suicide Attempt

Lamotrigine
    Dosage: ingested approximately 100-200 capsules of lamotrigine 100mg (total 10-20g)
    Administration route: Oral
    Indication: Suicide Attempt



Possible Baclofen side effects in male

Reported by a physician from United States on 2012-06-20

Patient: male

Reactions: Overdose, Depressed Level of Consciousness

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Baclofen
    Dosage: 799.7 mcg/day flex mode
    Indication: Muscle Spasticity

Baclofen
    Dosage: 799.7 mcg/day flex mode
    Indication: Spinal Cord Injury



Possible Baclofen side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: female

Reactions: Medical Device Complication, Constipation, Bradyphrenia, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Multiple Sclerosis



Possible Baclofen side effects in 48 year old female

Reported by a physician from Japan on 2012-06-08

Patient: 48 year old female

Reactions: Pneumonia, Pancytopenia

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

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: male

Reactions: Pneumonia, Vomiting, Drug Ineffective, Pain in Extremity, Suicide Attempt, Feeling Abnormal

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Paraparesis

Other drugs received by patient: Baclofen



Possible Baclofen side effects in male

Reported by a physician from United States on 2012-05-30

Patient: male

Reactions: Implant Site Erosion, Skin Disorder, Device Extrusion, Wound Infection, Cardiac Arrest, Myocardial Infarction, Stress

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Multiple Sclerosis

Baclofen
    Indication: Muscle Spasticity



Possible Baclofen side effects in 18 year old male

Reported by a physician from United States on 2012-05-29

Patient: 18 year old male

Reactions: Incorrect Route of Drug Administration, Pneumonia Aspiration, Vomiting, Hypotension, Implant Site Effusion, Abnormal Behaviour, Device Damage, Complication of Device Removal, Accidental Overdose, Device Dislocation, Implant Site Fibrosis, Device Connection Issue

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: see b5
    Indication: Cerebral Palsy

Baclofen
    Dosage: see b5
    Indication: Muscle Spasticity



Possible Baclofen side effects in 22 year old male

Reported by a physician from Japan on 2012-05-24

Patient: 22 year old male

Reactions: Cardio-Respiratory Arrest, Brain Hypoxia, Ventricular Fibrillation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Nervous System Disorder

Baclofen
    Indication: Paralysis



Possible Baclofen side effects in 40 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-23

Patient: 40 year old female

Reactions: Overdose, Hypotension, Coma, Toxicity To Various Agents, Apnoea, Seizure Like Phenomena

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 41 year old male

Reported by a physician from United States on 2012-05-23

Patient: 41 year old male

Reactions: Intentional Overdose, Autonomic Nervous System Imbalance, Hypothermia, Muscle Contractions Involuntary, Tachycardia, Hypotension, Hyperreflexia, Coma, Serotonin Syndrome, Drug Withdrawal Syndrome, Delirium, Dysarthria, Areflexia, Suicide Attempt

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: ^at least 600mg^
    Administration route: Oral
    Indication: Suicide Attempt

Baclofen

Other drugs received by patient: Desvenlafaxine; Duloxetine Hydrochloride



Possible Baclofen side effects in 48 year old female

Reported by a physician from Japan on 2012-05-18

Patient: 48 year old female

Reactions: Pneumonia, Hypotension, Acute Respiratory Distress Syndrome, Pancytopenia, Cardiac Arrest

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

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in male

Reported by a physician from United States on 2012-05-16

Patient: male

Reactions: Skin Disorder, Stress, Cardiac Arrest, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Multiple Sclerosis



Possible Baclofen side effects in 29 year old male

Reported by a physician from Japan on 2012-05-15

Patient: 29 year old male

Reactions: Peripheral Coldness, Disseminated Intravascular Coagulation, Blood Albumin Decreased, Blood Calcium Increased, Pyrexia, Platelet Distribution Width Increased, Activated Partial Thromboplastin Time Prolonged, Haematocrit Decreased, Blood Sodium Decreased, Drug Therapy Changed, Muscle Spasms, Vomiting, Blood Urea Increased, Blood Chloride Decreased, Blood Lactate Dehydrogenase Increased, International Normalised Ratio Increased, Alanine Aminotransferase Increased, Protein Total Decreased, Mean Platelet Volume Increased, Drug Withdrawal Syndrome, Haemoglobin Decreased, Serratia Sepsis, Aspartate Aminotransferase Increased, Septic Shock, Complex Partial Seizures

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Horizon 10; Platelets; Futhan



Possible Baclofen side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-14

Patient: male

Reactions: Pneumonia, Vomiting, Disease Recurrence, Pain in Extremity, Drug Ineffective, Suicide Attempt, Muscle Spasticity, Feeling Abnormal, Disease Progression

