Fesoterodine

Muscarinic receptor antagonist for overactive bladder

ATC code: G04BD11

Brand names: Toviaz

Updated 24 Sep 2026 · Methodology

Indications

Overactive bladder

Second line

Fesoterodine is a second-line muscarinic blocker for overactive bladder. NG123 (2024) and AEU 2023 place behavioural therapy first: bladder training, caffeine and fluid control, pelvic floor exercises for at least 8–12 weeks. Add fesoterodine if symptoms persist after behavioural therapy. AEMPS approves 4–8 mg once daily; start at 4 mg, titrate upward after 4 weeks if response is inadequate. Reduction in urgency episodes vs placebo: 1–2 per day (Cochrane 2012).

Sources

ICD-10: N32.8 · ICD-11: GC50.0

Urge urinary incontinence

Second line

AEMPS approves fesoterodine for urge urinary incontinence in adults after behavioural therapy fails. The EIGHT trial (Chapple 2014, NEJM) showed fesoterodine 8 mg outperforms tolterodine 4 mg on daily incontinence episodes, but the gain is modest (around 0.5 episodes). Dry mouth reaches 28–35%, which drives 30–40% of patients to stop therapy within 6 months (Sears AUA 2020).

Sources

AEMPS: Ficha técnica de Fesoterodina (Toviaz) (2023)

ICD-10: N39.4 · ICD-11: MF50.21

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Frequent urination without prior evaluation

Not recommended

Fesoterodine is for overactive bladder, not a symptomatic drug for frequent toilet visits. Increased urinary frequency is a symptom that may mean urinary tract infection, diabetes mellitus, benign prostatic hyperplasia, neurological disease, or excess caffeine and fluid intake. Prescribing a muscarinic blocker without a bladder ultrasound and urinalysis can mask UTI, bladder cancer or BPH outlet obstruction. In older men with untreated BPH, fesoterodine raises the risk of acute urinary retention (AEMPS warning). If this drug was prescribed without a bladder ultrasound, urinalysis, or discussion of behavioural therapy, consider seeking a second opinion.

Sources

ICD-10: R35 · ICD-11: MF50.0

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

Prodrug: non-specific plasma esterases rapidly hydrolyse fesoterodine into the active metabolite 5-hydroxymethyl-tolterodine (the same active metabolite as for tolterodine). Competitively blocks muscarinic M2 and M3 receptors in the detrusor, suppressing involuntary contractions during the filling phase. Active metabolite bioavailability around 52%, half-life 7 hours. Not affected by CYP2D6 polymorphism (unlike tolterodine), so dosing is identical across patients.

Safety

Contraindications

Hypersensitivity to fesoterodine or tolterodine
Urinary retention
Gastric retention
Uncontrolled narrow-angle glaucoma
Myasthenia gravis
Severe hepatic impairment (Child-Pugh C)
Strong CYP3A4 inhibitors with severe renal impairment

Serious adverse effects

Acute urinary retention (especially with untreated BPH)
QT prolongation
Angio-oedema
Cognitive impairment in older patients
Acute angle-closure glaucoma

Common adverse effects

Dry mouth (28–35%)
Constipation (5–9%)
Dry eyes
Headache
Dyspepsia
Urinary tract infection

Pregnancy: can you take Fesoterodine?

AEMPS summary of product characteristics (section 4.6): there are not enough data on fesoterodine use in pregnant women. Animal studies showed low embryotoxicity; oral fesoterodine given to pregnant mice and rabbits during organogenesis caused fetal toxicity at maternal exposures 6 and 3 times the maximum recommended human dose, respectively, based on AUC. The potential risk for humans is unknown, and fesoterodine is not recommended during pregnancy.

Breastfeeding: can you take Fesoterodine?

Limited data. The active metabolite 5-hydroxymethyl-tolterodine passes into animal milk. AEMPS advises choosing either drug discontinuation or breastfeeding interruption. Lactation-compatible antimuscarinics: oxybutynin or trospium.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions44 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

