Index of reports
> Life Threatening Events (41)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 41 Next >>
Possible Lioresal side effects in male
Reported by a physician from France on 2012-07-10
Patient: male
Reactions: Pancreatitis Acute, Pneumonia, Systemic Inflammatory Response Syndrome, Circulatory Collapse, Respiratory Distress, Organ Failure
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Aspirin
Administration route: Oral
Indication: Cerebrovascular Accident
Dipiperon
Administration route: Oral
Diprivan
Indication: Anaesthesia
Start date: 2012-02-27
End date: 2012-02-27
Lioresal
Indication: Cerebrovascular Accident
Depakene
Administration route: Oral
Indication: Epilepsy
End date: 2012-02-28
Possible Lioresal side effects in
Reported by a physician from Denmark on 2012-06-15
Patient:
Reactions: Underdose, Condition Aggravated, Muscle Spasticity, Device Leakage, Multi-Organ Failure, Overdose, Respiratory Failure, Device Connection Issue, Intracranial Hypotension
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 12 year old male
Reported by a physician from United States on 2012-05-15
Patient: 12 year old male
Reactions: Back Pain, Mydriasis, Pyrexia, Somnolence, Overdose, Hypopnoea, Hypotonia, Bradycardia, Device Malfunction, Altered State of Consciousness, Lethargy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from Australia on 2012-05-11
Patient: male
Reactions: Overdose, Cardio-Respiratory Arrest, Hypoxic-Ischaemic Encephalopathy, Lower Respiratory Tract Infection, Convulsion, Loss of Consciousness
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 18 year old male
Reported by a physician from United States on 2012-05-07
Patient: 18 year old male
Reactions: Pneumonia Aspiration, Wrong Technique in Drug Usage Process, Vomiting, Hypotension, Device Damage, Abnormal Behaviour, Complication of Device Removal, Muscle Tightness, Implant Site Reaction, Overdose, Implant Site Fibrosis, Procedural Complication, Implant Site Induration
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Cerebral Palsy
Possible Lioresal side effects in 17 year old male
Reported by a physician from United States on 2012-05-02
Patient: 17 year old male
Reactions: Agitation, Exposure To Contaminated Device, Tonic Clonic Movements, Muscle Spasticity, Malaise, Cardio-Respiratory Arrest, Overdose, Bronchial Wall Thickening, Circulatory Collapse, Acute Respiratory Failure, Cough, Hypertonia, Scoliosis, Muscle Contracture, Drug Withdrawal Syndrome, Rash Macular, Convulsion, Urinary Tract Infection Enterococcal, Pseudomonas Test Positive, Fungal Test Positive, Meningitis Bacterial, Hypertension, Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1730 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 1730 mcg/day
Indication: Cerebral Palsy
Possible Lioresal side effects in 31 year old female
Reported by a physician from United States on 2012-04-25
Patient: 31 year old female
Reactions: Agitation, Pruritus, Drug Ineffective, Muscle Spasticity, Device Dislocation, Malaise, Overdose, Injury, Device Connection Issue, Device Malfunction, Hypersomnia, Pain in Extremity, Drug Withdrawal Syndrome, Discomfort, Device Failure, Device Breakage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-24
Patient: male
Reactions: Blood Creatine Phosphokinase Increased, Pain, Mental Status Changes, Hypernatraemia, Pyrexia, Somnolence, Hypokalaemia, Urinary Retention, Gastrooesophageal Reflux Disease, Lethargy, Hypertonia, Hypotension, Urinary Tract Infection, Convulsion, Tremor, Flushing, Bradycardia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Cerebral Palsy
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
Possible Lioresal side effects in 6 year old male
Reported by a physician from United States on 2012-04-23
Patient: 6 year old male
Reactions: Atelectasis, Metabolic Acidosis, Pneumonia, Implant Site Erosion, Hypotension, Hyperglycaemia, Wound Infection, Hypernatraemia, Respiratory Distress, Respiratory Rate Decreased, Pulmonary Oedema, Staphylococcal Bacteraemia, CSF Test Abnormal
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 6 year old male
Reported by a physician from United States on 2012-04-23
Patient: 6 year old male
Reactions: Atelectasis, Metabolic Acidosis, Pneumonia, Implant Site Erosion, Hypotension, Hyperglycaemia, Hypernatraemia, Wound Infection Staphylococcal, Cardiac Disorder, Haemodynamic Instability, Respiratory Rate Decreased, Hypopnoea, Pulmonary Oedema, Staphylococcal Bacteraemia, CSF Test Abnormal
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-19
Patient: female
Reactions: Pruritus, Hypotension, Muscle Spasticity, Drug Withdrawal Syndrome, Device Occlusion, Somnolence, Device Dislocation, Implant Site Swelling, Therapeutic Response Decreased, Multiple Drug Overdose, Bradycardia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-18
Patient: male
Reactions: Contusion, Wrist Fracture, Abasia, Pain, Fear, Hand Fracture, Fall, Suicidal Ideation, Foot Fracture, Concussion, Overdose, Procedural Complication, Dysgraphia, RIB Fracture, Muscle Spasms, Medical Device Complication, Nightmare, Nausea, Anxiety, Post-Traumatic Stress Disorder, Communication Disorder, Device Infusion Issue, Insomnia, Facial Bones Fracture, Homicidal Ideation, Withdrawal Syndrome
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United Kingdom on 2012-04-17
Patient: male
Reactions: Abdominal Pain, Back Pain, Hypotension
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a individual with unspecified qualification from United States on 2012-04-13
Patient: male
Reactions: Medical Device Complication, Withdrawal Syndrome, Cardiac Arrest, Post Procedural Infection
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 73 year old male
Reported by a physician from United States on 2012-04-11
Patient: 73 year old male
Reactions: Confusional State, Overdose, Coma, Headache, Device Connection Issue, Delirium, Lethargy, Implant Site Swelling
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 12 year old male
Reported by a physician from United States on 2012-04-11
Patient: 12 year old male
Reactions: Back Pain, Mydriasis, Overdose, Hypopnoea, Hypotonia, Bradycardia, Pyrexia, Somnolence, Lethargy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-09
Patient: female
Reactions: Agitation, Respiratory Rate Decreased, Overdose, Oedema, Loss of Consciousness, Lethargy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 52 year old male
Reported by a physician from France on 2012-04-06
Patient: 52 year old male
Reactions: Pancreatitis Acute, Circulatory Collapse, Respiratory Distress
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Dipiperon
Administration route: Oral
Depakene
Administration route: Oral
Indication: Epilepsy
End date: 2012-02-28
Diprivan
Indication: Anaesthesia
Start date: 2012-02-27
End date: 2012-02-27
Aspirin
Administration route: Oral
Indication: Cerebrovascular Accident
Lioresal
Indication: Cerebrovascular Accident
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-05
Patient: male
Reactions: Blood Creatine Phosphokinase Increased, Pain, Mental Status Changes, Implant Site Infection, Wound Infection Staphylococcal, Hyperhidrosis, Procedural Haemorrhage, Hypertonia, Metabolic Acidosis, Dystonia, Restlessness, Urinary Tract Infection, Cognitive Disorder, Toxicity To Various Agents, Drug Withdrawal Syndrome, Blood Lactic Acid Increased, Tremor, Depressed Level of Consciousness, Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-05
Patient: male
Reactions: Blood Creatine Phosphokinase Increased, Implant Site Infection, Mental Status Changes, Hyperhidrosis, Wound Infection Staphylococcal, Procedural Haemorrhage, Hypertonia, Metabolic Acidosis, Blood Urine Present, Restlessness, Dystonia, Urinary Tract Infection, Cognitive Disorder, Urine Abnormality, Drug Withdrawal Syndrome, Toxicity To Various Agents, Blood Lactic Acid Increased, Tremor, Depressed Level of Consciousness, Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 28 year old male
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: 28 year old male
Reactions: Incision Site Infection, Meningitis, Device Breakage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Oral Baclofen; Valium
Possible Lioresal side effects in 47 year old female
Reported by a physician from United States on 2012-04-03
Patient: 47 year old female
Reactions: Therapeutic Response Decreased, Incision Site Infection, Underdose
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Fentanyl; Hydromorphone HCL; Bupivacaine HCL
Possible Lioresal side effects in 17 year old male
Reported by a physician from United States on 2012-03-15
Patient: 17 year old male
Reactions: Meningitis Bacterial, Muscle Spasticity
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1730 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 1730 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-03-15
Patient: female
Reactions: Nasopharyngitis, Device Kink, Device Damage, Drug Withdrawal Syndrome, Muscle Spasticity, Device Dislocation, Fall, Device Leakage, Poor Quality Sleep, Device Connection Issue, Urinary Retention, Hypertonia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 236 mcg/day
Indication: Cerebrovascular Accident
Lioresal
Dosage: 236 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in 18 year old male
Reported by a physician from United States on 2012-03-13
Patient: 18 year old male
Reactions: Incorrect Route of Drug Administration, Pneumonia Aspiration, Hypotension, Abnormal Behaviour, Implant Site Effusion, Muscle Tightness, Device Dislocation, Accidental Overdose, Procedural Vomiting, Implant Site Induration
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Cerebral Palsy
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
Possible Lioresal side effects in 17 year old male
Reported by a physician from United States on 2012-02-13
Patient: 17 year old male
Reactions: Drug Withdrawal Syndrome, Device Related Infection, Muscle Spasticity, Convulsion, Urinary Tract Infection Enterococcal, Cardio-Respiratory Arrest, Respiratory Failure, Meningitis Bacterial, Hypertension, Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1730 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 1730 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-02-06
Patient: female
Reactions: Nasopharyngitis, Device Kink, Muscle Spasticity, Fall, Device Dislocation, Malaise, Insomnia, Dysuria, Withdrawal Syndrome, Hypertonia, Device Breakage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 236 mcg/fday
Indication: Muscle Spasticity
Lioresal
Dosage: 236 mcg/fday
Indication: Cerebrovascular Accident
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-02-03
Patient: male
Reactions: Malaise, Cardio-Respiratory Arrest, Condition Aggravated, Muscle Spasticity, Meningitis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1730 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 1730 mcg/day
Indication: Cerebral Palsy
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-02-01
Patient: male
Reactions: Pyrexia, Drug Withdrawal Syndrome, Muscle Rigidity, Convulsion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1100 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 1100 mcg/day
Indication: Multiple Sclerosis
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-01-31
Patient: male
Reactions: Drug Dose Omission, Pneumonia, Coma, Pyrexia, Withdrawal Syndrome, Muscle Rigidity, Convulsion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1100 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 1100 mcg/day
Indication: Multiple Sclerosis
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