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Comtan (Entacapone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Comtan (Entacapone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (66)
Death (12)
Life Threatening Events (9)

Reports by Reaction Type

Dysphagia (8)Pain in Extremity (8)Blood Creatine Phosphokinase Increased (6)Parkinson's Disease (6)Abnormal Behaviour (6)Dyskinesia (5)Muscle Spasms (5)Chromaturia (5)Akinesia (5)Tremor (5)Suicide Attempt (5)Altered State of Consciousness (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Comtan (Entacapone). For a complete list or a specific selection of reports, please use the links above.

Possible Comtan side effects in 70 year old female

Reported by a physician from Japan on 2012-08-27

Patient: 70 year old female, weighing 53.5 kg (117.7 pounds)

Reactions: Coronary Artery Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded Therapy
    Dosage: double blind (5mg or placebo) (1 in 1 d)
    Administration route: Oral
    Start date: 2011-10-20

Blinded Therapy
    Dosage: double blind (3mg or placebo) (1 in 1 d)
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-10-12
    End date: 2011-10-19

Brotizolam
    Dosage: 0.25 mg, 1x/day
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-04-14

Cabergoline
    Dosage: 0.5 mg, 1x/day
    Administration route: Oral
    Indication: Parkinson's Disease

Carbidopa
    Dosage: unk
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2007-07-10

Clonazepam
    Dosage: 1 mg, 1x/day
    Administration route: Oral
    Indication: Insomnia
    Start date: 2007-01-01

Comtan
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2009-06-15

Famotidine
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-05-06

Flurbiprofen
    Dosage: unk
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2008-06-19

Gasmotin
    Dosage: 5 mg, 2x/day
    Administration route: Oral
    Indication: Prophylaxis

Magmitt
    Dosage: 1650 mg, 3x/day
    Administration route: Oral
    Indication: Constipation
    Start date: 2007-01-01

Symmetrel
    Dosage: 50 mg, 2x/day
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2009-12-21

Tizanidine Hydrochloride
    Dosage: 1 mg, 3x/day
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2007-12-20

Other drugs received by patient: Digoxin



Possible Comtan side effects in 70 year old female

Reported by a physician from Japan on 2012-08-15

Patient: 70 year old female, weighing 53.5 kg (117.7 pounds)

Reactions: Coronary Artery Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded Therapy
    Dosage: blinded therapy
    Administration route: Oral
    Start date: 2011-10-20

Blinded Therapy
    Dosage: blinded therapy
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-10-12
    End date: 2011-10-19

Brotizolam
    Dosage: 0.25 mg, 1x/day
    Administration route: Oral
    Start date: 2011-04-14

Cabergoline
    Dosage: 0.5 mg, 1x/day
    Administration route: Oral

Carbidopa
    Dosage: unk
    Administration route: Oral
    Start date: 2007-07-10

Clonazepam
    Dosage: 1 mg, 1x/day
    Administration route: Oral
    Start date: 2007-01-01

Comtan
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2009-06-15

Famotidine
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Start date: 2011-05-06

Flurbiprofen
    Dosage: unk
    Administration route: Oral
    Start date: 2008-06-19

Gasmotin
    Dosage: 5 mg, 2x/day
    Administration route: Oral

Magmitt
    Dosage: 1650 mg, 3x/day
    Administration route: Oral
    Start date: 2007-01-01

Symmetrel
    Dosage: 50 mg, 2x/day
    Administration route: Oral
    Start date: 2009-12-21

Tizanidine Hydrochloride
    Dosage: unk
    Administration route: Oral
    Start date: 2007-12-20

Other drugs received by patient: Digoxin



Possible Comtan side effects in 63 year old male

Reported by a physician from Japan on 2012-08-14

Patient: 63 year old male

Reactions: Pulmonary Tuberculosis, Concomitant Disease Aggravated, Rash

Drug(s) suspected as cause:
Comtan
    Dosage: 500, 5 tablet daily
    Administration route: Oral
    Start date: 2012-07-24

Comtan
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-04-01
    End date: 2012-07-23

Other drugs received by patient: Madopar; Permax



Possible Comtan side effects in 78 year old female

Reported by a pharmacist from Japan on 2012-08-13

Patient: 78 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Carbidopa and Levodopa



Possible Comtan side effects in female

Reported by a physician from Japan on 2012-08-09

Patient: female, weighing 37.0 kg (81.4 pounds)

Reactions: Encephalitis, Altered State of Consciousness, Convulsion

Drug(s) suspected as cause:
Comtan
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Parkinson's Disease

Symmetrel
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Parkinson's Disease
    End date: 2012-07-04

Other drugs received by patient: Selbex; Pramipexole Dihydrochloride; Zonisamide; Menest; Selegiline Hydrochloride; Isosorbide Mononitrate



Possible Comtan side effects in 81 year old male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 81 year old male

