LOW-VOLUME · FEMALE-LED
darifenacin Side Effects
darifenacin (also sold as Enablex) is a LOW-VOLUME FAERS extract #503 of 524 by FAERS report count. Still opens on FEMALE-LED: 76% of sex-coded reports are female (407 F / 131 M).
Data updated 2026-05-15
- 596
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
darifenacin reporting skew - 76% of sex-coded reports are female (407 F / 131 M). Volume band LOW-VOLUME #503 of 524 by FAERS report count; caseload SIGNAL.
Thinner FAERS extract for darifenacin (Enablex) (596 reports #503 of 524 by FAERS report count). 76% of sex-coded reports are female (407 F / 131 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2005–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
PERIPHERAL SWELLING leads 91 of 596 reports
FEMALE-LED reporters · age peak 75+
Female-led reporters (76% of sex-coded rows)
Age peak 75+ (180 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (56 reports, 9.4%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 24 |
| ASPHYXIA | 20 |
| ARTERIOSCLEROSIS CORONARY ARTERY | 16 |
| COMPLETED SUICIDE | 7 |
| ARTERIOSCLEROSIS | 6 |
| RESPIRATORY FAILURE | 3 |
| ACUTE KIDNEY INJURY | 2 |
| ATRIAL FIBRILLATION | 2 |
| BRADYCARDIA | 2 |
| CONDITION AGGRAVATED | 2 |
| COVID-19 | 2 |
| DEMENTIA | 2 |
| FALL | 2 |
| GASTROINTESTINAL HAEMORRHAGE | 2 |
| LUNG INFILTRATION | 2 |
| PNEUMONIA | 2 |
| SEPSIS | 2 |
| TACHYCARDIA | 2 |
| ABDOMINAL DISCOMFORT | 1 |
| ABDOMINAL PAIN | 1 |
Reactions in Hospitalization Reports
Hospitalization mid-share (174, 29.2%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| DYSPNOEA | 31 |
| FALL | 19 |
| DRUG INTERACTION | 17 |
| URINARY TRACT INFECTION | 17 |
| PNEUMONIA | 16 |
| FATIGUE | 13 |
| ACUTE KIDNEY INJURY | 12 |
| COGNITIVE DISORDER | 10 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 10 |
| CONDITION AGGRAVATED | 9 |
| CONTRAINDICATED PRODUCT ADMINISTERED | 9 |
| DYSURIA | 9 |
| HYPONATRAEMIA | 9 |
| MALAISE | 9 |
| OEDEMA PERIPHERAL | 9 |
| WEIGHT DECREASED | 9 |
| CEREBRAL HAEMORRHAGE | 8 |
| DEPRESSION | 8 |
| DIZZINESS | 8 |
| HYPOXIA | 8 |
How to read darifenacin FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-MID)
FAERS holds 596 voluntary reports linked to darifenacin (Enablex), 2005-2025. Death is listed on 56 (9.4%). Hospitalization appears on 174 (29.2%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and FEMALE-LED skew still differ by drug; not a complete safety profile.
Read with darifenacin
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 580 FAERS cases (Δ 16 lighter vs darifenacin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 637 FAERS cases (Δ 41 heavier vs darifenacin); DEATH-MARKED · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 541 FAERS cases (Δ 55 lighter vs darifenacin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 537 FAERS cases (Δ 59 lighter vs darifenacin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.7 pp vs darifenacin's DEATH-HEAVY): CASELOAD · HOSP-MID.
darifenacin stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.