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Lioresal (Baclofen Intrathecal) - Condition Aggravated - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Condition Aggravated (71)

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

 Reports 1 - 30 of 71   Next >>

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 2012-07-31

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 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 2012-07-17

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 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 physician from United States on 2012-06-29

Patient: female

Reactions: Foot Deformity, Implant Site Infection, Condition Aggravated, Muscle Spasticity, Abdominal Pain Upper, Hand Deformity, Balance Disorder, Device Connection Issue, Incorrect Dose Administered by Device, Device Breakage

Drug(s) suspected as cause:
Lioresal
    Dosage: 360.2 mcg/day
    Indication: Spinal Cord Disorder

Lioresal
    Dosage: 360.2 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 360.2 mcg/day
    Indication: Spinal Cord Injury



Possible Lioresal side effects in male

Reported by a physician from Spain on 2012-06-27

Patient: male

Reactions: Medical Device Complication, Multi-Organ Failure, Condition Aggravated, Muscle Spasticity, Apallic Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a physician from Canada on 2012-06-26

Patient: male

Reactions: Drug Ineffective, Body Temperature Increased, Muscle Spasticity, Overdose, Dialysis, Self-Medication, Hypersomnia, Medical Device Complication, Condition Aggravated, Autonomic Dysreflexia, Convulsion, Renal Failure, Abdominal Rigidity, Consciousness Fluctuating, Hypotonia, Insomnia, Hypertension, Device Breakage

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 2012-06-19

Patient: male

Reactions: Performance Status Decreased, Drug Ineffective, Urinary Tract Infection, Underdose, Condition Aggravated, Muscle Spasticity, Neuromyelitis Optica, Musculoskeletal Stiffness

Drug(s) suspected as cause:
Lioresal
    Dosage: 777 mcg, daily, intrathecal
    Indication: Muscle Spasticity

Lioresal
    Dosage: 777 mcg, daily, intrathecal
    Indication: Multiple Sclerosis



Possible Lioresal side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-19

Patient: male

Reactions: Performance Status Decreased, Hypersensitivity, Intervertebral Discitis, Abasia, Urinary Tract Infection, Condition Aggravated, Enterococcus Test Positive, Muscle Spasticity, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Alcohol Abuse, Condition Aggravated, Muscle Spasticity, Fall, Implant Site Reaction, Aspiration, Device Breakage, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 999.7 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 999.7 mcg/day
    Indication: Stiff Person Syndrome



Possible Lioresal side effects in 78 year old male

Reported by a physician from United States on 2012-06-18

Patient: 78 year old male

Reactions: Condition Aggravated, Intracranial Aneurysm, Headache, Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in

Reported by a physician from Denmark on 2012-06-15

Patient:

Reactions: Underdose, Condition Aggravated, Muscle Spasticity, Device Leakage, Multi-Organ Failure, Overdose, Respiratory Failure, Device Connection Issue, Intracranial Hypotension

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-14

Patient: 47 year old female

Reactions: Migraine, Malaise, Anaemia, Condition Aggravated, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 4 g total daily
    Indication: Migraine
    Start date: 2008-11-02
    End date: 2008-11-04

Acupan
    Dosage: 120 mg total daily
    Indication: Migraine
    Start date: 2008-11-02
    End date: 2008-11-04

Effexor XR
    Dosage: 225 mg total daily
    Administration route: Oral
    Indication: Depression

Indoramin
    Dosage: 2 tablets total daily
    Administration route: Oral
    Indication: Migraine
    Start date: 2008-10-15
    End date: 2008-11-04

Ketoprofen
    Dosage: 100 mg, 3x/day
    Indication: Migraine
    Start date: 2008-11-02
    End date: 2008-11-04

Lioresal
    Dosage: 5 mg, 3x/day
    Administration route: Oral
    Indication: Migraine
    Start date: 2008-10-25
    End date: 2008-11-04

Propranolol
    Dosage: 40 mg, 2x/day
    Administration route: Oral
    Start date: 2008-10-15
    End date: 2008-11-04

