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.
- hot, dry skin and extreme thirst;
- severe stomach pain, or constipation for 3 days or longer;
- pain or burning when you urinate;
- vision changes, eye pain, or seeing halos around lights;
- urinating less than usual or not at all;
- confusion, hallucinations;
- high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- headache, dizziness, drowsiness, feeling tired;
- dry mouth, hoarse voice;
- dry eyes, blurred vision;
- nausea, loss of appetite, upset stomach, heartburn;
- mild constipation; or
- fever, sore throat, body aches, or other flu symptoms.
This is not a complete list of side effects and others may occur.
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.
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.
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