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Tasmar (Tolcapone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tasmar (Tolcapone) 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 (11)
Disability (2)

Reports by Reaction Type

Pathological Gambling (4)Kleptomania (3)Dyskinesia (2)Generalised Oedema (2)Impulse-Control Disorder (2)Pleural Effusion (2)Congestive Cardiomyopathy (2)Atrial Fibrillation (2)Abnormal Behaviour (2)Cardiac Failure (2)Confusional State (1)Flight of Ideas (1)

Possible Tasmar side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) on 2012-08-10

Patient: 47 year old male

Reactions: Volvulus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasmar

Other drugs received by patient: Clozapine; Modopar; Requip



Possible Tasmar side effects in female

Reported by a physician from France on 2012-07-03

Patient: female

Reactions: Kleptomania, Pathological Gambling

Drug(s) suspected as cause:
Madopar
    Indication: Parkinson's Disease

Isicom 100
    Indication: Parkinson's Disease

Tasmar
    Indication: Parkinson's Disease

Neupro Pflaster
    Indication: Parkinson's Disease

Other drugs received by patient: PK-Merz 100; Lactulose; Requip



Possible Tasmar side effects in female

Reported by a physician from Germany on 2012-06-26

Patient: female

Reactions: Impulse-Control Disorder, Kleptomania, Pathological Gambling

Drug(s) suspected as cause:
Carbidopa and Levodopa
    Dosage: daily dose: 750 mg
    Administration route: Oral
    Indication: Parkinson's Disease

Neupro
    Dosage: 8 mg/24 hour
    Indication: Parkinson's Disease

Tasmar
    Administration route: Oral
    Indication: Parkinson's Disease

Madopar LT
    Dosage: 5x1
    Administration route: Oral
    Indication: Parkinson's Disease

Requip
    Dosage: single dose 8
    Administration route: Oral
    Indication: Parkinson's Disease

Other drugs received by patient: PK-Merz; Lactulose



Possible Tasmar side effects in female

Reported by a physician from Germany on 2012-06-26

Patient: female

Reactions: Impulse-Control Disorder, Kleptomania, Pathological Gambling, Theft

Drug(s) suspected as cause:
Carbidopa and Levodopa
    Dosage: 125mg unknown
    Administration route: Oral
    Indication: Parkinson's Disease

Madopar
    Dosage: 125mg five times per day
    Administration route: Oral
    Indication: Parkinson's Disease

Neupro
    Dosage: 8mg per day
    Indication: Parkinson's Disease

Requip
    Dosage: 8mg three times per day
    Administration route: Oral
    Indication: Parkinson's Disease

Tasmar
    Dosage: 100mg three times per day
    Administration route: Oral
    Indication: Parkinson's Disease

Other drugs received by patient: Lactulose; L-Dopa; PK-Merz



Possible Tasmar side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-11

Patient: 71 year old male

Reactions: Confusional State, Irritability, Abnormal Behaviour, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Modopar
    Dosage: unknown dose
    Administration route: Oral

Tasmar
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-12-01
    End date: 2012-03-19

Neupro
    Dosage: unknown dose

Other drugs received by patient: Acetaminophen



Possible Tasmar side effects in female

Reported by a physician from France on 2012-05-11

Patient: female

Reactions: ON and Off Phenomenon, Dyskinesia, Delirium

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Modopar
    Dosage: 125mg five times per day
    Administration route: Oral
    End date: 2012-01-01

Tasmar
    Indication: Product Used FOR Unknown Indication

Azilect
    Indication: Product Used FOR Unknown Indication

Requip
    Dosage: 24mg per day
    Indication: Parkinson's Disease
    End date: 2012-01-14

Modopar
    Dosage: 250mg per day
    Administration route: Oral
    End date: 2012-01-01

Modopar
    Dosage: 62.5mg in the morning
    Administration route: Oral
    Indication: Parkinson's Disease
    End date: 2012-01-01

Modopar
    Dosage: 250mg at night
    Administration route: Oral
    End date: 2012-01-01



Possible Tasmar side effects in 75 year old male

Reported by a physician from Germany on 2012-04-18

Patient: 75 year old male, weighing 79.0 kg (173.8 pounds)

Reactions: Cardiac Failure, Congestive Cardiomyopathy, Pleural Effusion, Atrial Fibrillation, Generalised Oedema

