Quick answers
- What is Fesoterodine fumarate used for?
- The FDA-approved label (Fesoterodine Fumarate, Ascend Laboratories, LLC, July 16, 2026) says: “Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Fesoterodine fumarate?
- The “Adverse Reactions” section of the FDA label (Fesoterodine Fumarate, Ascend Laboratories, LLC, July 16, 2026) begins: “The following clinically significant adverse reactions are described elsewhere in labeling: Angioedema [see Warnings and Precautions (5.1)] Urinary Retention [see Warnings and Precautions (5.2)] Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3)] Most frequently reported adverse events with fesoterodine fumarate extended-release tablets in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; fesoterodine fumarate extended-release tablet 4 mg, 19%; fesoterodine fumarate extended-release tablet 8 mg, 35%) and constipation (placebo, 2%; fesoterodine fumarate extended-release tablet 4 mg, 4%; fesoterodine fumarate extended-release tablet 8 mg, 6%).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Fesoterodine fumarate?
- The “Drug Interactions” section of the FDA label (Fesoterodine Fumarate, Ascend Laboratories, LLC, July 16, 2026) begins: “Antimuscarinic Drugs Coadministration of fesoterodine fumarate extended-release tablets 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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fesoterodine fumarate have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fesoterodine fumarate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fesoterodine fumarate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 16, 2025 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Fesoterodine fumarate?
- 12 companies list prescription products of Fesoterodine fumarate in the FDA NDC Directory, including Dr. Reddy's Laboratories Inc., Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals Inc.
What Fesoterodine fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. …
— FDA label: Fesoterodine Fumarate, Ascend Laboratories, LLC, effective July 16, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, extended release, oral), Fesoterodine Fumarate, Ascend Laboratories, LLC; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 12 FDA labels for this medicine have a boxed warning.
Fesoterodine fumarate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following clinically significant adverse reactions are described elsewhere in labeling: Angioedema [see Warnings and Precautions (5.1)] Urinary Retention [see Warnings and Precautions (5.2)] Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3)] Most frequently reported adverse events with fesoterodine fumarate extended-release tablets in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; fesoterodine fumarate extended-release tablet 4 mg, 19%; fesoterodine fumarate extended-release tablet 8 mg, 35%) and constipation (placebo, 2%; fesoterodine fumarate extended-release tablet 4 mg, 4%; fesoterodine fumarate extended-release tablet 8 mg, 6%).
Read more of this section
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Pediatric use information is approved for Pfizer Inc.'s TOVIAZ® (fesoterodine fumarate) Extended-Release Tablets. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Overactive Bladder (OAB) The safety of fesoterodine fumarate extended-release tablets was evaluated in Phase 2 and 3 controlled trials in a total of 2,859 patients with overactive bladder, of which 2,288 were treated with fesoterodine fumarate extended-release tablets. Of this total, 782 received fesoterodine fumarate extended-release tablets 4 mg/day, and 785 received fesoterodine fumarate extended-release tablets 8 mg/day with treatment periods of 8-or 12-weeks. Approximately 80% of these patients had greater than 10-weeks of exposure to fesoterodine fumarate extended-release tablets in these trials. A total of 1,964 patients participated in two 12-week, Phase 3 efficacy and safety studies and subsequent open- label extension studies. In these two studies combined, 554 patients received fesoterodine fumarate extended-release tablets 4 mg/day and 566 patients received fesoterodine fumarate extended-release tablets 8 mg/day. In Phase 2 and 3 placebo-controlled trials combined, the incidences of serious adverse events in patients receiving placebo, fesoterodine fumarate extended-release tablets 4 mg, and fesoterodine fumarate extended-release tablets 8 mg were 1.9%, 3.5%, and 2.9%, respectively. All serious adverse events were judged to be not related or unlikely to be related to study medication by the investigator, except for four patients receiving fesoterodine fumarate extended-release tablets who reported one serious adverse reaction each: angina, chest pain, gastroenteritis, and QT prolongation on ECG. The most commonly reported adverse event in patients treated with fesoterodine fumarate extended-release tablets was dry mouth. The incidence of dry mouth was higher in those taking 8 mg/day (35%) and in those taking 4 mg/day (19%), as compared to placebo (7%). Dry mouth led to discontinuation in 0.4%, 0.4%, and 0.8% of patients receiving placebo, fesoterodine fumarate extended-release tablets 4 mg, and fesoterodine fumarate extended-release tablets 8 mg, respectively.
