Fesoterodine Accord
Antimuscarinic Treatment for Overactive Bladder
Quick Facts About Fesoterodine Accord
Key Takeaways About Fesoterodine Accord
- Effective OAB treatment: Fesoterodine significantly reduces episodes of urgency, urge incontinence, and frequent urination in adults with overactive bladder
- Flexible dosing: Available in 4 mg (starting dose) and 8 mg (increased dose) extended-release tablets, taken once daily with or without food
- Most common side effect – dry mouth: Dry mouth occurs in more than 10% of patients but is usually mild to moderate in severity
- Allergy alert: Contains soy lecithin and lactose – do not take if you are allergic to peanuts or soy, or if you have severe lactose intolerance
- Do not crush or chew: The extended-release tablet must be swallowed whole to ensure proper drug release throughout the day
What Is Fesoterodine Accord and What Is It Used For?
Fesoterodine Accord contains the active substance fesoterodine fumarate and belongs to the antimuscarinic (anticholinergic) class of medicines. It is used in adults to treat the symptoms of overactive bladder (OAB), including urinary urgency, urge incontinence, and increased urinary frequency.
Overactive bladder is a common condition that affects millions of people worldwide, with an estimated prevalence of 12–17% in the general adult population. It is characterised by a sudden, compelling desire to urinate (urgency) that is difficult to postpone, often accompanied by involuntary urine leakage (urge incontinence) and the need to urinate more frequently than usual, including during the night (nocturia). OAB can significantly impact quality of life, leading to social embarrassment, anxiety, depression, and sleep disturbances.
Fesoterodine works by blocking muscarinic receptors – specifically the M3 subtype – on the smooth muscle of the urinary bladder (the detrusor muscle). Under normal circumstances, the neurotransmitter acetylcholine binds to these receptors and triggers the detrusor muscle to contract, allowing the bladder to empty. In overactive bladder, however, the detrusor muscle contracts involuntarily before the bladder is full, causing the characteristic symptoms of urgency and frequency. By blocking the muscarinic receptors, fesoterodine reduces these involuntary contractions, increases bladder capacity, and provides the patient with greater control over when they urinate.
Fesoterodine is a prodrug, meaning that it is not pharmacologically active in its original form. After oral administration, it is rapidly and extensively converted by non-specific esterases (enzymes present in the blood and gut wall) to its active metabolite, 5-hydroxymethyl tolterodine (5-HMT). This is the same active metabolite produced by the related drug tolterodine. The prodrug design provides more predictable bioavailability compared to tolterodine, because the conversion does not depend on the highly variable liver enzyme CYP2D6.
Clinical trials have demonstrated that fesoterodine significantly reduces the number of urgency episodes, incontinence episodes, and the frequency of urination compared to placebo. In the FACT (Fesoterodine Assessment and Comparison versus Tolterodine) study, fesoterodine 8 mg was shown to provide superior improvement in urgency episodes compared to tolterodine extended-release 4 mg. The European Association of Urology (EAU) and the American Urological Association (AUA) both recommend antimuscarinics as a first-line pharmacological treatment for overactive bladder.
Fesoterodine is available under several brand names worldwide, including TOVIAZ (the original branded product by Pfizer), Fesoterodine Zentiva, Fesoterodine STADA, and Fesoterodine Accord. All contain the same active substance and work in the same way. Fesoterodine Accord is a generic formulation manufactured by Accord Healthcare, providing an affordable alternative while maintaining the same quality and efficacy standards required by the European Medicines Agency (EMA).
What Should You Know Before Taking Fesoterodine Accord?
Before starting fesoterodine, inform your doctor about all your medical conditions, especially urinary retention, gastrointestinal obstruction, narrow-angle glaucoma, myasthenia gravis, and liver or kidney problems. Fesoterodine is contraindicated in several conditions and interacts with many medications.