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tasmar
    Indication: Parkinson's Disease
    Start date: 2010-10-07
    End date: 2011-12-01

L-Dopa-Retard

Other drugs received by patient: Clarium; Azilect; Madopar; L-Dopa



Possible Tasmar side effects in 75 year old male

Reported by a physician from Germany on 2012-04-18

Patient: 75 year old male, weighing 79.0 kg (173.8 pounds)

Reactions: Cardiac Failure, Atrial Fibrillation, Pleural Effusion, Congestive Cardiomyopathy, Generalised Oedema

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tasmar
    Indication: Parkinson's Disease
    Start date: 2010-10-07
    End date: 2011-12-01

L-Dopa-Retard

Other drugs received by patient: Madopar; Clarium; L-Dopa; Azilect



Possible Tasmar side effects in male

Reported by a physician from Germany on 2012-03-15

Patient: male

Reactions: Medication Error, Hallucination

Drug(s) suspected as cause:
Tasmar
    Administration route: Oral

Rasagiline Mesylate
    Administration route: Oral

Requip
    Dosage: 6mg twice per day
    Administration route: Oral
    Indication: Parkinson's Disease

L-Dopa
    Administration route: Oral



Possible Tasmar side effects in male

Reported by a consumer/non-health professional from France on 2011-11-25

Patient: male

Reactions: Dystonia, Increased Appetite, Motor Dysfunction, Flight of Ideas, Dyskinesia, Abnormal Behaviour, Akinesia, Paraesthesia, Affective Disorder, Myalgia, Overdose, Insomnia, Pathological Gambling, Treatment Failure, Drug Dependence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Parlodel
    Dosage: 2.5 mg, tid
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 1996-10-29
    End date: 1997-02-24

Parlodel
    Dosage: 5 mg, tid
    Administration route: Oral
    Start date: 1997-02-25
    End date: 1998-10-26

Parlodel
    Dosage: 10 mg, qid
    Administration route: Oral
    Start date: 2000-06-06
    End date: 2002-11-14

Pergolide Mesylate
    Dosage: 0.25 mg, qid
    Administration route: Oral
    Start date: 2001-05-16
    End date: 2001-05-30

Pergolide Mesylate
    Dosage: 1 mg, qid
    Administration route: Oral
    Start date: 2003-04-29
    End date: 2003-10-28

Madopar Dispersible
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 2000-06-06
    End date: 2000-08-02

Madopar Dispersible
    Dosage: 1.5 tab twice + 1 tab daily
    Administration route: Oral
    Start date: 2001-12-01

Madopar Dispersible
    Dosage: 3 df, qd
    Administration route: Oral
    Start date: 2005-06-05
    End date: 2006-12-05

Sinemet
    Dosage: 7 df, qd
    Administration route: Oral
    Start date: 2002-11-15
    End date: 2003-10-28

Sinemet
    Dosage: 5.5 df, qd
    Administration route: Oral
    Start date: 2001-06-01
    End date: 2001-11-28

Madopar
    Dosage: 3 df, qd
    Administration route: Oral
    Start date: 1996-10-29
    End date: 1998-09-17

Madopar Dispersible
    Dosage: 0.5 df, qd
    Administration route: Oral
    Start date: 2001-06-01
    End date: 2001-11-28

Madopar
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 1996-10-29
    End date: 1998-10-25

Tasmar
    Dosage: 3 df, qd
    Administration route: Oral
    Start date: 1998-10-20

Sinemet
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2007-01-30

Sinemet
    Dosage: 5.5 tablets daily
    Administration route: Oral
    Start date: 2002-03-12
    End date: 2002-11-14

Sinemet
    Dosage: 4.5 tablets daily
    Administration route: Oral
    Start date: 2002-11-15

Parlodel
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2002-05-27
    End date: 2003-04-12

Trivastal
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 2007-01-30

Madopar
    Dosage: 6 df, qd
    Administration route: Oral
    Start date: 2000-06-06
    End date: 2000-08-02

Madopar
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2001-11-29
    End date: 2003-10-28

Madopar Dispersible
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2002-03-03
    End date: 2003-04-11

Sinemet
    Dosage: 5 df, qd
    Administration route: Oral
    Start date: 2001-06-01
    End date: 2001-11-28

Sinemet
    Dosage: 6 df, qd
    Administration route: Oral
    Start date: 2001-11-29
    End date: 2002-11-14

Sinemet
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2006-12-06
    End date: 2007-01-29

Sinemet
    Dosage: 5 df, qd
    Administration route: Oral
    Start date: 2001-12-12
    End date: 2002-03-11

Parlodel
    Dosage: 10 mg, bid
    Start date: 2002-11-15

Pergolide Mesylate
    Dosage: 1 mg, qid
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2001-02-05
    End date: 2001-05-15

Madopar Dispersible
    Dosage: 0.5 df, qd
    Administration route: Oral
    Start date: 2006-12-06
    End date: 2007-01-29

Madopar Dispersible
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 2007-03-20

Parlodel
    Dosage: 2.5 mg, qid
    Administration route: Oral
    Start date: 2001-06-01
    End date: 2002-08-01

Parlodel
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2000-11-29
    End date: 2001-02-05

Pergolide Mesylate
    Dosage: 1 mg, tid
    Administration route: Oral
    Start date: 2003-10-29

Pergolide Mesylate
    Dosage: 1 mg, tid
    Administration route: Oral
    Start date: 2005-06-05

Madopar
    Dosage: 5 df, qd
    Administration route: Oral
    Start date: 1998-10-26
    End date: 2000-06-05

Madopar
    Dosage: 1

Madopar Dispersible
    Dosage: 0.5 df, qid
    Administration route: Oral
    Start date: 2001-11-29
    End date: 2001-12-01

Madopar
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 1998-10-26

Madopar
    Dosage: 5 df, qd
    Administration route: Oral
    Start date: 2000-08-03
    End date: 2001-11-28

Madopar
    Dosage: 5 df, qd
    Administration route: Oral
    Start date: 2003-10-29
    End date: 2006-12-05

Madopar
    Dosage: 4 df, qd
    Administration route: Oral
    Start date: 2006-12-06
    End date: 2007-03-19

Madopar Dispersible
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2000-08-03
    End date: 2001-02-04

Madopar Dispersible
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2003-10-29

Madopar Dispersible
    Dosage: 4 df, qd
    Administration route: Oral
    Start date: 2007-01-30
    End date: 2007-03-19

Tasmar
    Dosage: 3 df, qd
    Administration route: Oral
    Start date: 1998-09-18
    End date: 1998-10-19

Sinemet
    Dosage: 4 df, qd
    Administration route: Oral
    Start date: 2001-02-05
    End date: 2001-05-31

Sinemet
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2003-10-29

Parlodel
    Dosage: 5 mg, bid
    Administration route: Oral
    Start date: 2002-11-15

Parlodel
    Dosage: 40 mg

Trivastal
    Dosage: 4 df, qd
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2006-06-19
    End date: 2007-01-29

Madopar
    Dosage: 4 df, qd
    Administration route: Oral
    Start date: 1998-09-18
    End date: 1998-10-25

Madopar
    Dosage: 4 df, qd
    Administration route: Oral
    Start date: 2007-03-20

Madopar Dispersible
    Dosage: 0.5 df, qid
    Administration route: Oral
    Start date: 2001-02-05
    End date: 2001-05-31

Madopar Dispersible
    Dosage: 1.5 df, 5qd
    Administration route: Oral
    Start date: 2003-04-12
    End date: 2003-10-28

Sinemet
    Dosage: 6 df, qd
    Administration route: Oral
    Start date: 2001-11-29
    End date: 2001-12-11

Other drugs received by patient: Amantadine HCL; Lexomil; Huile DE Paraffine; Imovane; Dopa and Dopa Derivatives; Proctolog; Paroxetine HCL; Amantadine HCL; Imovane; Amantadine HCL; Ketoconazole; Proctolog; Comtan; Dopa and Dopa Derivatives; Lexomil; Lexomil; Actapulgite; Lexomil; Motilium



Possible Tasmar side effects in 56 year old

Reported by a consumer/non-health professional from Germany on 2011-10-14

Patient: 56 year old

Reactions: Dyspnoea, Drug Ineffective, Gout, Diplegia, Therapeutic Response Unexpected, Condition Aggravated, Asthenia, Pulmonary Fibrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupro
    Dosage: 16mg per day

Entacapone

Isicom

Tasmar

Requip
    Dosage: 12mg per day
    Administration route: Oral
    Indication: Parkinson's Disease

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