Darifenacin
داریفناسین
🚻 Genito Urinary System And Sex HormonesM3 antimuscarinic
Market / country: 🇺🇸 USA
Enablex (US)
🧮 Dose calculator
Overactive bladder · Regimen source: FDA Darifenacin ER · 2
- • Swallow whole. Moderate hepatic impairment or potent CYP3A4 inhibitors: max 7.5 mg; severe hepatic impairment not recommended. FDA Darifenacin ER · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Urinary retention; gastric retention; uncontrolled narrow-angle glaucoma. FDA Darifenacin ER · 4
Warnings
- • Urinary retention (especially with bladder outlet obstruction); angioedema; decreased GI motility; CNS effects (confusion, somnolence). FDA Darifenacin ER · 5
Formulations
- 7.5 mg extended-release tablet — tablet 🇺🇸 USA FDA Darifenacin ER · 3
- 15 mg extended-release tablet — tablet 🇺🇸 USA FDA Darifenacin ER · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Darifenacin ER · 8.1
“Risk Summary There are no available data on darifenacin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Darifenacin ER · 8.2
“Risk Summary There are no data on the presence of darifenacin in human milk, the effects on the breastfed infant, or the effects of darifenacin on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Darifenacin ER · 8.4
“The safety and effectiveness of darifenacin extended-release tablets in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Darifenacin ER · 8.5
“No dose adjustment is recommended for elderly patients [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14 )] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA205209
- DailyMed (FDA label)FDA Darifenacin ER
- MedlinePlus (NIH)Darifenacin
- WHO ATC/DDDG04BD10
- Darooyab (Iran)Darifenacin
🇮🇷 Registered in Iran Darooyab · G-878/Darifenacin
Dosage forms with Iranian generic codes, per Darooyab.
- 18533 · DARIFENACIN 15 MG TAB · قرص داریفناسین ۱۵ میلیگرم
- 11433 · DARIFENACIN 7.5MG TAB · قرص داریفناسین ۷٫۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Darifenacin ER · 3FDA Darifenacin ER · 2FDA Darifenacin ER · 4FDA Darifenacin ER · 5FDA Darifenacin ER · SPL approval / marketing categoryFDA Darifenacin ER · 8.1FDA Darifenacin ER · 8.2FDA Darifenacin ER · 8.4FDA Darifenacin ER · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-878/Darifenacin
- Clinical review⚠ Unverified