Contraindications
You should not take Fesoterodine Accord if any of the following apply to you:
- Allergy to fesoterodine, peanuts, or soy – the tablets contain soy lecithin (E322); people with peanut or soy allergy must not take this medication
- Urinary retention – inability to empty the bladder completely; fesoterodine could worsen this condition
- Gastric retention – delayed gastric emptying; antimuscarinic drugs slow gastrointestinal motility further
- Uncontrolled narrow-angle glaucoma – fesoterodine can increase intraocular pressure, worsening glaucoma that is not being treated
- Myasthenia gravis – a neuromuscular disease causing severe muscle weakness; antimuscarinics can exacerbate symptoms
- Severe ulcerative colitis – antimuscarinic effects on the bowel may worsen this inflammatory condition
- Toxic megacolon – an abnormally enlarged or distended colon; further reduction in bowel motility is dangerous
- Severe hepatic (liver) impairment – significantly altered drug metabolism increases the risk of toxicity
- Moderate-to-severe liver or kidney impairment combined with strong CYP3A4 inhibitors – such as ketoconazole, itraconazole, ritonavir, atazanavir, indinavir, saquinavir, nelfinavir, clarithromycin, telithromycin, or nefazodone; this combination can cause dangerously high drug levels
Warnings and Precautions
Talk to your doctor or pharmacist before taking Fesoterodine Accord if you have or have had any of the following conditions:
- Difficulty emptying the bladder (e.g. due to prostatic hyperplasia) – antimuscarinics can worsen urinary retention. Your doctor may monitor your post-void residual volume
- Severe constipation or reduced bowel motility – fesoterodine slows gut movement and can worsen constipation
- Controlled narrow-angle glaucoma – use only with specialist ophthalmological monitoring
- Significant kidney or liver disease – dose adjustment may be required; your doctor may limit the dose to 4 mg daily
- Autonomic neuropathy – can affect blood pressure, bowel function, and sexual function
- Gastrointestinal motility disorders – conditions affecting food passage and digestion
- Gastro-oesophageal reflux disease (GORD) – heartburn or acid reflux may worsen
- Urinary tract infection – your doctor may prescribe antibiotics before starting fesoterodine
Heart Conditions
Speak to your doctor if you suffer from any of the following cardiovascular conditions, as fesoterodine may affect heart rhythm and cardiovascular function:
- QT prolongation on ECG or if you take medications known to prolong the QT interval – there is a theoretical risk of cardiac arrhythmia
- Slow heart rate (bradycardia) – antimuscarinic effects on the heart require careful monitoring
- Heart disease including myocardial ischaemia (reduced blood flow to the heart muscle), irregular heartbeat, or heart failure
- Low potassium levels (hypokalaemia) – increases vulnerability to cardiac arrhythmia
Use in Children and Adolescents
Fesoterodine Accord is not recommended for children and adolescents under 18 years of age. The safety and efficacy of fesoterodine in this age group have not been established. There are no paediatric clinical trials providing sufficient evidence to support its use in younger patients. If a child or adolescent has symptoms of overactive bladder, alternative treatments should be discussed with a paediatric urologist.
Pregnancy and Breastfeeding
You should not take Fesoterodine Accord if you are pregnant, as the effects of fesoterodine on pregnancy and foetal development have not been adequately studied in humans. Animal reproduction studies are limited, and the potential risks are unknown. If you discover that you are pregnant while taking fesoterodine, stop taking it and contact your doctor immediately for alternative treatment options.
It is not known whether fesoterodine or its active metabolite passes into breast milk. Therefore, breastfeeding is not recommended during treatment with Fesoterodine Accord. If you are breastfeeding or planning to breastfeed, discuss the risks and benefits with your doctor before starting this medication.
If you are of childbearing potential, you should use effective contraception while taking fesoterodine. If you are planning to become pregnant, talk to your doctor about stopping the medication in advance and discuss alternative approaches to managing your overactive bladder symptoms.
Driving and Operating Machinery
Fesoterodine Accord can cause blurred vision, dizziness, and drowsiness in some patients. If you experience any of these effects, do not drive a vehicle or operate machinery until the symptoms have resolved. These effects are more common at the beginning of treatment or after a dose increase. You are responsible for assessing whether you are fit to drive or perform tasks requiring alertness. Discuss any concerns with your doctor or pharmacist.
