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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