(fee-soe-ter-o-deen) ,


(trade name)


Therapeutic: urinary tract antispasmodics
Pharmacologic: anticholinergics
Pregnancy Category: C


Treatment of overactive bladder function that results in urinary frequency, urgency, or urge incontinence.


Acts as a competitive muscarinic receptor antagonist resulting in inhibition of cholinergically mediated bladder contraction.

Therapeutic effects

Decreased urinary frequency, urgency, and urge incontinence.


Absorption: Rapidly absorbed following oral administration, but is rapidly converted to its active metabolite (bioavailability of metabolite 52%); further metabolism occurs in the liver via CYP2D6 and CYP3A4 enzyme systems. 16% of active metabolite is excreted in urine, most of the remainder of inactive metabolites are renally excreted. 7% excreted in feces.
Distribution: Unknown.
Metabolism and Excretion: Rapidly converted by esterases to active metabolite.
Half-life: 7 hr (following oral administration).

Time/action profile (active metabolite)

POrapid5 hr24 hr


Contraindicated in: Hypersensitivity;Urinary retention;Gastric retention;Severe hepatic impairment;Uncontrolled narrow-angle glaucoma.
Use Cautiously in: Significant bladder outlet obstruction (↑ risk of retention);Severe renal insufficiency (dose adjustment required);↓ GI motility including severe constipation;Treated narrow-angle glaucoma (use only if benefits outweigh risks);Myasthenia gravis;Severe renal impairment (dose should not exceed 4 mg/day); Geriatric: ↑ risk of anticholinergic side effects in patients >75 yr; Obstetric / Lactation: Avoid using unless potential benefits outweighs potential risk to fetus/neonate; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • drowsiness
  • headache


  • tachycardia (dose related)


  • dry mouth (most frequent)
  • constipation
  • nausea
  • upper abdominal pain


  • dysuria
  • urinary retention


  • back pain


  • angioedema (life-threatening)


Drug-Drug interaction

Concurrent use of potent CYP3A4 enzyme inhibitors including ketoconazole, itraconazole, and clarithromycin ↑ blood levels and risk of toxicity; daily dose should not exceed 4 mg.Use less potent inhibitors of CYP3A4 (such as erythromycin ) with caution; escalate dose carefully.Anticholinergic effects may alter the GI absorption of other drugs.


Oral (Adults) 4 mg once daily initially may be ↑ to 8 mg/daily; Concurrent potent CYP3A4 inhibitors or CCr <30 mL/min—dose should not exceed 4 mg/day.


Extended-release tablets: 4 mg, 8 mg

Nursing implications

Nursing assessment

  • Assess for urinary urgency, frequency, and urge incontinence periodically throughout therapy.
  • Monitor for signs and symptoms of angioedema (swelling of face, lips, tongue, and/or larynx). May occur with first or subsequent doses. Discontinue therapy and prove supportive therapy. Have epinephrine, corticosteroids, and resuscitation equipment available.
  • Lab Test Considerations: May cause ↑ ALT and GGT.

Potential Nursing Diagnoses

Impaired urinary elimination (Indications)
Urinary retention (Indications)


  • Oral: Administer without regard to food.
    • Extended-release tablets should be swallowed whole; do not break, crush, or chew.

Patient/Family Teaching

  • Instruct patient to take fesoterodine as directed. If a dose is missed, omit and begin taking again the next day; do not take 2 doses the same day. Advise patient to read the Patient Information sheet prior to initiation of therapy and with each Rx refill.
  • May cause drowsiness, dizziness, and blurred vision. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to avoid alcohol; may increase drowsiness.
  • Advise patient to use caution in hot environments; may cause decreased sweating and severe heat illness.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to stop medication and notify health care professional if signs and symptoms of angioedema occur.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decreased urinary frequency, urgency, and urge incontinence.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
The anticholinergics segment has been further sub-segmented into solifenacin, oxybutynin, fesoterodine, darifenacin, tolterodine, trospium, and others.
Darifenacin (Enablex), fesoterodine (Toviaz), flavoxate (Urispas), oxybutynin (Ditropan), solifenacin (Vesicare), tolterodine (Detrai), and trospium (Sanctura).
Basic characteristics of the antimuscarinic drugs Darifenacin 507.5 Low M3 Fesoterodine 527.6 Low Non-selective Oxybutynin 393.9 High Non-selective Propiverine 403.9 (*) Limited data Non-selective Solifenacin 480.5 Moderate Predominantly M3 Tolterodine 475.6 Moderate Non-selective Trospium 427.9 Low Non-selective BBB: Blood-brain barrier, (*) Value expressed in g/moL Table 2.
Researchers analyzed data from a multicenter, double-blind, randomized, controlled trial of daily antimuscarinic therapy (4-8 mg fesoterodine) or placebo in 645 women with urgency-predominant incontinence, which also evaluated sleep quality and daytime sleepiness.
(6) Currently in Canada there are six anticholinergic drugs approved for treatment of OAB symptoms: darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine and trospium.
We report three main clinical pictures of OAB: a male patient presenting with lower urinary tract symptoms (LUTS), including urgency; a young woman with comorbidities; and an elderly woman with mixed urinary incontinence, with the aim of highlighting the specific features of these real-life cases, discussing the most appropriate management, and assessing how fesoterodine treatment may meet these patients' expectations.
The approval came a few days after the company's Fesoterodine Fumarate extended-release tablets for overactive bladder were granted final approval.
Long-term safety, tolerability and efficacy of fesoterodine in subjects with overactive bladder symptoms stratified by age: pooled analysis of two open-label extension studies.
Antimuscarinic medications, such as darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, and trospium, carry significant risks for anti-cholinergic side effects (American Geriatrics Society Beers Criteria Update Expert Panel, 2015).
Effects of the moderate CYP3A4 inhibitor, fluconazole, on the pharmacokinetics of fesoterodine in healthy subjects.
[sup][18] The current first-line pharmacotherapeutic treatment options indicated for NDO are muscarinic receptor antagonists, such as solifenacin, tolterodine, fesoterodine, and so on.