Important Information About Excipients
Fesoterodine Accord tablets contain lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medication. The amount of lactose in each tablet is small, but patients with rare hereditary conditions such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
The tablets also contain soy lecithin (E322) in the film coating. If you are allergic to peanuts or soy, you must not use Fesoterodine Accord. Soy lecithin can trigger allergic reactions in sensitised individuals, ranging from mild skin reactions to severe anaphylaxis in rare cases.
How Does Fesoterodine Accord Interact with Other Drugs?
Fesoterodine interacts with several drug classes, including strong CYP3A4 inhibitors (which increase its blood levels), CYP3A4 inducers (which decrease its effectiveness), and other antimuscarinic or anticholinergic drugs (which amplify side effects). Always inform your doctor about all medications, supplements, and herbal products you are taking.
The active metabolite of fesoterodine (5-HMT) is metabolised by two liver enzymes: CYP2D6 and CYP3A4. Drugs that inhibit these enzymes can increase blood levels of 5-HMT, potentially leading to enhanced side effects. Conversely, drugs that induce CYP3A4 can reduce the effectiveness of fesoterodine by accelerating its breakdown. Additionally, combining fesoterodine with other antimuscarinic medications can significantly increase the risk and severity of anticholinergic side effects such as dry mouth, constipation, urinary retention, and cognitive impairment.
Drugs That Increase Fesoterodine Levels
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole / Itraconazole | Antifungal agents | Strong CYP3A4 inhibitors; significantly increase fesoterodine blood levels | Contraindicated in patients with kidney or moderate-to-severe liver impairment. In other patients, limit dose to 4 mg daily |
| Ritonavir / Atazanavir / Indinavir / Saquinavir / Nelfinavir | HIV protease inhibitors | Strong CYP3A4 inhibitors; markedly increase fesoterodine levels | Contraindicated in patients with kidney or liver impairment. Use with extreme caution in other patients; do not exceed 4 mg daily |
| Clarithromycin / Telithromycin | Macrolide antibiotics | Strong CYP3A4 inhibitors; increase fesoterodine exposure | Contraindicated in patients with kidney or liver impairment. Limit dose to 4 mg daily in other patients |
| Nefazodone | Antidepressant | Potent CYP3A4 inhibitor; increases fesoterodine levels | Contraindicated in patients with kidney or liver impairment. Limit dose to 4 mg daily in other patients |
| Fluoxetine / Paroxetine | SSRI antidepressants | CYP2D6 inhibitors; may moderately increase fesoterodine levels | Monitor for increased side effects; dose reduction may be needed |
| Bupropion | Antidepressant / Smoking cessation | CYP2D6 inhibitor; may increase fesoterodine levels | Monitor for increased anticholinergic side effects |
| Quinidine | Antiarrhythmic | CYP2D6 inhibitor; may increase fesoterodine levels | Monitor heart rhythm and anticholinergic side effects |
| Cinacalcet | Hyperparathyroidism treatment | CYP2D6 inhibitor; may increase fesoterodine levels | Monitor for increased side effects |
Drugs That Decrease Fesoterodine Effectiveness
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Rifampicin | Antibiotic (TB treatment) | Strong CYP3A4 inducer; significantly reduces fesoterodine blood levels and effectiveness | Avoid combination; consider alternative OAB treatment during rifampicin therapy |
| Carbamazepine | Antiepileptic | CYP3A4 inducer; decreases fesoterodine levels | Monitor OAB symptom control; higher dose may be needed but evidence is limited |
| Phenytoin / Phenobarbital | Antiepileptic / Barbiturate | CYP3A4 inducers; decrease fesoterodine levels | Monitor for reduced OAB symptom control |
| St. John’s Wort (Hypericum perforatum) | Herbal supplement | CYP3A4 inducer; may reduce fesoterodine effectiveness | Avoid concurrent use |
Drugs with Additive Anticholinergic Effects
Taking fesoterodine together with other anticholinergic or antimuscarinic medications can significantly increase the risk of side effects such as dry mouth, constipation, difficulty emptying the bladder, and drowsiness. Inform your doctor if you are taking any of the following:
- Amantadine – used for Parkinson’s disease
- Metoclopramide and similar drugs – used for gastrointestinal motility and nausea
- Certain antidepressants – particularly tricyclic antidepressants (e.g. amitriptyline, imipramine)
- Antipsychotic (neuroleptic) medications – many have significant anticholinergic properties
- Other OAB medications – such as oxybutynin, solifenacin, tolterodine, or darifenacin
- Methadone – used for severe pain management and opioid dependence treatment
Elderly patients are particularly vulnerable to anticholinergic burden – the cumulative effect of taking multiple medications with anticholinergic properties. This can increase the risk of cognitive impairment, confusion, falls, and urinary retention. If you are an older adult taking several medications, ask your doctor or pharmacist to review your total anticholinergic burden before starting fesoterodine.
