FDA-filed SPL labeling · retrieved through openFDA

Fesoterodine

Fesoterodine is an oral extended-release medication used to treat overactive bladder in adults and, as Toviaz, neurogenic detrusor overactivity in children aged 6 and older.

Brand name Toviaz
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveApr 7, 2026
Clinical labels in scope ⓘ12
AvailabilityRx
Earliest approval/marketing year ⓘ2008
FDA-listed product records ⓘ65
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026 🚨Recall on record · 2
⭐ Fesoterodine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Fesoterodine is a once-daily extended-release tablet that calms an overactive bladder, reducing urgency, frequency, and leakage in adults; Toviaz is also approved for bladder overactivity caused by nerve conditions in children 6 and older. Dry mouth and constipation are the most common side effects, and strong CYP3A4 inhibitors like ketoconazole can raise drug levels enough to require a dose change. Swallow the tablet whole, take it with or without food, and let your prescriber know about all other medications before you start.
How we write & review this content — our editorial policy →

📖 Fesoterodine: Patient Information Guide

A plain-language walkthrough of Fesoterodine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Fesoterodine is an extended-release oral tablet used across the following conditions:

  • Overactive bladder (OAB) in adults — treats urgency (sudden, hard-to-ignore urge to urinate), frequent urination, and urge urinary incontinence (leaking caused by that sudden urge)
  • Neurogenic detrusor overactivity (NDO) in children aged 6 and older weighing more than 25 kg — Toviaz (fesoterodine fumarate extended-release tablets) is specifically approved for this use; the generic fesoterodine fumarate labeling does not include pediatric NDO information due to marketing exclusivity
⚙️How it works▾

Fesoterodine is a muscarinic receptor antagonist — it blocks specific nerve receptors in the bladder wall that normally trigger muscle contractions. Once you take it orally, your body rapidly converts it into its active form (called 5-hydroxymethyl tolterodine), which is responsible for the drug's effects. By blocking those receptors, fesoterodine reduces unwanted bladder contractions, increases the amount of urine the bladder can hold before the urge kicks in, and helps you regain control over when you go.

💊How it's taken▾

Fesoterodine is taken once daily by mouth as an extended-release tablet. It can be taken with or without food — food has no clinically meaningful effect on how the drug works. The tablet must be swallowed whole; do not chew, crush, or split it, as this would destroy the extended-release design.

  • Dose adjustments may be needed for adults with kidney impairment
  • Adults taking strong CYP3A4 inhibitors (like ketoconazole or clarithromycin) should not exceed the lower dose — your prescriber will guide this
  • For pediatric NDO patients, dosing is based on body weight and may be titrated over time under medical supervision

Always follow your prescriber's exact instructions, and don't adjust your dose on your own.

🤒Side effects — in detail▾

The most common side effects of fesoterodine are related to its anticholinergic (nerve-blocking) action:

  • Dry mouth — the most frequently reported; more common at higher doses
  • Constipation
  • Dry eyes
  • Urinary tract infection (UTI)
  • Difficult or painful urination (dysuria)
  • Upset stomach or indigestion (dyspepsia)
  • Nausea
  • Headache, dizziness, or drowsiness
  • Increased heart rate — mild increases have been seen in both adults and children
  • In children treated for NDO: diarrhea, abdominal pain, and weight gain were also reported, along with some vision-related effects (blurred vision, accommodation difficulty)

Stop the medication and get emergency help if you develop swelling of the face, lips, tongue, or throat (angioedema), or if you suddenly cannot urinate at all — these require immediate medical attention.