— FDA label: Fesoterodine Fumarate, Ascend Laboratories, LLC, effective July 16, 2026. This is part of the section. Read the full label on DailyMed →
Fesoterodine fumarate drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Antimuscarinic Drugs Coadministration of fesoterodine fumarate extended-release tablets 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.
Read more of this section
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. 7.2 CYP3A4 Inhibitors Doses of fesoterodine fumarate extended-release tablets 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)]. In a study in adults, coadministration of the strong CYP3A4 inhibitor ketoconazole with fesoterodine led to approximately a doubling of the maximum concentration (C max) and area under the concentration versus time curve (AUC) of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of fesoterodine. Compared with CYP2D6 extensive metabolizers not taking ketoconazole, further increases in the exposure to 5-HMT were observed in subjects who were CYP2D6 poor metabolizers taking ketoconazole [see Clinical Pharmacology (12.3)]. There is no clinically relevant effect of moderate CYP3A4 inhibitors on the pharmacokinetics of fesoterodine. 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% to 28%) and 27% (18% to 36%) respectively. No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice). 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)]. Pediatric use information is approved for Pfizer Inc.'s TOVIAZ ® (fesoterodine fumarate) Extended-Release Tablets. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 7.3 CYP3A4 Inducers No dosing adjustments are recommended in the presence of CYP3A4 inducers, such as rifampin and carbamazepine. Following induction of CYP3A4 by coadministration of rifampin 600 mg once a day, C max and AUC of the active metabolite of fesoterodine decreased by approximately 70% and 75%, respectively, after oral administration of fesoterodine fumarate extended-release tablets 8 mg. The terminal half-life of the active metabolite was not changed. 7.4 CYP2D6 Inhibitors The interaction with CYP2D6 inhibitors was not tested clinically. In poor metabolizers for CYP2D6, representing a maximum CYP2D6 inhibition, C max and AUC of the active metabolite are increased 1.7- and 2-fold, respectively.
— FDA label: Fesoterodine Fumarate, Ascend Laboratories, LLC, effective July 16, 2026. This is part of the section. Read the full label on DailyMed →
Fesoterodine fumarate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
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. (2.1) Adult Patients with Renal Impairment: Refer to the full prescribing information for recommended dosage. (2.3) Dosage Modifications Due to Strong CYP3A4 Inhibitors: Refer to the full prescribing information for recommended dosage. (2.5) Administration: Swallow whole with liquid.
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Do not chew, divide, or crush. Take with or without food. (2.6) 2.1 Recommended Dosage for Adult Patients With OAB The recommended starting dosage of fesoterodine fumarate extended-release tablets in adults is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of fesoterodine fumarate extended-release tablets 8 mg once daily. For administration instructions, see Dosage and Administration (2.6). 2.3 Recommended Dosage in Adult Patients with Renal Impairment The recommended dosage of fesoterodine fumarate extended-release tablets in adult patients with renal impairment is described in Table 1 [see Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.6). Table 1: Fesoterodine fumarate extended-release tablets Recommended Dose in Adult Patients With Renal Impairment (Administered Orally Once Daily) Estimated Creatinine Clearance 1 Recommended Dose CLcr 30 to 89 mL/min 8 mg CLcr 15 to 29 mL/min 4 mg CLcr <15 mL/min 4 mg 1 Calculate CLcr using the Cockcroft-Gault formula 2.5 Fesoterodine fumarate extended-release tablets Dosage Modifications Due to Strong CYP3A4 Inhibitors Adult Patients with OAB The maximum recommended dosage is fesoterodine fumarate extended-release tablet 4 mg orally once daily in adult patients taking strong CYP3A4 inhibitors [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. For administration instructions, see Dosage and Administration (2.6). 2.6 Administration Instructions Swallow fesoterodine fumarate extended-release tablets whole with liquid. Do not chew, divide, or crush. Take with or without food [see Clinical Pharmacology (12.3)]. Pediatric use information is approved for Pfizer Inc.'s TOVIAZ ® (fesoterodine fumarate) Extended-Release Tablets. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Table from the label
| Estimated Creatinine Clearance1 | Recommended Dose |
|---|---|
| CLcr 30 to 89 mL/min | 8 mg |
| CLcr 15 to 29 mL/min | 4 mg |
| CLcr <15 mL/min | 4 mg |
— FDA label: Fesoterodine Fumarate, Ascend Laboratories, LLC, effective July 16, 2026. Read the full label on DailyMed →
Fesoterodine fumarate in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary There are no available data with the use of fesoterodine fumarate extended-release tablets in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
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In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times respectively the maximum recommended human dose (MRHD) of 8 mg/day, based on AUC (see Data). The background risk of major birth defects and miscarriage for the indicated population are unknown. However, in the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data No dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. In mice at 6 to 27 times the expected exposure at the maximum recommended human dose (MRHD)of 8 mg based on AUC (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. One fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. In rabbits treated at 3 to 11 times the MRHD (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. In rabbits at 9 to 11 times the MRHD (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). In rabbits at 3 times the MRHD (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. Oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. No effects were noted on mating and reproduction of the F 1 dams or on the F 2 offspring.