Other drugs received by patient: Trimeprazine Tartrate; Tercian



Possible Lioresal side effects in 62 year old female

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

Patient: 62 year old female

Reactions: Condition Aggravated

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Dilaudid; Clonidine; Bupivicaine



Possible Lioresal side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: female

Reactions: Malaise, Decubitus Ulcer, Streptococcus Test Positive, Condition Aggravated, Muscle Spasticity, Discomfort, Muscle Spasms, Infection

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-05

Patient: female

Reactions: Cirrhosis Alcoholic, Hepatic Encephalopathy, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aldactone
    Dosage: 4 tablets total daily, then dose was increased to 150mg 3x per day from unknown date to 25-feb-2009
    Administration route: Oral

Effexor XR
    Dosage: 75 mg 3times per day from an unknown date to an unknown date in 2009;then the dose was decreased
    Administration route: Oral
    Indication: Depression

Ethanol
    Dosage: } 2 l of wine per day with additional aperitives
    Administration route: Oral

Lioresal
    Dosage: 30 mg, 3x/day
    Administration route: Oral
    Indication: Muscle Contracture
    End date: 2009-02-25



Possible Lioresal side effects in 53 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-23

Patient: 53 year old female

Reactions: Cirrhosis Alcoholic, Hepatic Encephalopathy, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aldactone
    Dosage: 150 mg, 3x/day
    Administration route: Oral
    Indication: Ascites

Aldactone
    Dosage: 6 tablets day
    End date: 2009-02-25

Effexor XR
    Dosage: 75 mg, 3x/day
    Administration route: Oral
    Indication: Depression

Ethanol
    Dosage: wine 2 liters/day in addition to pre-dinner drinks
    Administration route: Oral

Lioresal
    Dosage: 30 mg, 3x/day
    Administration route: Oral
    Indication: Muscle Contracture
    End date: 2009-02-25



Possible Lioresal side effects in 53 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-22

Patient: 53 year old female

Reactions: Cirrhosis Alcoholic, Hepatic Encephalopathy, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aldactone
    Dosage: 4 tablets total daily, then dose was increased to 150mg 3x per day from unknown date to 25-feb-2009
    Administration route: Oral

Effexor XR
    Dosage: 75 mg 3times per day from an unknown date to an unknown date in 2009;then the dose was decreased
    Administration route: Oral
    Indication: Depression

Ethanol
    Dosage: } 2 l of wine per day with additional aperitives
    Administration route: Oral

Lioresal
    Dosage: 30 mg, 3x/day
    Administration route: Oral
    Indication: Muscle Contracture
    End date: 2009-02-25



Possible Lioresal side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: female

Reactions: Device Kink, Pain, Condition Aggravated, Muscle Spasticity, Device Malfunction, Device Dislocation, Disease Progression

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5 mcg, daily, intr
    Indication: Multiple Sclerosis

Lioresal
    Dosage: see b5 mcg, daily, intr
    Indication: Muscle Spasticity



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 36 year old female

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

Patient: 36 year old female

Reactions: PRE-Existing Disease, Condition Aggravated

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal
    Dosage: 600.8 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 600.8 mcg/day
    Indication: Multiple Sclerosis



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 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 male

Reported by a physician from United States on 2012-04-16

Patient: male

Reactions: Pain, NO Therapeutic Response, Condition Aggravated

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Ketamine HCL; Tetracaine Polygyl Sterile Ophthalmic Solution; Hydromorphone HCL; Clonidine



Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-13

Patient: female

Reactions: Back Pain, Unresponsive To Stimuli, Post Procedural Complication, Implant Site Effusion, Condition Aggravated, Headache, Device Failure, Respiratory Failure, Nuclear Magnetic Resonance Imaging Abnormal, Scar

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 55 year old female

Reported by a physician from United States on 2012-04-13

Patient: 55 year old female

Reactions: Implant Site Infection, Coma, Condition Aggravated, Muscle Spasticity, Device Occlusion

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 female

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: female

Reactions: Device Leakage, Weight Decreased, Drug Effect Decreased, Device Extrusion, Condition Aggravated, Muscle Spasticity, Mood Swings, Device Dislocation

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

Lioresal
    Indication: Multiple Sclerosis



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