VESIcare Side Effects
Please note - some side effects for VESIcare may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of VESIcare - for the consumer
VESIcare
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using VESIcare:
Seek medical attention right away if any of these SEVERE side effects occur when using VESIcare:Blurred vision; constipation; cough; dizziness; dry eyes; dry mouth; indigestion or stomach upset; tiredness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; bloody or cloudy urine; constipation lasting 3 or more days; fever or chills; pain below the ribs; pain while urinating; severe stomach pain; unusual or severe headache; urinary retention (unable to empty the bladder).
For the professional
VESIcare
VESIcare has been evaluated for safety in 1811 patients in randomized, placebo-controlled trials. Expected side effects of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The most common adverse events reported in patients treated with VESIcare were dry mouth and constipation and the incidence of these side effects was higher in the 10 mg compared to the 5 mg dose group. In the four 12-week double-blind clinical trials there were three intestinal serious adverse events in patients, all treated with VESIcare 10 mg (one fecal impaction, one colonic obstruction, and one intestinal obstruction). The overall rate of serious adverse events in the double-blind trials was 2%. Angioneurotic edema has been reported in one patient taking VESIcare 5 mg. Compared to twelve weeks of treatment with VESIcare, the incidence and severity of adverse events were similar in patients who remained on drug for up to 12 months. The most frequent reason for discontinuation due to an adverse event was dry mouth, 1.5%. Table 6 lists adverse events, regardless of causality, that were reported 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.
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SYSTEM ORGAN CLASS MedDRA Preferred Term |
Placebo (%) |
VESIcare 5 mg (%) |
VESIcare 10 mg (%) |
| Number of Patients | 1216 | 578 | 1233 |
| Number of Patients with Treatment-emergent AE | 634 | 265 | 773 |
| 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 Tract 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 Surveillance
The following events have been reported in association with solifenacin use in worldwide postmarketing experience: General: hypersensitivity reactions, including angioedema, rash, pruritis, and urticaria; Central Nervous: confusion and hallucinations. 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.
TopMore resources:
VESIcare - Includes detailed dosage instructions.
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