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

 
 



Index of reports > Cases with Withdrawal Syndrome (39)

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

 Reports 1 - 30 of 39   Next >>

Possible Lioresal side effects in female

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

Patient: female

Reactions: Tachycardia, Underdose, Withdrawal Syndrome, Vibratory Sense Increased, Hallucination, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 175 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 175 mcg/day
    Indication: Multiple Sclerosis



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 7 year old male

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

Patient: 7 year old male

Reactions: Aphasia, Pain, Implant Site Effusion, Muscle Spasticity, Device Occlusion, Implant Site Fibrosis, Therapy Cessation, Device Connection Issue, Crying, Dystonia, Condition Aggravated, Device Leakage, Therapeutic Response Decreased, Foreign Body Reaction, Implant Site Scar, Withdrawal Syndrome, Device Breakage

Drug(s) suspected as cause:
Lioresal
    Dosage: 1100 mcg/mday
    Indication: Cerebral Palsy

Lioresal
    Dosage: 1100 mcg/mday
    Indication: Muscle Spasticity



Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient: female

Reactions: Headache, Muscle Tightness, Drug Tolerance, Abnormal Behaviour, Neck Injury, Posture Abnormal, Peritonitis, Paraesthesia, Convulsion, Therapeutic Response Decreased, Gastric Volvulus, Withdrawal Syndrome, Feeling Abnormal, Bradyphrenia, Device Breakage, Infection, Infusion Site Mass

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

Lioresal
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-06-19

Patient: male

Reactions: Pruritus, Skin Graft, General Physical Health Deterioration, Muscle Tightness, Treatment Noncompliance, Device Failure, Gait Disturbance, Withdrawal Syndrome, Feeling Abnormal

Adverse event resulted in: hospitalization

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 2012-05-18

Patient: female

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

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

Lioresal
    Indication: Cerebral Palsy



Possible Lioresal side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11

Patient: male

Reactions: Nephrolithiasis, Surgery, Implant Site Erosion, Wound Dehiscence, Implant Site Effusion, Unevaluable Event, Withdrawal Syndrome, Incision Site Blister, Discomfort

Drug(s) suspected as cause:
Lioresal
    Dosage: 1332 mcg/day
    Indication: Cerebral Palsy

Lioresal
    Dosage: 1332 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-05-03

Patient: male

Reactions: Confusional State, Pruritus, Urticaria, Hypotension, Underdose, Muscle Spasticity, Erythema, Flushing, Withdrawal Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 1560 mcg/day, intrath.
    Indication: Muscle Spasticity

Lioresal
    Dosage: 1560 mcg/day, intrath.
    Indication: Spinal Cord Injury



Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-01

Patient: female

Reactions: Confusional State, Pruritus, Disorientation, Balance Disorder, Crying, Vomiting, Aggression, Discomfort, Irritability, Device Failure, Hallucination, Visual, Feeling Jittery, Insomnia, Drug Withdrawal Convulsions, Withdrawal Syndrome, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 1558.9mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 1558.9mcg/day
    Indication: Brain Injury

Lioresal
    Dosage: 1558.9mcg/day
    Indication: Head Injury



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 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 male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18

Patient: male

Reactions: Withdrawal Syndrome

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 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 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 physician from United States on 2012-04-13

Patient: female

Reactions: Photosensitivity Reaction, CSF Protein Abnormal, Pyrexia, Headache, CSF Cell Count Abnormal, CSF Glucose Abnormal, Hyperhidrosis, Malaise, Musculoskeletal Stiffness, Meningitis, Muscle Spasms, Decreased Appetite, Vomiting, Nausea, Therapeutic Response Decreased, Withdrawal Syndrome, Gait Disturbance, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal

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



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 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 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 female

Reported by a physician from United States on 2012-04-12

Patient: female

Reactions: Medical Device Complication, Dystonia, Incorrect Dose Administered, Underdose, Fall, Convulsion, Disease Progression, Device Leakage, Overdose, Malaise, Withdrawal Syndrome, 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 2012-04-12

Patient: male

Reactions: Muscle Atrophy, Device Occlusion, Device Computer Issue, Overdose, Hypoaesthesia Oral, Facial Paresis, Oedema Peripheral, Device Connection Issue, Lymphoedema, Blood Sodium Decreased, Muscle Spasms, Medical Device Complication, Polydipsia, Pain in Extremity, Diplegia, Hypotension, Condition Aggravated, Muscular Weakness, Cerebrovascular Accident, Arthralgia, NO Therapeutic Response, Hypotonia, Depressed Level of Consciousness, Withdrawal Syndrome

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 2012-04-11

Patient: male

Reactions: Implant Site Erosion, Withdrawal Syndrome

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 2012-04-11

Patient: male

Reactions: Medical Device Complication, Overdose, Withdrawal Syndrome, Device Dislocation, Implant Site Swelling, Intracranial Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5
    Indication: Brain Injury

Lioresal
    Dosage: see b5
    Indication: Muscle Spasticity



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 male

Reported by a consumer/non-health professional from United States on 2012-03-30

Patient: male

Reactions: Underdose, Withdrawal Syndrome, Scar

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 100 mcg, daily, intrath
    Indication: Muscle Spasticity

Lioresal
    Dosage: 100 mcg, daily, intrath
    Indication: Spinal Cord Disorder

Lioresal
    Dosage: 100 mcg, daily, intrath
    Indication: Spinal Cord Injury



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-02-28

Patient: male

Reactions: Flushing, Wrong Technique in Drug Usage Process, Dizziness, Withdrawal Syndrome, Implant Site Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 439.6 mcg/day
    Indication: Drug Therapy

Lioresal
    Dosage: 439.6 mcg/day
    Indication: Multiple Sclerosis



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: 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 2012-01-31

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 2012-01-31

Patient: female

Reactions: Malaise, Nasopharyngitis, Withdrawal Syndrome, Device Dislocation, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 236 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 236 mcg/day
    Indication: Cerebrovascular Accident



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