Generic Name

Solifenacin

Brand Names
VESIcare, Solifenacine
FDA approval date: January 05, 2005
Classification: Cholinergic Muscarinic Antagonist
Form: Tablet, Suspension

What is VESIcare (Solifenacin)?

VESIcare (Solifenacin): Restoring Control for Overactive Bladder (OAB)

Living with an overactive bladder can be frustrating and isolating. The frequent, urgent need to urinate often with little warning can disrupt sleep, work, and social life. For many adults, this condition causes embarrassment and anxiety about leaving home or being far from a restroom. VESIcare (solifenacin) is a medication designed to bring back control and confidence by calming an overactive bladder and reducing those sudden urges.

VESIcare belongs to a class of drugs called **antimuscarinics**, which help relax the bladder muscles. It’s a long-established, prescription-only treatment approved by the U.S. Food and Drug Administration (FDA) for managing overactive bladder (OAB) with symptoms such as urgency, frequency, and urge incontinence. Whether used as a first-line therapy or after other approaches like bladder training haven’t worked well enough, VESIcare is known for improving daily comfort and restoring quality of life.


What does VESIcare do?

VESIcare is used to treat the symptoms of overactive bladder, including:

  • Urgency: a sudden, strong need to urinate immediately
  • Frequency: needing to urinate too often, even during the night
  • Urge incontinence: accidental leakage caused by inability to reach the bathroom in time

By calming the muscles that control urination, VESIcare helps the bladder hold urine longer and reduces unexpected leaks. Patients often notice fewer bathroom trips, less urgency, and improved sleep after consistent use.

Clinical studies have shown that solifenacin significantly reduces daily urinary frequency and incontinence episodes compared to placebo (Mayo Clinic, 2024). Many people begin noticing symptom relief within a few weeks, though full benefit may take longer as the body adjusts to the medication.


How does VESIcare work?

VESIcare works by blocking specific receptors in the bladder wall called **muscarinic receptors**. These receptors normally respond to acetylcholine, a natural body chemical that signals the bladder muscles to contract and release urine.

In people with overactive bladder, these signals can become overactive or misfired, causing the bladder to contract too often or at the wrong times. By blocking these receptors, solifenacin **reduces involuntary bladder contractions**, allowing the bladder to fill more completely before signaling the need to urinate.

Clinically, this mechanism matters because it restores bladder stability and capacity, giving patients more time between bathroom visits and greater control over their daily routines. It’s a proven, safe way to manage bladder overactivity without requiring invasive procedures.


VESIcare Side Effects and Warnings

Like all prescription medicines, VESIcare can cause side effects. Most are mild and temporary, improving as the body adjusts to treatment.

Common Side Effects include:

  • Dry mouth
  • Constipation
  • Blurred vision
  • Mild drowsiness
  • Dry eyes

These effects occur because solifenacin also reduces secretions and muscle activity in other parts of the body, not just the bladder. Drinking water regularly, using sugar-free gum for dry mouth, or adding fiber to the diet can help ease these symptoms.

Serious but less common side effects include:

  • Painful or difficult urination (possible urinary retention)
  • Confusion, hallucinations, or severe dizziness (more likely in older adults)
  • Fast or irregular heartbeat
  • Allergic reactions such as rash, swelling, or difficulty breathing

Who should avoid VESIcare:

People with **urinary retention**, uncontrolled narrow-angle glaucoma, severe liver disease, or certain gastrointestinal conditions like severe constipation or bowel obstruction should not use this medication. Those with kidney or liver impairment may need dose adjustments.

Seek immediate medical attention if you experience severe abdominal pain, vision changes, or an inability to urinate. It’s also important to inform your doctor about all other medications you take, as VESIcare can interact with antifungal drugs, antibiotics, and certain heart medications.


VESIcare Dosage and Monitoring

VESIcare comes in tablet form, taken **once daily by mouth**, with or without food. Patients are advised to swallow the tablet whole with water, not to crush or chew it.

The dose is individualized based on symptom control, side effects, and overall health. Your healthcare provider may start with a lower dose and increase it if needed.