⚠️Warnings & precautions▾
  • Angioedema (serious swelling): Swelling of the face, lips, tongue, or throat has occurred — sometimes after just the first dose. This can block your airway and become life-threatening. Stop fesoterodine immediately and seek emergency care if this happens.
  • Urinary retention: Fesoterodine is not recommended for people with significant bladder outlet blockage and is contraindicated in those who already cannot urinate. It can make retention worse and potentially injure the kidneys.
  • Slowed gut function: The medication can slow bowel movement. It is contraindicated in gastric retention and not recommended in people with severe constipation.
  • Narrow-angle glaucoma: Fesoterodine can worsen this eye condition. It is contraindicated in uncontrolled narrow-angle glaucoma and should be used with caution in controlled cases.
  • Drowsiness and CNS effects: Headache, dizziness, and somnolence (sleepiness) can occur. Do not drive or use heavy machinery until you know how this drug affects you.
  • Myasthenia gravis: Use with caution — fesoterodine may worsen muscle weakness in people with this condition.
  • Heart rate increases in children: Meaningful increases in heart rate were observed in pediatric NDO patients, especially younger children on higher doses. Heart rate should be monitored.
🔀What it interacts with▾

Fesoterodine can interact with several drugs and substances — always share your full medication list with your prescriber and pharmacist:

  • Other anticholinergic/antimuscarinic drugs — combining them amplifies side effects like dry mouth, constipation, and urinary retention
  • Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin) — nearly double the amount of active drug in your blood; doses above the lower level are not recommended in adults taking these, and pediatric dosing must also be reduced or the drug avoided
  • Moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem, verapamil, grapefruit juice) — cause a modest increase in drug levels; no dose adjustment required, but worth flagging to your pharmacist
  • CYP3A4 inducers (rifampin, carbamazepine) — can reduce fesoterodine levels by about 70–75%, potentially making it less effective; no dose adjustment is currently recommended, but your prescriber should be aware
  • Warfarin — no meaningful interaction found in studies, but continue standard INR monitoring as usual
  • Oral contraceptives — no clinically significant changes in hormone levels were seen

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not take if you have urinary retention, gastric (stomach) retention, uncontrolled narrow-angle glaucoma, or a known allergy to fesoterodine or tolterodine
  • Tell your doctor if you have any bladder outlet obstruction or difficulty emptying your bladder
  • Tell your doctor if you have narrow-angle glaucoma that is being treated — the medication can still be used with caution
  • Tell your doctor if you have severe constipation or very slow gut movement
  • Tell your doctor if you have myasthenia gravis — fesoterodine may worsen muscle weakness
  • Kidney impairment: Dose adjustments are needed in adults with reduced kidney function — your prescriber will determine the right amount
  • Pregnancy: No human safety data exist. Animal studies showed fetal effects at high doses. Discuss risks and benefits honestly with your doctor
  • Breastfeeding: It is not known whether fesoterodine passes into breast milk. Discuss with your doctor before using
  • Older adults (especially 75+): More likely to experience anticholinergic side effects including dry mouth, constipation, dizziness, and UTIs — use with extra monitoring
  • Children under 6, or weighing 25 kg or less: Safety and effectiveness have not been established
🚑If you take too much▾

Taking too much fesoterodine can cause severe anticholinergic effects — think extreme dry mouth, inability to urinate, rapid heart rate, confusion, or blurred vision. Treatment focuses on managing these symptoms and supporting the body. An ECG (heart tracing) is recommended to monitor heart rhythm after an overdose — if you suspect an overdose, seek emergency medical help immediately.

📡Pharmacodynamics — effects in the body▾

Fesoterodine works directly on the bladder: in clinical studies, it increased both the volume of urine needed to trigger the first bladder contraction and the overall bladder capacity, in a dose-related way. It does not appear to affect the heart's electrical rhythm (QT interval) at therapeutic or even high doses, though it does modestly raise heart rate — by a few beats per minute at typical doses in adults, and somewhat more in children at higher doses.

🔬Pharmacokinetics — how your body processes it▾

After you swallow fesoterodine, it is rapidly converted by enzymes in your body into its active form — fesoterodine itself is never actually detected in the bloodstream. The active form reaches peak blood levels in about 5 hours and has a half-life (the time for half of it to leave your body) of roughly 7 hours after oral dosing. It is processed mainly by the liver (via the CYP2D6 and CYP3A4 enzyme pathways) and cleared primarily through urine. About 7% of people process CYP2D6 more slowly, which roughly doubles the amount of active drug in their system — an important reason your prescriber may adjust your dose based on other medications you take.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) . Protect from moisture.

