Solifenacin

Antimuscarinic for overactive bladder

ATC code: G04BD08

Brand names: Vesicare, Vesomni

Updated 24 Sep 2026 · Methodology

Indications

Overactive bladder

Second line

Second-line for overactive bladder after behavioral therapy failure (bladder training, caffeine reduction, pelvic floor exercises) per EAU 2024 and AUA 2019. Dose 5 mg once daily; up-titrate to 10 mg if needed. Effect develops over 4 weeks, with assessment at 12 weeks. In the STAR head-to-head trial (Chapple 2005), solifenacin outperformed tolterodine on urgency episodes.

Sources

ICD-10: N32.8 · ICD-11: GC50.0

Urge urinary incontinence

Second line

AEMPS approves solifenacin for urge urinary incontinence in adults after behavioural therapy fails. Cochrane 2012 pooled antimuscarinic data: they reduce incontinence episodes by 1–3 per day vs placebo. AEU 2023 prefers solifenacin in patients aged 18–65 with intact cognitive function due to M3 selectivity and tolerability.

Sources

ICD-10: N39.4 · ICD-11: MF50.21

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Anti-aging and longevity

Not recommended

Solifenacin is an antimuscarinic drug. It is prescribed for overactive bladder with frequency and urgency symptoms (AEMPS Ficha Técnica). Solifenacin is prescribed for anti-aging strengthening of the urinary system outside an overactive bladder indication. No clinical studies of prophylactic use in this setting exist. The drug causes anticholinergic adverse effects: dry mouth, constipation, blurred vision, confusion (especially in older adults; the AGS Beers Criteria 2023 lists antimuscarinics as potentially inappropriate for older adults), urinary retention (paradoxically), and QT prolongation. If solifenacin was prescribed outside confirmed overactive bladder, consider seeking a second opinion.

Sources

Frequent urination without prior evaluation

Not recommended

Solifenacin is heavily marketed as a drug for «frequent toilet visits». Increased urinary frequency is a symptom that may mean UTI, diabetes mellitus, BPH, neurological disease, or excess caffeine and fluid intake. Per Beers Criteria 2023 (AGS) all muscarinic blockers fall into the «avoid in older adults» category, especially with cognitive impairment. The Gray et al. cohort study (JAMA Intern Med 2015) showed cumulative anticholinergic exposure over 3 years is linked to a 54% increase in dementia risk. If solifenacin was prescribed without a bladder ultrasound, urinalysis, or discussion of behavioural therapy, consider seeking a second opinion.

Sources

ICD-10: R35 · ICD-11: MF50.0

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

A selective M3 muscarinic antagonist with preferential action on bladder smooth muscle. Reduces involuntary detrusor contractions, urgency, and frequency. Bladder-to-salivary-gland M3 selectivity is roughly 4:1, so dry mouth is less common than with oxybutynin. CYP3A4-metabolized; half-life 45–68 hours.

Safety

Contraindications

Solifenacin hypersensitivity
Severe GI disorders (megacolon, paralytic ileus)
Urinary retention
Angle-closure glaucoma
Myasthenia gravis
Severe hepatic impairment
Strong CYP3A4 inhibitor combination with severe renal or moderate hepatic impairment

Serious adverse effects

Acute urinary retention
Acute angle-closure glaucoma
QT prolongation (rare, with overdose)
Cognitive impairment and confusion in older adults
Severe allergic reaction
Gastrointestinal obstruction

Common adverse effects

Dry mouth (10–28%)
Constipation
Blurred vision
Drowsiness
Urinary retention
Nausea
Fatigue

Pregnancy: can you take Solifenacin?

Limited pregnancy data. OAB in pregnancy usually does not require pharmacotherapy – behavioral measures are first-line. When treatment is needed, deferring initiation until postpartum is preferred.

Breastfeeding: can you take Solifenacin?

No data on milk excretion. Not used during lactation.

Calculate RID Full profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take once daily, with or without food, preferably at the same time. With eGFR under 30 or moderate hepatic impairment, max dose 5 mg. In patients over 65 it appears on the 2023 Beers list for anticholinergic burden – falls and cognitive decline risk. Weigh benefit and risk carefully, start at minimum dose. Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin) cap the dose at 5 mg.

Drug–drug interactions

1 pair found. Sorted from critical to minor.

