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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