"Jan. 25, 2013 -- The FDA has approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women 18 and older.
The condition affects more than 20 million American women, according to Merck, the drug's manu"...
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
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (e.g., stimulant-type with stool softener).
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 immediately if any of these unlikely but serious side effects occur: severe stomach/abdominal pain, constipation for 3 or more days, difficulty urinating, signs of kidney infection (e.g., burning/painful urination, lower back pain, fever).
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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
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|
|Abdominal Pain Upper||1||1.9||1.2|
|INFECTIONS AND INFESTATIONS|
|Urinary Tract Infection NOS||2.8||2.8||4.8|
|NERVOUS SYSTEM DISORDERS|
|Dry Eyes NOS||0.6||0.3||1.6|
|RENAL AND URINARY DISORDERS|
|GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS|
|Edema Lower Limb||0.7||0.3||1.1|
|RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS|
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:
Metabolism and nutrition disorders: decreased appetite, hyperkalemia;
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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