MajorAmitriptylineTricyclic antidepressants (TCA)

Mechanism

Amitriptyline has marked anticholinergic properties (amitriptyline label). Solifenacin blocks muscarinic receptors and also causes anticholinergic adverse effects (solifenacin label). These effects add up. According to the amitriptyline label, tricyclic antidepressants can potentiate the action of anticholinergic drugs on the eye, brain, bowel and bladder, which raises the risk of paralytic ileus and hyperpyrexia. The second pathway is cardiac. QT interval prolongation is a common adverse reaction to amitriptyline (amitriptyline label). QT prolongation and torsade de pointes have occurred with solifenacin in patients with risk factors (solifenacin label). The labels describe no pharmacokinetic interaction. Solifenacin does not inhibit the cytochrome P450 (CYP) enzymes that break down amitriptyline and is unlikely to change its clearance. The labels say nothing about the effect of amitriptyline on solifenacin.

Symptoms

Peripheral anticholinergic effects include dry mouth, constipation, urinary retention, blurred vision, a fast heartbeat and, in people with a narrow anterior chamber angle, an attack of angle-closure glaucoma (both labels). The most serious complications are paralytic ileus and overheating with high fever, especially in hot weather, because sweating decreases (amitriptyline and solifenacin labels). Central effects include confusion, hallucinations, drowsiness and delirium (both labels). Older people have a higher risk of falls (amitriptyline label, US Food and Drug Administration, ). An arrhythmia due to QT interval prolongation shows as palpitations or fainting, and the electrocardiogram shows a long QT interval.

Management

The combination is not recommended. The amitriptyline label says to avoid it with anticholinergic drugs because of the risk of paralytic ileus and hyperpyrexia (Spanish Agency of Medicines and Medical Devices, AEMPS, section 4.5). The solifenacin label of the US Food and Drug Administration () does not recommend solifenacin in patients who take drugs known to prolong the QT interval. Amitriptyline is one of these drugs (amitriptyline label, 4.4 and 4.8). For nocturnal enuresis in children, amitriptyline must not be combined with any anticholinergic drug (amitriptyline label, 4.4). Solifenacin tablets are not for children (solifenacin label, 4.2). If both drugs are still prescribed, supervise closely and adjust doses carefully. In older patients, start amitriptyline at low doses (US amitriptyline label, FDA). Before starting, rule out the solifenacin contraindications: urinary retention, severe gastrointestinal disorders, angle-closure glaucoma or a risk of these conditions (solifenacin label, 4.3). For the heart, take into account the risk factors named in both labels: marked bradycardia, decompensated heart failure, low or high potassium, low magnesium and known QT prolongation. If confusion, hallucinations or drowsiness appear, consider lowering the solifenacin dose or stopping it (US solifenacin label, FDA). Ask the patient to report constipation lasting 3 days or more or abdominal pain, and to avoid overheating in hot weather (US solifenacin label; amitriptyline label). When solifenacin is stopped to switch to another drug with anticholinergic action, wait about one week (solifenacin label, 4.5).

