Drug Safety Information for URECHOLINE (Bethanechol chloride)

Adverse Drug Reactions for URECHOLINE* (Bethanechol 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 URECHOLINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea58
2Fall52
3Pain51
4Urinary tract infection50
5Fatigue45
6Dizziness40
7Asthenia37
8Gait disturbance37
9Drug ineffective*35
10Pyrexia35
11Headache33
12Diarrhoea32
13Dyspnoea32
14Vomiting31
15Anxiety28
16Pneumonia28
17Death27
18Chest pain27
19Arthralgia26
20Malaise26

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

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

Reason # of FDA Reports
1Product used for unknown indication629
2Bladder disorder197
3Urinary retention61
4Neurogenic bladder44
5Gastrooesophageal reflux disease36
6Urinary incontinence35
7Nausea25
8Urinary tract infection16
9Urinary tract disorder16
10Gastrointestinal hypomotility15

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


Types of Adverse Events for URECHOLINE

Total Reports Filed with FDA: 4613


Number of FDA Adverse Event Reports by Patient Age for URECHOLINE

Total Reports Filed with FDA: 4613*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bethanechol chloride (Myotonachol, Urecholine, Bethanecol, Myocholine, Myotonine, Bethanechol, Duvoid, Bethanechol chloride)

Charts are based on 4613 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 URECHOLINE Reviews and Review Summary .

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.

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