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VESIcare

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The condition affects more than 20 million American women, according to Merck, the drug's manu"...

VESIcare

VESIcare

VESIcare Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Vesicare (solifenacin) is a drug that reduces muscle spasms of the bladder muscles. It is used to treat the symptoms of overative bladder such as incontinence, urinary frequency, and urgency. Side effects can include mild constipation, dry mouth, dry eyes, nausea, and dizziness. Other side effects may also occur. Vesicare is administered as a tablet taken once daily.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

VESIcare in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using solifenacin and call your doctor at once if you have any of these serious side effects:

  • hot, dry skin and extreme thirst;
  • severe stomach pain, or constipation for 3 days or longer;
  • pain or burning when you urinate; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth;
  • dry eyes, blurred vision;
  • mild constipation;
  • nausea, mild stomach pain or upset;
  • dizziness, tired feeling; or
  • fever, sore throat, body aches, or other flu symptoms.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

VESIcare Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth, constipation, drowsiness, stomach upset, blurred vision, dry eyes, headache, or unusual tiredness/weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, constipation for 3 or more days, difficulty urinating, signs of kidney infection (such as burning/painful/frequent urination, fever, pink/bloody urine), mental/mood changes (such as confusion, hallucinations).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for VESIcare (Solifenacin Succinate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

VESIcare FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 Adverse Reactions, Derived from All Adverse 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 1.7 3.3
  Dyspepsia 1 1.4 3.9
  Abdominal Pain Upper 1 1.9 1.2
  Vomiting NOS 0.9 0.2 1.1
INFECTIONS AND INFESTATIONS
  Urinary Tract Infection NOS 2.8 2.8 4.8
  Influenza 1.3 2.2 0.9
  Pharyngitis NOS 1 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 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) »

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VESIcare - User Reviews

VESIcare User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication VESIcare sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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