Prescription medicine
Darifenacin First approved as Enablex
Darifenacin (Enablex) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $0.432 per darifenacin ER 15 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the darifenacin FDA label on DailyMed (effective February 10, 2026, Torrent Pharmaceuticals Limited); the NDA 21513 record on Drugs@FDA; every darifenacin label on DailyMed.
Highlights of the record
FDA label of February 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDarifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Forms and strengths
- 7.5 mg
- 15 mg
Extended-release tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- December 22, 2004 Enablex, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first March 13, 2015; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 8 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.432 per tablet Darifenacin ER 15 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 857 through July 30, 2026
What is darifenacin used for?
From the label: indications and usageDarifenacin 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.
Conditions named in the indications of darifenacin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Darifenacin), Torrent Pharmaceuticals Limited, effective February 10, 2026 (SPL set e84f1ae3-b9a2-4a15-a299-c75373891cc1), via openFDA; the full label on DailyMed
What does the patient leaflet for darifenacin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking darifenacin extended-release tablets?Darifenacin extended-release tablets can cause blurred vision or dizziness. Do not drive or operate heavy machinery until you know how darifenacin extended-release tablets affects you.
Source: FDA drug label (Darifenacin), Torrent Pharmaceuticals Limited, effective February 10, 2026 (SPL set e84f1ae3-b9a2-4a15-a299-c75373891cc1), via openFDA; the full label on DailyMed
Is there a generic for darifenacin (Enablex)?
The FDA approved the first generic darifenacin on March 13, 2015. 9 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists darifenacin from 8 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for darifenacin (Enablex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.432 per Darifenacin ER 15 mg tablet, up 21% from $0.357 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Darifenacin ER 15 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Darifenacin ER 15 mg tablet | Generic | $0.432 per tablet | $12.97 | +21% |
| Darifenacin ER 7.5 mg tablet | Generic | $0.549 per tablet | $16.48 | -6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has darifenacin been recalled?
The FDA's Enforcement Report lists 2 recalls naming darifenacin since 2021: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the darifenacin label say about other medicines?
The darifenacin label names 19 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name darifenacin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | drug interactions | The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone). |
| Digoxin | drug interactions | Routine therapeutic drug monitoring for digoxin should be continued [see Clinical Pharmacology (12.3)]. |
| Diltiazem | drug interactions | No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (for example, erythromycin, fluconazole, diltiazem and verapamil) [see Dosage and Administration (2) and Clinical Pharmacology (12.3)]. |
| Duloxetine | drug interactions | No dosing adjustments are recommended in the presence of CYP2D6 inhibitors (for example, paroxetine, fluoxetine, quinidine and duloxetine) [see Clinical Pharmacology (12.3)]. |
| Erythromycin | drug interactions | No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (for example, erythromycin, fluconazole, diltiazem and verapamil) [see Dosage and Administration (2) and Clinical Pharmacology (12.3)]. |
| Flecainide | drug interactions | DRUG INTERACTIONS Caution should be taken when darifenacin extended-release tablets is used concomitantly with medications that are predominantly metabolized by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine and tricyclic antidepressants ( 7.2 ) The concomitant use of darifenacin … |
| Fluconazole | drug interactions | No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (for example, erythromycin, fluconazole, diltiazem and verapamil) [see Dosage and Administration (2) and Clinical Pharmacology (12.3)]. |
| Fluoxetine | drug interactions | No dosing adjustments are recommended in the presence of CYP2D6 inhibitors (for example, paroxetine, fluoxetine, quinidine and duloxetine) [see Clinical Pharmacology (12.3)]. |
| Itraconazole | drug interactions | The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone). |
| Ketoconazole | drug interactions | The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone). |
| Levonorgestrel | drug interactions | Combination oral contraceptives Darifenacin (10 mg three times daily) had no effect on the pharmacokinetics of the combination oral contraceptives containing levonorgestrel and ethinyl estradiol [see Clinical Pharmacology (12.3)]. |
| Midazolam | drug interactions | Darifenacin (30 mg daily) did not have a significant impact on midazolam (7.5 mg) pharmacokinetics [ see Clinical Pharmacology (12.3)]. |
| Nelfinavir | drug interactions | The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone). |
| Paroxetine | drug interactions | No dosing adjustments are recommended in the presence of CYP2D6 inhibitors (for example, paroxetine, fluoxetine, quinidine and duloxetine) [see Clinical Pharmacology (12.3)]. |
Every other medicine the darifenacin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Quinidine | drug interactions | No dosing adjustments are recommended in the presence of CYP2D6 inhibitors (for example, paroxetine, fluoxetine, quinidine and duloxetine) [see Clinical Pharmacology (12.3)]. |
| Ritonavir | drug interactions | … potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone). |
| Thioridazine | drug interactions | … CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine and tricyclic antidepressants ( 7.2 ) The concomitant use of darifenacin extended-release tablets with other … |
| Verapamil | drug interactions | No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (for example, erythromycin, fluconazole, diltiazem and verapamil) [see Dosage and Administration (2) and Clinical … |
| Warfarin | drug interactions | Darifenacin had no significant effect on prothrombin time when a single dose of warfarin 30 mg was co-administered with darifenacin (30 mg daily) at steady-state. |
Other labels that name darifenacin
Source: FDA drug label (Darifenacin), Torrent Pharmaceuticals Limited, effective February 10, 2026 (SPL set e84f1ae3-b9a2-4a15-a299-c75373891cc1), via openFDA; the full label on DailyMed
What do FAERS reports show for darifenacin?
The FDA Adverse Event Reporting System holds 857 reports that list darifenacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 106 are coded as a death and 252 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as darifenacin?
7 other medicines are given the same way (oral) and in the same FDA class as darifenacin or labeled mainly for the same use (overactive bladder), the same class first. Overactive bladder lists all 9 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxybutynin | Overactive bladder | 41 labelers | $0.048 per tablet 5 mg tablet | No current entry |
| Solifenacin | Overactive bladder | 20 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Tolterodine | Overactive bladder | 14 labelers | $0.268 per capsule 2 mg capsule | No current entry |
| Trospium | Overactive bladder | 20 labelers | $0.211 per tablet 20 mg tablet | No current entry |
| Fesoterodine | Overactive bladder | 11 labelers | $0.794 per tablet 4 mg tablet | No current entry |
| Mirabegron | Overactive bladder | 8 labelers | $9.39 per tablet 50 mg tablet | No current entry |
| Vibegron | Overactive bladder | none listed | $16.46 per tablet 75 mg tablet | No current entry |
Every medicine labeled for the same conditions as darifenacin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does darifenacin compare with medicines for the same use?
1 side-by-side page set darifenacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to darifenacin
- 7 medicines for the same use
- Other cholinergic muscarinic antagonists
- the pharmacologic class, with prices and generics
- Darifenacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other