Drug information for COMTAN

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	200MG	Prescription	(Reference Drug)	ENTACAPONE	entacapone	ORION	20796 2010-10-13 Letter 2010-10-11 Label 2009-02-04 Label 2009-02-04 Label 2009-02-03 Letter 2009-02-03 Letter 1999-12-30 Review 1999-12-30 Letter 1999-12-30 Label

Drug Adverse Effects information for COMTAN

Role code	Indications	Reaction	# Reports
PS	DRUG EFFECT DECREASED	DYSKINESIA	1
PS	DRUG EFFECT DECREASED	DYSPNOEA	1
PS	DRUG EFFECT DECREASED	RED BLOOD CELL COUNT DECREASED	1
PS	DRUG EFFECT DECREASED	RESPIRATORY FAILURE	1
PS	DRUG EFFECT DECREASED	WHITE BLOOD CELL COUNT DECREASED	1
PS	PARKINSON'S DISEASE	ABDOMINAL PAIN	6
PS	PARKINSON'S DISEASE	ABNORMAL BEHAVIOUR	10
PS	PARKINSON'S DISEASE	AGGRESSION	1
PS	PARKINSON'S DISEASE	AGITATION	9
PS	PARKINSON'S DISEASE	AKINESIA	9
PS	PARKINSON'S DISEASE	ALOPECIA	4
PS	PARKINSON'S DISEASE	AMIMIA	9
PS	PARKINSON'S DISEASE	ASPARTATE AMINOTRANSFERASE INCREASED	1
PS	PARKINSON'S DISEASE	AUTONOMIC NERVOUS SYSTEM IMBALANCE	1
PS	PARKINSON'S DISEASE	BACK PAIN	9
PS	PARKINSON'S DISEASE	BALANCE DISORDER	9
PS	PARKINSON'S DISEASE	BLOOD ALKALINE PHOSPHATASE INCREASED	1
PS	PARKINSON'S DISEASE	BLOOD BILIRUBIN INCREASED	3
PS	PARKINSON'S DISEASE	BLOOD CREATININE INCREASED	1
PS	PARKINSON'S DISEASE	BLOOD UREA INCREASED	1
PS	PARKINSON'S DISEASE	C-REACTIVE PROTEIN INCREASED	9
PS	PARKINSON'S DISEASE	CHOLESTASIS	3
PS	PARKINSON'S DISEASE	CHROMATURIA	15
PS	PARKINSON'S DISEASE	COGNITIVE DISORDER	1
PS	PARKINSON'S DISEASE	COMPULSIVE SHOPPING	9
PS	PARKINSON'S DISEASE	CORNEAL REFLEX DECREASED	9
PS	PARKINSON'S DISEASE	CROHN'S DISEASE	1
PS	PARKINSON'S DISEASE	DECREASED APPETITE	7
PS	PARKINSON'S DISEASE	DECUBITUS ULCER	3
PS	PARKINSON'S DISEASE	DEHYDRATION	1
PS	PARKINSON'S DISEASE	DELIRIUM	1
PS	PARKINSON'S DISEASE	DELUSION	1
PS	PARKINSON'S DISEASE	DEPRESSED MOOD	9
PS	PARKINSON'S DISEASE	DEPRESSION	9
PS	PARKINSON'S DISEASE	DYSKINESIA	9
PS	PARKINSON'S DISEASE	DYSPNOEA	11
PS	PARKINSON'S DISEASE	DYSSTASIA	3
PS	PARKINSON'S DISEASE	DYSTHYMIC DISORDER	9
PS	PARKINSON'S DISEASE	DYSURIA	3
PS	PARKINSON'S DISEASE	FALL	9
PS	PARKINSON'S DISEASE	GAMMA-GLUTAMYLTRANSFERASE INCREASED	1
