Drug information for SANCTURA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 20MG Prescription AB (Reference Drug) TROSPIUM CHLORIDE trospium chloride ALLERGAN 21595
2011-09-30 Label

2011-09-28 Letter

2011-02-09 Label

2011-02-04 Letter

2009-06-04 Label

2006-12-28 Letter

2006-09-15 Letter

2006-09-12 Label

2005-03-14 Letter

2005-03-14 Label

2004-07-08 Review

2004-06-01 Label

2004-06-01 Letter

Drug Adverse Effects information for SANCTURA

Role code Indications Reaction # Reports
PS DIABETES MELLITUS PRURITUS 1
PS DIABETES MELLITUS RASH 1
PS DIABETES MELLITUS URTICARIA 1
PS HYPERTONIC BLADDER CONFUSIONAL STATE 1
PS HYPERTONIC BLADDER CONSTIPATION 1
PS HYPERTONIC BLADDER CONTUSION 1
PS HYPERTONIC BLADDER FALL 1
PS HYPERTONIC BLADDER FEELING ABNORMAL 1
PS HYPERTONIC BLADDER HALLUCINATION, VISUAL 1
PS HYPERTONIC BLADDER ROAD TRAFFIC ACCIDENT 1
PS HYPERTONIC BLADDER SLEEP DISORDER 1
PS HYPERTONIC BLADDER TACHYCARDIA 1
PS HYPERTONIC BLADDER TREMOR 1
PS NOCTURIA PRURITUS 1
PS NOCTURIA RASH 1
PS NOCTURIA URTICARIA 1
SS DEMENTIA ORTHOSTATIC HYPOTENSION 1
SS DEMENTIA PULMONARY EMBOLISM 1
SS DYSLIPIDAEMIA ORTHOSTATIC HYPOTENSION 1
SS DYSLIPIDAEMIA PULMONARY EMBOLISM 1
SS GLAUCOMA ORTHOSTATIC HYPOTENSION 1
SS GLAUCOMA PULMONARY EMBOLISM 1
SS HYPERTONIC BLADDER CONFUSIONAL STATE 1
SS HYPERTONIC BLADDER CONSTIPATION 1
SS HYPERTONIC BLADDER CONTUSION 1
SS HYPERTONIC BLADDER FALL 1
SS HYPERTONIC BLADDER FEELING ABNORMAL 1
SS HYPERTONIC BLADDER HALLUCINATION, VISUAL 1
SS HYPERTONIC BLADDER ORTHOSTATIC HYPOTENSION 1
SS HYPERTONIC BLADDER PULMONARY EMBOLISM 1
SS HYPERTONIC BLADDER ROAD TRAFFIC ACCIDENT 1
SS HYPERTONIC BLADDER SLEEP DISORDER 1
SS HYPERTONIC BLADDER TACHYCARDIA 1
SS HYPERTONIC BLADDER TREMOR 1
SS HYPOTHYROIDISM ORTHOSTATIC HYPOTENSION 1
SS HYPOTHYROIDISM PULMONARY EMBOLISM 1
SS OSTEOPOROSIS ORTHOSTATIC HYPOTENSION 2
SS OSTEOPOROSIS PULMONARY EMBOLISM 2
SS PAIN ORTHOSTATIC HYPOTENSION 1
SS PAIN PULMONARY EMBOLISM 1
SS PARKINSON'S DISEASE ORTHOSTATIC HYPOTENSION 1
SS PARKINSON'S DISEASE PULMONARY EMBOLISM 1
C ATRIAL FIBRILLATION ARTHRALGIA 3
C ATRIAL FIBRILLATION DYSPEPSIA 3
C BACK PAIN DEATH 1
C BACK PAIN PERIRECTAL ABSCESS 1
C BLOOD CHOLESTEROL INCREASED ARTHRALGIA 2
C BLOOD CHOLESTEROL INCREASED DYSPEPSIA 2
C CONSTIPATION ADENOCARCINOMA 1
C CONSTIPATION DEATH 1
C CONSTIPATION PERIRECTAL ABSCESS 1
C DEMENTIA DEATH 3
C DEMENTIA PERIRECTAL ABSCESS 3
C DEPRESSION ADVERSE EVENT 1
C DEPRESSION DRUG DOSE OMISSION 1
C DEPRESSION DRUG WITHDRAWAL SYNDROME 1
C DEPRESSION FALL 1
C DEPRESSION FEELING ABNORMAL 1
