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.
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.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; bloody or cloudy urine; constipation lasting 3 or more days; fast, slow, or irregular heartbeat; fever or chills; mood or mental changes (eg, confusion, depression, hallucinations); pain below the ribs; pain while urinating; severe stomach pain; unusual or severe headache; urinary retention (unable to empty the bladder).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopVESIcare Side Effects - for the Professional
VESIcare
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.
|
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 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 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, and urticaria;
Central Nervous: headache, confusion, hallucinations and somnolence;
Cardiovascular: QT prolongation; Torsade de Pointes.
TopSide Effects by Body System - for Healthcare Professionals
Gastrointestinal
Gastrointestinal side effects have been reported the most frequently. These have included dry mouth (7.7% to 27.6%) and constipation (3.7% to 13.4%). Dyspepsia (1.4% to 3.9%), nausea (1.7% to 3.3%), abdominal pain (upper) (1.2% to 1.9%), and vomiting (0.2% to 1.1%) have also been reported.
Respiratory
Respiratory side effects have included cough (0.2% to 1.1%).
Psychiatric
Psychiatric side effects have included depression (0.8% to 1.2%). Confusion and hallucinations have been reported during postmarketing experience.
Ocular
Ocular side effects have included blurred vision (3.8% to 5.9%) and dry eyes (0.3 to 1.6%). Anticholinergic side effects including fixed and dilated pupils have been reported in patients with chronic use of or at doses higher than the maximum recommended dose.
Nervous system
Nervous system side effects have included dizziness (1.8% to 1.9%) and tremors. Headache has been reported during postmarketing experience.
Genitourinary
Genitourinary side effects have included urinary tract infections (2.8% to 4.8%) and urinary retention (1.4%).
General
In general, the most frequently reported side effects have included dry mouth and constipation and the incidence of these side effects was higher in 10 mg compared to 5 mg dose group. In a four 12-week double-blind clinical trial, there were three intestinal serious side effects in patients, all treated with 10 mg. The overall rate of serious side effects was 2%. Compared to twelve weeks of therapy, the incidence and severity of side effects were similar in patients who remained on therapy for up to 12 months. The most frequent reason for discontinuation due to a side effect was dry mouth (1.5%).
Cardiovascular
A cardiac electrophysiologic study evaluating the QT interval at the time of peak plasma concentrations, following 10 and 30 mg solifenacin doses, has reported a QT prolongation effect. The effect appeared greater with the highest solifenacin dosage, although the effect did not appear as large as that of the positive control moxifloxacin at its therapeutic dose.
Cardiovascular side effects have included hypertension (0.5% to 1.4%). A prolonged QT interval effect has been reported during cardiac electrophysiologic studies. Torsades de Pointes have been reported during postmarketing experience.
Dermatologic
Dermatologic side effects have included dry skin.
Immunologic
Immunologic side effects have included infections. These have included influenza (0.9% to 2.2%) and pharyngitis (0.3% to 1.1%).
Metabolic
Metabolic side effects have included heat prostration with the use of anticholinergic drugs, similar to solifenacin, in hot environments.
Hypersensitivity
Hypersensitivity side effects including angioedema, rash, pruritus, and urticaria have been reported during postmarketing experience.
Other
Other side effects have included fatigue (1% to 2.1%) and edema of the lower limbs (0.3% to 1.1%).
TopMore VESIcare resources
- VESIcare Prescribing Information (FDA)
- VESIcare MedFacts Consumer Leaflet (Wolters Kluwer)
- Vesicare Monograph (AHFS DI)
- Vesicare Advanced Consumer (Micromedex) - Includes Dosage Information
- Vesicare Consumer Overview
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