PS	PARKINSON'S DISEASE	HALLUCINATION	2
PS	PARKINSON'S DISEASE	HYPERHIDROSIS	1
PS	PARKINSON'S DISEASE	HYPOMANIA	9
PS	PARKINSON'S DISEASE	HYPOTENSION	1
PS	PARKINSON'S DISEASE	IRRITABILITY	10
PS	PARKINSON'S DISEASE	MUSCLE RIGIDITY	9
PS	PARKINSON'S DISEASE	MUSCLE SPASMS	15
PS	PARKINSON'S DISEASE	MUSCULOSKELETAL PAIN	9
PS	PARKINSON'S DISEASE	MYOCLONUS	1
PS	PARKINSON'S DISEASE	NECK PAIN	9
PS	PARKINSON'S DISEASE	NEUROSIS	9
PS	PARKINSON'S DISEASE	OCULAR ICTERUS	6
PS	PARKINSON'S DISEASE	PAIN IN EXTREMITY	6
PS	PARKINSON'S DISEASE	PARKINSON'S DISEASE	6
PS	PARKINSON'S DISEASE	PENILE SIZE REDUCED	4
PS	PARKINSON'S DISEASE	PSYCHOMOTOR HYPERACTIVITY	9
PS	PARKINSON'S DISEASE	PSYCHOTIC BEHAVIOUR	9
PS	PARKINSON'S DISEASE	PYREXIA	6
PS	PARKINSON'S DISEASE	RED BLOOD CELL COUNT DECREASED	2
PS	PARKINSON'S DISEASE	RED BLOOD CELL SEDIMENTATION RATE INCREASED	9
PS	PARKINSON'S DISEASE	RED BLOOD CELLS URINE POSITIVE	3
PS	PARKINSON'S DISEASE	RENAL IMPAIRMENT	1
PS	PARKINSON'S DISEASE	RESPIRATORY FAILURE	2
PS	PARKINSON'S DISEASE	SALIVA DISCOLOURATION	6
PS	PARKINSON'S DISEASE	SPEECH DISORDER	1
PS	PARKINSON'S DISEASE	SUICIDAL IDEATION	9
PS	PARKINSON'S DISEASE	SUICIDE ATTEMPT	9
PS	PARKINSON'S DISEASE	THYMUS DISORDER	9
PS	PARKINSON'S DISEASE	TOXICITY TO VARIOUS AGENTS	1
PS	PARKINSON'S DISEASE	TREMOR	10
PS	PARKINSON'S DISEASE	WEIGHT INCREASED	9
PS	PARKINSON'S DISEASE	WHITE BLOOD CELL COUNT DECREASED	2
PS	PARKINSON'S DISEASE	YELLOW SKIN	6
SS	DRUG EFFECT DECREASED	DYSKINESIA	2
SS	DRUG EFFECT DECREASED	DYSPNOEA	2
SS	DRUG EFFECT DECREASED	RED BLOOD CELL COUNT DECREASED	2
SS	DRUG EFFECT DECREASED	RESPIRATORY FAILURE	2
SS	DRUG EFFECT DECREASED	WHITE BLOOD CELL COUNT DECREASED	2
SS	PARKINSON'S DISEASE	ABNORMAL BEHAVIOUR	27
SS	PARKINSON'S DISEASE	AGITATION	27
SS	PARKINSON'S DISEASE	AKINESIA	27
SS	PARKINSON'S DISEASE	AMIMIA	27
SS	PARKINSON'S DISEASE	BACK PAIN	27
SS	PARKINSON'S DISEASE	BALANCE DISORDER	27
SS	PARKINSON'S DISEASE	C-REACTIVE PROTEIN INCREASED	27
SS	PARKINSON'S DISEASE	CHROMATURIA	27
SS	PARKINSON'S DISEASE	COMPULSIVE SHOPPING	27
SS	PARKINSON'S DISEASE	CORNEAL REFLEX DECREASED	27
SS	PARKINSON'S DISEASE	DEPRESSED MOOD	27
SS	PARKINSON'S DISEASE	DEPRESSION	27
