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Lioresal (Baclofen Intrathecal) - Hypertonia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Hypertonia (44)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) where reactions include hypertonia. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 44   Next >>

Possible Lioresal side effects in female

Reported by a physician from United States on 2012-07-26

Patient: female

Reactions: Muscle Spasticity, Headache, Device Dislocation, Drug Tolerance, Musculoskeletal Stiffness, Unevaluable Event, Adhesion, Hypertonia, Peritoneal Necrosis, Abnormal Behaviour, Condition Aggravated, Underdose, Posture Abnormal, Drug Withdrawal Syndrome, Paraesthesia, Convulsion, Peritonitis, Dysarthria, Nervous System Disorder, Gastric Volvulus, Feeling Abnormal, Device Breakage, Infection, Infusion Site Cyst

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

Lioresal
    Dosage: see b5
    Indication: Muscle Spasticity



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-07-17

Patient: female

Reactions: Necrosis, Headache, Muscle Spasticity, Device Occlusion, Device Dislocation, Muscle Tightness, Implant Site Cyst, Musculoskeletal Stiffness, Hypertonia, Medical Device Complication, Condition Aggravated, Abnormal Behaviour, Implant Site Mass, Peritonitis, Paraesthesia, Convulsion, Implant Site Reaction, Dysarthria, Therapeutic Response Decreased, Hypotonia, Gastric Volvulus, Withdrawal Syndrome, Feeling Abnormal, Spinal Column Stenosis, Infection, Inflammation

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5
    Indication: Muscle Spasticity

Lioresal
    Dosage: see b5
    Indication: Cerebral Palsy



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-07-16

Patient: female

Reactions: Muscle Spasticity, Headache, Device Dislocation, Muscle Tightness, Device Occlusion, Drug Tolerance, Peritoneal Necrosis, Hypertonia, Postoperative Adhesion, Mass, Abnormal Behaviour, Drug Withdrawal Syndrome, Posture Abnormal, Gastric Disorder, Paraesthesia, Peritonitis, Convulsion, Dysarthria, Gastric Volvulus, Nervous System Disorder, Feeling Abnormal, Device Breakage, Infection

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5
    Indication: Muscle Spasticity

Lioresal
    Dosage: see b5
    Indication: Cerebral Palsy



Possible Lioresal side effects in 22 year old male

Reported by a physician from United States on 2012-07-16

Patient: 22 year old male

Reactions: Blood Creatine Phosphokinase Increased, Pyrexia, Drug Withdrawal Syndrome, Muscle Spasticity, Hypertonia

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-07-06

Patient: female

Reactions: Blood Creatine Phosphokinase Increased, Dystonia, Drug Withdrawal Syndrome, Discomfort, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 350 mcg/day
    Indication: Cerebral Palsy

Lioresal
    Dosage: 350 mcg/day
    Indication: Muscle Spasticity



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 2012-05-31

Patient: male

Reactions: Pruritus, Dyskinesia, Drug Withdrawal Syndrome, Erythema, Oedema Peripheral, Feeling Jittery, Musculoskeletal Stiffness, Hypertonia, Muscle Spasms

Drug(s) suspected as cause:
Lioresal
    Dosage: 600 mcg/day
    Indication: Cerebral Palsy

Lioresal
    Dosage: 600 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-05-15

Patient: male

Reactions: Staphylococcal Infection, Wound Complication, Staphylococcus Test Positive, Hypertonia, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Ibuprofen (Advil)



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 22 year old male

Reported by a physician from United States on 2012-04-26

Patient: 22 year old male

Reactions: Pain, Clonus, Withdrawal Syndrome, Muscle Spasticity, Device Occlusion, Device Battery Issue, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 125. mcg, daily,intrath
    Indication: Muscle Spasticity

Lioresal
    Dosage: 125. mcg, daily,intrath
    Indication: Cerebral Palsy



Possible Lioresal side effects in 16 year old male

Reported by a physician from United States on 2012-04-26

Patient: 16 year old male

Reactions: Pruritus, Vomiting, Wound Dehiscence, Nausea, Device Issue, Clonus, Implant Site Effusion, Drug Withdrawal Syndrome, Device Occlusion, Tremor, Insomnia, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: male

