Prescription medicine
Fesoterodine Brand names: Toviaz
Fesoterodine (Toviaz) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.794 per fesoterodine ER 4 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the fesoterodine FDA label on DailyMed (effective April 7, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 22030 record on Drugs@FDA; every fesoterodine label on DailyMed.
Highlights of the record
FDA label of April 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageToviaz is indicated for the treatment of:
Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Forms and strengths
- 4 mg
- 8 mg
Film-coated extended-release tablet; extended-release tablet.
On the market
- Earliest approval on file
- October 31, 2008 Toviaz, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first December 10, 2015; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 11 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 7, 2027 Toviaz tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.794 per tablet Fesoterodine ER 4 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2025 0 Class I among all firms' recalls; latest December 16, 2025
- FAERS reports
- 10,773 through July 30, 2026
What is fesoterodine used for?
From the label: indications and usageToviaz is indicated for the treatment of:
Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 )
Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2 ) 1.1 Adult Overactive Bladder Toviaz is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity Toviaz is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.
Conditions named in the indications of fesoterodine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Toviaz), Pfizer Laboratories Div Pfizer Inc, effective April 7, 2026 (SPL set 5be745f0-8ae7-4c3c-9962-37d6263326f1), via openFDA; the full label on DailyMed
What does the patient leaflet for fesoterodine 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 TOVIAZ?TOVIAZ can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how TOVIAZ affects you. • Use caution in hot environments. Decreased sweating and severe heat illness can happen when medicines such as TOVIAZ are used in a hot environment. • Drinking alcohol while taking medicines such as TOVIAZ may cause increased drowsiness.
From the patient leaflet: How should I store TOVIAZ?Store TOVIAZ at room temperature between 68° to 77°F (20° to 25°C). • Protect the medicine from moisture by keeping the bottle closed tightly. • Keep TOVIAZ and all medicines out of the reach of children.
Source: FDA drug label (Toviaz), Pfizer Laboratories Div Pfizer Inc, effective April 7, 2026 (SPL set 5be745f0-8ae7-4c3c-9962-37d6263326f1), via openFDA; the full label on DailyMed
Is there a generic for fesoterodine (Toviaz)?
The FDA approved the first generic fesoterodine on December 10, 2015. 11 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists fesoterodine from 11 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Toviaz tablets, the last expiring on December 7, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2015 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fesoterodine (Toviaz)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.794 per Fesoterodine ER 4 mg tablet, down 10% from $0.878 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.
- Fesoterodine ER 4 mg tablet (generic)
- Toviaz ER 8 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fesoterodine ER 4 mg tablet | Generic | $0.794 per tablet | $23.81 | -10% |
| Fesoterodine ER 8 mg tablet | Generic | $0.839 per tablet | $25.18 | -5% |
| Toviaz ER 4 mg tablet | Brand | $9.28 per tablet | $278.35 | -0.1% |
| Toviaz ER 8 mg tablet | Brand | $9.26 per tablet | $277.87 | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fesoterodine been recalled?
The FDA's Enforcement Report lists 2 recalls naming fesoterodine since 2025: 0 Class I (the most serious), 0 Class II, 2 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 16, 2025 | Class III | Alembic Pharmaceuticals Limited | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. |
| October 10, 2025 | Class III | Alembic Pharmaceuticals Limited | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fesoterodine label say about other medicines?
The fesoterodine label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name fesoterodine. 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 |
|---|---|---|
| Carbamazepine | drug interactions | No dosing adjustments are recommended in the presence of CYP3A4 inducers, such as rifampin and carbamazepine. |
| Cimetidine | drug interactions | The effect of weak CYP3A4 inhibitors (e.g. cimetidine) was not examined; it is not expected to be in excess of the effect of moderate inhibitors [see Clinical Pharmacology (12.3) ]. |
| Clarithromycin | drug interactions | Doses of Toviaz greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin [see Dosage and Administration (2.5) ]. |
| Diltiazem | drug interactions | No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice). |
| Erythromycin | drug interactions | No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice). |
| Fluconazole | drug interactions | Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 200 mg twice a day for 2 days, the average (90% confidence interval) increase in C max and AUC of the active metabolite of fesoterodine was approximately 19% (11%–28%) and 27% (18%–36%) respectively. |
| Itraconazole | drug interactions | Doses of Toviaz greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin [see Dosage and Administration (2.5) ]. |
| Ketoconazole | drug interactions | Doses of Toviaz greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin [see Dosage and Administration (2.5) ]. |
| Levonorgestrel | drug interactions | In the presence of fesoterodine, there are no clinically significant changes in the plasma concentrations of combined oral contraceptives containing ethinyl estradiol and levonorgestrel [see Clinical Pharmacology (12.3) ]. |
| Rifampin | drug interactions | No dosing adjustments are recommended in the presence of CYP3A4 inducers, such as rifampin and carbamazepine. |
| Tolterodine | contraindications | CONTRAINDICATIONS 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 [see Clinical Pharmacology (12.1) ]. |
| Verapamil | drug interactions | No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice). |
| Warfarin | drug interactions | Warfarin A clinical study has shown that fesoterodine 8 mg once daily has no significant effect on the pharmacokinetics or the anticoagulant activity (PT/INR) of warfarin 25 mg. |
Other labels that name fesoterodine
Source: FDA drug label (Toviaz), Pfizer Laboratories Div Pfizer Inc, effective April 7, 2026 (SPL set 5be745f0-8ae7-4c3c-9962-37d6263326f1), via openFDA; the full label on DailyMed
What do FAERS reports show for fesoterodine?
The FDA Adverse Event Reporting System holds 10,773 reports that list fesoterodine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 439 are coded as a death and 2,320 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 fesoterodine?
7 other medicines are given the same way (oral) and in the same FDA class as fesoterodine 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 |
| Mirabegron | Overactive bladder | 8 labelers | $9.39 per tablet 50 mg tablet | No current entry |
| Darifenacin | Overactive bladder | 8 labelers | $0.432 per tablet 15 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 fesoterodine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fesoterodine compare with medicines for the same use?
4 side-by-side pages set fesoterodine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fesoterodine
- 7 medicines for the same use
- Fesoterodine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other