Vesomni

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Vesomni

Property Description
Active ingredients Tamsulosin Hydrochloride, Solifenacin Succinate
Form Oral modified-release tablet (Film-coated)
Pharmacological class Alpha-adrenergic antagonist and Antimuscarinic agent
Common use Addressing lower urinary tract symptoms (LUTS) in men
Origin Synthetic compound

Vesomni is a prescription-only, synthetic fixed-dose combination product formulated as an oral modified-release tablet. The medicine contains two distinct active ingredients, Tamsulosin Hydrochloride and Solifenacin Succinate. Its core identity is rooted in its design to address, in a single formulation, both the storage and voiding phases of specific lower urinary tract symptoms (LUTS) in adult men, offering a comprehensive therapeutic approach.


Vesomni's Pharmacological Class and Dual Action

Vesomni is classified as a combination urological agent that integrates two separate pharmacological classes. Tamsulosin Hydrochloride functions as an alpha-adrenergic antagonist, while Solifenacin Succinate is categorized as an antimuscarinic agent. This dual-component nature, provided as a modified-release tablet, distinguishes it from monotherapies that contain only one of these active substances.

The medicine is characterized by its dual therapeutic action, achieved by combining muscle relaxation with bladder stabilization. This synergistic design is clinically recognized for providing effective relief for both the difficulty in passing urine and the associated issues of urinary urgency and frequency.


Why is Vesomni Designed as a Prolonged-Release Combination?

Vesomni is specifically engineered as a modified-release tablet to ensure the controlled and sustained delivery of both active ingredients over an extended time period. This structure is essential for maintaining stable therapeutic concentrations of Tamsulosin Hydrochloride and Solifenacin Succinate throughout the day. The fixed-dose combination structure is designed to simplify the patient’s regimen compared to taking two separate tablets, offering a practical solution for continuous, comprehensive symptom management.

Regulatory References

  1. NIH Clinical Study (NCT01018511)

What side effects are possible with Vesomni ?

Possible Side Effects and Safety Information

This section outlines the officially documented side effects and safety restrictions for Vesomni (solifenacin succinate and tamsulosin hydrochloride).

Adverse Reactions Overview

Adverse reactions are classified by frequency based on regulatory documentation:

Frequency Selected Adverse Reactions (Examples)
Common (up to 1 in 10 men) Dry mouth, constipation, dyspepsia, dizziness, blurred vision, fatigue, ejaculation disorders (e.g., retrograde ejaculation).
Uncommon (up to 1 in 100 men) Urinary tract infection, somnolence (sleepiness), dysgeusia, dry eyes, orthostatic hypotension (dizziness upon standing), headache, palpitations, vomiting.
Rare (up to 1 in 1,000 men) Acute urinary retention, faecal impaction, syncope (fainting), angioedema (swelling of the face, lips, or throat), hallucination.
Very Rare (up to 1 in 10,000 men) Stevens-Johnson syndrome, confusional state, priapism (prolonged erection).

Serious and clinically significant adverse reactions that have been reported include acute urinary retention (uncommon, and the most serious side effect observed in clinical studies), angioedema (rare, potentially life-threatening swelling), and syncope (rare).

Safety Restrictions and Monitoring

Contraindications: Use is strictly prohibited in patients with a known hypersensitivity to the components, severe hepatic impairment, severe renal impairment when concurrently taking strong CYP3A4 inhibitors (e.g., ketoconazole), uncontrolled narrow-angle glaucoma, myasthenia gravis, or a history of orthostatic hypotension.

Cautionary Considerations: Use requires particular caution and monitoring in patients with a risk of urinary retention (even without obstruction), gastrointestinal obstructive disorders, and those at risk of decreased gastrointestinal motility. The tamsulosin component is associated with Intraoperative Floppy Iris Syndrome (IFIS), a potential complication during cataract or glaucoma surgery. Due to the risk of dizziness and blurred vision, patients are advised against operating heavy machinery until they know how the medicine affects them.

Overdose and Emergency Response

Overdose and when to seek help

This information is based strictly on officially documented clinical signs, manifestations, and required actions as stated in government regulatory labeling for Vesomni (Solifenacin Succinate and Tamsulosin Hydrochloride).