MajorAtazanavir
«Inhibidores potentes del CYP3A4: Después de la inhibición del CYP3A4 mediante la administración concomitante de 200 mg de ketoconazol dos veces al día, la C max y el AUC del metabolito activo de…»
AEMPS, section 4.5 · Open on CIMA
MajorCarbamazepine
«Inductores del CYP3A4: La inducción del CYP3A4 puede llevar a niveles plasmáticos subterapéuticos. No se recomienda el uso concomitante con inductores del CYP3A4 (por ejemplo, carbamazepina…»
AEMPS, section 4.5 · Open on CIMA
MajorClarithromycin
«Inhibidores potentes del CYP3A4: Después de la inhibición del CYP3A4 mediante la administración concomitante de 200 mg de ketoconazol dos veces al día, la C max y el AUC del metabolito activo de…»
AEMPS, section 4.5 · Open on CIMA
MajorClarithromycin
«CYP3A4 Inhibitors: Doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole…»
FDA, section 7 · Open on DailyMed
Majorinductores del CYP3A4class named in the label
«Inductores del CYP3A4: La inducción del CYP3A4 puede llevar a niveles plasmáticos subterapéuticos. No se recomienda el uso concomitante con inductores del CYP3A4 (por ejemplo, carbamazepina…»
AEMPS, section 4.5 · Open on CIMA
Majorinhibidores del CYP3A4class named in the label
«Uso concomitante de inhibidores potentes del CYP3A4 en pacientes con insuficiencia renal o hepática de moderada a grave.»
AEMPS, section 4.3 · Open on CIMA
MajorItraconazole
«Inhibidores potentes del CYP3A4: Después de la inhibición del CYP3A4 mediante la administración concomitante de 200 mg de ketoconazol dos veces al día, la C max y el AUC del metabolito activo de…»
AEMPS, section 4.5 · Open on CIMA
MajorItraconazole
«CYP3A4 Inhibitors: Doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole…»
FDA, section 7 · Open on DailyMed
MajorKetoconazole
«Inhibidores potentes del CYP3A4: Después de la inhibición del CYP3A4 mediante la administración concomitante de 200 mg de ketoconazol dos veces al día, la C max y el AUC del metabolito activo de…»
AEMPS, section 4.5 · Open on CIMA
MajorKetoconazole
«CYP3A4 Inhibitors: Doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole…»
FDA, section 7 · Open on DailyMed
MajorPhenobarbital
«Inductores del CYP3A4: La inducción del CYP3A4 puede llevar a niveles plasmáticos subterapéuticos. No se recomienda el uso concomitante con inductores del CYP3A4 (por ejemplo, carbamazepina…»
AEMPS, section 4.5 · Open on CIMA
MajorPhenytoin
«Inductores del CYP3A4: La inducción del CYP3A4 puede llevar a niveles plasmáticos subterapéuticos. No se recomienda el uso concomitante con inductores del CYP3A4 (por ejemplo, carbamazepina…»
AEMPS, section 4.5 · Open on CIMA
MajorRifampicin
«Inductores del CYP3A4: La inducción del CYP3A4 puede llevar a niveles plasmáticos subterapéuticos. No se recomienda el uso concomitante con inductores del CYP3A4 (por ejemplo, carbamazepina…»
AEMPS, section 4.5 · Open on CIMA
MajorRitonavir
«Inhibidores potentes del CYP3A4: Después de la inhibición del CYP3A4 mediante la administración concomitante de 200 mg de ketoconazol dos veces al día, la C max y el AUC del metabolito activo de…»
AEMPS, section 4.5 · Open on CIMA
ModerateCYP3A4 inhibitorsclass named in the label
«CYP3A4 Inhibitors: Doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole…»
FDA, section 7 · Open on DailyMed
ModerateDiltiazem
«Inhibidores moderados del CYP3A4: Después del bloqueo del CYP3A4 mediante la administración concomitante de 200 mg de fluconazol, inhibidor moderado del CYP3A4, dos veces al día durante 2 días, la C…»
AEMPS, section 4.5 · Open on CIMA
ModerateErythromycin
«Inhibidores moderados del CYP3A4: Después del bloqueo del CYP3A4 mediante la administración concomitante de 200 mg de fluconazol, inhibidor moderado del CYP3A4, dos veces al día durante 2 días, la C…»
AEMPS, section 4.5 · Open on CIMA
ModerateFluconazole
«Inhibidores moderados del CYP3A4: Después del bloqueo del CYP3A4 mediante la administración concomitante de 200 mg de fluconazol, inhibidor moderado del CYP3A4, dos veces al día durante 2 días, la C…»
AEMPS, section 4.5 · Open on CIMA
Moderateinhibidores del CYP2D6class named in the label
«Inhibidores del CYP2D6: No se ha evaluado clínicamente la interacción con inhibidores del CYP2D6. La C max y el AUC medios del metabolito activo son del orden de 1,7 y 2 veces mayores…»
AEMPS, section 4.5 · Open on CIMA
ModerateVerapamil
«Inhibidores moderados del CYP3A4: Después del bloqueo del CYP3A4 mediante la administración concomitante de 200 mg de fluconazol, inhibidor moderado del CYP3A4, dos veces al día durante 2 días, la C…»
AEMPS, section 4.5 · Open on CIMA
anticoagulantesclass named in the label
«Warfarina: En un ensayo clínico con voluntarios sanos se ha demostrado que fesoterodina 8 mg una vez al día no produce un efecto significativo en la farmacocinética, ni en la actividad anticoagulante…»
AEMPS, section 4.5 · Open on CIMA
anticoagulantsclass named in the label
«Warfarin: A clinical study has shown that fesoterodine 8 mg once daily has no significant effect on the pharmacokinetics or the anticoagulant activity (PT/INR) of warfarin 25 mg. Standard therapeutic…»
FDA, section 7 · Open on DailyMed
anticonceptivos hormonalesclass named in the label
«Anticonceptivos orales: La fesoterodina no afecta a la supresión de la ovulación producida por los anticonceptivos hormonales orales. En presencia de fesoterodina, no hay ningún cambio en la…»
AEMPS, section 4.5 · Open on CIMA
antidepresivos tricíclicosclass named in the label
«Interacciones farmacológicas: Se debe tener cuidado cuando se administre fesoterodina conjuntamente con otros antimuscarínicos y medicamentos que presenten propiedades anticolinérgicas (por ejemplo…»
AEMPS, section 4.5 · Open on CIMA
antipsicóticosclass named in the label
«Interacciones farmacológicas: Se debe tener cuidado cuando se administre fesoterodina conjuntamente con otros antimuscarínicos y medicamentos que presenten propiedades anticolinérgicas (por ejemplo…»
AEMPS, section 4.5 · Open on CIMA
Carbamazepine
«CYP3A4 Inducers: No dosing adjustments are recommended in the presence of CYP3A4 inducers, such as rifampin and carbamazepine. Following induction of CYP3A4 by coadministration of rifampin 600 mg…»
FDA, section 7 · Open on DailyMed
CYP2D6 inhibitorsclass named in the label
«CYP2D6 Inhibitors: The interaction with CYP2D6 inhibitors was not tested clinically. In poor metabolizers for CYP2D6, representing a maximum CYP2D6 inhibition, C max and AUC of the active metabolite…»
FDA, section 7 · Open on DailyMed
CYP3A4 inducersclass named in the label
«CYP3A4 Inducers: No dosing adjustments are recommended in the presence of CYP3A4 inducers, such as rifampin and carbamazepine. Following induction of CYP3A4 by coadministration of rifampin 600 mg…»
FDA, section 7 · Open on DailyMed
Diltiazem
«CYP3A4 Inhibitors: There is no clinically relevant effect of moderate CYP3A4 inhibitors on the pharmacokinetics of fesoterodine. Following blockade of CYP3A4 by coadministration of the moderate…»
FDA, section 7 · Open on DailyMed
Erythromycin
«CYP3A4 Inhibitors: There is no clinically relevant effect of moderate CYP3A4 inhibitors on the pharmacokinetics of fesoterodine. Following blockade of CYP3A4 by coadministration of the moderate…»
FDA, section 7 · Open on DailyMed
Estradiol
«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…»
FDA, section 7 · Open on DailyMed
Ethinylestradiol
«Anticonceptivos orales: La fesoterodina no afecta a la supresión de la ovulación producida por los anticonceptivos hormonales orales. En presencia de fesoterodina, no hay ningún cambio en la…»
AEMPS, section 4.5 · Open on CIMA
Fluconazole
«CYP3A4 Inhibitors: There is no clinically relevant effect of moderate CYP3A4 inhibitors on the pharmacokinetics of fesoterodine. Following blockade of CYP3A4 by coadministration of the moderate…»
FDA, section 7 · Open on DailyMed
hormonal contraceptivesclass named in the label
«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…»
FDA, section 7 · Open on DailyMed
Levonorgestrel
«Anticonceptivos orales: La fesoterodina no afecta a la supresión de la ovulación producida por los anticonceptivos hormonales orales. En presencia de fesoterodina, no hay ningún cambio en la…»
AEMPS, section 4.5 · Open on CIMA
Levonorgestrel
«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…»
FDA, section 7 · Open on DailyMed
Metoclopramide
«Interacciones farmacológicas: Fesoterodina puede reducir el efecto de medicamentos que estimulan la motilidad del tracto gastrointestinal, como metoclopramida.»
AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

