Muscarinic receptor antagonist for overactive bladder
ATC code: G04BD11 (Fesoterodine)
Brand names
Toviaz
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.
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).
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).
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
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.
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FDA Category C. No controlled human pregnancy studies. AEMPS does not recommend use in pregnancy unless the expected benefit outweighs the risk. Effective contraception is reasonable in women of reproductive age on therapy.
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.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
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.
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.
FDA category C. FDA Category C. No controlled human pregnancy studies. AEMPS does not recommend use in pregnancy unless the expected benefit outweighs the risk. Effective contraception is reasonable in women of reproductive age on therapy.
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.
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.