Documented Overdose Manifestations

Overdose with Vesomni may present with symptoms related to the activity of both components, including dry mouth, dizziness, blurred vision, over-excitability, and hallucinations or seizures (convulsions). Severe clinical manifestations may include increased heart rate (tachycardia) and acute urinary retention (inability to completely or partially pass urine).

Severe Outcomes and Emergency Action

The most serious outcomes documented in regulatory guidance relate to profound effects on the cardiovascular and nervous systems, including severe hypotensive effects (significantly low blood pressure) and severe anticholinergic effects, which can potentially lead to changes in mental status. Immediate medical attention is required in the event of any suspected overdose or accidental intake. Patients must contact a doctor, pharmacist, or hospital immediately for advice.

Supportive Management and Antidote Status

Regulatory documents outline that management is primarily supportive. Procedures may include the administration of activated charcoal or gastric lavage (stomach washout) by a healthcare professional, typically within one hour of ingestion, with the explicit instruction to not induce vomiting. In the event of acute hypotension, the patient should be placed in a supine position to help restore blood pressure. No specific antidote is known for the combination product. Monitoring requirements, such as checking renal function, are noted if pressor agents are used to manage severe hypotension.

Therapeutic Uses of Vesomni

Vesomni is commonly used for the symptomatic management of moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). It is generally applied in contexts where patients experience persistent, disruptive LUTS and supportive symptom management is deemed appropriate.

Vesomni is applied across therapeutic domains involving both bladder control and urinary flow symptoms, addressing groups of symptoms that may become intense and interfere with daily functioning. This includes easing symptoms such as urinary urgency and frequency, as well as hesitancy and a weak urine stream.

The combination is considered relevant for patients who require additional symptomatic support to manage both obstructive difficulties and irritative bladder problems concurrently. “It is applicable in conditions where symptoms cluster into patterns requiring supportive management.” Easing these distressing symptoms contributes to improved comfort during periods of heightened symptoms and may assist with maintaining functional stability.


Quick Fact: Supports Management of Mixed LUTS

Regulatory References

  1. Scottish Medicines Consortium guidance

Eligibility and Restrictions for Use

Eligibility Scope

Vesomni is officially limited to adult men (aged 18 and older) who are experiencing lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). Use in children and adolescents (under 18 years) is contraindicated and not recommended.

Absolute Contraindications

Regulatory documents state that the medicine is contraindicated in patients with a history of orthostatic hypotension, severe hepatic impairment (Child-Pugh score > 9), myasthenia gravis, narrow-angle glaucoma, or severe gastrointestinal conditions (including toxic megacolon). It must also not be used by patients undergoing haemodialysis or those with known hypersensitivity to any component.

Conditional Restrictions

Use is contraindicated if severe renal impairment or moderate hepatic impairment is combined with simultaneous treatment using a strong CYP3A4 inhibitor. The medicine should be used with caution in patients with severe renal impairment or moderate hepatic impairment alone, and in those at high risk of urinary retention. Women are a non-indicated population for this medicine.


Official Eligibility Structure

Official regulatory documents define who can and cannot use the medicine through a series of absolute contraindications and conditional restrictions, confining its use to the intended adult male population. These rules formally prohibit use based on severe organ impairment, specific high-risk neurological or vascular diseases, and certain critical gastrointestinal disorders. The official labeling explicitly confirms the medicine is not indicated for women, children, or adolescents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information describes specific pharmacokinetic and pharmacodynamic interactions that require careful consideration during co-administration.

Pharmacokinetic Interactions

Co-administration with medicines that inhibit specific liver enzymes (CYP3A4 and CYP2D6) can increase the body's exposure to both components of Vesomni, solifenacin and tamsulosin. Strong CYP3A4 inhibitors, such as ketoconazole, ritonavir, and itraconazole, are associated with the most significant restrictions.

  • Strong CYP3A4 Inhibitors: Use with caution. This combination is not recommended for patients with severe kidney impairment or moderate liver impairment.
  • CYP2D6 Inhibitors: Restrictions apply when a strong CYP3A4 inhibitor is used concurrently in patients known to be CYP2D6 poor metabolizers.
  • CYP3A4 Inducers: Medicines like rifampicin, which induce these enzymes, may reduce the therapeutic effect of Vesomni.

