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Index of reports
> Life Threatening Events (9)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Comtan (Entacapone) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Comtan side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-19
Patient: 53 year old male
Reactions: Blepharospasm, Psychiatric Symptom, Atrioventricular Block Complete
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Alprazolam
Dosage: 0.4 mg, 2 in 1 d
Administration route: Oral
Indication: Anxiety Disorder
Cabergoline
Dosage: 1 mg, 1 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
End date: 2012-06-19
Carbidopa
Dosage: 87.5 mg, 6 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2011-07-20
Comtan
Dosage: 100 mg, 1 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Donepezil HCL
Dosage: 5 mg, 1 in 1 d
Administration route: Oral
Start date: 2011-07-05
End date: 2012-06-21
Donepezil HCL
Dosage: blinded therapy (3mg or placebo) (1 in 1 d)
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2011-06-23
End date: 2011-07-04
Pramipexole Dihydrochloride
Dosage: 1 mg, 2 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Pramipexole Dihydrochloride
Dosage: 0.25 mg, 1 in 1 d
Administration route: Oral
Start date: 2012-01-18
Seroquel
Dosage: 25 mg, 1 in 1 d
Administration route: Oral
Indication: Psychiatric Symptom
Start date: 2012-06-21
End date: 2012-06-23
Symmetrel
Dosage: 50 mg, 4 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
End date: 2012-06-19
Zyprexa
Dosage: 5 mg, 1 in 1 d
Administration route: Oral
Indication: Psychiatric Symptom
Start date: 2012-06-23
Other drugs received by patient: Rinderon-V
Possible Comtan side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-13
Patient: 53 year old male
Reactions: Blepharospasm, Psychiatric Symptom, Atrioventricular Block Complete
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Alprazolam
Dosage: 0.4 mg, 2 in 1 d
Administration route: Oral
Indication: Anxiety Disorder
Cabergoline
Dosage: 1 mg, 1 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
End date: 2012-06-19
Comtan
Dosage: 100 mg, 1 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Donepezil HCL
Dosage: 5 mg, 1 in 1 d
Administration route: Oral
Start date: 2011-07-05
End date: 2012-06-21
Donepezil HCL
Dosage: blinded therapy (3mg or placebo) (1 in 1 d)
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2011-06-23
End date: 2011-07-04
Dopacol
Dosage: 87.5 mg, 6 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2011-07-20
Pramipexole Dihydrochloride
Dosage: 0.25 mg, 1 in 1 d
Administration route: Oral
Start date: 2012-01-18
Pramipexole Dihydrochloride
Dosage: 1 mg, 2 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Seroquel
Dosage: 25 mg, 1 in 1 d
Administration route: Oral
Indication: Psychiatric Symptom
Start date: 2012-06-21
End date: 2012-06-23
Symmetrel
Dosage: 50 mg, 4 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
End date: 2012-06-19
Zyprexa
Dosage: 5 mg, 1 in 1 d
Administration route: Oral
Indication: Psychiatric Symptom
Start date: 2012-06-23
Other drugs received by patient: Rinderon-V
Possible Comtan side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-11
Patient: 53 year old male
Reactions: Blepharospasm, Atrioventricular Block Complete, Psychiatric Symptom
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cabergoline
Dosage: 1 mg, 1 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
End date: 2012-06-19
Comtan
Dosage: 100 mg, 1 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Donepezil HCL
Dosage: blinded therapy (3mg or placebo) (1 in 1 d)
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2011-06-23
End date: 2011-07-04
Donepezil HCL
Dosage: 5 mg, 1 in 1 d
Administration route: Oral
Start date: 2011-07-05
End date: 2012-06-21
Dopacol
Dosage: 87.5 mg, 6 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2011-07-20
Pramipexole Dihydrochloride
Dosage: 0.25 mg, 1 in 1 d
Administration route: Oral
Start date: 2012-01-18
Pramipexole Dihydrochloride
Dosage: 1 mg, 2 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Seroquel
Dosage: 25 mg, 1 in 1 d
Administration route: Oral
Indication: Psychiatric Symptom
Start date: 2012-06-21
End date: 2012-06-23
Symmetrel
Dosage: 50 mg, 4 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
End date: 2012-06-19
Zyprexa
Dosage: 5 mg, 1 in 1 d
Administration route: Oral
Indication: Psychiatric Symptom
Start date: 2012-06-23
Other drugs received by patient: Alprazolam; Rinderon-V
Possible Comtan side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-10
Patient: 53 year old male
Reactions: Blepharospasm, Atrioventricular Block Complete, Psychiatric Symptom
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cabergoline
Dosage: 1 mg, 1 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
End date: 2012-06-19
Carbidopa + Levodopa
Dosage: 87.5 mg, 6 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2011-07-20
Comtan
Dosage: 100 mg, 1 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Donepezil HCL
Dosage: blinded therapy (3mg or placebo) (1 in 1 d)
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2011-06-23
End date: 2011-07-04
Donepezil HCL
Dosage: 5 mg, 1 in 1 d
Administration route: Oral
Start date: 2011-07-05
End date: 2012-06-21
Pramipexole Dihydrochloride
Dosage: 0.25 mg, 1 in 1 d
Administration route: Oral
Start date: 2012-01-18
Pramipexole Dihydrochloride
Dosage: 1 mg, 2 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
Seroquel
Dosage: 25 mg, 1 in 1 d
Administration route: Oral
Indication: Psychiatric Symptom
Start date: 2012-06-21
End date: 2012-06-23
Symmetrel
Dosage: 50 mg, 4 in 1 d
Administration route: Oral
Indication: Parkinson's Disease
End date: 2012-06-19
Zyprexa
Dosage: 5 mg, 1 in 1 d
Administration route: Oral
Indication: Psychiatric Symptom
Start date: 2012-06-23
Other drugs received by patient: Rinderon-V; Alprazolam
Possible Comtan side effects in male
Reported by a physician from United States on 2012-05-17
Patient: male
Reactions: Apparent Death, Intestinal Obstruction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Comtan
Possible Comtan side effects in 70 year old female
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: 70 year old female
Reactions: Haemorrhage, DRY Mouth, Dyskinesia, Abnormal Behaviour, Suicide Attempt
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Comtan
Other drugs received by patient: Sinemet
Possible Comtan side effects in female
Reported by a physician from United States on 2012-04-26
Patient: female
Reactions: Movement Disorder, Haemorrhage, Tongue Disorder, DRY Mouth, Suicide Attempt, Abnormal Behaviour, Feeling Abnormal
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Comtan
Dosage: 5 df, qd
Comtan
Dosage: unk ukn, unk
Other drugs received by patient: Sinemet
Possible Comtan side effects in 77 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2011-10-07
Patient: 77 year old male
Reactions: Wrong Drug Administered, Depressed Level of Consciousness
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Clonazepam
Dosage: start date : july 2011
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Comtan
Dosage: start date : july 2011
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Madopar
Dosage: start date : july 2011
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Quetiapine Fumarate
Dosage: start date : july 2011 , drug name seroquel prolong
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Comtan side effects in 77 year old male
Reported by a pharmacist from Spain on 2011-10-03
Patient: 77 year old male
Reactions: Wrong Drug Administered, Depressed Level of Consciousness, Drug Interaction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Comtan
Other drugs received by patient possibly interacting with the suspect drug:
Clonazepam
Dosage: 5 mg, unk
Administration route: Oral
Start date: 2011-07-01
Madopar
Dosage: 375 mg, unk
Administration route: Oral
Start date: 2011-07-01
Seroquel XR
Dosage: 400 mg, unk
Start date: 2011-07-01
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