vesicare
Pharmaranks rates Vesicare 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Vesicare (Solifenacin Succinate) is a cholinergic muscarinic antagonist used to treat Overactive Urinary Bladder, Urge Urinary Incontinence.
Solifenacin Succinate · by Astellas
Available as a generic: Solifenacin Succinate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Solifenacin Succinate
- Drug class
- Cholinergic Muscarinic Antagonist
- Form
- Tablet
- Strength
- Solifenacin Succinate 10MG · Solifenacin Succinate 5MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Astellas
- Half-life
- about 45 to 68 hours (how long it stays in your system)
- What the pharmacy pays
- ~$5.40 for 30 — not your price
- FDA application
- NDA021518
- Availability
- Discontinued (per FDA)
What is Vesicare?
From the FDA label:VESIcare (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S )-(3 R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each VESIcare tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each VESIcare tablet also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg VESIcare tablet) or red ferric oxide (10 mg VESIcare tablet). structure of Solifenacin succinate
How to use
5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily. ( 2.1 ) • Do not exceed the 5 mg dose of VESIcare in patients with: o Severe renal impairment creatinine clearance < 30 mL/min/1.73 m 2 . ( 2.2 , 8.6 ) o Moderate hepatic impairment (Child-Pugh B). VESIcare is not recommended in patients with severe hepatic impairment (Child-Pugh C). ( 2.3 , 8.7 ) o Concomitant use of strong CYP3A4 inhibitors. ( 2.4 , 7.1 ) 2.1 Dosing Information The recommended oral dose of VESIcare is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. VESIcare should be taken with water and swallowed whole. VESIcare can be administered with or without food. 2.2 Dosing Recommendations in Patients with Renal Impairment Do not exceed 5 mg once daily in patients with severe renal impairment (CL cr < 30 mL/min/1.73 m 2 ) [see Use in Specific Populations ( 8.6 )] . 2.3 Dosing Recommendations in Patients with Hepatic Impairment Do not exceed 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Do not use VESIcare in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations ( 8.7 )] . 2.4 Dosing Recommendations in Patients Taking CYP3A4 Inhibitors Do not exceed 5 mg once daily when VESIcare is administered with strong CYP3A4 inhibitors such as ketoconazole [see Drug…
Side effects
The most common adverse reactions (> 4% in VESIcare-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 adult patients in four randomized, placebo-controlled trials (Studies 1-4) [see Clinical Studies ( 14 )] . 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 dose group 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 was reported in one patient taking VESIcare 5 mg.…
Warnings
Important safety information
Angioedema and Anaphylactic Reactions : Promptly discontinue VESIcare and provide appropriate therapy. ( 5.1 ) • Urinary Retention : VESIcare is not recommended for use in patients with clinically significant bladder outlet obstruction. ( 5.2 ) • Gastrointestinal Disorders : VESIcare is not recommended for use in patients with decreased gastrointestinal motility. ( 5.3 ) • Central Nervous System Effects : Somnolence has been reported with VESIcare. Advise patients not to drive or operate heavy machinery until they know how VESIcare affects them. ( 5.4 ) • Controlled Narrow-Angle Glaucoma : Use VESIcare with caution in patients being treated for narrow-angle glaucoma. ( 5.5 ) • QT Prolongation in Patients at High Risk of QT Prolongation : VESIcare is not recommended for use in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. ( 5.6 ) 5.1 Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin succinate. In some cases, angioedema occurred after the first dose, however, cases have been reported to occur hours after the first dose or after multiple doses. Anaphylactic reactions have also been reported in patients treated with solifenacin succinate. Angioedema associated with upper airway swelling and anaphylactic reactions may be life-threatening. VESIcare is contraindicated in patients with a known or suspected hypersensitivity to solifenacin succinate [see Contraindications ( 4 )] . If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue VESIcare and provide appropriate therapy and/or measures necessary to ensure a patent airway. 