Pharmacodynamic Interactions

Interaction constraints also exist for medicines with similar effects:

  • Other Anticholinergic Medicines: Co-administration may enhance both the desired and undesirable effects. An interval of approximately one week should be allowed before commencing other anticholinergic therapy.
  • Alpha1-adrenoceptor Antagonists: Concomitant use with other alpha-blockers should be approached with caution due to the risk of additive hypotensive effects.
  • Gastrointestinal Motility Stimulants: The effect of medicines that stimulate intestinal movement may be reduced due to the action of solifenacin.

Mechanism of Action

How Vesomni Works: Pharmacodynamics

Vesomni is a fixed-dose combination product that modulates detrusor muscle contractility and tone through two distinct mechanistic domains: cholinergic receptor antagonism (via solifenacin) and beta3-adrenoceptor agonism (via tamsulosin).

Cholinergic Receptor Antagonism

Solifenacin acts as a competitive antagonist at muscarinic M3 receptors ( M3 R), which are the primary mediators of contraction in the detrusor muscle. By blocking the binding of acetylcholine (ACh) to M3 R, solifenacin inhibits the signaling sequence that typically triggers detrusor muscle excitation. The resulting physiological effect is a reduction in the frequency and amplitude of involuntary detrusor contractions.

beta3-Adrenoceptor Agonism

Simultaneously, tamsulosin functions as an agonist (activator) at beta3-adrenoceptors (beta3 AR) located in the bladder wall. Activation of beta3 AR initiates a Gs protein-coupled signaling cascade that increases intracellular cyclic adenosine monophosphate (cAMP) levels. This pathway leads to the relaxation of detrusor smooth muscle. The net physiological consequence promotes detrusor compliance during the urine storage phase.

Dosage and Administration Information

Official Administration Protocol for Vesomni

Vesomni is administered solely through the oral route as a fixed-dose, modified-release tablet. The established dosing regimen is to take one tablet (6 mg solifenacin / 0.4 mg tamsulosin) once daily. This single tablet constitutes both the standard starting dose and the maximum daily dose that should be administered.

The tablet's modified-release formulation requires specific handling instructions to ensure the active ingredients are delivered steadily over time. Patients must swallow the tablet whole and are explicitly cautioned not to crush, chew, or split it. Administration is flexible regarding mealtime, as the tablet may be taken either with or without food. To maintain consistent exposure, the tablet should be taken at approximately the same time each day.

Treatment is typically part of a long-term strategy for chronic symptom management, though usage should be subject to periodic clinical review. If a daily dose is missed, a double dose should not be taken to compensate; the individual should simply take the next tablet at its scheduled time.

High-Level Usage Constraints

Constraint Area Official Guideline
Renal/Hepatic Impairment Use with caution in patients with severe renal or moderate hepatic impairment; maximum dose is one tablet daily.
Concomitant Inhibitors Requires caution when taken with strong CYP3A4 inhibitors; maximum dose is limited to one tablet daily.
Pediatric Use The product is not indicated for use in children or adolescents.

Recent Clinical Evidence

Research Evidence for Moderate to Severe LUTS in Men

Research on the Solifenacin/Tamsulosin combination has primarily been conducted through short-term, randomized controlled trials (RCTs). These studies were applied in studies examining patient-reported experiences among adult men diagnosed with lower urinary tract symptoms (LUTS) linked to benign prostatic hyperplasia (BPH). The evidence contributes to the broader evidence landscape; studies describe patient-reported experience related to urgency, frequency, and difficulties with urine flow. This research explored patient-reported outcomes, including perceived discomfort and functional measures like Post-Void Residual (PVR) volume.

Focus on Dual Symptoms: Storage and Voiding

Studies focusing on this combination product examined conditions where symptoms may vary in intensity. Researchers monitored outcomes related to physical discomfort and outcomes describing episodic or acute changes. The core studies evaluated whether this fixed-dose combination was associated with changes in both the Storage Subscore (tracking urgency, frequency) and the overall Total Score of the International Prostate Symptom Score (IPSS). Findings indicate that some studies reported measured differences in the change in urgency and frequency between the combination product and Tamsulosin monotherapy. Research explores symptom changes, but study results reflect group patterns.


How the Combination Performed Against Monotherapy in Trials

Clinical research trials compared the combination product against Tamsulosin monotherapy (taking only one active ingredient) and against an inactive placebo. These trials assessed short-term symptom patterns, typically lasting about 12 weeks for the masked phase. Research describes patterns related to measured changes in patient-reported quality of life (QoL) and the overall bother associated with LUTS. Some studies reported measured differences in the change in the Storage Subscore compared to Tamsulosin monotherapy, but comparative evidence for certain objective measures like Maximum Urinary Flow Rate (Q max) is not fully established.


Long-Term Studies and Durability of Follow-Up

Research describes group patterns related to long-term maintenance, but findings do not predict individual outcomes. The primary controlled comparisons were short-term. To address this, open-label extension studies were conducted, monitoring patients for up to 52 weeks. However, because these extended studies lacked a controlled, masked comparison group, the long-term comparative evidence is not fully established. There is limited information where both the combination and monotherapy groups were directly compared under double-blind conditions beyond the initial few months.

Key Studies & References

  1. Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (NEPTUNE) - ClinicalTrials.gov NCT01018511
  2. Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms (NEPTUNE II) - ClinicalTrials.gov NCT01021332
  3. PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands Vesomni 6 mg/0.4 mg modified-release tablets
  4. solifenacin and tamsulosin (Vesomni) - Scottish Medicines Consortium (SMC) Advice

Frequently Asked Questions (FAQ)

Common questions about Vesomni (FAQ)


Q: What is the main purpose of taking Vesomni?

According to regulatory documents, Vesomni is described as a treatment for storage symptoms associated with moderate to severe lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). These symptoms include problems like urinary frequency, urgency, and urge incontinence (leaking urine).

Q: Is Vesomni used to treat the prostate, bladder, or both?

Official information indicates that Vesomni addresses symptoms originating from both the prostate and the bladder. The combination provides dual action: one component helps relax the muscles in the prostate and bladder neck, and the other reduces involuntary muscle contractions in the bladder wall.

Q: Does Vesomni start working immediately or does it take time?

While one of the components reaches its highest concentration in the body within a few hours, the full clinical benefits of the medicine are evaluated over longer periods. Official studies supporting the medicine's use often track changes in urinary symptoms over a period such as 12 weeks of treatment.

Q: How long does the effect of one dose of Vesomni typically last?

The tablet is a modified-release formulation designed to be taken once daily. This dosing schedule is supported by studies which show that one of the active ingredients remains in the body for an extended duration.

Q: Can Vesomni cause a feeling of dry mouth?

Dry mouth is commonly described in official product information as one of the most frequently reported side effects. This effect results from the action of one of the active components, which can reduce saliva production.

Q: Are there common side effects I should know about?

Official product information commonly describes dry mouth and constipation as frequently reported side effects. Other possible, less frequent effects include blurred vision, dizziness, and nausea.

Q: Does Vesomni affect sleep or cause drowsiness?

Drowsiness (somnolence) is listed in the official warnings for this medicine. Official warnings indicate that caution is necessary when performing activities like driving or operating machinery.

Q: Is there a known interaction between Vesomni and alcohol?

Alcohol consumption can potentially contribute to low blood pressure, which may cause lightheadedness or feelings of dizziness. Official documents mention that the use of alcohol with the medicine is a topic that should be discussed with a healthcare provider.

Q: Can Vesomni affect blood pressure?

Low blood pressure, also known as hypotension, is described as a possible effect in official warnings. This may be especially noticeable when quickly standing up from a sitting or lying position, leading to lightheadedness.

Q: Is Vesomni suitable for people with certain heart conditions?

The medicine may affect the cardiovascular system, and warnings are noted regarding low blood pressure and the heart’s electrical rhythm, called the QT interval. For people with pre-existing heart conditions, the potential risks are described as requiring consultation with a prescribing physician.

Q: Why might a person not be able to use Vesomni?

Official documents indicate that the medicine is not recommended for use in people with certain conditions, including specific types of severe stomach or bowel issues, uncontrolled narrow-angle glaucoma, or a known allergy to the active ingredients. Restrictions also apply to those on kidney dialysis or with severe liver or kidney disease being treated with certain other medicines.