C DEPRESSION JOINT INJURY 1
C DEPRESSION KNEE ARTHROPLASTY 1
C DEPRESSION NEPHROLITHIASIS 1
C DEPRESSION POSTOPERATIVE ADHESION 1
C DEPRESSION TACHYPHRENIA 1
C ERECTILE DYSFUNCTION EJACULATION DISORDER 1
C FIBROMYALGIA ARTHRALGIA 3
C FIBROMYALGIA DYSPEPSIA 3
C GASTROOESOPHAGEAL REFLUX DISEASE ADENOCARCINOMA 1
C HYPERCHOLESTEROLAEMIA DEATH 1
C HYPERCHOLESTEROLAEMIA PERIRECTAL ABSCESS 1
C HYPERTENSION ARTHRALGIA 1
C HYPERTENSION DYSPEPSIA 1
C HYPERTONIC BLADDER ARTHRALGIA 1
C HYPERTONIC BLADDER DYSPEPSIA 1
C HYPOTHYROIDISM ARTHRALGIA 1
C HYPOTHYROIDISM DYSPEPSIA 1
C INFECTION DEATH 1
C INFECTION PERIRECTAL ABSCESS 1
C INSOMNIA ARTHRALGIA 1
C INSOMNIA DYSPEPSIA 1
C MICTURITION URGENCY DRUG INEFFECTIVE 1
C MICTURITION URGENCY INFUSION SITE PAIN 1
C MICTURITION URGENCY PERIPHERAL COLDNESS 1
C MICTURITION URGENCY VASCULAR ACCESS COMPLICATION 1
C MINERAL SUPPLEMENTATION ARTHRALGIA 1
C MINERAL SUPPLEMENTATION DYSPEPSIA 1
C MULTIPLE MYELOMA ERYTHEMA 1
C MULTIPLE MYELOMA EYE DISORDER 1
C MULTIPLE MYELOMA FULL BLOOD COUNT ABNORMAL 1
C MULTIPLE SCLEROSIS ADENOCARCINOMA 1
C MULTIPLE SCLEROSIS CONTUSION 1
C MULTIPLE SCLEROSIS DRUG INEFFECTIVE 1
C MULTIPLE SCLEROSIS FATIGUE 1
C MULTIPLE SCLEROSIS HEADACHE 1
C MULTIPLE SCLEROSIS HEART RATE IRREGULAR 1
C MULTIPLE SCLEROSIS INFUSION SITE PAIN 1
C MULTIPLE SCLEROSIS PAIN 1
C MULTIPLE SCLEROSIS PERIPHERAL COLDNESS 1
C MULTIPLE SCLEROSIS VASCULAR ACCESS COMPLICATION 1
C MUSCLE SPASTICITY ADENOCARCINOMA 1
C NEUROGENIC BLADDER ADENOCARCINOMA 1
C NOCTURIA DEATH 1
C NOCTURIA PERIRECTAL ABSCESS 1
C ORTHOSTATIC HYPOTENSION DEATH 1
C ORTHOSTATIC HYPOTENSION PERIRECTAL ABSCESS 1
C OSTEOPOROSIS ABASIA 2
C OSTEOPOROSIS ADENOCARCINOMA 1
C OSTEOPOROSIS ANAEMIA POSTOPERATIVE 2
C OSTEOPOROSIS ARTHRALGIA 2
C OSTEOPOROSIS CALLUS FORMATION DELAYED 2
C OSTEOPOROSIS FALL 2
C OSTEOPOROSIS FEMUR FRACTURE 2
C OSTEOPOROSIS GASTRIC DISORDER 2
C OSTEOPOROSIS PAIN IN EXTREMITY 2
C OSTEOPOROSIS POSTOPERATIVE WOUND COMPLICATION 2
C OSTEOPOROSIS PROCEDURAL HYPOTENSION 2
C OSTEOPOROSIS PROCEDURAL PAIN 2
C OSTEOPOROSIS STRESS FRACTURE 2
C PARKINSON'S DISEASE DEATH 4
C PARKINSON'S DISEASE PERIRECTAL ABSCESS 4
C PROPHYLAXIS DEATH 1
C PROPHYLAXIS PERIRECTAL ABSCESS 1
C PROSTATE CANCER DEATH 1
C PROSTATE CANCER PERIRECTAL ABSCESS 1
C PSORIATIC ARTHROPATHY DEATH 1
C PSORIATIC ARTHROPATHY PERIRECTAL ABSCESS 1
C VITAMIN SUPPLEMENTATION ARTHRALGIA 3
C VITAMIN SUPPLEMENTATION DYSPEPSIA 3
C WOUND INFECTION DEATH 1
C WOUND INFECTION PERIRECTAL ABSCESS 1
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