Drug Safety Information for DITROPAN XL (Oxybutynin chloride)

Safety-related Labeling Changes for DITROPAN XL (OXYBUTYNIN CHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for GELNIQUE (OXYBUTYNIN CHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for DITROPAN XL* (Oxybutynin 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 DITROPAN XL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fall539
2Nausea*522
3Drug ineffective480
4Asthenia462
5Dizziness462
6Fatigue459
7Dyspnoea431
8Urinary tract infection419
9Pain*408
10Diarrhoea356
11Headache347
12Vomiting346
13Depression307
14Gait disturbance306
15Confusional state285
16Constipation279
17Hypertension272
18Chest pain268
19Pyrexia261
20Oedema peripheral257

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

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

Reason # of FDA Reports
1Product used for unknown indication3938
2Urinary incontinence*1674
3Hypertonic bladder*1310
4Bladder disorder1161
5Incontinence*569
6Pollakiuria506
7Bladder spasm436
8Micturition urgency*256
9Neurogenic bladder179
10Ill-defined disorder149

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


Types of Adverse Events for DITROPAN XL

Total Reports Filed with FDA: 48212


Number of FDA Adverse Event Reports by Patient Age for DITROPAN XL

Total Reports Filed with FDA: 48212*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Oxybutynin chloride (Gelnique, Ditropan, Oxybutynin chloride, Ditropan xl)

Charts are based on 48212 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 DITROPAN XL 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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