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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 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 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 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 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 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 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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