MajorDarunavir
«Established and Other Potentially Significant Drug Interactions: Urinary antispasmodics fesoterodine solifenacin  fesoterodine  solifenacin When fesoterodine is co-administered with…»
FDA, section 7 · Open on DailyMed
MajorItraconazole
«Urológicos: se debe evitar el uso concomitante Insuficiencia renal o hepática normal: usar con precaución con una dosis máxima de fesoterodina de 4 mg.»
AEMPS, section 4.5 · Open on CIMA
ModerateDarunavir
«MEDICAMENTOS UROLÓGICOS: Utilizar con precaución. Monitorizar las reacciones adversas de fesoterodina o solifenacina, puede ser necesaria la reducción de la dosis de fesoterodina o solifenacina.»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Fesoterodine used for?

Fesoterodine is evaluated for the following indications with varying evidence strength: Overactive bladder (evidence tier B), Urge urinary incontinence (evidence tier B), Frequent urination without prior evaluation (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Fesoterodine?

Common side effects of Fesoterodine (≥ 1 in 100): Dry mouth (28–35%), Constipation (5–9%), Dry eyes, Headache, Dyspepsia, Urinary tract infection. See the Safety section for uncommon and serious reactions.

Is Fesoterodine safe during pregnancy?

Is Fesoterodine compatible with breastfeeding?

Who should not take Fesoterodine?

Fesoterodine is contraindicated in: Hypersensitivity to fesoterodine or tolterodine; Urinary retention; Gastric retention; Uncontrolled narrow-angle glaucoma; Myasthenia gravis. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 12/14/2023
FDA / DailyMedLabel dated 07/16/2026

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