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Lioresal (Baclofen Intrathecal) - Nausea - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Nausea ()

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

Possible Lioresal side effects in female

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

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Nausea, Activities of Daily Living Impaired, Abasia, Asthenia, Wound Secretion, 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 2012-05-16

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 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 46 year old male

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

Patient: 46 year old male

Reactions: Cellulitis, Body Temperature Increased, Nausea, Headache, Device Related Infection, Soft Tissue Infection, Renal Failure, Post Lumbar Puncture Syndrome, Acute Sinusitis, Chronic Sinusitis, Musculoskeletal Stiffness, Meningitis, Intracranial Hypotension

Adverse event resulted in: hospitalization

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

Lioresal
    Indication: Spinal Cord Disorder

Lioresal
    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 male

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: male

Reactions: Pruritus, Nausea, Clonus, Pain, Headache, Hyperhidrosis, Rash Macular, Device Leakage, Social Avoidant Behaviour, Injury, Hypertonia

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 38 year old female

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

Patient: 38 year old female

Reactions: Movement Disorder, Unresponsive To Stimuli, Abasia, Headache, Muscle Spasticity, Somnolence, Speech Disorder, Incontinence, Overdose, Musculoskeletal Stiffness, Device Connection Issue, Nausea, Hypotension, Muscular Weakness, Toxicity To Various Agents, Dysarthria, Hypotonia, Depressed Level of Consciousness, Asthenia

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-23

Patient: female

Reactions: Product Quality Issue, Dyspnoea, Nausea, Sensation of Heaviness, Headache, Hypoaesthesia, Somnolence, Paraesthesia, Diplopia, Device Computer Issue, Hypoaesthesia Oral, Overdose, Device Infusion Issue, Swelling, Somnambulism, Feeling Abnormal

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-18

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 2012-04-13

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 female

Reported by a consumer/non-health professional from United States on 2012-04-09

Patient: female

Reactions: Agitation, Vomiting, Drug Effect Decreased, Nausea, Restlessness, Condition Aggravated, Muscle Spasticity, Headache, Herpes Zoster, Insomnia, Dizziness, Product Odour Abnormal

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Prialt; Dialudid



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-03-28

Patient: female

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

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: SEE Image



Possible Lioresal side effects in 46 year old male

Reported by a physician from United States on 2012-02-10

Patient: 46 year old male

Reactions: Cellulitis, Nausea, Body Temperature Increased, Post Procedural Complication, Headache, Device Related Infection, Soft Tissue Infection, Renal Failure, Acute Sinusitis, Chronic Sinusitis, Musculoskeletal Stiffness, Meningitis, Intracranial Hypotension

Adverse event resulted in: hospitalization

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

Lioresal
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-02-09

Patient: male

Reactions: Pruritus, Nausea, Clonus, Pain, Device Damage, Drug Withdrawal Syndrome, Headache, Hyperhidrosis, Rash Macular, Hypertonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 300 - 370 mcg, daily
    Indication: Muscle Spasticity

Lioresal
    Dosage: 300 - 370 mcg, daily
    Indication: Brain Injury

Lioresal
    Dosage: 300 - 370 mcg, daily
    Indication: Head Injury



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 16 year old male

Reported by a physician from United States on 2012-01-13

Patient: 16 year old male

Reactions: Pruritus, Device Occlusion, Postoperative Wound Infection, Device Connection Issue, Hypertonia, Muscle Spasms, Vomiting, Wound Dehiscence, Nausea, Clonus, Device Damage, Drug Withdrawal Syndrome, Secretion Discharge, Tremor, Incision Site Complication, Central Nervous System Infection, Insomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 38 year old female

Reported by a physician from United States on 2011-12-19

Patient: 38 year old female

Reactions: Abasia, Unresponsive To Stimuli, Muscle Spasticity, Headache, Somnolence, Speech Disorder, Incontinence, Overdose, Musculoskeletal Stiffness, Device Connection Issue, Nausea, Hypotension, Muscular Weakness, Condition Aggravated, Toxicity To Various Agents, Dysarthria, Hypotonia, Depressed Level of Consciousness, Asthenia, Immobile

