fesoterodine
Brand names: Toviaz
Fesoterodine is a medicine that helps control an overactive bladder. It reduces the feeling of needing to go to the bathroom so often.
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.
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.
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.
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.
Storage
Store at room temperature (68° to 77°F) and protect from moisture.
Side Effects (from patient reports)
Based on 6,279 FDA adverse event reports.
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 tak...
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.
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?
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.
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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.
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dutasteride
Avodart
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men.
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dutasteride/tamsulosin
Jalyn
This medicine combines two drugs to treat enlarged prostate in men.
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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 6,279 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, 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.
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