Reactions: Pruritus, Nausea, Clonus, Pain, Headache, Hyperhidrosis, Rash Macular, Device Leakage, Social Avoidant Behaviour, Injury, Hypertonia

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-04-25

Patient: female

Reactions: Pain in Extremity, Paradoxical Drug Reaction, NO Therapeutic Response, Muscle Rigidity, Hypertonia, Muscle Spasms

Adverse event resulted in: 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 male

Reported by a physician from United States on 2012-04-23

Patient: male

Reactions: Pruritus, Restlessness, Abasia, Clonus, Underdose, Device Damage, Priapism, Withdrawal Syndrome, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 9 year old female

Reported by a physician from United States on 2012-04-20

Patient: 9 year old female

Reactions: Clonus, Muscle Spasticity, Drug Withdrawal Syndrome, Device Occlusion, Irritability, Adhesion, Device Malfunction, Hypertonia, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-04-17

Patient: male

Reactions: Pump Reservoir Issue, Drug Withdrawal Syndrome, Muscle Spasticity, Tremor, Malaise, Device Infusion Issue, Insomnia, Injury, Cardiovascular Disorder, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-04-16

Patient: female

Reactions: Posturing, Therapeutic Response Decreased, Pruritus, Dystonia, Device Infusion Issue, Condition Aggravated, Withdrawal Syndrome, Hypertonia

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 2012-04-13

Patient: female

Reactions: Agitation, Pruritus, Clonus, Muscle Spasticity, Device Occlusion, Withdrawal Syndrome, Device Connection Issue, Scar, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 18 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-13

Patient: 18 year old male

Reactions: Hiccups, Pyrexia, Withdrawal Syndrome, Device Malfunction, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Periactin; Valium; Oral Baclofen



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: male

Reactions: Medical Device Complication, Therapeutic Response Unexpected, Urinary Tract Infection, Condition Aggravated, Glucose Tolerance Impaired, Muscle Spasticity, Hypertonia

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 13 year old male

Reported by a physician from United States on 2012-04-09

Patient: 13 year old male

Reactions: Clonus, Pain, Granuloma, Muscle Tightness, Tremor, Insomnia, Medical Device Site Reaction, Device Malfunction, Scar, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 17 year old female

Reported by a physician from United States on 2012-04-06

Patient: 17 year old female

Reactions: Wound Dehiscence, Clonus, Implant Site Pain, Implant Site Effusion, Implant Site Infection, Implant Site Haematoma, Drug Withdrawal Syndrome, Muscle Spasticity, Pancreatitis, Device Connection Issue, Hypertonia

Adverse event resulted in: 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: Irritability, Agitation, Pruritus, Restlessness, Shunt Malfunction, Mood Swings, Hypertonia

Adverse event resulted in: 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 male

Reported by a physician from United States on 2012-04-05

Patient: male

Reactions: Blood Pressure Increased, Rhabdomyolysis, Tachycardia, Urinary Retention Postoperative, Muscle Spasticity, Hyperhidrosis, Malaise, Intestinal Dilatation, Injury, Unevaluable Event, Device Battery Issue, Hypertonia

Adverse event resulted in: 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, 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 9 year old female

Reported by a physician from United States on 2012-03-30

Patient: 9 year old female

Reactions: Clonus, Condition Aggravated, Muscle Spasticity, Irritability, Adhesion, Withdrawal Syndrome, Device Malfunction, Hypertonia, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



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 23 year old female

Reported by a physician from United States on 2012-03-08

Patient: 23 year old female

Reactions: Pain, Insomnia, Condition Aggravated, Asthenia, Device Malfunction, Hypertonia, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 94.5 mcg, daily intrathecal
    Indication: Muscle Spasticity

Lioresal
    Dosage: 94.5 mcg, daily intrathecal
    Indication: Cerebral Palsy



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