Sources

Pair details →Amitriptyline →

Label mentions22 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

MajorItraconazole
«Solifenacina es metabolizada por el CYP3A4. La administración simultánea de ketoconazol (200 mg/día), un potente inhibidor del CYP3A4, duplicó el AUC de solifenacina mientras que la administración de…»
AEMPS, section 4.5 · Open on CIMA
MajorKetoconazole
«Pacientes con insuficiencia renal grave o insuficiencia hepática moderada en tratamiento simultáneo con un inhibidor potente de CYP3A4, por ejemplo, ketoconazol (ver sección 4.5).»
AEMPS, section 4.3 · Open on CIMA
MajorKetoconazole
«DRUG INTERACTIONS: Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see…»
FDA, section 7 · Open on DailyMed
MajorRitonavir
«Solifenacina es metabolizada por el CYP3A4. La administración simultánea de ketoconazol (200 mg/día), un potente inhibidor del CYP3A4, duplicó el AUC de solifenacina mientras que la administración de…»
AEMPS, section 4.5 · Open on CIMA
ModerateCYP3A4 inhibitorsclass named in the label
«DRUG INTERACTIONS: Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see…»
FDA, section 7 · Open on DailyMed
Moderateinhibidores del CYP3A4class named in the label
«Solifenacina es metabolizada por el CYP3A4. La administración simultánea de ketoconazol (200 mg/día), un potente inhibidor del CYP3A4, duplicó el AUC de solifenacina mientras que la administración de…»
AEMPS, section 4.5 · Open on CIMA
anticonceptivos hormonalesclass named in the label
«Anticonceptivos orales: La administración de solifenacina no mostró interacción farmacocinética de solifenacina con los anticonceptivos orales de combinación (etinilestradiol/levonorgestrel).»
AEMPS, section 4.5 · Open on CIMA
Carbamazepine
«No se han estudiado los efectos de la inducción enzimática sobre la farmacocinética de la solifenacina y sus metabolitos ni el efecto de los sustratos con elevada afinidad por el CYP3A4 sobre la…»
AEMPS, section 4.5 · Open on CIMA
Cisapride
«Interacciones farmacológicas: La solifenacina puede reducir el efecto de los medicamentos que estimulan la motilidad del tubo digestivo, como metoclopramida y cisaprida.»
AEMPS, section 4.5 · Open on CIMA
Digoxin
«Digoxina: La administración de solifenacina no mostró efectos sobre la farmacocinética de digoxina.»
AEMPS, section 4.5 · Open on CIMA
Diltiazem
«No se han estudiado los efectos de la inducción enzimática sobre la farmacocinética de la solifenacina y sus metabolitos ni el efecto de los sustratos con elevada afinidad por el CYP3A4 sobre la…»
AEMPS, section 4.5 · Open on CIMA
Ethinylestradiol
«Anticonceptivos orales: La administración de solifenacina no mostró interacción farmacocinética de solifenacina con los anticonceptivos orales de combinación (etinilestradiol/levonorgestrel).»
AEMPS, section 4.5 · Open on CIMA
inductores del CYP3A4class named in the label
«No se han estudiado los efectos de la inducción enzimática sobre la farmacocinética de la solifenacina y sus metabolitos ni el efecto de los sustratos con elevada afinidad por el CYP3A4 sobre la…»
AEMPS, section 4.5 · Open on CIMA
Levonorgestrel
«Anticonceptivos orales: La administración de solifenacina no mostró interacción farmacocinética de solifenacina con los anticonceptivos orales de combinación (etinilestradiol/levonorgestrel).»
AEMPS, section 4.5 · Open on CIMA
Metoclopramide
«Interacciones farmacológicas: La solifenacina puede reducir el efecto de los medicamentos que estimulan la motilidad del tubo digestivo, como metoclopramida y cisaprida.»
AEMPS, section 4.5 · Open on CIMA
Phenytoin
«No se han estudiado los efectos de la inducción enzimática sobre la farmacocinética de la solifenacina y sus metabolitos ni el efecto de los sustratos con elevada afinidad por el CYP3A4 sobre la…»
AEMPS, section 4.5 · Open on CIMA
Rifampicin
«No se han estudiado los efectos de la inducción enzimática sobre la farmacocinética de la solifenacina y sus metabolitos ni el efecto de los sustratos con elevada afinidad por el CYP3A4 sobre la…»
AEMPS, section 4.5 · Open on CIMA
Verapamil
«No se han estudiado los efectos de la inducción enzimática sobre la farmacocinética de la solifenacina y sus metabolitos ni el efecto de los sustratos con elevada afinidad por el CYP3A4 sobre la…»
AEMPS, section 4.5 · Open on CIMA
Warfarin
«Warfarina: La administración de solifenacina no alteró la farmacocinética de R -warfarina ni de S- warfarina ni su efecto sobre el tiempo de protrombina.»
AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

MajorDarunavir
«Established and Other Potentially Significant Drug Interactions: Urinary antispasmodics fesoterodine solifenacin  fesoterodine  solifenacin When fesoterodine is co-administered with…»
FDA, section 7 · Open on DailyMed
MajorItraconazole
«Urológicos: Insuficiencia renal grave: contraindicado Insuficiencia hepática moderada o grave: contraindicado Usar con precaución en todos los demás pacientes, con una dosis máxima de solifenacina de…»
AEMPS, section 4.5 · Open on CIMA
ModerateDarunavir
«MEDICAMENTOS UROLÓGICOS: Utilizar con precaución. Monitorizar las reacciones adversas de fesoterodina o solifenacina, puede ser necesaria la reducción de la dosis de fesoterodina o solifenacina.»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Solifenacin used for?

Solifenacin is evaluated for the following indications with varying evidence strength: Overactive bladder (evidence tier A), 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.

What are the side effects of Solifenacin?

Common side effects of Solifenacin (≥ 1 in 100): Dry mouth (10–28%), Constipation, Blurred vision, Drowsiness, Urinary retention, Nausea. See the Safety section for uncommon and serious reactions.

Is Solifenacin safe during pregnancy?

Limited pregnancy data. OAB in pregnancy usually does not require pharmacotherapy – behavioral measures are first-line. When treatment is needed, deferring initiation until postpartum is preferred.

Is Solifenacin compatible with breastfeeding?

No data on milk excretion. Not used during lactation.

Who should not take Solifenacin?

Solifenacin is contraindicated in: Solifenacin hypersensitivity; Severe GI disorders (megacolon, paralytic ileus); Urinary retention; Angle-closure glaucoma; Myasthenia gravis. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 03/30/2026
FDA / DailyMedLabel dated 07/06/2026

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