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Sanctura (Trospium) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sanctura (Trospium) 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 (4)
Death (1)
Life Threatening Events (2)

Reports by Reaction Type

Confusional State (2)Contusion (2)Tachycardia (2)Constipation (2)Fall (2)Tremor (2)Road Traffic Accident (2)Hallucination, Visual (2)Sleep Disorder (2)Feeling Abnormal (2)Pruritus (1)Urticaria (1)

Possible Sanctura side effects in 6 year old female

Reported by a physician from United States on 2012-02-15

Patient: 6 year old female, weighing 90.7 kg (199.5 pounds)

Reactions: Confusional State, Contusion, Tachycardia, Fall, Constipation, Tremor, Road Traffic Accident, Sleep Disorder, Hallucination, Visual, Feeling Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sanctura
    Dosage: unk
    Start date: 2005-07-09

Sanctura
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Hypertonic Bladder
    Start date: 2005-07-09
    End date: 2005-07-21

Other drugs received by patient: Coumadin; Fosamax; Lopressor; Lipitor; Norvasc; Hyzaar; Levoxyl



Possible Sanctura side effects in 83 year old male

Reported by a pharmacist from United States on 2011-12-21

Patient: 83 year old male, weighing 99.6 kg (219.1 pounds)

Reactions: Pruritus, Urticaria, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sanctura
    Dosage: po recent
    Administration route: Oral
    Indication: Nocturia

Metformin HCL
    Dosage: 500mg bid po chronic
    Administration route: Oral
    Indication: Diabetes Mellitus

Other drugs received by patient: Ibuprofen (Advil); Colace; Benadryl; Multivitamin; Fluocinolone Acetonide; Vitamin D; Prednisone TAB



Possible Sanctura side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: female, weighing 90.7 kg (199.5 pounds)

Reactions: Confusional State, Contusion, Tachycardia, Fall, Constipation, Tremor, Road Traffic Accident, Sleep Disorder, Hallucination, Visual, Feeling Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sanctura
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Hypertonic Bladder

Sanctura
    Dosage: unk
    Start date: 2005-07-09

Other drugs received by patient: Coumadin; Fosamax; Hyzaar; Lipitor; Norvasc; Levoxyl; Lopressor



Possible Sanctura side effects in 89 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-20

Patient: 89 year old female

Reactions: Pulmonary Embolism, Orthostatic Hypotension

Adverse event resulted in: death

Drug(s) suspected as cause:
Sinemet
    Dosage: 1df:1.5tabs of levadopa100mg/carbidopa 25mg
    Indication: Parkinson's Disease

Sanctura
    Dosage: sanctura xr tabs
    Indication: Hypertonic Bladder

Other drugs received by patient: Aricept; Calcium Carbonate; Pravachol; Acetaminophen; Synthroid; Timolol Maleate; Fosamax

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