What Is the Correct Dosage of Fesoterodine Accord?
The recommended starting dose is one 4 mg extended-release tablet once daily, swallowed whole with water. Your doctor may increase the dose to 8 mg once daily depending on your response and tolerability. Do not crush or chew the tablet.
Always take Fesoterodine Accord exactly as your doctor or pharmacist has instructed. If you are unsure about anything, ask your doctor or pharmacist for clarification. Fesoterodine is formulated as an extended-release (prolonged-release) tablet, designed to release the active substance gradually over the course of the day. Crushing, chewing, or breaking the tablet would destroy this controlled-release mechanism and could lead to an excessively rapid release of the drug, increasing the risk of side effects.
Adults
Overactive Bladder – Standard Dosing
Starting dose: 4 mg once daily
Maximum dose: 8 mg once daily
Your doctor will typically start you on 4 mg once daily and assess your response after 4–8 weeks. If your symptoms are not adequately controlled and you are tolerating the medication well, the dose may be increased to 8 mg once daily. The tablet can be taken with or without food, at any time of day. For best results, try to take it at the same time each day.
Patients with Kidney or Liver Impairment
Dose Adjustments for Organ Impairment
Mild kidney impairment: No dose adjustment needed
Moderate kidney impairment: Maximum dose of 4 mg daily when taking strong CYP3A4 inhibitors
Severe kidney impairment: Maximum dose of 4 mg daily; use with caution
Mild-to-moderate liver impairment: Maximum dose of 4 mg daily when taking strong CYP3A4 inhibitors
Severe liver impairment: Contraindicated – do not use
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. However, elderly patients may be more sensitive to antimuscarinic side effects, including dry mouth, constipation, drowsiness, and confusion. Your doctor will consider your overall health, kidney and liver function, and other medications before prescribing fesoterodine and will monitor you more closely for adverse effects. In frail elderly patients, a maximum dose of 4 mg daily may be more appropriate.
Missed Dose
If you forget to take a dose of Fesoterodine Accord, take it as soon as you remember – but do not take more than one tablet per day. If it is nearly time for your next dose, skip the missed dose and continue with your regular schedule. Never take a double dose to compensate for a forgotten tablet. If you find it difficult to remember your medication, consider setting a daily alarm or using a pill organiser.
Overdose
If you have taken too much Fesoterodine Accord, or if a child has accidentally swallowed the medication, contact your doctor, go to the nearest hospital emergency department, or call your local poison control centre immediately. Bring the medication packaging with you. Symptoms of overdose may include severe dry mouth, difficulty urinating, rapid heartbeat, blurred vision, agitation, hallucinations, and in severe cases, respiratory depression. Treatment is supportive and symptomatic; there is no specific antidote for fesoterodine overdose.
Stopping Treatment
Do not stop taking Fesoterodine Accord without consulting your doctor first. If you stop taking the medication abruptly, your overactive bladder symptoms (urgency, frequency, incontinence) are likely to return. Your doctor will advise you on whether to continue treatment, switch to an alternative medication, or try non-pharmacological approaches such as pelvic floor muscle training, bladder training, or lifestyle modifications.
