Molecule
Solifenacin is a cholinergic muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. It is available as tablets and extended-release tablets for oral use. MedsAcross supplies Solifenacin 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.
Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Source: US FDA prescribing information
Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.
Source: US FDA prescribing information
• 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily. • Do not exceed the 5 mg dose of solifenacin succinate tablets in patients with: o Severe renal impairment creatinine clearance < 30 mL/min/1.73 m 2. o Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate tablets are not recommended in patients with severe hepatic impairment (Child-Pugh C). o Concomitant use of strong CYP3A4 inhibitors.
Source: US FDA prescribing information
Solifenacin succinate tablets are contraindicated in patients: With urinary retention, With gastric retention, With uncontrolled narrow-angle glaucoma, and Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. Reported adverse reactions have included anaphylaxis and angioedema. • Urinary retention. • Gastric retention. • Uncontrolled narrow-angle glaucoma. • Hypersensitivity to this product or any of its components.
Source: US FDA prescribing information
• Angioedema and Anaphylactic Reactions: Promptly discontinue solifenacin succinate tablets and provide appropriate therapy. • Urinary Retention: solifenacin succinate tablets is not recommended for use in patients with clinically significant bladder outlet obstruction. • Gastrointestinal Disorders: solifenacin succinate tablets are not recommended for use in patients with decreased gastrointestinal motility. • Central Nervous System Effects: Somnolence has been reported with solifenacin succinate tablets. Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate tablets affect them. • Controlled Narrow-Angle Glaucoma: Use solifenacin succinate tablets with caution in patients being treated for narrow-angle glaucoma.
Source: US FDA prescribing information
The most common adverse reactions (> 4% in solifenacin succinate tablets -treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses, and urinary tract infection and blurred vision at the 10 mg dose.
Source: US FDA prescribing information
CYP3A4 Inhibitors: Do not exceed the 5 mg dose of solifenacin succinate tablets with concomitant use of strong CYP3A4 inhibitors. Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin. The dosage of solifenacin succinate tablets greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors.
Source: US FDA prescribing information
Store at 20ºC to 25ºC (68ºF to 77ºF) with excursions permitted from 15ºC to 30ºC (59°F to 86ºF).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Solifenacin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Solifenacin 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Solifenacin 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Solifenacin 10 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.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 19 November 2004 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 3 presentations of Solifenacin and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Solifenacin on 19 November 2004, according to Drugs@FDA.
No listed presentation of Solifenacin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.