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Paraparesis

Other drugs received by patient: Baclofen



Possible Baclofen side effects in 55 year old female

Reported by a physician from Japan on 2012-05-10

Patient: 55 year old female

Reactions: Bedridden, Cardio-Respiratory Arrest, Meningitis, White Blood Cell Count Increased, Muscle Spasms

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 48 year old female

Reported by a physician from Japan on 2012-05-09

Patient: 48 year old female

Reactions: Pneumonia, Pancytopenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-09

Patient: female

Reactions: Cardiac Arrest, Constipation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Baclofen
    Indication: Multiple Sclerosis

Baclofen
    Indication: Muscle Spasticity



Possible Baclofen side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-09

Patient: female

Reactions: Sepsis, Cystitis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Spinal Cord Injury



Possible Baclofen side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-04

Patient:

Reactions: Aspiration, Somnolence

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Tegretol

Zolpidem Tartrate

Baclofen

Tranxene



Possible Baclofen side effects in 51 year old female

Reported by a physician from United States on 2012-05-01

Patient: 51 year old female

Reactions: Overdose, Hypotension, Coma, Suicide Attempt, Toxicity To Various Agents

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen

Baclofen
    Administration route: Oral
    Indication: Overdose

Other drugs received by patient: Phenobarbital TAB; Digoxin; Warfarin Sodium; Hydroxyzine; Paroxetine; Clorazepate Dipotassium; Phenytoin



Possible Baclofen side effects in female

Reported by a physician from United States on 2012-05-01

Patient: female

Reactions: Brain Oedema, Mental Status Changes, Meningitis, Muscle Spasticity, Convulsion

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: see image
    Indication: Muscle Spasticity

Baclofen
    Dosage: see image
    Indication: Spinal Cord Injury



Possible Baclofen side effects in male

Reported by a physician from United States on 2012-04-27

Patient: male

Reactions: Wound Infection, Device Related Infection, Cardiac Arrest, Stress

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Multiple Sclerosis



Possible Baclofen side effects in 29 year old male

Reported by a physician from Japan on 2012-04-19

Patient: 29 year old male

Reactions: Blood Bilirubin Increased, Serratia Infection, Disseminated Intravascular Coagulation, Blood Albumin Decreased, Blood Calcium Increased, Pyrexia, Feeling Cold, Platelet Distribution Width Increased, Activated Partial Thromboplastin Time Prolonged, Haematocrit Decreased, RED Blood Cell Count Decreased, Blood Sodium Decreased, Blood Urea Increased, Blood Chloride Decreased, Alanine Aminotransferase Increased, International Normalised Ratio Increased, Drug Withdrawal Syndrome, Mean Platelet Volume Increased, Protein Total Decreased, Convulsion, Haemoglobin Decreased, Blood Glucose Decreased, Aspartate Aminotransferase Increased, Septic Shock, Bilirubin Conjugated Increased, Asthenia, Complex Partial Seizures

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 55 year old female

Reported by a physician from Japan on 2012-04-18

Patient: 55 year old female

Reactions: Cardio-Respiratory Arrest, General Physical Health Deterioration, Meningitis, Muscle Spasms, White Blood Cell Count Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 40 year old female

Reported by a individual with unspecified qualification from United States on 2012-04-17

Patient: 40 year old female

Reactions: Overdose, Hypotension, Unresponsive To Stimuli, Areflexia, Coma, Delirium

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Nabumetone; Diphenhydramine HCL; Alprazolam



Possible Baclofen side effects in 51 year old female

Reported by a individual with unspecified qualification from United States on 2012-04-17

Patient: 51 year old female

Reactions: Blood Pressure Systolic Decreased, Unresponsive To Stimuli, Coma, Body Temperature Decreased, Respiratory Rate Decreased, Hypoxic-Ischaemic Encephalopathy, Overdose, Suicide Attempt

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Hydroxyzine; Phenytoin; Clorazepate Dipotassium; Paroxetine; Phenobarbital TAB; Digoxin; Warfarin Sodium; Baclofen



Possible Baclofen side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-09

Patient: 52 year old male

Reactions: Pancreatitis Acute, Circulatory Collapse, Respiratory Distress

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pipamperone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Aspirin
    Administration route: Oral
    Indication: Cerebrovascular Accident

Baclofen
    Indication: Cerebrovascular Accident

Depakote
    Administration route: Oral
    Indication: Epilepsy
    End date: 2012-02-28

Diphivan
    Indication: Anaesthesia
    Start date: 2012-02-27
    End date: 2012-02-27



Possible Baclofen side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-21

Patient: female

Reactions: Pulmonary Oedema, Urosepsis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Baclofen
    Indication: Spinal Cord Injury

Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Spinal Cord Disorder



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