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Index of reports
> Cases with Coma ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) where reactions include coma. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Lioresal side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-19
Patient: 54 year old male
Reactions: Overdose, Coma, Convulsion
Adverse event resulted in: death
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 65 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15
Patient: 65 year old male
Reactions: Bedridden, Drug Ineffective, Sedation, Coma, Feeling Abnormal
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-06-07
Patient: female
Reactions: Rhabdomyolysis, Dystonia, Coma, Device Damage, Drug Withdrawal Syndrome, Muscle Spasticity, Device Leakage, Overdose, Device Connection Issue, Device Malfunction
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 2012-05-18
Patient: female
Reactions: Rhabdomyolysis, Dystonia, Coma, Device Damage, Muscle Spasticity, Device Leakage, Overdose, Device Connection Issue, Withdrawal Syndrome, Device Malfunction
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Cerebral Palsy
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 female
Reported by a physician from United States on 2012-04-19
Patient: female
Reactions: Thrombosis, Tongue Discolouration, Glossodynia, Pain, Coma, Headache, Device Dislocation, Device Malfunction, Medical Device Complication, Product Quality Issue, Pain in Extremity, Neuroma, Medical Device Pain, Ileus Paralytic, Burning Sensation, Device Leakage, Syncope, Arthritis Infective, Vision Blurred, Infection, Infected Skin Ulcer
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Bupivicaine; Morphine Sulfate
Possible Lioresal side effects in male
Reported by a physician from Italy on 2012-04-16
Patient: male
Reactions: Device Material Issue, Body Temperature Increased, Clonus, Coma, Overdose, Device Connection Issue, Meningitis, Muscle Spasms
Adverse event resulted in: death, hospitalization
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 73 year old male
Reported by a physician from United States on 2012-04-11
Patient: 73 year old male
Reactions: Confusional State, Overdose, Coma, Headache, Device Connection Issue, Delirium, Lethargy, Implant Site Swelling
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-01-31
Patient: male
Reactions: Drug Dose Omission, Pneumonia, Coma, Pyrexia, Withdrawal Syndrome, Muscle Rigidity, Convulsion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1100 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 1100 mcg/day
Indication: Multiple Sclerosis
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 male
Reported by a consumer/non-health professional from Switzerland on 2011-12-21
Patient: male
Reactions: General Physical Health Deterioration, Coma, Drug Administration Error
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Ritalin
Possible Lioresal side effects in 65 year old male
Reported by a consumer/non-health professional from United States on 2011-10-25
Patient: 65 year old male
Reactions: Brain Death, Device Ineffective, Coma
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-13
Patient: male
Reactions: Bedridden, Brain Death, Sedation, Coma, Feeling Abnormal
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in female
Reported by a physician from United States on 2011-10-05
Patient: female
Reactions: Implant Site Discharge, Coma, Implant Site Effusion, Condition Aggravated, Implant Site Infection, Muscle Spasticity, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 73 year old male
Reported by a physician from United States on 2011-10-04
Patient: 73 year old male
Reactions: Confusional State, Pump Reservoir Issue, Device Ineffective, Implant Site Effusion, Coma, Headache, Delirium, Device Computer Issue, Overdose, Device Power Source Issue, Device Connection Issue, Intracranial Hypotension, Lethargy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
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