Darifenacin is a cholinergic muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. It is available as extended-release tablets for oral use. MedsAcross supplies Darifenacin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Darifenacin 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.
Source: US FDA prescribing information
Darifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play a role in cholinergically mediated functions, including contractions of the urinary bladder smooth muscle. In vitro studies using human recombinant muscarinic receptor subtypes show that darifenacin has greater affinity for the M 3 receptor than for the other known muscarinic receptors (9- and 12-fold greater affinity for M 3 compared to M 1 and M 5, respectively, and 59-fold greater affinity for M 3 compared to both M 2 and M 4 ). M 3 receptors are involved in contraction of human bladder.
Source: US FDA prescribing information
The recommended starting dose of darifenacin extended-release tablets is 7.5 mg orally once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy. Darifenacin extended-release tablets should be taken orally once daily with water. Darifenacin extended-release tablets may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed. For patients with moderate hepatic impairment (Child-Pugh B) or when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of darifenacin extended-release tablets should not exceed 7.5 mg. Darifenacin extended-release tablets are not recommended for use in patients with severe hepatic impairment (Child-Pugh C).
Source: US FDA prescribing information
Darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: urinary retention gastric retention, or uncontrolled narrow-angle glaucoma. Darifenacin extended-release tablets is contraindicated in patients with, or at risk for, the following conditions: urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma.
Source: US FDA prescribing information
Darifenacin extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. Darifenacin extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Darifenacin extended-release tablets should be used with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks. Central Nervous System Effects: Somnolence has been reported with darifenacin. Advise patients not to drive or operate heavy machinery until they know how darifenacin affects them
Source: US FDA prescribing information
The most frequently reported adverse reactions (greater than 3 %) for darifenacin extended-release tablets are: constipation, dry mouth, headache, dyspepsia, nausea, urinary tract infection, accidental injury, and flu symptoms
Source: US FDA prescribing information
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. The concomitant use of darifenacin extended-release tablets with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to effects of gastrointestinal motility
Source: US FDA prescribing information
Storage Store at 20° to 25°C (68° to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Darifenacin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Darifenacin 15 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Darifenacin 7.5 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Darifenacin and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Darifenacin on 22 December 2004, according to Drugs@FDA.
Yes. Darifenacin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Darifenacin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Darifenacin is classified under ATC code G04BD10 (Darifenacin).
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