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Index of reports
> Cases with Pneumonia ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) where reactions include pneumonia. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-07-31
Patient: male
Reactions: Confusional State, Pneumonia, Dysphagia, Drug Hypersensitivity, Urinary Tract Infection, Incorrect Dose Administered, Respiratory Depression, Cognitive Disorder, Sedation, Oesophageal Disorder, Increased Bronchial Secretion, Cough
Drug(s) suspected as cause:
Lioresal
Dosage: 100 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 100 mcg/day
Indication: Brain Injury
Lioresal
Dosage: 100 mcg/day
Indication: Head Injury
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-07-24
Patient: male
Reactions: Pneumonia, Impaired Healing, Sepsis, Urinary Tract Infection, Implant Site Haematoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Lioresal
Dosage: 360 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 360 mcg/day
Indication: Multiple Sclerosis
Possible Lioresal side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient: female
Reactions: Device Leakage, Pneumonia, Musculoskeletal Stiffness, Implant Site Calcification, Device Occlusion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 749.5 mcg/day
Indication: Multiple Sclerosis
Lioresal
Dosage: 749.5 mcg/day
Indication: Muscle Spasticity
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 female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10
Patient: female
Reactions: Device Leakage, Pneumonia, Musculoskeletal Stiffness, Implant Site Calcification
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 749.5 mcg/day
Indication: Multiple Sclerosis
Lioresal
Dosage: 749.5 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in 70 year old male
Reported by a physician from United States on 2012-07-06
Patient: 70 year old male
Reactions: Pneumonia
Adverse event resulted in: death
Drug(s) suspected as cause:
Lioresal
Dosage: 674.0 mcg/day
Indication: Cerebrovascular Accident
Lioresal
Dosage: 674.0 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-07-03
Patient: male, weighing 15.0 kg (32.9 pounds)
Reactions: Hyperpyrexia, Drug Screen Positive, Unresponsive To Stimuli, Accidental Death, Brain Injury, Subdural Haematoma, Pulmonary Oedema, Bacterial Infection, Hydrocephalus, Hyperchloraemia, Pneumonia, Blood Urea Increased, Cerebral Atrophy, Hyponatraemia, Blood Potassium Increased, Blood Glucose Decreased, Keloid Scar, Hypoxic-Ischaemic Encephalopathy, Subarachnoid Haemorrhage, Pneumonia Bacterial, Dehydration, Haemophilus Sepsis, Staphylococcus Test Positive, Near Drowning, Scar
Adverse event resulted in: death
Drug(s) suspected as cause:
Lioresal
Dosage: 225 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 225 mcg/day
Indication: Brain Injury
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-05-31
Patient: male
Reactions: Pneumonia, Pump Reservoir Issue, Implant Site Pain, Abnormal Behaviour, Drug Withdrawal Syndrome, Device Occlusion, Implant Site Swelling, Malaise, Oedema Peripheral, Injury, Device Malfunction, Hypertonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 450.2 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 450.2 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25
Patient: male
Reactions: Pneumonia, Drug Effect Decreased, Urinary Tract Infection, Unresponsive To Stimuli, International Normalised Ratio Increased, Drug Withdrawal Syndrome, Muscle Tightness, Skin Ulcer, Sepsis, Urosepsis, Myocardial Infarction, Cough, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Spinal Cord Injury
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
Possible Lioresal side effects in 44 year old female
Reported by a physician from United States on 2012-05-01
Patient: 44 year old female
Reactions: Confusional State, Pump Reservoir Issue, Drug Ineffective, Pain, Mental Status Changes, Lower Limb Fracture, Disorientation, Fall, Suicidal Ideation, Device Power Source Issue, Medication Residue, Spastic Paralysis, Pneumonia, Muscle Contracture, Urinary Tract Infection, Device Damage, General Physical Health Deterioration, Cognitive Disorder, Cachexia, Anxiety, Disease Recurrence, Suicide Attempt, Mental Disorder, Secondary Progressive Multiple Sclerosis, Asthenia, Blood Pressure Decreased, Device Breakage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see image
Indication: Muscle Spasticity
Lioresal
Dosage: see image
Indication: Multiple Sclerosis
Possible Lioresal side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-27
Patient: male
Reactions: Pneumonia, Unresponsive To Stimuli, Ulcer, Urosepsis, Device Alarm Issue, Myocardial Infarction, Muscle Spasms, Device Battery Issue
