Drug information for SANCTURA XR

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
CAPSULE, EXTENDED RELEASE; ORAL	60MG	Prescription	(Reference Drug)	TROSPIUM CHLORIDE	trospium chloride	ALLERGAN	22103 2011-09-16 Letter 2011-09-16 Label 2011-02-04 Letter 2011-01-31 Label 2009-06-04 Label 2008-07-11 Review 2007-08-07 Letter

Drug Adverse Effects information for SANCTURA XR

Role code	Indications	Reaction	# Reports
C	ANXIETY	ALTERED STATE OF CONSCIOUSNESS	3
C	ANXIETY	DEATH	3
C	ANXIETY	MULTIPLE SCLEROSIS RELAPSE	3
C	ANXIETY	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	ATRIAL FIBRILLATION	FALL	1
C	ATRIAL FIBRILLATION	HAEMATOMA	1
C	BIPOLAR I DISORDER	ARRHYTHMIA	1
C	BIPOLAR I DISORDER	CATARACT	1
C	BIPOLAR I DISORDER	CYSTITIS INTERSTITIAL	1
C	BIPOLAR I DISORDER	DEPRESSION	1
C	BIPOLAR I DISORDER	FATIGUE	1
C	BIPOLAR I DISORDER	WHITE BLOOD CELL COUNT DECREASED	1
C	CONSTIPATION	ALTERED STATE OF CONSCIOUSNESS	3
C	CONSTIPATION	DEATH	3
C	CONSTIPATION	MULTIPLE SCLEROSIS RELAPSE	3
C	CONSTIPATION	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	CORONARY ARTERY DISEASE	FALL	1
C	CORONARY ARTERY DISEASE	HAEMATOMA	1
C	CYSTITIS INTERSTITIAL	ARRHYTHMIA	1
C	CYSTITIS INTERSTITIAL	CATARACT	1
C	CYSTITIS INTERSTITIAL	WHITE BLOOD CELL COUNT DECREASED	1
C	DEPRESSION	ALTERED STATE OF CONSCIOUSNESS	3
C	DEPRESSION	ARRHYTHMIA	1
C	DEPRESSION	CATARACT	1
C	DEPRESSION	CYSTITIS INTERSTITIAL	1
C	DEPRESSION	DEATH	3
C	DEPRESSION	DEPRESSION	1
C	DEPRESSION	FATIGUE	1
C	DEPRESSION	MULTIPLE SCLEROSIS RELAPSE	3
C	DEPRESSION	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	DEPRESSION	WHITE BLOOD CELL COUNT DECREASED	1
C	FACTOR V LEIDEN MUTATION	ALTERED STATE OF CONSCIOUSNESS	3
C	FACTOR V LEIDEN MUTATION	DEATH	3
C	FACTOR V LEIDEN MUTATION	MULTIPLE SCLEROSIS RELAPSE	3
C	FACTOR V LEIDEN MUTATION	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	GASTROOESOPHAGEAL REFLUX DISEASE	ALTERED STATE OF CONSCIOUSNESS	3
C	GASTROOESOPHAGEAL REFLUX DISEASE	DEATH	3
C	GASTROOESOPHAGEAL REFLUX DISEASE	MULTIPLE SCLEROSIS RELAPSE	3
C	GASTROOESOPHAGEAL REFLUX DISEASE	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	HYPERSENSITIVITY	ALTERED STATE OF CONSCIOUSNESS	3
C	HYPERSENSITIVITY	DEATH	3
C	HYPERSENSITIVITY	MULTIPLE SCLEROSIS RELAPSE	3
C	HYPERSENSITIVITY	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	INSOMNIA	ALTERED STATE OF CONSCIOUSNESS	3
C	INSOMNIA	DEATH	3
C	INSOMNIA	MULTIPLE SCLEROSIS RELAPSE	3
C	INSOMNIA	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	MULTIPLE SCLEROSIS	ALTERED STATE OF CONSCIOUSNESS	3
C	MULTIPLE SCLEROSIS	DEATH	3
C	MULTIPLE SCLEROSIS	MULTIPLE SCLEROSIS RELAPSE	3
C	MULTIPLE SCLEROSIS	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	MUSCLE DISORDER	CYSTITIS INTERSTITIAL	1
C	MUSCLE DISORDER	DEPRESSION	1
C	MUSCLE DISORDER	FATIGUE	1
C	MUSCLE SPASTICITY	ALTERED STATE OF CONSCIOUSNESS	3
C	MUSCLE SPASTICITY	DEATH	3
C	MUSCLE SPASTICITY	MULTIPLE SCLEROSIS RELAPSE	3
C	MUSCLE SPASTICITY	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	MUSCULOSKELETAL DISCOMFORT	ARRHYTHMIA	1
C	MUSCULOSKELETAL DISCOMFORT	CATARACT	1
C	MUSCULOSKELETAL DISCOMFORT	WHITE BLOOD CELL COUNT DECREASED	1
C	OSTEOPOROSIS	ALTERED STATE OF CONSCIOUSNESS	3
C	OSTEOPOROSIS	DEATH	3
C	OSTEOPOROSIS	MULTIPLE SCLEROSIS RELAPSE	3
C	OSTEOPOROSIS	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	PAIN	ALTERED STATE OF CONSCIOUSNESS	3
C	PAIN	DEATH	3
C	PAIN	MULTIPLE SCLEROSIS RELAPSE	3
C	PAIN	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3
C	PERCUTANEOUS CORONARY INTERVENTION	FALL	1
C	PERCUTANEOUS CORONARY INTERVENTION	HAEMATOMA	1
C	THYROID DISORDER	ARRHYTHMIA	1
C	THYROID DISORDER	CATARACT	1
C	THYROID DISORDER	CYSTITIS INTERSTITIAL	1
C	THYROID DISORDER	DEPRESSION	1
C	THYROID DISORDER	FATIGUE	1
C	THYROID DISORDER	WHITE BLOOD CELL COUNT DECREASED	1
C	VITAMIN SUPPLEMENTATION	ALTERED STATE OF CONSCIOUSNESS	3
C	VITAMIN SUPPLEMENTATION	DEATH	3
C	VITAMIN SUPPLEMENTATION	MULTIPLE SCLEROSIS RELAPSE	3
C	VITAMIN SUPPLEMENTATION	PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	3

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