Because solifenacin is processed in the liver and kidneys, doctors may perform periodic tests to check organ function. Monitoring helps ensure safe and effective treatment, especially for older adults or those with preexisting medical conditions.

If a dose is missed, patients should take it as soon as they remember, unless it’s close to the next scheduled dose. Doubling up to make up for a missed dose is not recommended.


Does VESIcare have a generic version?

Yes. The generic form of VESIcare is solifenacin succinate, and it is FDA-approved. Generic solifenacin contains the same active ingredient, dosage strength, and effectiveness as the brand-name version.

Generic solifenacin, a more affordable alternative to VESIcare, offers the same safety and effectiveness. Patient preference for VESIcare may depend on availability, insurance, or individual response.


Conclusion

VESIcare (solifenacin) is a trusted, effective medication that helps people with overactive bladder regain control, confidence, and peace of mind. By relaxing bladder muscles and reducing involuntary contractions, it decreases the urgency and frequency of urination while preventing embarrassing leakage.

Although side effects like dry mouth or constipation can occur, they are typically manageable with simple lifestyle adjustments. Regular follow-up with a healthcare provider ensures that the medication remains safe and tailored to your needs.

Every patient’s experience is unique; what matters most is open communication with your doctor about any changes in symptoms or comfort level. When used correctly and monitored properly, VESIcare offers lasting relief, helping patients reclaim their independence and enjoy daily life without constant worry about bladder control.


References

  • Mayo Clinic. (2024). Solifenacin (oral route) description and precautions. Retrieved from mayoclinic.org
  • MedlinePlus. (2024). Solifenacin: Drug information. National Library of Medicine. Retrieved from medlineplus.gov
  • U.S. Food and Drug Administration (FDA). (2023). Approved Drug Products: Solifenacin succinate. Retrieved from accessdata.fda.gov
  • National Institutes of Health (NIH). (2024). Overactive bladder: Treatment and management. Retrieved from nih.gov