SS	PARKINSON'S DISEASE	DYSKINESIA	4
SS	PARKINSON'S DISEASE	DYSPNOEA	31
SS	PARKINSON'S DISEASE	DYSTHYMIC DISORDER	27
SS	PARKINSON'S DISEASE	FALL	27
SS	PARKINSON'S DISEASE	HYPOMANIA	27
SS	PARKINSON'S DISEASE	IRRITABILITY	27
SS	PARKINSON'S DISEASE	MUSCLE RIGIDITY	27
SS	PARKINSON'S DISEASE	MUSCLE SPASMS	27
SS	PARKINSON'S DISEASE	MUSCULOSKELETAL PAIN	27
SS	PARKINSON'S DISEASE	NECK PAIN	27
SS	PARKINSON'S DISEASE	NEUROSIS	27
SS	PARKINSON'S DISEASE	PARKINSON'S DISEASE	2
SS	PARKINSON'S DISEASE	PSYCHOMOTOR HYPERACTIVITY	27
SS	PARKINSON'S DISEASE	PSYCHOTIC BEHAVIOUR	27
SS	PARKINSON'S DISEASE	RED BLOOD CELL COUNT DECREASED	4
SS	PARKINSON'S DISEASE	RED BLOOD CELL SEDIMENTATION RATE INCREASED	27
SS	PARKINSON'S DISEASE	RESPIRATORY FAILURE	4
SS	PARKINSON'S DISEASE	SUICIDAL IDEATION	27
SS	PARKINSON'S DISEASE	SUICIDE ATTEMPT	27
SS	PARKINSON'S DISEASE	THYMUS DISORDER	27
SS	PARKINSON'S DISEASE	TREMOR	27
SS	PARKINSON'S DISEASE	WEIGHT INCREASED	27
SS	PARKINSON'S DISEASE	WHITE BLOOD CELL COUNT DECREASED	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	DEPRESSED LEVEL OF CONSCIOUSNESS	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	PARKINSON'S DISEASE	8
SS	PRODUCT USED FOR UNKNOWN INDICATION	WRONG DRUG ADMINISTERED	4
C	ARTHRITIS BACTERIAL	EOSINOPHILIC PNEUMONIA	1
C	BRONCHOPULMONARY ASPERGILLOSIS	ALTERED STATE OF CONSCIOUSNESS	3
C	BRONCHOPULMONARY ASPERGILLOSIS	HYPOGLYCAEMIA	3
C	BRONCHOPULMONARY ASPERGILLOSIS	SEPSIS	2
C	CATARACT	DEPRESSION	1
C	CATARACT	EMOTIONAL DISTRESS	1
C	CATARACT	PATHOLOGICAL GAMBLING	1
C	COMPULSIONS	ACTIVITIES OF DAILY LIVING IMPAIRED	1
C	COMPULSIONS	ADJUSTMENT DISORDER	1
C	COMPULSIONS	ANHEDONIA	1
C	COMPULSIONS	ANXIETY	1
C	COMPULSIONS	APATHY	1
C	COMPULSIONS	ASTHENIA	1
C	COMPULSIONS	COMPULSIONS	1
C	COMPULSIONS	DEPRESSION	1
C	COMPULSIONS	DISTURBANCE IN SOCIAL BEHAVIOUR	1
C	COMPULSIONS	EATING DISORDER	1
C	COMPULSIONS	FEELING GUILTY	1
C	COMPULSIONS	FEELING OF DESPAIR	1
C	COMPULSIONS	FEELINGS OF WORTHLESSNESS	1
C	COMPULSIONS	GAIT DISTURBANCE	1
C	COMPULSIONS	GENERAL PHYSICAL HEALTH DETERIORATION	1
C	COMPULSIONS	IMPAIRED WORK ABILITY	1
C	COMPULSIONS	IMPULSIVE BEHAVIOUR	1
C	COMPULSIONS	INSOMNIA	1
