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Lioresal (Baclofen Intrathecal) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (652)

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

 Reports 1 - 30 of 652   Next >>

Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: female

Reactions: Sepsis, Device Related Infection, Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Dilaudid; Droperidol; Bupivacaine HCL



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male

Reactions: Condition Aggravated, Muscle Spasticity, Fall, Device Failure, Fatigue, Insomnia, Intracranial Hypotension, Muscle Spasms

Adverse event resulted in: hospitalization

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

Lioresal
    Dosage: see b5
    Indication: Post Laminectomy Syndrome



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: male

Reactions: Implant Site Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 700 mcg/day
    Indication: Cerebral Palsy

Lioresal
    Dosage: 700 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: male

Reactions: Implant Site Erythema, RED Blood Cell Sedimentation Rate Increased, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 700 mcgiday
    Indication: Muscle Spasticity

Lioresal
    Dosage: 700 mcgiday
    Indication: Cerebral Palsy



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-07

Patient: male

Reactions: Renal Disorder, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exelon
    Dosage: 4.5 mg, two times daily
    Indication: Dementia Alzheimer's Type

Exelon
    Indication: Head Discomfort

Lioresal
    Dosage: 1 df, daily
    Indication: Bone Marrow Disorder



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 male

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

Patient: male

Reactions: Medical Device Change, Implant Site Infection, Implant Site Erythema, Device Malfunction

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 57 year old male

Reported by a physician from Germany on 2012-08-03

Patient: 57 year old male, weighing 82.0 kg (180.4 pounds)

Reactions: Device Leakage, Medical Device Complication, Psychotic Disorder, Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 14 year old male

Reported by a physician from United States on 2012-08-02

Patient: 14 year old male

Reactions: Pseudomonas Test Positive, Implant Site Discharge, Implant Site Infection, Wound Infection, Klebsiella Test Positive, Intracranial Hypotension

Adverse event resulted in: hospitalization

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 2012-08-01

Patient: male

Reactions: Therapeutic Response Decreased, Pruritus, Device Kink, Device Power Source Issue, Muscle Spasticity, Hypertension, Muscle Spasms

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

Lioresal
    Indication: Spinal Cord Injury

Lioresal
    Indication: Spinal Cord Disorder



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-08-01

Patient: male, weighing 86.2 kg (189.6 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-08-01

Patient: male

Reactions: Medical Device Complication, Intracranial Hypotension, Implant Site Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 800 mcg/day
    Indication: Spinal Cord Injury

Lioresal
    Dosage: 800 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: female

Reactions: Malaise, Hypotonia, Wound Sepsis, Muscle Spasms, Infected Skin Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 96 mcg/day/intrathecal
    Indication: Muscle Spasticity

Lioresal
    Dosage: 96 mcg/day/intrathecal
    Indication: Cerebral Palsy



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-08-01

Patient: female

Reactions: Stevens-Johnson Syndrome, Infection

Adverse event resulted in: hospitalization

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

Lioresal
    Indication: Multiple Sclerosis



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 consumer/non-health professional from United States on 2012-07-31

Patient: male

Reactions: Therapeutic Response Decreased, Pruritus, Device Kink, Device Power Source Issue, Condition Aggravated, Muscle Spasticity, Hypertension, Muscle Spasms

Drug(s) suspected as cause:
Lioresal
    Indication: Spinal Cord Disorder

Lioresal
    Indication: Muscle Spasticity

Lioresal
    Indication: Spinal Cord Injury



Possible Lioresal side effects in 27 year old male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 27 year old male

Reactions: Tinnitus, Wound Dehiscence, Drug Hypersensitivity, Implant Site Infection, Muscle Spasticity, Wound Infection Staphylococcal, Device Failure, Renal Failure, Device Deployment Issue, Meningitis, Device Connection Issue

Drug(s) suspected as cause:
Lioresal
    Indication: Head Injury

Lioresal
    Indication: Brain Injury

Lioresal
    Indication: Cerebral Palsy



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 male

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

Patient: male

Reactions: Staphylococcal Infection, Implant Site Infection

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male

Reactions: NO Therapeutic Response, Device Occlusion, Muscle Spasms

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

Lioresal
    Indication: Cerebral Palsy



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 27 year old male

Reported by a physician from United States on 2012-07-23

Patient: 27 year old male

Reactions: Tinnitus, Drug Hypersensitivity, Implant Site Infection, Device Related Infection, Renal Failure, Staphylococcal Infection, NO Therapeutic Response, Meningitis

Adverse event resulted in: hospitalization

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

Lioresal
    Indication: Cerebral Palsy

Lioresal
    Indication: Head Injury



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-07-23

Patient: male

Reactions: Cerebrovascular Accident

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 938.7 mcg/day
    Indication: Head Injury

Lioresal
    Dosage: 938.7 mcg/day
    Indication: Brain Injury

Lioresal
    Dosage: 938.7 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-07-19

Patient: male

Reactions: Implant Site Discharge, Implant Site Erythema, Implant Site Swelling

Drug(s) suspected as cause:
Lioresal



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 14 year old female

Reported by a physician from United States on 2012-07-18

Patient: 14 year old female

Reactions: Convulsive Threshold Lowered

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal
    Dosage: 105.0 mcg/ay
    Indication: Brain Injury

Lioresal
    Dosage: 105.0 mcg/ay
    Indication: Muscle Spasticity



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-07-18

Patient: female

Reactions: Drug Ineffective, Implant Site Effusion, Twiddler's Syndrome, Device Breakage

Drug(s) suspected as cause:
Lioresal



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 2012-07-17

Patient: female

Reactions: Post Procedural Complication, Device Issue, Condition Aggravated, Muscle Spasticity, Fall, Treatment Noncompliance, Incision Site Complication, Swelling, Muscle Spasms, Device Breakage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 999.7 mcg/day
    Indication: Stiff Person Syndrome

Lioresal
    Dosage: 999.7 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

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

Patient: male

Reactions: Implant Site Infection, Implant Site Erythema

Drug(s) suspected as cause:
Lioresal



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