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 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 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 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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