Fesoterodine

Mechanism-of-action class: Cholinergic Muscarinic Antagonists.

• Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.ICD-10: N32.81

• Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following: known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see Clinical Pharmacology (12.1) ] . Reactions have included angioedema [see Warnings and Precautions (5.1) ] .contraindicated

OAB in Adults : The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of 8 mg once daily. ( 2.1 ) Adult Patients with Renal Impairment : Refer to the full prescribing information for recommended dosage. ( 2.3 ) Dosage Modifications Due to Strong CYP3A4 Inhibitors : Refer to the full prescribing information for recommended dosage. ( 2.5 ) Administration : Swallow whole with liquid. Do not chew, divide, or crush. Take with or without food. ( 2.6 ) 2.1 Recommended Dosage for Adult Patients With OAB The recommended starting dosage of fesoterodine fumarate extended-release tablets in adults is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of fesoterodine fumarate extended-release tablets 8 mg once daily. For administration instructions, see Dosage and Administration (2.6) . Pediatric use information is approved for Pfizer Inc.’s TOVIAZ ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 2.3 Recommended Dosage in Adult Patients With Renal Impairment The recommended dosage of fesoterodine fumarate extended-release tablets in adult patients with renal impairment is described in Table 1 [ see Use in Specific Populations (8.6) ] . For administration instructions, see Dosage and Administration (2.6) .

Angioedema : Promptly discontinue fesoterodine fumarate and provide appropriate therapy. ( 5.1 ) Urinary Retention: Fesoterodine fumarate is not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention. (5.2) Decreased Gastrointestinal Motility: Fesoterodine fumarate is not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. (5.3) Worsening of Narrow-Angle Glaucoma: Use fesoterodine fumarate with caution in patients being treated for narrow-angle glaucoma. (5.4) Central Nervous System Effects : Somnolence has been reported with fesoterodine fumarate. Advise patients not to drive or operate heavy machinery until they know how fesoterodine fumarate affects them. (5.5) Worsening of Myasthenia Gravis Symptoms: Use fesoterodine fumarate with caution in patients with myasthenia gravis. (5.6) 5.1 Angioedema Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine fumarate. In some cases, angioedema occurred after the first dose; however, cases have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life-threatening. Fesoterodine fumarate is contraindicated in patients with a known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients [see Contraindications (4) ] .

The following clinically significant adverse reactions are described elsewhere in labeling: Angioedema [see Warnings and Precautions (5.1) ] Urinary Retention [see Warnings and Precautions (5.2) ] Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3) ] Most frequently reported adverse events with fesoterodine fumarate in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; fesoterodine fumarate 4 mg, 19%; fesoterodine fumarate 8 mg, 35%) and constipation (placebo, 2%; fesoterodine fumarate 4 mg, 4%; fesoterodine fumarate 8 mg, 6%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Pediatric use information is approved for Pfizer Inc.’s TOVIAZ ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Overactive Bladder (OAB) The safety of fesoterodine fumarate was evaluated in Phase 2 and 3 controlled trials in a total of 2,859 patients with overactive bladder, of which 2,288 were treated with fesoterodine fumarate.

8.1 Pregnancy Risk Summary There are no available data with the use of fesoterodine fumarate in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times respectively, the maximum recommended human dose (MRHD) of 8 mg/day, based on AUC (see Data ) . The background risk of major birth defects and miscarriage for the indicated population are unknown. However, in the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. In mice at 6 to 27 times the expected exposure at the maximum recommended human dose (MRHD) of 8 mg based on AUC (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. One fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range.

Overdosage with fesoterodine fumarate can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended.

• Oct 31, 2008NDANDA022030Pfizer
• Dec 10, 2015ANDAANDA204827Alkem Labs Ltd
• Feb 17, 2017ANDAANDA205007Aurobindo Pharma
• Oct 3, 2017ANDAANDA204946Zydus Pharms
• Aug 13, 2019ANDAANDA204975Dr Reddys
• Jan 4, 2023ANDAANDA204973Alembic
• Jan 4, 2023ANDAANDA205002Amneal Pharms Ny
• Jan 9, 2024ANDAANDA204792Hetero Labs Ltd V

1. 1Drug Ineffective1,66916%
2. 2Dry Mouth8237.7%
3. 3Fall5304.9%
4. 4Off Label Use5114.8%
5. 5Fatigue5104.8%
6. 6Constipation5044.7%
7. 7Urinary Retention5024.7%
8. 8Pain4464.2%
9. 9Headache4213.9%
10. 10Dizziness3933.7%
11. 11Malaise3333.1%
12. 12Confusional State3303.1%
13. 13Condition Aggravated3293.1%
14. 14Diarrhoea3253.0%
15. 15Nausea3243.0%

The 10 most recently updated of 70 ClinicalTrials.gov registrations naming Fesoterodine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis
  Completed · Early phase 1 · Interventional · 25 enrolled · Thanakrit Visuthikosol
  NCT07016451updated 2026-05-15
• Deprescribing dRrugs for Overactive Bladder in General Practice (DROP)
  Active not recruiting · Interventional · 72 enrolled · Anne Estrup Olesen
  NCT06110975updated 2025-12-02
• A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
  Completed · Observational · 1,524 enrolled · Astellas Scientific & Medical Affairs, Inc.
  NCT02386072updated 2024-10-16
• Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
  Completed · Observational · 5,589 enrolled · Astellas Pharma Singapore Pte. Ltd.
  NCT03602508updated 2024-10-16
• Fall Prevention in Older Adults With OAB
  Completed · Phase 4 · Interventional · 74 enrolled · University of Pennsylvania
  NCT03946124updated 2023-05-06
• Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
  Completed · Phase 4 · Interventional · 20 enrolled · Brigham and Women's Hospital
  NCT04090190updated 2022-11-15
• Drug Use Investigation for Toviaz
  Completed · Observational · 2,521 enrolled · Pfizer
  NCT01936870updated 2021-06-11
• BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG
  Completed · Phase 1 · Interventional · 18 enrolled · Pfizer
  NCT04478357updated 2021-05-07
• Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administer
  Completed · Phase 1 · Interventional · 37 enrolled · Pfizer
  NCT04452838updated 2021-02-10
• A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
  Completed · Phase 3 · Interventional · 181 enrolled · Pfizer
  NCT01557244updated 2021-02-02

CPIC-curated drug–gene pairs for Fesoterodine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2D6CPIC C (provisional)FDA label: Informative PGx

Frequently asked questions

How does Fesoterodine work?

Mechanism-of-action class: Cholinergic Muscarinic Antagonists.

What is Fesoterodine used for?

According to FDA labeling, Fesoterodine carries indications including: Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Fesoterodine?

Fesoterodine is classified as Drugs for urinary frequency and incontinence, Cholinergic Muscarinic Antagonists, Decreased Bladder Contractility.

What are the brand names for Fesoterodine?

Fesoterodine is marketed under brand names including Toviaz.

What are the contraindications for Fesoterodine?

Fesoterodine labeling lists contraindications including: Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following: known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see Clinical Pharmacology (12.1) ] . Reactions have included angioedema [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.