— FDA label: Fesoterodine Fumarate, Ascend Laboratories, LLC, effective July 16, 2026. Read the full label on DailyMed →
When Fesoterodine fumarate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following: known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see Clinical Pharmacology (12.1)].
Read more of this section
Reactions have included angioedema [see Warnings and Precautions (5.1)] urinary retention [see Warnings and Precautions (5.2)] gastric retention [see Warnings and Precautions (5.3)] uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.4)] Known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules.(4) Urinary retention (4) Gastric retention (4) Uncontrolled narrow-angle glaucoma. (4)
— FDA label: Fesoterodine Fumarate, Ascend Laboratories, LLC, effective July 16, 2026. Read the full label on DailyMed →
Fesoterodine fumarate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Overdosage with fesoterodine fumarate extended-release tablets can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended.
— FDA label: Fesoterodine Fumarate, Ascend Laboratories, LLC, effective July 16, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 24 in the FDA NDC Directory |
| Brand names | Toviaz |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fesoterodine fumarate 4 mg tablet, extended release | Generic | $0.7765 per tablet |
| fesoterodine fumarate 4 mg tablet, film coated, extended release | Generic | $0.7765 per tablet |
| fesoterodine fumarate 4 mg tablet, film coated, extended release | Brand: Toviaz | $9.30 per tablet |
| fesoterodine fumarate 8 mg tablet, extended release | Generic | $0.8849 per tablet |
| fesoterodine fumarate 8 mg tablet, film coated, extended release | Generic | $0.8849 per tablet |
| fesoterodine fumarate 8 mg tablet, film coated, extended release | Brand: Toviaz | $9.27 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Dr. Reddy's Laboratories Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Alembic Pharmaceuticals Inc.2 products
- Zydus Lifesciences Limited2 products
- Pfizer Laboratories Div Pfizer Inc2 products
- Aurobindo Pharma Limited2 products
- Ascend Laboratories, LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- NorthStar RxLLC2 products
- Golden State Medical Supply, Inc.2 products
- Zydus Pharmaceuticals USA Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022030 TOVIAZ | Pfizer | October 31, 2008 | 12, latest February 28, 2024 2024: Labeling · 2024: Labeling · 2021: Efficacy |
Generic approvals (7)
- ANDA204827Alkem Labs Ltd · December 10, 2015
- ANDA205007Aurobindo Pharma · February 17, 2017
- ANDA204946Zydus Pharms · October 3, 2017
- ANDA204975DR Reddys · August 13, 2019
- ANDA204973Alembic · January 4, 2023
- ANDA205002Amneal Pharms Ny · January 4, 2023
- ANDA204792Hetero Labs Ltd V · January 9, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 16, 2025 · Class III · Ongoing · D-0248-2026
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, N — Alembic Pharmaceuticals Limited
-
October 10, 2025 · Class III · Ongoing · D-0156-2026
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminst — Alembic Pharmaceuticals Limited
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 810071, 810075, 810077, 810079 |
|---|---|
| SPL set ID of the quoted label | b1abd9cb-c480-437b-8531-e2de3e188363 |
| FDA labels (SPL) | 12 |
| FDA applications | NDA022030, 7 ANDA |
| Active ingredients (FDA) | FESOTERODINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- ToviazBrand page: products, maker and price
- Overactive bladderCondition named on the label: hospitals that treat it
- Dr. Reddy's Laboratories Inc.Maker or distributor
- Alembic Pharmaceuticals LimitedMaker or distributor
- Alembic Pharmaceuticals Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fesoterodine Fumarate, Ascend Laboratories, LLC, effective July 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →