DARIFENACIN: 83 Adverse Event Reports & Safety Profile
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83
Total FAERS Reports
20 (24.1%)
Deaths Reported
23
Hospitalizations
83
As Primary/Secondary Suspect
5
Life-Threatening
2
Disabilities
First Report: 20080903 · Latest Report: 20240301
What Are the Most Common DARIFENACIN Side Effects?
#1 Most Reported
Asphyxia
20 reports (24.1%)
#2 Most Reported
Arteriosclerosis coronary artery
16 reports (19.3%)
#3 Most Reported
Drug interaction
11 reports (13.3%)
All DARIFENACIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Asphyxia | 20 | 24.1% | 20 | 0 |
| Arteriosclerosis coronary artery | 16 | 19.3% | 16 | 0 |
| Death | 11 | 13.3% | 11 | 0 |
| Drug ineffective | 11 | 13.3% | 0 | 2 |
| Drug interaction | 11 | 13.3% | 0 | 8 |
| Peripheral swelling | 8 | 9.6% | 0 | 7 |
| Acute kidney injury | 7 | 8.4% | 0 | 5 |
| Hyponatraemia | 7 | 8.4% | 0 | 7 |
| Urinary retention | 7 | 8.4% | 0 | 6 |
| Weight decreased | 7 | 8.4% | 0 | 4 |
| Arteriosclerosis | 6 | 7.2% | 6 | 0 |
| Cognitive disorder | 6 | 7.2% | 0 | 6 |
| Concomitant disease aggravated | 6 | 7.2% | 0 | 6 |
| Dry mouth | 6 | 7.2% | 0 | 3 |
| Dysuria | 6 | 7.2% | 0 | 6 |
| Inappropriate antidiuretic hormone secretion | 6 | 7.2% | 0 | 6 |
| Product use in unapproved indication | 6 | 7.2% | 0 | 6 |
| Urinary tract infection | 6 | 7.2% | 0 | 6 |
| Condition aggravated | 5 | 6.0% | 0 | 4 |
| Contusion | 5 | 6.0% | 0 | 2 |
Who Reports DARIFENACIN Side Effects? Age & Gender Data
Gender: 66.7% female, 33.3% male. Average age: 77.1 years. Most reports from: CA. View detailed demographics →
Is DARIFENACIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 1 |
| 2015 | 2 | 0 | 1 |
| 2016 | 3 | 0 | 2 |
| 2017 | 2 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 3 | 0 | 0 |
| 2020 | 7 | 0 | 6 |
| 2022 | 1 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
What Is DARIFENACIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 35 |
| Micturition urgency | 9 |
| Hypertonic bladder | 7 |
| Dysuria | 6 |
| Lower urinary tract symptoms | 6 |
| Urinary retention | 6 |
| Urinary tract infection | 6 |
| Urinary incontinence | 5 |
Official FDA Label for DARIFENACIN
Official prescribing information from the FDA-approved drug label.