C	COMPULSIONS	JUDGEMENT IMPAIRED	1
C	COMPULSIONS	LIBIDO DECREASED	1
C	COMPULSIONS	LIBIDO INCREASED	1
C	COMPULSIONS	MANIA	1
C	COMPULSIONS	MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION	1
C	COMPULSIONS	MOOD SWINGS	1
C	COMPULSIONS	PAIN	1
C	COMPULSIONS	PANIC ATTACK	1
C	COMPULSIONS	PARANOIA	1
C	COMPULSIONS	PARTNER STRESS	1
C	COMPULSIONS	PATHOLOGICAL GAMBLING	1
C	COMPULSIONS	PSYCHIATRIC SYMPTOM	1
C	COMPULSIONS	ROAD TRAFFIC ACCIDENT	1
C	COMPULSIONS	SELF ESTEEM DECREASED	1
C	COMPULSIONS	SEXUAL DYSFUNCTION	1
C	COMPULSIONS	SOCIAL AVOIDANT BEHAVIOUR	1
C	COMPULSIONS	SOMNOLENCE	1
C	COMPULSIONS	WEIGHT DECREASED	1
C	DECUBITUS ULCER	APPLICATION SITE DISCOLOURATION	1
C	DECUBITUS ULCER	DIARRHOEA	1
C	DECUBITUS ULCER	PNEUMONIA ASPIRATION	1
C	DECUBITUS ULCER	WOUND SECRETION	1
C	DEMENTIA ALZHEIMER'S TYPE	DEATH	1
C	DEPRESSION	ACTIVITIES OF DAILY LIVING IMPAIRED	5
C	DEPRESSION	ADJUSTMENT DISORDER	5
C	DEPRESSION	ANHEDONIA	5
C	DEPRESSION	ANXIETY	5
C	DEPRESSION	APATHY	5
C	DEPRESSION	ASTHENIA	5
C	DEPRESSION	COMPULSIONS	5
C	DEPRESSION	DEPRESSION	5
C	DEPRESSION	DISTURBANCE IN SOCIAL BEHAVIOUR	5
C	DEPRESSION	EATING DISORDER	5
C	DEPRESSION	FEELING GUILTY	5
C	DEPRESSION	FEELING OF DESPAIR	5
C	DEPRESSION	FEELINGS OF WORTHLESSNESS	5
C	DEPRESSION	GAIT DISTURBANCE	5
C	DEPRESSION	GENERAL PHYSICAL HEALTH DETERIORATION	5
C	DEPRESSION	IMPAIRED WORK ABILITY	5
C	DEPRESSION	IMPULSIVE BEHAVIOUR	5
C	DEPRESSION	INSOMNIA	5
C	DEPRESSION	JUDGEMENT IMPAIRED	5
C	DEPRESSION	LIBIDO DECREASED	5
C	DEPRESSION	LIBIDO INCREASED	5
C	DEPRESSION	MANIA	5
C	DEPRESSION	MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION	5
C	DEPRESSION	MOOD SWINGS	5
C	DEPRESSION	PAIN	5
C	DEPRESSION	PANIC ATTACK	5
C	DEPRESSION	PARANOIA	5
C	DEPRESSION	PARTNER STRESS	5
C	DEPRESSION	PATHOLOGICAL GAMBLING	5
C	DEPRESSION	PSYCHIATRIC SYMPTOM	5
C	DEPRESSION	ROAD TRAFFIC ACCIDENT	5
C	DEPRESSION	SELF ESTEEM DECREASED	5
C	DEPRESSION	SEXUAL DYSFUNCTION	5
C	DEPRESSION	SOCIAL AVOIDANT BEHAVIOUR	5
C	DEPRESSION	SOMNOLENCE	5
C	DEPRESSION	WEIGHT DECREASED	5
C	DYSLIPIDAEMIA	DEPRESSION	1
C	DYSLIPIDAEMIA	EMOTIONAL DISTRESS	1
C	DYSLIPIDAEMIA	PATHOLOGICAL GAMBLING	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DEPRESSION	3