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
Lioresal
Dosage: see b5
Indication: Spinal Cord Injury
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-24
Patient: male
Reactions: Agitation, Vomiting, Pneumonia, Grimacing, Nausea, Moaning, Drug Withdrawal Syndrome, Muscle Twitching, Device Occlusion, Convulsion, Irritability, Sepsis, Musculoskeletal Stiffness
Adverse event resulted in: death, 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, 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 male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-23
Patient: male
Reactions: Pneumonia, International Normalised Ratio Increased, Unresponsive To Stimuli, Ulcer, Urosepsis, Device Alarm Issue, Myocardial Infarction, Device Battery Issue, Incorrect Dose Administered by Device, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Spinal Cord Injury
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, 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 4 year old male
Reported by a physician from United States on 2012-04-12
Patient: 4 year old male
Reactions: Urine Analysis Abnormal, Abdominal Pain, Vomiting, Pneumonia, Cough, Infection
Adverse event resulted in: 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 2012-04-06
Patient: female
Reactions: Pneumonia, Incision Site Complication, Implant Site Infection, Pyrexia, Meningitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-02-27
Patient: male
Reactions: Pneumonia, Implant Site Pain, Oedema Peripheral, Abnormal Behaviour, Drug Withdrawal Syndrome, Hypertonia, Implant Site Swelling
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 450.2 mcg/day; see image
Indication: Cerebral Palsy
Lioresal
Dosage: 450.2 mcg/day; see image
Indication: Muscle Spasticity
Possible Lioresal side effects in 44 year old female
Reported by a physician from United States on 2012-02-21
Patient: 44 year old female
Reactions: Confusional State, Spastic Paralysis, Pneumonia, Urinary Tract Infection, Cognitive Disorder, Disorientation, Suicidal Ideation, Cachexia, Anxiety, Disease Recurrence, Suicide Attempt, Mental Disorder, Multiple Sclerosis, Device Malfunction
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Multiple Sclerosis
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-02-08
Patient: male
Reactions: Agitation, Pneumonia, Vomiting, Dyspnoea, Nausea, Grimacing, Dyskinesia, Condition Aggravated, Moaning, Muscle Twitching, Device Occlusion, Muscle Tightness, Convulsion, Irritability, Sepsis, Musculoskeletal Stiffness, Withdrawal Syndrome, Hypertonia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5 mcg, daily, intr
Indication: Cerebral Palsy
Lioresal
Dosage: see b5 mcg, daily, intr
Indication: Muscle Spasticity
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-02-06
Patient: female
Reactions: Pneumonia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 512.8 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 512.8 mcg/day
Indication: Multiple Sclerosis
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-02-03
Patient: female
Reactions: Pneumonia, Multiple Sclerosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 512.8 mcg/day
Indication: Multiple Sclerosis
Lioresal
Dosage: 512.8 mcg/day
Indication: Muscle Spasticity
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
Possible Lioresal side effects in female
Reported by a physician from United States on 2011-11-23
Patient: female
Reactions: Pneumonia, Respiratory Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Lioresal
Dosage: 286.2 mcg daily
Indication: Muscle Spasticity
Lioresal
Dosage: 286.2 mcg daily
Indication: Multiple Sclerosis
Possible Lioresal side effects in male
Reported by a physician from United States on 2011-11-09
Patient: male
Reactions: Agitation, Vomiting, Dyspnoea, Pneumonia, Nausea, Grimacing, Clonus, Moaning, Drug Withdrawal Syndrome, Muscle Twitching, Device Occlusion, Convulsion, Sepsis, Shunt Malfunction, Musculoskeletal Stiffness, Hypertonia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5 mcg, dailu, intr
Indication: Muscle Spasticity
Lioresal
Dosage: see b5 mcg, dailu, intr
Indication: Cerebral Palsy
Possible Lioresal side effects in 4 year old male
Reported by a physician from United States on 2011-10-11
Patient: 4 year old male
Reactions: Abdominal Pain, Pneumonia, Vomiting, Urinary Tract Infection, Implant Site Effusion, Intracranial Pressure Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-04
Patient: female
Reactions: Pneumonia, Implant Site Infection, Meningitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
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