This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (652)
Death (160)
Life Threatening Events (41)
Disability (3)
Reports by Reaction Type
Muscle Spasticity (125),
Drug Withdrawal Syndrome (82),
Condition Aggravated (71),
Implant Site Infection (61),
Implant Site Effusion (55),
Muscle Spasms (52),
Medical Device Complication (47),
Pain (44),
Device Dislocation (44),
Overdose (44),
Hypertonia (44),
Device Malfunction (43)
Below are a few examples of reports where side effects / adverse reactions may be related to Lioresal (Baclofen Intrathecal). For a complete list or a specific selection of reports, please use the links above.
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 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 2012-08-08
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 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 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 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 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 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 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 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 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 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 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 2012-07-19
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 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 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 2012-07-17
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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