C	GASTROOESOPHAGEAL REFLUX DISEASE	EMOTIONAL DISTRESS	3
C	GASTROOESOPHAGEAL REFLUX DISEASE	PATHOLOGICAL GAMBLING	3
C	GLAUCOMA	DEPRESSION	1
C	GLAUCOMA	EMOTIONAL DISTRESS	1
C	GLAUCOMA	PATHOLOGICAL GAMBLING	1
C	HYPERTENSION	DEPRESSION	1
C	HYPERTENSION	EMOTIONAL DISTRESS	1
C	HYPERTENSION	PATHOLOGICAL GAMBLING	1
C	NAUSEA	ACTIVITIES OF DAILY LIVING IMPAIRED	1
C	NAUSEA	ADJUSTMENT DISORDER	1
C	NAUSEA	ANHEDONIA	1
C	NAUSEA	ANXIETY	1
C	NAUSEA	APATHY	1
C	NAUSEA	ASTHENIA	1
C	NAUSEA	COMPULSIONS	1
C	NAUSEA	DEPRESSION	1
C	NAUSEA	DISTURBANCE IN SOCIAL BEHAVIOUR	1
C	NAUSEA	EATING DISORDER	1
C	NAUSEA	FEELING GUILTY	1
C	NAUSEA	FEELING OF DESPAIR	1
C	NAUSEA	FEELINGS OF WORTHLESSNESS	1
C	NAUSEA	GAIT DISTURBANCE	1
C	NAUSEA	GENERAL PHYSICAL HEALTH DETERIORATION	1
C	NAUSEA	IMPAIRED WORK ABILITY	1
C	NAUSEA	IMPULSIVE BEHAVIOUR	1
C	NAUSEA	INSOMNIA	1
C	NAUSEA	JUDGEMENT IMPAIRED	1
C	NAUSEA	LIBIDO DECREASED	1
C	NAUSEA	LIBIDO INCREASED	1
C	NAUSEA	MANIA	1
C	NAUSEA	MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION	1
C	NAUSEA	MOOD SWINGS	1
C	NAUSEA	PAIN	1
C	NAUSEA	PANIC ATTACK	1
C	NAUSEA	PARANOIA	1
C	NAUSEA	PARTNER STRESS	1
C	NAUSEA	PATHOLOGICAL GAMBLING	1
C	NAUSEA	PSYCHIATRIC SYMPTOM	1
C	NAUSEA	ROAD TRAFFIC ACCIDENT	1
C	NAUSEA	SELF ESTEEM DECREASED	1
C	NAUSEA	SEXUAL DYSFUNCTION	1
C	NAUSEA	SOCIAL AVOIDANT BEHAVIOUR	1
C	NAUSEA	SOMNOLENCE	1
C	NAUSEA	WEIGHT DECREASED	1
C	PARKINSON'S DISEASE	ABNORMAL BEHAVIOUR	3
C	PARKINSON'S DISEASE	ACTIVITIES OF DAILY LIVING IMPAIRED	5
C	PARKINSON'S DISEASE	ADJUSTMENT DISORDER	5
C	PARKINSON'S DISEASE	AFFECTIVE DISORDER	3
C	PARKINSON'S DISEASE	AKINESIA	3
C	PARKINSON'S DISEASE	ALTERED STATE OF CONSCIOUSNESS	12
C	PARKINSON'S DISEASE	ANHEDONIA	5
C	PARKINSON'S DISEASE	ANXIETY	5
C	PARKINSON'S DISEASE	APATHY	5
C	PARKINSON'S DISEASE	ASTHENIA	5
C	PARKINSON'S DISEASE	BLOOD PRESSURE INADEQUATELY CONTROLLED	1
C	PARKINSON'S DISEASE	COMPLETED SUICIDE	2
C	PARKINSON'S DISEASE	COMPULSIONS	5
C	PARKINSON'S DISEASE	DEATH	1
C	PARKINSON'S DISEASE	DEPRESSION	15
C	PARKINSON'S DISEASE	DISTURBANCE IN SOCIAL BEHAVIOUR	5
C	PARKINSON'S DISEASE	DRUG DEPENDENCE	3
C	PARKINSON'S DISEASE	DYSKINESIA	3
C	PARKINSON'S DISEASE	DYSTONIA	3
