Prescription medication · Anticholinergic (Overactive Bladder)

fesoterodine

Also sold as Toviaz. This medicine treats overactive bladder (OAB) in adults.

Data updated 2026-05-15

4,770
FDA reports
15
InteractionsSeveral interactions
1
Recall record

What the data shows

fesoterodine (Toviaz) is a prescription Anticholinergic (Overactive Bladder), with 4,770 FDA adverse-event reports on file, with 15 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

fesoterodine (Toviaz) is a prescription Anticholinergic (Overactive Bladder). This medicine treats overactive bladder (OAB) in adults.

Fesoterodine is a medicine that helps control an overactive bladder. It reduces the feeling of needing to go to the bathroom so often.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Generic Price

$0.81/unit

Generic Available

Yes (7 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug →

What it does

This medicine treats overactive bladder (OAB) in adults.

Common side effects

Dry mouth, Constipation

Key warnings

Fesoterodine can cause swelling of the face, lips, tongue, or throat.

The sections below are summarized in plain English from fesoterodine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Fesoterodine belongs to a class of drugs called anticholinergics. It works by blocking certain nerve signals to the bladder. This helps to relax the bladder muscles and reduce the urge to urinate.

Side Effects (from patient reports)

Based on 4,770 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for fesoterodine, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

Fesoterodine can cause swelling of the face, lips, tongue, or throat. This can be life-threatening, so stop taking the medicine and get medical help right away if this happens. Fesoterodine is not recommended if you have a blockage in your bladder or have problems with food moving through your digestive system. Use with caution if you have narrow-angle glaucoma or myasthenia gravis.

Known Drug Interactions

major darunavir

Urinary antispasmodics fesoterodine ↑ fesoterodine When fesoterodine is co-administered with darunavir/ritonavir, do not exceed a fesoterodine dose of 4 mg once daily.

Mechanism: Darunavir interferes with the way your body clears fesoterodine, leading to higher levels of the medication in your blood.

major itraconazole

Fesoterodine Patients with moderate to severe renal or hepatic impairment : Contraindicated during and 2 weeks after itraconazole treatment.

Mechanism: Itraconazole prevents the body from getting rid of fesoterodine, leading to higher amounts of the drug in your blood.

moderate ketoconazole

7.2 CYP3A4 Inhibitors Doses of fesoterodine fumarate 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, co-administration 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...

Mechanism: Ketoconazole stops your body from breaking down fesoterodine properly, which can double the amount of medicine in your blood.

moderate clarithromycin

7.2 CYP3A4 Inhibitors Doses of fesoterodine fumarate 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) ] .

Mechanism: Clarithromycin blocks the process your body uses to get rid of fesoterodine, causing the drug levels to rise.

minor estradiol

7.6 Oral Contraceptives 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) ] .

Mechanism: Fesoterodine does not change the amount of estradiol in your blood, so the two drugs do not have a meaningful effect on each other.

Check all your medications →

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I cut the tablet in half?
No, swallow the tablet whole. Do not chew, crush, or divide it.
Can I take this medicine if I have glaucoma?
Use with caution if you are being treated for narrow-angle glaucoma. Do not use if you have uncontrolled narrow-angle glaucoma.
What should I do if I get a very dry mouth?
Try sugar-free candy or gum. Talk to your doctor if it bothers you.
Can I drive while taking this medicine?
Fesoterodine can cause sleepiness. Do not drive or operate heavy machinery until you know how it affects you.
What if I have kidney problems?
Your doctor may need to adjust your dose if you have kidney problems.
Can I take this with other medicines?
Tell your doctor about all the medicines you take, including over-the-counter drugs and supplements.
How long does it take for this medicine to work?
It may take a few weeks to notice the full effects of this medicine.
What if I am taking medicine for depression?
Talk to your doctor. Some medicines for depression can interact with fesoterodine.
Can I drink grapefruit juice while taking this?
Grapefruit juice can affect how this medicine works. Talk to your doctor.
What is the starting dose?
The usual starting dose is 4 mg once a day.
What are the common side effects of fesoterodine?
The registry lists Dry mouth, Constipation among the most-reported FAERS reaction terms for fesoterodine. The compiled record contains 4,770 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does fesoterodine interact with other medications?
The registry has 15 documented interaction rows for fesoterodine. Notable source-record pairings include darunavir, itraconazole, ketoconazole. These rows are not a complete medication review.
What drug class is fesoterodine?
fesoterodine belongs to the Anticholinergic (Overactive Bladder) drug class. It requires a prescription (Rx). This medicine treats overactive bladder (OAB) in adults.
What pregnancy or breastfeeding source fields are listed for fesoterodine?
The FDA label for fesoterodine contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has fesoterodine been recalled?
There is 1 recall associated with fesoterodine products. Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. Check the recalls section below for full details and affected products.

Active Recalls

Class III December 16, 2025

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Alembic Pharmaceuticals Limited

Related Medications in Anticholinergic (Overactive Bladder)

Other drugs grouped near fesoterodine - same-class peers and common alternatives.

alfuzosin

Uroxatral

Alfuzosin is a medicine that helps men with enlarged prostate glands.

Compare with fesoterodine →

bethanechol

Urecholine

Bethanechol helps you to urinate if you have trouble emptying your bladder.

Compare with fesoterodine →

darifenacin

Enablex

Darifenacin (Enablex) is a medicine that helps control an overactive bladder.

Compare with fesoterodine →

dutasteride

Avodart

Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men.

Compare with fesoterodine →

dutasteride/tamsulosin

Jalyn

This medicine combines two drugs to treat enlarged prostate in men.

Compare with fesoterodine →

Compare fesoterodine vs alfuzosin side-by-side →

Medication Guides

Understanding Drug Interactions

How CYP450 enzymes, inhibitors, and inducers affect your medications

Generic vs Brand Name Drugs

FDA requirements, cost savings, and when the difference matters

Narrow Therapeutic Index Drugs

FDA bioequivalence and label-record context for narrow therapeutic index medicines

Common Drug Interactions

Dangerous medication combinations and how to protect yourself

Save on fesoterodine

Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.

Check Prices on GoodRx →

Disclosure: This link may earn us a commission at no extra cost to you. See our terms.

What the FDA Data Shows for fesoterodine

The FDA label for fesoterodine (sold under brand names such as Toviaz) classifies it as a prescription-only medication in the Anticholinergic (Overactive Bladder) class. This medicine treats overactive bladder (OAB) in adults. Official labeling lists 2 commonly reported side effects, including Dry mouth, Constipation.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 4,770 voluntary reports. The database also lists 15 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.81.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: April 12, 2024

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page