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

 
 



Index of reports > Cases with Somnolence ()

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

Possible Lioresal side effects in 8 year old female

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

Patient: 8 year old female

Reactions: Movement Disorder, Overdose, Vomiting, Somnolence, Influenza Like Illness

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 2012-06-18

Patient: female

Reactions: Agitation, Confusional State, Restlessness, Illusion, Drug Withdrawal Syndrome, Disorientation, Somnolence, Delirium, Delusion, Anxiety, Hallucination, Visual

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: male

Reactions: Coma, Pyrexia, Muscle Rigidity, Somnolence, Speech Disorder, Device Malfunction, Incorrect Dose Administered by Device, Product Quality Issue, Blood Pressure Increased, Dysphagia, Rash, Dysarthria, Dysstasia, Hallucination, Visual, Feeding Disorder, Asthenia, Feeling Drunk

Adverse event resulted in: hospitalization

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

Lioresal
    Dosage: see image
    Indication: Muscle Spasticity

Other drugs received by patient: SEE Image



Possible Lioresal side effects in 12 year old male

Reported by a physician from United States on 2012-05-15

Patient: 12 year old male

Reactions: Back Pain, Mydriasis, Pyrexia, Somnolence, Overdose, Hypopnoea, Hypotonia, Bradycardia, Device Malfunction, Altered State of Consciousness, Lethargy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 92 year old male

Reported by a physician from Spain on 2012-05-02

Patient: 92 year old male

Reactions: Confusional State, Somnolence

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal
    Dosage: unk
    Administration route: Oral
    Indication: Trigeminal Neuralgia
    Start date: 2005-01-01

Neurontin
    Dosage: 600 mg, 3x/day
    Administration route: Oral
    Indication: Trigeminal Neuralgia
    Start date: 2005-01-01

Lorazepam
    Dosage: 2 mg, unk
    Administration route: Oral
    Start date: 2011-12-27

Other drugs received by patient: Metformin



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: male

Reactions: Pain, Urinary Incontinence, Coma, Pyrexia, Somnolence, Muscle Rigidity, Overdose, Device Malfunction, Product Quality Issue, Blood Pressure Increased, Dysphagia, Drug Withdrawal Syndrome, Rash, Dysarthria, Dysstasia, Hallucination, Visual, Mental Disorder, Feeding Disorder, Feeling Drunk, Asthenia

Adverse event resulted in: hospitalization

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 health professional (non-physician/pharmacist) from United States on 2012-04-27

Patient: male

Reactions: Overdose, Mental Status Changes, Gait Disturbance, Disorientation, Somnolence

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 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 male

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

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Pain, Mental Status Changes, Hypernatraemia, Pyrexia, Somnolence, Hypokalaemia, Urinary Retention, Gastrooesophageal Reflux Disease, Lethargy, Hypertonia, Hypotension, Urinary Tract Infection, Convulsion, Tremor, Flushing, Bradycardia

Adverse event resulted in: life threatening event, hospitalization

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 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 female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: female

Reactions: Pruritus, Hypotension, Muscle Spasticity, Drug Withdrawal Syndrome, Device Occlusion, Somnolence, Device Dislocation, Implant Site Swelling, Therapeutic Response Decreased, Multiple Drug Overdose, Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 92 year old male

Reported by a physician from Spain on 2012-04-13

Patient: 92 year old male

Reactions: Confusional State, Somnolence

Adverse event resulted in: death

Drug(s) suspected as cause:
Neurontin
    Dosage: 600 mg, 3x/day
    Administration route: Oral
    Indication: Trigeminal Neuralgia
    Start date: 2005-01-01

Lioresal
    Dosage: unk
    Administration route: Oral
    Indication: Trigeminal Neuralgia
    Start date: 2005-01-01

Lorazepam
    Dosage: 2 mg, unk
    Administration route: Oral
    Start date: 2011-12-27

Other drugs received by patient: Metformin



Possible Lioresal side effects in 92 year old male

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

Patient: 92 year old male

Reactions: Confusional State, Death, Somnolence

Adverse event resulted in: death

Drug(s) suspected as cause:
Lioresal
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Trigeminal Neuralgia
    Start date: 2005-01-01

Lorazepam
    Dosage: 2 mg, unk
    Administration route: Oral
    Start date: 2011-12-27

Gabapentin

Other drugs received by patient: Metformin HCL



Possible Lioresal side effects in 12 year old male

Reported by a physician from United States on 2012-04-11

Patient: 12 year old male

Reactions: Back Pain, Mydriasis, Overdose, Hypopnoea, Hypotonia, Bradycardia, Pyrexia, Somnolence, Lethargy

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 2012-04-03

Patient: female

Reactions: Decreased Activity, Dyskinesia, Muscle Spasticity, Somnolence, Tremor, Respiratory Rate Decreased, Overdose, Hypokinesia, Hypopnoea, Dizziness, Staring, Spinal Deformity, Muscle Spasms, Lethargy

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: SEE Image



Possible Lioresal side effects in 10 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-27

Patient: 10 year old male

Reactions: Fall, Somnolence, Muscle Tightness, Respiratory Rate Decreased, Overdose, Eye Movement Disorder, Lethargy, Hypersomnia

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 2012-01-27

Patient: male

Reactions: Pain, Aphasia, Urinary Incontinence, Coma, Pyrexia, Muscle Rigidity, Somnolence, Cardiac Disorder, Overdose, Eye Movement Disorder, Device Malfunction, Product Quality Issue, Dysphagia, General Physical Health Deterioration, Drug Withdrawal Syndrome, Rash, Dysarthria, Dysstasia, Hallucination, Visual, Activities of Daily Living Impaired, Mental Disorder, Hypertension, Asthenia, Blood Pressure Fluctuation, Feeling Drunk