C	PARKINSON'S DISEASE	EATING DISORDER	5
C	PARKINSON'S DISEASE	EMOTIONAL DISTRESS	10
C	PARKINSON'S DISEASE	EPISTAXIS	2
C	PARKINSON'S DISEASE	FEELING GUILTY	5
C	PARKINSON'S DISEASE	FEELING OF DESPAIR	5
C	PARKINSON'S DISEASE	FEELINGS OF WORTHLESSNESS	5
C	PARKINSON'S DISEASE	FLIGHT OF IDEAS	3
C	PARKINSON'S DISEASE	GAIT DISTURBANCE	5
C	PARKINSON'S DISEASE	GAMBLING	2
C	PARKINSON'S DISEASE	GENERAL PHYSICAL HEALTH DETERIORATION	5
C	PARKINSON'S DISEASE	HAEMORRHAGE	1
C	PARKINSON'S DISEASE	HYPOGLYCAEMIA	12
C	PARKINSON'S DISEASE	IMPAIRED WORK ABILITY	5
C	PARKINSON'S DISEASE	IMPULSIVE BEHAVIOUR	5
C	PARKINSON'S DISEASE	INCREASED APPETITE	3
C	PARKINSON'S DISEASE	INSOMNIA	8
C	PARKINSON'S DISEASE	JUDGEMENT IMPAIRED	5
C	PARKINSON'S DISEASE	LIBIDO DECREASED	5
C	PARKINSON'S DISEASE	LIBIDO INCREASED	5
C	PARKINSON'S DISEASE	MANIA	5
C	PARKINSON'S DISEASE	MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION	5
C	PARKINSON'S DISEASE	MOOD SWINGS	5
C	PARKINSON'S DISEASE	MOTOR DYSFUNCTION	3
C	PARKINSON'S DISEASE	MYALGIA	3
C	PARKINSON'S DISEASE	OBSESSIVE-COMPULSIVE DISORDER	2
C	PARKINSON'S DISEASE	OVERDOSE	3
C	PARKINSON'S DISEASE	PAIN	5
C	PARKINSON'S DISEASE	PANIC ATTACK	5
C	PARKINSON'S DISEASE	PARAESTHESIA	3
C	PARKINSON'S DISEASE	PARANOIA	5
C	PARKINSON'S DISEASE	PARTNER STRESS	5
C	PARKINSON'S DISEASE	PATHOLOGICAL GAMBLING	18
C	PARKINSON'S DISEASE	PSYCHIATRIC SYMPTOM	5
C	PARKINSON'S DISEASE	ROAD TRAFFIC ACCIDENT	5
C	PARKINSON'S DISEASE	SELF ESTEEM DECREASED	5
C	PARKINSON'S DISEASE	SEPSIS	8
C	PARKINSON'S DISEASE	SEXUAL DYSFUNCTION	5
C	PARKINSON'S DISEASE	SOCIAL AVOIDANT BEHAVIOUR	5
C	PARKINSON'S DISEASE	SOMNOLENCE	7
C	PARKINSON'S DISEASE	SUDDEN ONSET OF SLEEP	2
C	PARKINSON'S DISEASE	TREATMENT FAILURE	3
C	PARKINSON'S DISEASE	WEIGHT DECREASED	5
C	PNEUMONIA ASPIRATION	APPLICATION SITE DISCOLOURATION	1
C	PNEUMONIA ASPIRATION	DIARRHOEA	1
C	PNEUMONIA ASPIRATION	PNEUMONIA ASPIRATION	1
C	PNEUMONIA ASPIRATION	WOUND SECRETION	1
C	RHEUMATOID ARTHRITIS	DECUBITUS ULCER	1
C	RHEUMATOID ARTHRITIS	OSTEOARTHRITIS	1
C	RHEUMATOID ARTHRITIS	PATELLA FRACTURE	1
C	RHEUMATOID ARTHRITIS	PNEUMONIA	1

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