📄 Written from Fesoterodine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

195

Supplements & herbs that interact with Fesoterodine

195 supplements and herbal products have documented interactions with Fesoterodine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 147
  • Minor · 39
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major GRAPEFRUIT Major KAVA Major L-TRYPTOPHAN Major ST. JOHN'S WORT Major +187 more
Every supplement checked against Fesoterodine — ranked by severity The full interaction hub: 9 major · 147 moderate · 39 minor · every one linked to its full report. Check Fesoterodine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Fesoterodine — the kind of thing our pharmacy team would talk through with you at the counter.

What is fesoterodine actually doing for my bladder? ▾
It's calming down overactive signals in your bladder muscle. When your bladder squeezes too often or too urgently, it's because certain nerve receptors are overstimulated. Fesoterodine blocks those receptors, so your bladder can hold more urine, and those sudden, can't-wait urges become less frequent and less intense.
Do I have to take it with food? ▾
No, you can take it with or without food — it works either way. The one thing that does matter is how you take the tablet: swallow it whole with a glass of liquid. Don't chew, crush, or split it, because the tablet is designed to release the medication slowly over the day, and breaking it ruins that.
Dry mouth seems really common — is there anything I can do about it? ▾
Dry mouth is the most common side effect, and it's more noticeable at higher doses. Sipping water throughout the day, chewing sugar-free gum, or using sugar-free hard candies can help. For most people it's mild to moderate and tends to improve with time. If it's really bothering you, talk to your prescriber — there may be room to adjust your dose.
What side effects should make me call my doctor right away? ▾
The two big ones to watch for are swelling of the lips, tongue, or throat — even a little — and being completely unable to urinate. Both need medical attention right away. Also call your doctor if you develop new or worsening eye pain (especially if you have glaucoma), or if you feel so drowsy or confused that it's affecting your daily life.
I take other medications — are there any I need to watch out for? ▾
Yes, a few important ones. Certain antifungals (like ketoconazole) and some antibiotics (like clarithromycin) can raise fesoterodine levels significantly, so your prescriber will likely limit your dose if you take those. Also, if you're on any other bladder, allergy, or stomach medications with anticholinergic effects, combining them can make side effects like dry mouth and constipation worse. Always share your full medication list — including over-the-counter drugs and supplements — with your pharmacist.
Is it safe to drive while taking this? ▾
Be cautious, especially when you first start or increase your dose. Fesoterodine can cause drowsiness or dizziness in some people. The advice is to hold off on driving or operating heavy machinery until you know how it affects you personally. Once you've been on a stable dose and feel fine, most people don't have ongoing issues — but everyone's different.
Is Fesoterodine available over the counter? ▾
Fesoterodine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Fesoterodine first available? ▾
Fesoterodine has been available in the United States since at least 2008, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fesoterodine? ▾
Fesoterodine is supplied by 22 manufacturers listed in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc, Ascend Laboratories, LLC, Aurobindo Pharma Limited.

💬 Answers drafted from Fesoterodine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Fesoterodine supplement interactions195 checked — ranked by severity 🌿Drug & Supplement CheckerFesoterodine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fesoterodine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Fesoterodine comes

Fesoterodine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Extended-release tablet

By mouth
Brands Toviaz
How this form is used
What it may be used for
  • Treats overactive bladder (OAB) in adults with urgency, frequent urination, and urge urinary incontinence
  • Toviaz is approved to treat neurogenic detrusor overactivity (NDO) in children aged 6 and older weighing more than 25 kg
Important instructions
  • Swallow the tablet whole with liquid — do not chew, crush, or divide it
  • Take once daily, with or without food
  • If you take a strong CYP3A4 inhibitor (such as ketoconazole or clarithromycin), your prescriber may limit your dose
  • Follow your prescriber's guidance on dose — adjustments may be needed based on kidney function or other medications
Available strengths 2 strengths
4 mg 8 mg
57 FDA-listed product records ⓘ

