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 →
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.
How to Take It
Take fesoterodine tablets once a day by mouth. Swallow the tablet whole with some liquid. Do not chew, crush, or divide the tablet. You can take it with or without food.
This is a plain-language summary of fesoterodine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if fesoterodine can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if fesoterodine passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking this medicine.
This is a plain-language summary of fesoterodine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of fesoterodine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (68° to 77°F) and protect from moisture.
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
- Dry mouth
Dry mouth
823 reports
- Fall
Fall
529 reports
- Tiredness
Tiredness
505 reports
- Constipation
Constipation
503 reports
- Unable to empty bladder
Unable to empty bladder
502 reports
- Pain
Pain
440 reports
- Headache
Headache
416 reports
- Dizziness
Dizziness
394 reports
- Feeling unwell
Feeling unwell
333 reports
- Confusion 325
Confusion
325 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.
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
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.
What to do: When taking these medicines together, do not exceed a fesoterodine dose of 4 mg once daily.
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.
What to do: Avoid this combination if you have moderate to severe kidney or liver disease.
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.
What to do: If you take ketoconazole, your daily dose of fesoterodine should be limited to 4 mg.
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.
What to do: You should not take more than 4 mg of fesoterodine each day if you are also using clarithromycin.
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.
What to do: No special dosage changes are usually needed when taking these medications together.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I cut the tablet in half?
Can I take this medicine if I have glaucoma?
What should I do if I get a very dry mouth?
Can I drive while taking this medicine?
What if I have kidney problems?
Can I take this with other medicines?
How long does it take for this medicine to work?
What if I am taking medicine for depression?
Can I drink grapefruit juice while taking this?
What is the starting dose?
What are the common side effects of fesoterodine?
Does fesoterodine interact with other medications?
What drug class is fesoterodine?
Is fesoterodine safe during pregnancy?
Has fesoterodine been recalled?
Active Recalls
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Alembic Pharmaceuticals Limited
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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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: April 12, 2024
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages