Formulary
Fesoterodine fumarate: Indications, Dosing, Side Effects and Interactions
Fesoterodine fumarate clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Fesoterodine fumarate: Indications, Dosing, Side Effects and Interactions
Fesoterodine fumarate clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Urinary frequency,Urinary urgency,Urge incontinence**
- **Adult** (By Mouth): 4 mg once daily, increased if necessary up to 8 mg once daily.
Cautions
For all antimuscarinics (systemic) Acute myocardial infarction; arrhythmias (may be worsened); autonomic neuropathy; cardiac insufficiency (due to association with tachycardia); cardiac surgery (due to association with tachycardia); conditions characterised by tachycardia; congestive heart failure (may be worsened); coronary artery disease (may be worsened); diarrhoea; elderly (especially if frail); gastro-oesophageal reflux disease; hiatus hernia with reflux oesophagitis; hypertension; hyperthyroidism (due to association with tachycardia); individuals susceptible to angle-closure glaucoma; prostatic hyperplasia; pyrexia; ulcerative colitis Cautions, further information Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: if treating extrapyramidal side-effects of antipsychotic medications (risk of antimuscarinic toxicity) with delirium or dementia (risk of exacerbation of cognitive impairment), angle-closure glaucoma (contra-indicated; risk of acute exacerbation of glaucoma), or chronic prostatism (risk of urinary retention) if two or more antimuscarinic drugs prescribed concomitantly (risk of increased antimuscarinic toxicity)
Contraindications
For all antimuscarinics (systemic) Angle-closure glaucoma; gastro-intestinal obstruction; intestinal atony; myasthenia gravis (but some antimuscarinics may be used to decrease muscarinic side-effects of anticholinesterases); paralytic ileus; pyloric stenosis; severe ulcerative colitis; significant bladder outflow obstruction; toxic megacolon; urinary retention
Side effects
For all antimuscarinics (systemic) Common or very common Constipation; dizziness; drowsiness; dry mouth; dyspepsia; flushing; headache; nausea; palpitations; skin reactions; tachycardia; urinary disorders; vision disorders; vomiting Rare or very rare Angioedema; confusion (more common in elderly) Side-effects For fesoterodine fumarate Common or very common Diarrhoea; dry eye; gastrointestinal discomfort; insomnia; throat complaints Uncommon Cough; fatigue; gastrointestinal disorders; nasal dryness; taste altered; urinary tract infection; vertigo
Interactions
**Severe interactions:**
- Warfarin A clinical study in healthy volunteers has show n that fesoterodine 8 mg once daily has no significant effect on the pharmacokinetics or the anticoagulant activity of a single dose of...
**Other interactions (10):**
- Pharmacological interactions Caution should be exercised in coadministration of fesoterodine with other antimuscarinics and medicinal products with anticholinergic properties (e.g.
- Fesoterodine may reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract, such as metoclopramide.
- CYP3A4 inhibitors Potent CYP3A4 inhibitors Following inhibition of CYP3A4 by co-administration of ketoconazole 200 mg twice daily, C max and AUC of the active metabolite of fesoterodine increased...
- Therefore, the maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors (e.g.
- Moderate CYP3A4 inhibitors Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 200 mg twice a day for 2 days, C max and AUC of the active metabolite of...
- No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice).
Pregnancy
Manufacturer advises avoid-toxicity in animal studies.
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available). Dose adjustments Manufacturer advises increase dose cautiously in mild impairment; maximum 4 mg daily in moderate impairment.
Renal impairment
Use with caution. M Dose adjustments Increase dose cautiously if eGFR 30-80 mL/minute/1.73 m 2 ; max. 4 mg daily if eGFR less than 30 mL/minute/1.73 m 2 . M See Prescribing in renal impairment .
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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