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Brand Information

    VESIcare (solifenacin succinate)
    1INDICATIONS AND USAGE
    VESIcare
    2DOSAGE FORMS AND STRENGTHS
    Tablets:
    • 5 mg: round, light yellow, debossed with 150
    • 10 mg: round, light pink, debossed with 151
    3CONTRAINDICATIONS
    VESIcare is contraindicated in patients:
    • With urinary retention
    • With gastric retention
    • With uncontrolled narrow-angle glaucoma
    • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in VESIcare. Reported adverse reactions have included anaphylaxis and angioedema
    4OVERDOSAGE
    Overdosage with VESIcare can potentially result in severe antimuscarinic effects and should be treated accordingly. The highest dose ingested in an accidental overdose of solifenacin succinate was 280 mg (28 times the maximum dosage) in a 5-hour period. This case was associated with mental status changes. Some cases reported a decrease in the level of consciousness.
    Intolerable antimuscarinic adverse reactions (fixed and dilated pupils, blurred vision, failure of heel-to-toe exam, tremors, and dry skin) occurred on day 3 in normal volunteers taking 50 mg daily (5 times the maximum recommended therapeutic dose) and resolved within 7 days following discontinuation of drug.
    In the event of overdose with VESIcare, treat with gastric lavage and appropriate supportive measures. ECG monitoring is also recommended.
    5DESCRIPTION
    VESIcare (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1
    structure of Solifenacin succinate
    Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol.
    Each VESIcare tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each VESIcare tablet also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg VESIcare tablet) or red ferric oxide (10 mg VESIcare tablet).
    6CLINICAL STUDIES
    VESIcare was evaluated in four twelve-week, double-blind, randomized, placebo-controlled, parallel group, multicenter clinical trials for the treatment of overactive bladder in adult patients having symptoms of urinary frequency, urgency, and/or urge or mixed incontinence (with a predominance of urge). Entry criteria required that patients have symptoms of overactive bladder for ≥ 3 months duration. These studies involved 3027 patients (1811 on VESIcare and 1216 on placebo), and approximately 90% of these patients completed the 12-week studies. Two of the four studies evaluated the 5 and 10 mg VESIcare doses (Studies 1 and 2) and the other two evaluated only the 10 mg dose (Studies 3 and 4). All patients completing the 12-week studies were eligible to enter an open-label, long-term extension study (Study 5) and 81% of patients enrolling completed the additional 40-week treatment period. The majority of patients were Caucasian (93%) and female (80%) with a mean age of 58 years.
    The primary endpoint in all four trials was the mean change from baseline to 12 weeks in number of micturitions/24 hours. Secondary endpoints included mean change from baseline to 12 weeks in number of incontinence episodes/24 hours, and mean volume voided per micturition.
    The efficacy of VESIcare was similar across patient age groups and gender. The mean reduction in the number of micturitions per 24 hours was significantly greater with VESIcare 5 mg (2.3; p < 0.001) and VESIcare 10 mg (2.7; p < 0.001) compared to placebo (1.4). The mean reduction in the number of incontinence episodes per 24 hours was significantly greater with VESIcare 5 mg (1.5; p < 0.001) and VESIcare 10 mg (1.8; p < 0.001) treatment groups compared to the placebo treatment group (1.1). The mean increase in the volume voided per micturition was significantly greater with VESIcare 5 mg (32.3 mL; p < 0.001) and VESIcare 10 mg (42.5 mL; p < 0.001) compared with placebo (8.5 mL).
    The results for the primary and secondary endpoints in the four individual 12-week clinical studies of VESIcare are reported in Tables
    7HOW SUPPLIED/STORAGE AND HANDLING
    VESIcare is supplied as round, film-coated tablets, available in bottles as follows:
    Each 5 mg tablet is light yellow and debossed with a logo and “150” and is available as follows:
    1. Bottle of 30                                 NDC 51248-150-01
    Each 10 mg tablet is light pink and debossed with a logo and “151” and is available as follows:
    1. Bottle of 30                                  NDC 51248-151-01
    2. Bottle of 90                                  NDC 51248-151-03
    Store at 25°C (77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
    8PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information).
    Angioedema and Anaphylactic Reactions
    Inform patients that angioedema and anaphylactic reactions have been reported in patients treated with VESIcare. Angioedema and anaphylactic reactions may be life-threatening. Advise patients to promptly discontinue VESIcare therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing
    Urinary Retention
    Inform patients that VESIcare may cause urinary retention in patients with conditions associated with bladder outlet obstruction
    Gastrointestinal Disorders
    Inform patients that VESIcare may cause further decrease in gastrointestinal motility in patients with conditions associated with decreased gastrointestinal motility. VESIcare has been associated with constipation and dry mouth. Advise patients to contact their health care providers if they experience severe abdominal pain or become constipated for 3 or more days
    Central Nervous System Effects
    Because VESIcare, like other antimuscarinic agents, may cause central nervous system effects or blurred vision, advise patients to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effect on the patient has been determined
    Narrow-Angle Glaucoma
    Inform patients that VESIcare, like other antimuscarinics, may cause worsening of the glaucoma condition in patients with narrow-angle glaucoma
    Dry Skin
    Inform patients that VESIcare, like other antimuscarinics, may cause dry skin due to decreased sweating. Heat prostration due to decreased sweating can occur when VESIcare is used in a hot environment
    Marketed and Distributed by:
    VESIcare is a registered trademark of Astellas Pharma Inc.
    © 2004 – 2022 Astellas Pharma US, Inc.
    361078-VES
    9PRINCIPAL DISPLAY PANEL - 5 mg Carton
    VESIcare (solifenacin succinate) tablets 5 mg Carton
    NDC 51248-150-01
    VESIcare
    Each tablet contains 5 mg of solifenacin succinate
    Rx ONLY
    5 mg 30 tablets
    10PRINCIPAL DISPLAY PANEL – 10 mg Carton
    VESIcare (solifenacin succinate) tablets 10 mg Carton
    NDC 51248-151-01
    VESIcare
    Each tablet contains 10 mg of solifenacin succinate
    Rx ONLY
    10 mg 30 tablets
    VESIcare has been selected.