Fesoterodine is a prescription medicine indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency, among other approved uses. It is available as extended-release tablets for oral use. MedsAcross supplies Fesoterodine 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.
Toviaz is indicated for the treatment of: • Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg.
Source: US FDA prescribing information
Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine. Muscarinic receptors play a role in contractions of urinary bladder smooth muscle. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.
Source: US FDA prescribing information
• OAB in Adults: The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily. • NDO in Pediatric Patients 6 Years and Older: • Pediatric Patients Weighing Greater than 25 kg and up to 35 kg: The recommended dosage is 4 mg orally once daily. If needed, dosage may be increased to 8 mg orally once daily. • Pediatric Patients Weighing Greater than 35 kg: The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily. • Adult or Pediatric Patients with Renal Impairment: Refer to the full prescribing information for recommended dosage. • Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the full prescribing information for recommended dosage. • Administration: Swallow whole with liquid. Do not chew, divide, or crush.
Source: US FDA prescribing information
Toviaz is contraindicated in patients with any of the following: • known or suspected hypersensitivity to Toviaz or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. Reactions have included angioedema • urinary retention • gastric retention • uncontrolled narrow-angle glaucoma • Known or suspected hypersensitivity to Toviaz or any of its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. • Urinary retention. • Gastric retention. • Uncontrolled narrow-angle glaucoma.
Source: US FDA prescribing information
• Angioedema: Promptly discontinue Toviaz and provide appropriate therapy. • Urinary Retention: Toviaz is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. • Decreased Gastrointestinal Motility: Toviaz is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. • Worsening of Narrow-Angle Glaucoma: Use Toviaz with caution in patients being treated for narrow-angle glaucoma. • Central Nervous System Effects: Somnolence has been reported with Toviaz. Advise patients not to drive or operate heavy machinery until they know how Toviaz affects them. • Worsening of Myasthenia Gravis Symptoms: Use Toviaz with caution in patients with myasthenia gravis.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in labeling: • Angioedema • Urinary Retention • Decreased Gastrointestinal Motility • Most frequently reported adverse events with Toviaz in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%, Toviaz 4 mg, 19%, Toviaz 8 mg, 35%) and constipation (placebo, 2%, Toviaz 4 mg, 4%, Toviaz 8 mg, 6%). • Most frequently reported adverse reactions with Toviaz in pediatric patients (≥2%) with NDO were: diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, weight increased, and headache.
Source: US FDA prescribing information
Antimuscarinic Drugs Coadministration of Toviaz with other antimuscarinic agents that produce dry mouth, constipation, urinary retention, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Fesoterodine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fesoterodine 4 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Fesoterodine 8 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Toviaz 4 mg extended-release tabletOral | Pfizer Laboratories | US FDA | Available on request |
| Toviaz 8 mg extended-release tabletOral | Pfizer Laboratories | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Fesoterodine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Fesoterodine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fesoterodine, including Toviaz.
Yes. The US FDA first approved Fesoterodine on 31 October 2008, according to Drugs@FDA.
Yes. Fesoterodine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Fesoterodine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fesoterodine is classified under ATC code G04BD11 (Fesoterodine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.