Drug Safety Information for SANCTURA (Trospium chloride)

Adverse Drug Reactions for SANCTURA* (Trospium chloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with SANCTURA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective168
2Constipation145
3Fall121
4Dry mouth120
5Fatigue98
6Nausea95
7Urinary tract infection90
8Headache85
9Dizziness*83
10Diarrhoea77
11Confusional state76
12Dyspnoea75
13Asthenia69
14Vision blurred65
15Vomiting64
16Drug interaction62
17Urinary retention54
18Gait disturbance54
19Somnolence50
20Rash50

* This side effect also appears in "Top 10 Side Effects of SANCTURA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking SANCTURA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication1463
2Hypertonic bladder825
3Urinary incontinence488
4Pollakiuria141
5Neurogenic bladder136
6Incontinence127
7Urinary tract disorder126
8Micturition urgency120
9Bladder disorder117
10Bladder spasm83

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for SANCTURA

Total Reports Filed with FDA: 8973


Number of FDA Adverse Event Reports by Patient Age for SANCTURA

Total Reports Filed with FDA: 8973*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Trospium chloride (Santura, Spasmo-urgenin tc, Ceris, Sanctura xr, Trospium chloride, Uraplex, Spasmo-lyt, Sanctura, Trospi, Spasmolyt, Spasmex, Spasmo-urgenin)

Charts are based on 8973 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and SANCTURA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.