Antimuscarinic Pregnancy: No clinical data are available from women who became pregnant while taking solifenacin; animal studies do not indicate direct harmful effects on fertility or embryonal/foetal development, but the potential risk for humans is unknown and caution should be exercised when prescribing to pregnant women. No data on excretion in human milk are available; in mice solifenacin and/or its metabolites were excreted in milk and caused dose-dependent failure to thrive in neonatal mice, so use should be avoided during breastfeeding.

Solifenacin 5 mg

Brand names: Vesicare

Solifenacin is an antimuscarinic used to treat the urgency, frequency and urge incontinence of overactive bladder.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 5 mg solifenacin succinate once daily; if needed, the dose may be increased to 10 mg solifenacin succinate once daily

Route: Oral — swallowed whole with liquids; can be taken with or without food

Frequency: Once daily

Max: 10 mg once daily; no more than 5 mg once daily in severe renal impairment (creatinine clearance 30 mL/min or less), in moderate hepatic impairment (Child-Pugh 7 to 9), or when given simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole)

The recommended dose applies to adults including the elderly. The maximum effect of solifenacin can be determined after 4 weeks at the earliest. Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment, and if urinary tract infection is present an appropriate antibacterial therapy should be started. Hepatic impairment: no dose adjustment in mild hepatic impairment; moderate hepatic impairment (Child-Pugh 7 to 9) should be treated with caution and receive no more than 5 mg once daily; severe hepatic impairment is a contraindication. Paediatric population: the safety and efficacy of solifenacin in children have not yet been established, therefore solifenacin should not be used in children — no per-kg dose exists, hence paedDose is null. The fetched SPC is for the Solifenacin 10 mg film-coated tablet, but its section 4.2 covers both strengths and gives 5 mg once daily as the recommended starting dose, which matches this page. Section 4.5 (interactions) was cut off at the source-fetch limit in this bundle.

Dose adjustments

Renal

No dose adjustment is necessary for mild to moderate renal impairment (creatinine clearance greater than 30 mL/min). Patients with severe renal impairment (creatinine clearance 30 mL/min or less) should be treated with caution and receive no more than 5 mg once daily. Contraindicated in patients undergoing haemodialysis, and in severe renal impairment when combined with a potent CYP3A4 inhibitor.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

• 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily ( 2.1 ). • Do not exceed the 5 mg dose of solifenacin succinate tablets in patients with: • Severe renal impairment creatinine clearance <30 mL/min/1.73 m 2 ( 2.2 , 8.6 ). • Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate tablets are not recommended in patients with severe hepatic impairment (Child- Pugh C) ( 2.3 , 8.7 ). • Concomitant use of strong CYP3A4 inhibitors ( 2.4 , 7.1 ). 2.1 Dosing Information The recommended oral dose of solifenacin succinate tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2026-01-28. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Urinary retention
Severe gastrointestinal condition (including toxic megacolon)
Myasthenia gravis
Narrow angle glaucoma, and patients at risk for these conditions
Hypersensitivity to the active substance or to any of the excipients
Patients undergoing haemodialysis
Severe hepatic impairment
Severe renal impairment or moderate hepatic impairment in patients on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole

Side effects

Dry mouth — the most commonly reported adverse reaction; occurred in 11% of patients on 5 mg once daily and 22% on 10 mg once daily (4% on placebo)
Constipation, nausea, dyspepsia, abdominal pain (common)
Blurred vision (common); dry eyes (uncommon)
Urinary tract infection and cystitis; difficulty in micturition (uncommon) and urinary retention (rare)
Somnolence, dysgeusia, nasal dryness, dry skin, fatigue (uncommon)
Post-marketing: angioedema, anaphylactic reaction, QT prolongation and Torsade de Pointes, hallucinations and confusional state

Interactions

Potent CYP3A4 inhibitors (ketoconazole, and therapeutic doses of ritonavir, nelfinavir, itraconazole) — limit the solifenacin dose to a maximum of 5 mg once daily
Other medicinal products with anticholinergic properties — may result in more pronounced therapeutic effects and undesirable effects; allow an interval of approximately one week after stopping solifenacin before commencing other anticholinergic therapy
Cholinergic receptor agonists — may reduce the therapeutic effect of solifenacin
Medicinal products that stimulate gastrointestinal motility, such as metoclopramide and cisapride — solifenacin can reduce their effect
Bisphosphonates and other products that can cause or exacerbate oesophagitis — use with caution in patients with hiatus hernia / gastro-oesophageal reflux

Clinical monograph

How it works

It blocks muscarinic (mainly M3) receptors on the bladder detrusor muscle, reducing involuntary contractions and increasing bladder capacity.

Prescribing in practice

Avoid in narrow-angle glaucoma, significant urinary retention and gastrointestinal obstruction.
Anticholinergic effects (dry mouth, constipation, blurred vision) are common, and it can prolong the QT interval; it may also precipitate urinary retention.
Be mindful of the cumulative anticholinergic burden, which affects cognition and falls risk, especially in older people.

Monitoring

Review symptom benefit and anticholinergic side effects after a few weeks, watch for incomplete bladder emptying, and consider QT risk in susceptible patients.

Counselling the patient

A dry mouth, constipation or blurred vision can occur — tell us if these bother you.
Seek help if you find it hard or impossible to pass urine.
If you are older, this type of medicine can affect memory or steadiness, so mention any new confusion or falls.

Evidence & guidelines

A recommended antimuscarinic option for overactive bladder in NICE guidance on urinary incontinence.

Reference: NICE NG123; STAR trial; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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