📊 Fesoterodine across the U.S. market

How Fesoterodine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
22
Manufacturers
2
Brand names
65
FDA-listed product records ⓘ
2008
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Pfizer Laboratories Div Pfizer Inc9%
Ascend Laboratories, LLC9%
Aurobindo Pharma Limited9%
Golden State Medical Supply, Inc.6%
Zydus Pharmaceuticals USA Inc.6%
Zydus Lifesciences Limited6%
Other makers54%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Fesoterodine is used

A general measure of how commonly Fesoterodine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Fesoterodine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

24,735
Medicaid prescriptions filled (Q1–Q4 2025)
$2.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fesoterodine prescribed? Of the 1,596 medications we measure, Fesoterodine ranks #768 by Medicaid prescriptions — more than 52% of them.

Where Fesoterodine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #768 of 1,596
#763 Succinylcholine 25,454 Rx #764 Irinotecan Injection 25,359 Rx #765 Irinotecan 25,359 Rx #766 Ibandronate 25,078 Rx #767 Daratumumab and Hyalur... 24,846 Rx #768 Fesoterodine 24,735 Rx #769 Netarsudil Ophthalmic 24,727 Rx #770 Dapsone Topical 24,570 Rx #771 Atovaquone 24,509 Rx #772 Spironolactone and Hyd... 24,202 Rx #773 Metaxalone 23,917 Rx

Utilization by Fesoterodine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 8 mg 24 hr extended release oral tablet is the most-dispensed Fesoterodine product — about 52% of these Medicaid prescriptions.

24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet Most dispensed

12,778 Medicaid prescriptions (Q1–Q4 2025) 52% of Fesoterodine prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $106 per prescription (gross)

Summed across the 8 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 810077

24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet

11,957 Medicaid prescriptions (Q1–Q4 2025) 48% of Fesoterodine prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $104 per prescription (gross)

Summed across the 8 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 810071

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fesoterodine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 16 of 67 listed Fesoterodine NDCs with Medicaid activity.

🔍 Compare Fesoterodine products

A representative set of FDA-listed product records for Fesoterodine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 65 of 65 products — FDA National Drug Code Directory. See every product, package size and price: browse all 65 Fesoterodine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Fesoterodine RxCUI 797195 1 dose form · 2 strengths

Look up RxCUI 797195 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Toviaz

🏭 Manufacturers & labelers

Pfizer Laboratories Div Pfizer Inc 6 Ascend Laboratories, LLC 6 Aurobindo Pharma Limited 6 Golden State Medical Supply, Inc. 4 Zydus Pharmaceuticals USA Inc. 4 Zydus Lifesciences Limited 4 U.S. Pharmaceuticals 4 Dr.Reddy's Laboratories Inc., 4 Amneal Pharmaceuticals LLC 4 Alembic Pharmaceuticals Inc. 4 AvKARE 2 Camber Pharmaceuticals, Inc. 2 Aesica Pharmaceuticals GmbH 2 MSN Pharmachem Private Limited 2 NorthStar RxLLC 2 Amino Chemicals Ltd 2 Alembic Pharmaceuticals Limited 2 ANI Pharmaceuticals, Inc. 1 Hetero Drugs Limited 1 Maithri Laboratories Private Limited 1 Pfizer Ireland Pharmaceuticals Unlimited Company 1 Raks Pharma Pvt. Limited 1

RxNorm drug class

Fesoterodine belongs to the Drugs for urinary frequency and incontinence class.

Drug family (ATC) Drugs for urinary frequency and incontinence

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 7, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fesoterodine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fesoterodine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
12
NDC products indexed
65
Distinct labelers/manufacturers represented
22
Linked representative label ⓘ
Pfizer Laboratories Div Pfizer Inc
Linked label effective
Apr 7, 2026
Composite sections available
23
Linked SPL Set ID
5be745f0-8ae7-4c3c-9962-37d6263326f1
Linked SPL Document ID
ca2031f1-5425-4d31-bf14-c865ec4e89b7
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 12 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.