What Are the Side Effects of Fesoterodine Accord?
Like all medicines, fesoterodine can cause side effects, although not everyone experiences them. The most common side effect is dry mouth, which occurs in more than 1 in 10 people. Serious allergic reactions are rare but require immediate medical attention.
Side effects are categorised below by how frequently they occur. Most side effects associated with fesoterodine are related to its antimuscarinic mechanism of action and are dose-dependent – meaning they tend to be more common and more pronounced at the higher dose of 8 mg compared to 4 mg. Most adverse effects are mild to moderate in severity and often improve as your body adjusts to the medication over the first few weeks of treatment.
Severe allergic reactions, including angioedema (swelling of the face, lips, mouth, or throat), have been reported rarely. If you experience sudden swelling of the face or throat, difficulty breathing, or severe skin reactions, stop taking Fesoterodine Accord immediately and seek emergency medical help.
Very Common
- Dry mouth (usually mild to moderate; may increase risk of dental caries – maintain good oral hygiene and visit your dentist regularly)
Common
- Dry eyes
- Constipation
- Indigestion (dyspepsia)
- Difficulty or pain when urinating (dysuria)
- Dizziness
- Headache
- Abdominal pain
- Diarrhoea
- Nausea
- Difficulty sleeping (insomnia)
- Throat dryness
Uncommon
- Urinary tract infection
- Drowsiness (somnolence)
- Taste disturbances (dysgeusia)
- Vertigo (sensation of spinning)
- Skin rash
- Dry skin
- Itching (pruritus)
- Abdominal discomfort
- Excessive gas (flatulence)
- Difficulty emptying the bladder completely (urinary retention)
- Hesitancy when starting to urinate
- Extreme tiredness (fatigue)
- Increased heart rate (tachycardia)
- Palpitations (awareness of heartbeat)
- Liver function abnormalities
- Cough
- Nasal dryness
- Sore throat
- Acid reflux (gastro-oesophageal reflux)
- Blurred vision
Rare
- Hives (urticaria)
- Confusion
- Angioedema (severe allergic swelling)
If you experience any side effects, including any not listed above, talk to your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority. Reporting side effects helps provide more information on the safety of this medicine.
Dry mouth is the most frequently reported side effect of fesoterodine. To help manage it: drink water frequently throughout the day, use sugar-free gum or sweets to stimulate saliva production, avoid caffeine and alcohol which can worsen dryness, brush your teeth at least twice daily with fluoride toothpaste, and visit your dentist regularly for check-ups, as dry mouth increases the risk of dental caries (tooth decay) and oral infections.
How Should You Store Fesoterodine Accord?
Store Fesoterodine Accord at room temperature, out of the sight and reach of children. No special storage conditions are required. Check the expiry date on the packaging before use.
Keep Fesoterodine Accord out of the sight and reach of children at all times. Store the tablets in their original packaging to protect them from moisture. There are no special temperature requirements – normal room temperature is suitable.
Do not use this medicine after the expiry date stated on the carton, blister pack, or container after “EXP”. The expiry date refers to the last day of the stated month. If you notice that the tablets have changed in colour, smell, or appearance, do not use them and consult your pharmacist.
Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. Proper disposal helps protect the environment and prevents accidental exposure to others, particularly children and pets.
What Does Fesoterodine Accord Contain?
Each extended-release tablet contains 4 mg of fesoterodine fumarate (equivalent to 3.1 mg fesoterodine). The tablets also contain lactose, soy lecithin, and several other inactive ingredients in the tablet core and coating.
Active Ingredient
The active substance is fesoterodine fumarate. Each prolonged-release tablet contains 4 mg of fesoterodine fumarate, which is equivalent to 3.1 mg of fesoterodine (the free base). Fesoterodine fumarate is a white to off-white crystalline powder that is freely soluble in water.
