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 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 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 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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