Enablexdarifenacin
According to the FDA label: Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency ( 1 )
597 adverse event reports submitted to the FDA (2005–2026)
Top Reported Adverse Events
The most frequently reported events in association with Enablex in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Drug Ineffective 99 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Peripheral Swelling 91 reports
Swelling in the arms, legs, hands, or feet, often from fluid buildup.
Full definition in the glossary → See all drugs reporting this event →- Herpes Zoster 83 reports
- Pneumonia Viral 79 reports
Anaemia 59 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 59 reports
Oral Pain 57 reports
Pain inside the mouth.
Full definition in the glossary →Arthritis 56 reports
Inflammation of one or more joints, causing pain and stiffness. It often appears in reports as a condition being treated.
Full definition in the glossary →Blood Cholesterol Increased 54 reports
A blood test result showing a higher than normal cholesterol level.
Full definition in the glossary →- Liver Function Test Abnormal 54 reports
Synovitis 54 reports
Inflammation of the lining of a joint, causing swelling and pain.
Full definition in the glossary →Leukopenia 53 reports
A low level of white blood cells, which help fight infection. Closely related to neutropenia, which is a low level of one specific type of white blood cell.
Full definition in the glossary →Fibromyalgia 52 reports
A condition causing widespread muscle pain, fatigue, and tenderness. It often appears in reports as a condition being treated.
Full definition in the glossary →Infection 51 reports
A general report of an infection, used when no more specific type is given.
Full definition in the glossary →Joint Swelling 49 reports
Swelling in or around a joint.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 407 |
| Male | 132 |
| Unknown | 3 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1 |
| 18-34 | 9 |
| 35-49 | 36 |
| 50-64 | 81 |
| 65-74 | 63 |
| 75+ | 180 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Enablex. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 317 |
| Hospitalization | 174 |
| Non-Serious | 138 |
| Death | 56 |
| Life-Threatening | 14 |
| Disability | 9 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Enablex. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 17 |
| 2009 | 7 |
| 2010 | 48 |
| 2011 | 25 |
| 2012 | 15 |
| 2013 | 7 |
| 2014 | 10 |
| 2015 | 20 |
| 2016 | 23 |
| 2017 | 36 |
| 2018 | 65 |
| 2019 | 96 |
| 2020 | 67 |
| 2021 | 49 |
| 2022 | 42 |
| 2023 | 17 |
| 2024 | 28 |
| 2025 | 18 |
| 2026 (partial) | 1 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Enablex
In FDA adverse event reports that mention Enablex, these medications appeared most often in the same report.
- Furosemide (141 reports)
- Levothyroxine (140 reports)
- Pantoprazole (114 reports)
- Estradiol (101 reports)
- Lorazepam (97 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026