Inactive Ingredients (Excipients)
Tablet core: microcrystalline cellulose (E460), hypromellose (E464), anhydrous lactose, colloidal anhydrous silica (E551), magnesium stearate (E572).
Film coating: titanium dioxide (E171), polyvinyl alcohol – partially hydrolysed (E1203), talc (E553b), soy lecithin (E322), xanthan gum (E415), yellow iron oxide (E172).
Appearance and Packaging
Fesoterodine Accord 4 mg prolonged-release tablets are yellow, oval, film-coated tablets, debossed with “F I” on one side and plain on the other. The tablet size is approximately 13.2 × 6.7 mm. Fesoterodine Accord is available in blister packs of 14, 28, 30, 56, 84, or 100 tablets. It is also available in HDPE plastic containers with child-resistant polypropylene closures containing 90 tablets. Not all pack sizes may be marketed in every country.
This medicine contains soy lecithin and lactose. Do not take Fesoterodine Accord if you are allergic to peanuts or soy. If you have been told you are intolerant to certain sugars, consult your doctor before taking this medicine.
Frequently Asked Questions About Fesoterodine Accord
Fesoterodine Accord is used to treat the symptoms of overactive bladder (OAB) in adults. These symptoms include urinary urgency (a sudden, strong need to urinate), urge incontinence (involuntary urine leakage), and increased urinary frequency (needing to urinate more often than normal, including at night). It works by relaxing the bladder muscle to reduce involuntary contractions and increase bladder capacity.
The most common side effect is dry mouth, affecting more than 1 in 10 people. Other common side effects include dry eyes, constipation, indigestion, difficulty urinating, dizziness, headache, abdominal pain, diarrhoea, nausea, insomnia, and throat dryness. Most side effects are mild to moderate and tend to improve as your body adjusts to the medication. If side effects are bothersome, speak to your doctor – they may adjust your dose or suggest management strategies.
Fesoterodine should be used with caution if you have an enlarged prostate (benign prostatic hyperplasia, BPH), as antimuscarinic drugs can make it harder to empty your bladder completely, potentially leading to urinary retention. Your doctor will assess your individual situation, which may include measuring your post-void residual urine volume. In some cases, fesoterodine may be prescribed alongside an alpha-blocker (e.g. tamsulosin) to manage both the obstructive symptoms of BPH and the overactive bladder symptoms.
Fesoterodine may start to improve your symptoms within 1 to 2 weeks, but the full therapeutic effect is typically achieved after 8 to 12 weeks of continuous treatment. It is important to be patient and continue taking the medication as prescribed, even if you do not notice immediate improvement. If your symptoms are not adequately controlled after several weeks on the 4 mg dose, your doctor may increase the dose to 8 mg daily.
The safety of fesoterodine during pregnancy has not been established. There is insufficient data from human studies to determine whether fesoterodine poses risks to the developing baby. If you are pregnant, think you may be pregnant, or are planning to become pregnant, do not take fesoterodine and consult your doctor immediately for alternative approaches to managing your bladder symptoms. Non-pharmacological treatments such as pelvic floor exercises and bladder training are generally preferred during pregnancy.
Fesoterodine Accord tablets contain soy lecithin (E322) in the film coating. Because there is a known cross-reactivity between soy and peanut allergens, people with a confirmed allergy to either peanuts or soy must not take this medication. The soy lecithin could trigger an allergic reaction in sensitised individuals. If you are unsure about your allergy status, consult your doctor or allergist before starting this medication.
References and Medical Sources
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- European Association of Urology (EAU). Guidelines on Urinary Incontinence in Adults. 2024 Update. Available at: uroweb.org/guidelines. Accessed February 2026.
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- British National Formulary (BNF). Fesoterodine fumarate. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk. Accessed February 2026.
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Medical Editorial Team
This article was written and medically reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians in urology, clinical pharmacology, and internal medicine. Our editorial process follows international guidelines from the European Association of Urology (EAU), the American Urological Association (AUA), the International Continence Society (ICS), and the World Health Organization (WHO).
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