Q: What is the difference between Vesomni and a standalone alpha-blocker?

Vesomni is a fixed combination product that includes both an alpha-blocker component and an anticholinergic component. This combination provides dual mechanisms to address both the prostate and bladder aspects of lower urinary tract symptoms, whereas a standalone alpha-blocker only provides one of these actions.

Q: Are there special considerations for older patients using Vesomni?

Regulatory documents note that older patients may require clinical monitoring. Very rare reports of cognitive changes, such as confusion or hallucinations, have been observed, particularly in the elderly population.

Q: Can women take Vesomni?

According to official regulatory information, Vesomni is not indicated for use by women. It is approved only for men.

Q: Is it normal to feel dizzy after starting Vesomni?

Dizziness is noted in the official side effect descriptions. This effect may be linked to the potential for one of the active components to cause low blood pressure.

Q: Are there any major warnings associated with Vesomni?

Major warnings associated with the medicine include the risk of low blood pressure, serious allergic reactions such as angioedema (swelling of the face or throat), and the potential for a rare, serious, prolonged erection called priapism.

Q: What kind of studies or research support the use of Vesomni?

The medicine's approval is based on clinical trials, which typically include rigorous, controlled studies. These studies examine changes in urinary symptoms, such as frequency and urgency, over a specified treatment period.

Q: What should I do if I accidentally take too much Vesomni?

Taking too much of the medicine can cause certain effects, including low blood pressure. If more than the prescribed amount is believed to have been taken, regulatory documents advise calling a doctor or seeking immediate medical attention.

Q: Does Vesomni affect a person's ability to drive?

Official warnings advise that the medicine may cause effects such as drowsiness and blurred vision. Official warnings caution that care should be used when driving or operating machinery, particularly when beginning treatment.

Q: Can Vesomni cause problems with the eyes or vision?

Blurred vision is noted as a possible side effect. Furthermore, official information indicates that if an individual is scheduled for cataract or glaucoma surgery, the eye specialist's awareness of the patient's use of the tamsulosin component is advised.

Q: Does Vesomni interact with supplements or herbal products?

Warnings exist about potential interactions with certain herbal products that may induce or inhibit specific liver enzymes (like CYP3A4). The potential for interactions means that all supplements and herbal products should be reviewed with a healthcare provider.

Q: Does Vesomni cause sexual side effects?

Abnormal ejaculation (ejaculation disorder) is described in men using the medicine. Additionally, a rare but serious side effect reported is a long-lasting and painful erection (priapism).

Q: What should I do if I experience a serious side effect?

If signs of a serious reaction occur, such as swelling of the face, lips, tongue, or throat, or a severe skin reaction (e.g., blistering), official documents state that signs of a serious reaction require immediate informing of a doctor and discontinuation of the medicine.

Q: Can Vesomni be used by people with kidney issues?

The use of this medicine requires caution and potential monitoring in people with severe kidney disease. Regulatory information indicates it is contraindicated (should not be used) for those undergoing kidney dialysis.

Q: Is Vesomni known to cause any allergic reactions?

The medicine is contraindicated for individuals with a known allergy to the active ingredients. Serious allergic reactions, including angioedema and severe skin reactions, have been reported rarely, and immediate medical attention is necessary if they occur.

Q: What are the restrictions regarding grapefruit juice and Vesomni?

Grapefruit or grapefruit juice may potentially increase the amount of one of the active ingredients in the body by inhibiting a specific liver enzyme. Official information indicates that the intake of grapefruit or grapefruit juice should be limited due to the potential for interaction.

How should Vesomni be stored and disposed of?

Vesomni modified-release tablets do not require any special storage conditions for maintaining the 3-year shelf life. The medicine should be stored safely and kept out of the sight and reach of children.

The tablets are designed as a modified-release product and must be swallowed whole with water. To ensure the medication works as intended, do not crush, bite, or chew the tablets before swallowing.

When it comes to disposal, unused or expired Vesomni, or any waste material related to the product, should be handled and disposed of in accordance with local environmental requirements. This ensures the medicine is discarded safely and responsibly. Your pharmacist can provide guidance on local take-back programs or waste disposal methods.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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