VESIcare

Last updated on RxList: 2/23/2021
VESIcare Side Effects Center

What Is Vesicare?

Vesicare (solifenacin) is a muscarinic receptor antagonist that reduces muscle spasms of the bladder muscles and is used to treat the symptoms of overactive bladder such as incontinence, urinary frequency, and urgency.

What Are Side Effects of Vesicare?

Side effects of Vesicare include:

Dosage for Vesicare

The recommended dose of Vesicare is 5 mg administered as a tablet taken once daily.

What Drugs, Substances, or Supplements Interact with Vesicare?

Vesicare may interact with azole antifungals. Tell your doctor all medications and supplements you use.

Vesicare During Pregnancy and Breastfeeding

Vesicare may be harmful to an unborn baby and should not be used by pregnant women. It is not known whether solifenacin passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Vesicare Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is urinary incontinence? See Answer
VESIcare Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using solifenacin and call your doctor at once if you have:

  • severe stomach pain, or constipation for 3 days or longer;
  • pain or burning when you urinate;
  • headache, confusion, drowsiness, hallucinations;
  • vision changes, eye pain, or seeing halos around lights;
  • little or no urination, pain or burning when you urinate;
  • dehydration symptoms--dizziness, tiredness, feeling very thirsty or hot, decreased sweating, or hot and dry skin; or
  • high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects may include:

  • blurred vision;
  • dry mouth, dry eyes;
  • painful urination;
  • constipation; or
  • heat stroke--decreased sweating, dry skin, dizziness, tiredness, nausea, feeling hot.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for VESIcare (Solifenacin Succinate)

SLIDESHOW

Urinary Incontinence in Women: Types, Causes, and Treatments for Bladder Control See Slideshow
VESIcare Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

VESIcare has been evaluated for safety in 1811 patients in randomized, placebo-controlled trials. Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with VESIcare was higher in the 10 mg compared to the 5 mg dose group.

In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the VESIcare 10 mg group. Angioneurotic edema has been reported in one patient taking VESIcare 5 mg. Compared to 12 weeks of treatment with VESIcare, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months.

The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events, in randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with VESIcare 5 or 10 mg once daily for up to 12 weeks.

Table 1: Percentages of Patients with Identified Advers e Reactions , Derived from All Advers e Events Exceeding Placebo Rate and Reported by 1% or More Patients for Combined Pivotal Studies

  Placebo (%) VESIcare 5 mg (%) VESIcare 10 mg (%)
Number of Patients 1216 578 1233
GASTROINTESTINAL DISORDERS
Dry Mouth 4.2 10.9 27.6
Constipation 2.9 5.4 13.4
Nausea 2.0 1.7 3.3
Dyspepsia 1.0 1.4 3.9
Abdominal Pain Upper 1.0 1.9 1.2
Vomiting NOS 0.9 0.2 1.1
INFECTIONS AND INFESTATIONS
Urinary T ract Infection NOS 2.8 2.8 4.8
Influenza 1.3 2.2 0.9
Pharyngitis NOS 1.0 0.3 1.1
NERVOUS SYSTEM DISORDERS
Dizziness 1.8 1.9 1.8
EYE DISORDERS
Vision Blurred 1.8 3.8 4.8
Dry Eyes NOS 0.6 0.3 1.6
RENAL AND URINARY DISORDERS
Urinary Retention 0.6 0 1.4
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Edema Lower Limb 0.7 0.3 1.1
Fatigue 1.1 1.0 2.1
PSYCHIATRIC DISORDERS
Depression NOS 0.8 1.2 0.8
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Cough 0.2 0.2 1.1
VASCULAR DISORDERS
Hypertension NOS 0.6 1.4 0.5

Post-Marketing Experience

Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of solifenacin in their causation cannot be reliably determined.

The following events have been reported in association with solifenacin use in worldwide postmarketing experience:

General: peripheral edema, hypersensitivity reactions, including angioedema with airway obstruction, rash, pruritus, urticaria, and anaphylactic reaction;

Central Nervous: headache, confusion, hallucinations, delirium and somnolence;

Cardiovascular: QT prolongation; Torsade de Pointes, atrial fibrillation, tachycardia, palpitations;

Hepatic: liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl transferase);

Renal: renal impairment;

Metabolism and nutrition disorders: decreased appetite, hyperkalemia;

Dermatologic: exfoliative dermatitis and erythema multiforme;

Eye disorders: glaucoma;

Gastrointestinal disorders: gastroesophageal reflux disease and ileus;

Respiratory, thoracic and mediastinal disorders: dysphonia;

Musculoskeletal and connective tissue disorders: muscular weakness.

Read the entire FDA prescribing information for VESIcare (Solifenacin Succinate)

© VESIcare Patient Information is supplied by Cerner Multum, Inc. and VESIcare Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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