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 2011-11-09

Patient: male

Reactions: Agitation, Vomiting, Dyspnoea, Pneumonia, Nausea, Grimacing, Clonus, Moaning, Drug Withdrawal Syndrome, Muscle Twitching, Device Occlusion, Convulsion, Sepsis, Shunt Malfunction, Musculoskeletal Stiffness, Hypertonia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5 mcg, dailu, intr
    Indication: Muscle Spasticity

Lioresal
    Dosage: see b5 mcg, dailu, intr
    Indication: Cerebral Palsy



Possible Lioresal side effects in female

Reported by a physician from Israel on 2011-10-25

Patient: female, weighing 46.7 kg (102.7 pounds)

Reactions: Urinary Incontinence, Unresponsive To Stimuli, Dysmetropsia, Headache, Loss of Consciousness, Disinhibition, Cyanosis, Tongue Biting, Hemianopia Homonymous, Pyramidal Tract Syndrome, Ataxia, Joint Injury, Convulsion, Irritability, Dysphonia, Disturbance in Attention, Peripheral Coldness, Paresis, Metamorphopsia, Abasia, Aphasia, Central Nervous System Lesion, Tonic Clonic Movements, Disorientation, Muscle Spasticity, Constipation, Colour Blindness, Gamma-Glutamyltransferase Increased, Brain Oedema, Executive Dysfunction, Nausea, Muscular Weakness, Cerebral Atrophy, Status Epilepticus, Cerebellar Syndrome, Dysarthria, Visual Impairment, Gait Disturbance, Memory Impairment, Depressed Mood, Hypertension, Asthenia, Vasospasm

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Gilenya
    Dosage: 0.5mg
    Administration route: Oral
    Start date: 2010-03-09
    End date: 2010-10-26

Escitalopram
    Dosage: unk
    Indication: Anxiety
    Start date: 2009-06-26
    End date: 2010-10-25

Gilenya
    Dosage: dose blinded
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2009-06-30
    End date: 2010-03-08

Lioresal
    Dosage: unk
    Administration route: Oral
    Start date: 2009-01-20
    End date: 2010-10-26

Other drugs received by patient: Escitalopram; Modafinil; Ferrous Sulfate TAB



Possible Lioresal side effects in female

Reported by a physician from Israel on 2011-10-25

Patient: female, weighing 46.7 kg (102.7 pounds)

Reactions: Urinary Incontinence, Unresponsive To Stimuli, Dysmetropsia, Headache, Loss of Consciousness, Disinhibition, Cyanosis, Tongue Biting, Hemianopia Homonymous, Pyramidal Tract Syndrome, Ataxia, Joint Injury, Convulsion, Irritability, Dysphonia, Disturbance in Attention, Peripheral Coldness, Paresis, Metamorphopsia, Central Nervous System Lesion, Abasia, Aphasia, Tonic Clonic Movements, Disorientation, Muscle Spasticity, Constipation, Colour Blindness, Gamma-Glutamyltransferase Increased, Brain Oedema, Executive Dysfunction, Nausea, Muscular Weakness, Cerebral Atrophy, Status Epilepticus, Cerebellar Syndrome, Dysarthria, Visual Impairment, Memory Impairment, Gait Disturbance, Asthenia, Hypertension, Depressed Mood, Vasospasm

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Gilenya
    Dosage: dose blinded
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2009-06-30
    End date: 2010-03-08

Gilenya
    Dosage: 0.5mg
    Administration route: Oral
    Start date: 2010-03-09
    End date: 2010-10-26

Escitalopram
    Dosage: unk
    Indication: Anxiety
    Start date: 2009-06-26
    End date: 2010-10-25

Lioresal
    Dosage: unk
    Administration route: Oral
    Start date: 2009-01-20
    End date: 2010-10-26

Other drugs received by patient: Ferrous Sulfate TAB; Escitalopram; Modafinil



Possible Lioresal side effects in female

Reported by a physician from United States on 2011-10-03

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Implant Site Discharge, Nausea, Abasia, Condition Aggravated, Muscle Spasticity, Activities of Daily Living Impaired, Asthenia, Open Wound, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Copaxane; Prozac; Ambien; Multi-Vitamin; Bactroban; Viactive; Ditropan XL; Baclofen; Motrin; Macrodantin; Percocet; Cimara; Zanaflex; Tetracycline; Dyazide

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