Adverse event resulted in: hospitalization

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

Lioresal
    Dosage: see b5
    Indication: Cerebral Palsy



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-19

Patient: male

Reactions: Pain, Urinary Incontinence, Aphasia, Coma, Pyrexia, Muscle Rigidity, Somnolence, Cardiac Disorder, Overdose, Eye Movement Disorder, Device Malfunction, Incorrect Dose Administered by Device, Product Quality Issue, Dysphagia, General Physical Health Deterioration, Rash, Drug Withdrawal Syndrome, Dysarthria, Dysstasia, Activities of Daily Living Impaired, Hallucination, Visual, Mental Disorder, Hypertension, Asthenia, Feeling Drunk

Adverse event resulted in: hospitalization

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

Lioresal
    Dosage: see b5
    Indication: Cerebral Palsy



Possible Lioresal side effects in 5 year old female

Reported by a physician from Japan on 2012-01-05

Patient: 5 year old female, weighing 9.7 kg (21.3 pounds)

Reactions: Apnoea, Somnolence

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dantrium
    Dosage: daily dose: 3 mg
    Administration route: Oral
    Start date: 2008-06-01

Mystan
    Administration route: Oral
    Start date: 2009-04-20

Keppra
    Dosage: daily dose: 550 mg
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-01-01

Keppra
    Administration route: Oral
    Start date: 2011-05-23
    End date: 2011-06-05

Keppra
    Dosage: daily dose: 450 mg
    Administration route: Oral
    Start date: 2011-11-26
    End date: 2011-01-01

Phenobarbital TAB
    Dosage: daily dose: 100 mg
    Administration route: Oral
    Start date: 2008-05-01

Lioresal
    Dosage: daily dose: 6 mg
    Administration route: Oral
    Start date: 2010-10-01

Keppra
    Administration route: Oral
    Start date: 2011-10-24
    End date: 2011-11-25

Keppra
    Administration route: Oral
    Start date: 2011-05-09
    End date: 2011-05-22

Lexotan
    Administration route: Oral
    Start date: 2009-08-19

Keppra
    Administration route: Oral
    Start date: 2011-06-06
    End date: 2011-10-23

Haloperidol
    Dosage: 0.5 mg
    Administration route: Oral
    Start date: 2008-08-01

Other drugs received by patient: Alinamin-F; Gasmotin; Artane; Mucodyne; Lansoprazole; Neuquinon; Mucosolvan DS FOR Pediatric; Promacta



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 5 year old female

Reported by a physician from Japan on 2011-12-13

Patient: 5 year old female, weighing 9.7 kg (21.3 pounds)

Reactions: Apnoea, Somnolence

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Keppra
    Administration route: Oral

Dantrium
    Administration route: Oral

Keppra
    Administration route: Oral
    Start date: 2011-11-01
    End date: 2011-11-01

Lioresal

Mystan
    Administration route: Oral

Lexotan
    Administration route: Oral

Keppra
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-12-01

Phenobarbital TAB
    Administration route: Oral

Haloperidol
    Dosage: 0.5 mg
    Administration route: Oral



Possible Lioresal side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-12

Patient: 57 year old male

Reactions: Hypothermia, International Normalised Ratio Increased, General Physical Health Deterioration, Somnolence, Haemodynamic Instability, Sepsis, Respiratory Arrest, Salivary Hypersecretion, Bradycardia, Cardiac Arrest

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 10 milligram(s), 3 in 1 d, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-06

Zyprexa
    Dosage: 10 mg milligram(s), 1 in 1 d, oral
    Administration route: Oral
    Indication: Schizophrenia
    End date: 2011-01-06

Onfi (Clobazam) (Clobazam) (10 MG. Tablet)
    Dosage: 10 mg milligram(s), 2 in 1 d, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-06

Fluvoxamine Maleate
    Dosage: 1 df dosage form, 1 in 1 d, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-06

Other drugs received by patient: Clonazepam; Lamotrigine; Pentoxifylline



Possible Lioresal side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-14

Patient: 57 year old male

Reactions: Hypothermia, International Normalised Ratio Increased, General Physical Health Deterioration, Somnolence, Nosocomial Infection, Sepsis, Respiratory Arrest, Multiple Drug Overdose, Salivary Hypersecretion, Bradycardia, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 10 mg milligram(s), 3 in 1 d, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-06

Onfi
    Dosage: 10 mg milligram(s), 2 in 1 day, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-06

Fluvoxamine Maleate
    Dosage: 1 df dosage form, 1 in 1 d, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-06

Zyprexa
    Dosage: 10 mg milligram(s), 1 in 1 d, oral
    Administration route: Oral
    Indication: Schizophrenia
    End date: 2011-01-06

Other drugs received by patient: Clonazepam; Pentoxifylline; Lamotrigine



Possible Lioresal side effects in 12 year old male

Reported by a physician from United States on 2011-10-27

Patient: 12 year old male

Reactions: Back Pain, Mydriasis, Device Damage, Pyrexia, Somnolence, Device Leakage, Overdose, Hypopnoea, Hypotonia, Bradycardia, Incorrect Dose Administered by Device, Device Battery Issue, Lethargy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 407.8 mcg, daily, intra
    Indication: Cerebral Palsy

Lioresal
    Dosage: 407.8 mcg, daily, intra
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a physician from United States on 2011-10-12

Patient: male

Reactions: Overdose, Bradycardia, Somnolence, Lethargy, Hypokalaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-04

Patient: male

Reactions: Mental Status Changes, Disorientation, Somnolence, Overdose, Heart Rate Decreased, Hallucination, Visual, Depressed Level of Consciousness, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal

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