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Darifenacin

Published: July 26, 2026Updated: July 26, 2026

Darifenacin is a muscarinic receptor antagonist used to treat overactive bladder and urinary incontinence. It works by blocking muscarinic receptors in the bladder smooth muscle, reducing involuntary contractions and providing relief from urgency, frequency, and urge incontinence.

Quick summary

A bladder-relaxing medication that treats overactive bladder by blocking muscarinic receptors to reduce involuntary bladder contractions.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
G04BD10
RxNorm
136198
Generic
Darifenacin
Class
atc-g04
Brands
Enablex
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
7.5mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
not established
Maximum
consult physician
Frequency
not applicable
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
7.5mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses exceeding 75 mg may cause significant anticholinergic toxicity
Chronic overdose: Long-term use at supratherapeutic doses may lead to cumulative anticholinergic effects including cognitive impairment
Immediate actions
Supportive care and gastric decontamination if ingestion recent
Antidote
Physostigmine (for severe anticholinergic toxicity)(Reverses central and peripheral anticholinergic effects)
Poison Control: 1-800-222-1222

Special Populations

10 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh potential risks to fetus

Monitor

regular prenatal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh potential risks to fetus

Monitor

regular prenatal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh potential risks to fetus

Monitor

regular prenatal monitoring

Use with caution and monitor for adverse effects.

✗

lactation

breastfeeding
unsafe
FDA Category
C
Dose Adjustment

discontinue breastfeeding or avoid drug

Key Recommendations

darifenacin is excreted in breast milk, avoid use during breastfeeding

Monitor

monitor infant for anticholinergic effects

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly over 65
caution
FDA Category
N
Dose Adjustment

start at low end of dosing range

Key Recommendations

use with caution due to increased sensitivity to anticholinergic effects

Monitor

monitor for cognitive effects, constipation, urinary retention

Use with caution and monitor for adverse effects.

✗

pediatric_age

children under 18
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

not approved for use in pediatric patients, safety and efficacy not established

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

moderate renal impairment
caution
FDA Category
N
Dose Adjustment

no dose adjustment required for mild to moderate impairment

Key Recommendations

use with caution in severe renal impairment

Monitor

monitor renal function periodically

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
N
Dose Adjustment

use lower starting dose

Key Recommendations

use with caution, consider dose reduction

Monitor

monitor renal function and for adverse effects

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate hepatic impairment
caution
FDA Category
N
Dose Adjustment

reduce dose

Key Recommendations

use with caution, dose should not exceed 7.5 mg daily

Monitor

monitor liver function and for adverse effects

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

severe hepatic impairment
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

avoid use in severe hepatic impairment due to significantly increased exposure

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2004

FDA approval date for Darifenacin

drug_classWHO
2023

Drug class

Value:Antimuscarinic

Pharmacological classification

usageMedical guidelines
2023

Primary indication

Value:Overactive bladder, urinary urgency, urge incontinence

Therapeutic use

prescribingFDA
2023

Brand name

Value:Enablex

Commercial brand name

Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency

Competitive muscarinic receptor antagonist that blocks acetylcholine from binding to muscarinic receptors in the detrusor muscle, inhibiting involuntary bladder contractions

May cause anticholinergic side effects such as dry mouth, constipation, and blurred vision; use cautiously in patients with narrow-angle glaucoma, urinary retention, or severe hepatic impairment; efficacy may be reduced in CYP2D6 poor metabolizers

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy