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Lioresal (Baclofen Intrathecal) - Drug Withdrawal Syndrome - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Drug Withdrawal Syndrome (82)

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

 Reports 1 - 30 of 82   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 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 2012-07-16

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 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 female

Reported by a physician from United States on 2012-06-22

Patient: female

Reactions: Pruritus, Hypotension, Mental Status Changes, Headache, Drug Withdrawal Syndrome, Muscle Spasticity, Device Occlusion, Therapeutic Response Decreased, Neuropathy Peripheral, Hypoxia, Septic Shock

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 2012-06-18

Patient: female

Reactions: Agitation, Confusional State, Restlessness, Illusion, Drug Withdrawal Syndrome, Disorientation, Somnolence, Delirium, Delusion, Anxiety, Hallucination, Visual

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: female

Reactions: Device Computer Issue, Drug Withdrawal Syndrome, Incorrect Dose Administered by Device, Influenza, Influenza Like Illness

Drug(s) suspected as cause:
Lioresal
    Dosage: 1.66 mcg/day
    Indication: Post Laminectomy Syndrome

Lioresal
    Dosage: 1.66 mcg/day
    Indication: Pain

Other drugs received by patient: Fentanyl; Bupivacaine HCL



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-06-15

Patient: male

Reactions: Drug Dose Omission, Hypoxic-Ischaemic Encephalopathy, Cognitive Disorder, Drug Withdrawal Syndrome, Treatment Noncompliance, Convulsion

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 41 year old female

Reported by a physician from United States on 2012-06-14

Patient: 41 year old female

Reactions: Tachycardia, Drug Withdrawal Syndrome, Withdrawal Syndrome, Device Dislocation, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Bupivacaine HCL; Fentanyl; Clonidine



Possible Lioresal side effects in female

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

Patient: female

Reactions: Rhabdomyolysis, Dystonia, Coma, Device Damage, Drug Withdrawal Syndrome, Muscle Spasticity, Device Leakage, Overdose, Device Connection Issue, Device Malfunction

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

Lioresal
    Indication: Cerebral Palsy



Possible Lioresal side effects in 54 year old male

Reported by a physician from United States on 2012-05-31

Patient: 54 year old male

Reactions: Device Leakage, Wound Dehiscence, Tachycardia, Drug Withdrawal Syndrome, Wound Infection, Device Related Infection, Tremor

Drug(s) suspected as cause:
Lioresal
    Indication: Multiple Sclerosis

Lioresal
    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 2012-05-30

Patient: male

Reactions: Osteonecrosis, Implant Site Erosion, Device Extrusion, Pneumoperitoneum, Drug Withdrawal Syndrome

Adverse event resulted in: 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 2012-05-25

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 female

Reported by a physician from United States on 2012-05-16

Patient: female

Reactions: Nausea, Diarrhoea, Pain, Rhinorrhoea, Drug Withdrawal Syndrome, Abdominal Pain Upper, Device Breakage

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 9 year old female

Reported by a physician from United States on 2012-05-16

Patient: 9 year old female

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

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 2012-05-11

Patient: male

Reactions: Body Temperature Fluctuation, Pruritus, Mass, Underdose, Drug Withdrawal Syndrome, Muscle Spasticity, Muscle Rigidity, Hyperhidrosis, Rebound Effect, Lethargy, Device Breakage, Scar

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 2012-05-11

Patient: female

Reactions: Therapeutic Response Decreased, Pneumonia Aspiration, Hypotension, Drug Withdrawal Syndrome

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 2012-05-10

Patient: female

Reactions: Photosensitivity Reaction, Chills, Muscle Spasticity, Headache, Pyrexia, Fall, CSF Glucose Abnormal, Hyperhidrosis, Musculoskeletal Stiffness, Meningitis, Unevaluable Event, Cold Sweat, CSF Test Abnormal, Decreased Appetite, Muscle Spasms, Drug Effect Decreased, Nausea, Drug Hypersensitivity, CSF Cell Count Increased, Drug Withdrawal Syndrome, Allergy To Chemicals, CSF White Blood Cell Count Increased, Gait Disturbance, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Klonopin; Vancomycin; Copaxone; Amitriptyline HCL; Synthroid; Neurontin; Baclofen; Ceftriaxone Sodium; OAL; Toprol-XL



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-05-09

Patient: male

Reactions: Aphagia, Drug Effect Decreased, Implant Site Erosion, Drug Withdrawal Syndrome, Infection

Drug(s) suspected as cause:
Lioresal
    Dosage: 311.4 mcg/day
    Indication: Brain Injury

Lioresal
    Dosage: 311.4 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 311.4 mcg/day
    Indication: Head Injury



Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-02

Patient: female

Reactions: Device Kink, Pain, Device Inversion, Pyrexia, Drug Withdrawal Syndrome, Device Dislocation, Hyperhidrosis, Convulsion, Irritability, Volvulus, Muscle Spasms, Heart Rate Abnormal, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 493.0 mcg/day
    Indication: Cerebral Palsy

Lioresal
    Dosage: 493.0 mcg/day
    Indication: Muscle Spasticity



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 8 year old male

Reported by a physician from United States on 2012-04-30

Patient: 8 year old male

Reactions: Pruritus, Implant Site Infection, Condition Aggravated, Muscle Spasticity, Drug Withdrawal Syndrome, Device Occlusion, Hyperhidrosis, Therapeutic Response Decreased, Implant Site Reaction, Limb Discomfort, Implant Site Scar, Musculoskeletal Stiffness, Device Connection Issue, Device Malfunction

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 2012-04-27

Patient: male

Reactions: Pain, Urinary Incontinence, Coma, Pyrexia, Somnolence, Muscle Rigidity, Overdose, Device Malfunction, Product Quality Issue, Blood Pressure Increased, Dysphagia, Drug Withdrawal Syndrome, Rash, Dysarthria, Dysstasia, Hallucination, Visual, Mental Disorder, Feeding Disorder, Feeling Drunk, Asthenia

Adverse event resulted in: 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 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 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: 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 23 year old female

Reported by a physician from United States on 2012-04-24

Patient: 23 year old female

Reactions: Pruritus, Implant Site Infection, Muscle Spasticity, Drug Withdrawal Syndrome, Staphylococcus Test Positive

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-20

Patient: female

Reactions: Pain, Drug Withdrawal Syndrome, Tremor, Paraesthesia, Menopause, Abdominal Discomfort, Weight Increased, Fluid Retention

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Hydromorphone HCL; Prialt; Baclofen



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