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Metoprolol (Metaprolol); Omeprazole; Carbilvo; Januvia; Tinsulosia



Possible Comtan side effects in 63 year old male

Reported by a individual with unspecified qualification from Japan on 2012-08-08

Patient: 63 year old male

Reactions: Pulmonary Tuberculosis, Condition Aggravated, Rash

Drug(s) suspected as cause:
Comtan
    Dosage: oral; 5 tablet (500 mg) daily, oral
    Administration route: Oral
    Start date: 2011-04-01
    End date: 2012-07-23

Comtan
    Dosage: oral; 5 tablet (500 mg) daily, oral
    Administration route: Oral
    Start date: 2012-07-24

Other drugs received by patient: Permax; Madopar



Possible Comtan side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-08

Patient: 73 year old male

Reactions: Blood Creatine Phosphokinase Increased, Pain in Extremity

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Pramipexole Dihydrochloride; Cabergoline; Zonisamide



Possible Comtan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Carbilvo; Metoprolol Tartrate; Omeprazole; Tinsulosia; Januvia



Possible Comtan side effects in 78 year old female

Reported by a individual with unspecified qualification from Japan on 2012-08-01

Patient: 78 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Comtan



Possible Comtan side effects in 63 year old male

Reported by a pharmacist from Japan on 2012-07-31

Patient: 63 year old male

Reactions: Pulmonary Tuberculosis, Concomitant Disease Aggravated, Rash

Drug(s) suspected as cause:
Comtan
    Dosage: 500, 5 tablet daily
    Administration route: Oral
    Start date: 2012-07-24

Comtan
    Dosage: unk
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-04-01
    End date: 2012-07-23

Other drugs received by patient: Permax; Madopar



Possible Comtan side effects in 73 year old male

Reported by a physician from Japan on 2012-07-30

Patient: 73 year old male

Reactions: Blood Creatine Phosphokinase Increased, Pain in Extremity

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Pramipexole Dihydrochloride; Cabergoline; Zonisamide



Possible Comtan side effects in 78 year old female

Reported by a pharmacist from Japan on 2012-07-26

Patient: 78 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Comtan



Possible Comtan side effects in 73 year old male

Reported by a individual with unspecified qualification from Japan on 2012-07-24

Patient: 73 year old male

Reactions: Blood Creatine Phosphokinase Increased, Pain in Extremity

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: BI Siprol; Cabergoline; Treriep



Possible Comtan side effects in 67 year old female

Reported by a pharmacist from Japan on 2012-07-19

Patient: 67 year old female

Reactions: Confusional State, Compression Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Comtan
    Dosage: 300 mg
    Indication: Parkinson's Disease

Menest
    Dosage: 300 mg
    Indication: Parkinson's Disease

Pramipexole Dihydrochloride
    Dosage: 1.5 mg
    Administration route: Oral
    Indication: Parkinson's Disease



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 78 year old female

Reported by a individual with unspecified qualification from Japan on 2012-07-17

Patient: 78 year old female

Reactions: Dysphagia, Wrong Technique in Drug Usage Process, Parkinson's Disease, Disease Progression

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: EC Doparl



Possible Comtan side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-17

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Pain in Extremity

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Anti-Parkinson Drugs



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 73 year old male

Reported by a pharmacist from Japan on 2012-07-12

Patient: 73 year old male

Reactions: Blood Creatine Phosphokinase Increased, Pain in Extremity

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Cabergoline; Pramipexole Dihydrochloride; Zonisamide



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 pharmacist from Japan on 2012-07-09

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Pain in Extremity

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Anti-Parkinson Drugs



Possible Comtan side effects in 78 year old female

Reported by a pharmacist from Japan on 2012-07-09

Patient: 78 year old female

Reactions: Wrong Technique in Drug Usage Process, Dysphagia

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: EC Doparl



Possible Comtan side effects in male

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

Patient: male

Reactions: Confusional State, Fatigue, Dizziness

Drug(s) suspected as cause:
Comtan
    Dosage: unk

Levodopa
    Dosage: unk

Lyrica
    Dosage: unk
    Indication: Procedural Pain

Wellbutrin
    Dosage: unk



Possible Comtan side effects in

Reported by a pharmacist from Japan on 2012-06-15

Patient:

Reactions: Dysphagia, Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: EC Doparl



Possible Comtan side effects in 84 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-06-13

Patient: 84 year old male

Reactions: Pemphigoid

Drug(s) suspected as cause:
Comtan



Possible Comtan side effects in male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-05-31

Patient: male

Reactions: Pemphigoid

Drug(s) suspected as cause:
Comtan



Possible Comtan side effects in 68 year old male

Reported by a individual with unspecified qualification from Brazil on 2012-05-23

Patient: 68 year old male

Reactions: Dysphagia

Adverse event resulted in: death

Drug(s) suspected as cause:
Comtan

Other drugs received by patient: Prolopa



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

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