5.2 Urinary Retention The use of VESIcare, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction including patients with urinary retention, may result in further urinary retention and kidney injury. The use of VESIcare is not recommended in patients with clinically significant bladder outlet obstruction and is contraindicated in patients with urinary retention [see Contraindications ( 4 )] . 5.3 Gastrointestinal Disorders The use of VESIcare, like other antimuscarinic drugs, in patients with conditions associated with decreased gastrointestinal motility may result in further decreased gastrointestinal motility. VESIcare is contraindicated in patients with gastric retention [see Contraindications ( 4 )] . The use of VESIcare is not recommended in patients with conditions associated with decreased gastrointestinal motility. 5.4 Central Nervous System Effects VESIcare is associated with antimuscarinic central nervous system (CNS) adverse reactions [see Adverse Reactions ( 6.2 )] . A variety of CNS antimuscarinic adverse reactions have been reported, including headache, confusion, hallucinations, and somnolence. Monitor patients for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how VESIcare affects them. If a patient experiences antimuscarinic CNS adverse reactions, consider dose reduction or drug discontinuation. 5.5 Controlled Narrow-Angle Glaucoma VESIcare should be used with caution in patients being treated for narrow-angle glaucoma [see Contraindications ( 4 )] . 5.6 QT Prolongation in Patients at High Risk of QT Prolongation In a study of the effect of solifenacin succinate on the QT interval conducted in 76 healthy women [see Clinical Pharmacology ( 12.2 )] , solifenacin succinate 30 mg (three times the largest maximum recommended dose in adult patients) was associated with a mean increase in the Fridericia-corrected QT interval of 8 msec (90% CI, 4, 13). The QT prolonging effect appeared less with solifenacin succinate 10 mg than with solifenacin succinate 30 mg, and the effect of solifenacin succinate 30 mg did not appear as large as that of the positive control moxifloxacin at its therapeutic dose. The use of VESIcare is not recommended in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients who are taking medications known to prolong the QT interval.
Who should not take Vesicare
VESIcare is contraindicated in patients: • With urinary retention [see Warnings and Precautions ( 5.2 )] , • With gastric retention [see Warnings and Precautions ( 5.3 )] , • With uncontrolled narrow-angle glaucoma [see Warnings and Precautions ( 5.5 )] , and • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in VESIcare. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions ( 6.2 )] . • Urinary retention. ( 4 , 5.2 ) • Gastric retention. ( 4 , 5.3 ) • Uncontrolled narrow-angle glaucoma. ( 4 , 5.5 ) • Hypersensitivity to this product or any of its components. ( 4 , 5.1 , 6.2 )
Overdose — what happens if you take too much
Overdosage with VESIcare can potentially result in severe antimuscarinic effects and should be treated accordingly. The highest dose ingested in an accidental overdose of solifenacin succinate was 280 mg (28 times the maximum dosage) in a 5-hour period. This case was associated with mental status changes. Some cases reported a decrease in the level of consciousness. Intolerable antimuscarinic adverse reactions (fixed and dilated pupils, blurred vision, failure of heel-to-toe exam, tremors, and dry skin) occurred on day 3 in normal volunteers taking 50 mg daily (5 times the maximum recommended therapeutic dose) and resolved within 7 days following discontinuation of drug. In the event of overdose with VESIcare, treat with gastric lavage and appropriate supportive measures. ECG monitoring is also recommended.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
CYP3A4 Inhibitors : Do not exceed the 5 mg dose of VESIcare with concomitant use of strong CYP3A4 inhibitors. ( 7.1 ) 7.1 Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology ( 12.3 )] . The dosage of VESIcare greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 )] .
How long does Solifenacin Succinate stay in your body?
The elimination half-life of solifenacin succinate is about 45 to 68 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label gives this range for solifenacin itself after chronic (repeat) dosing, so a dose change takes roughly a week to fully settle. The label names one pharmacologically active metabolite, 4R-hydroxy solifenacin, but states it occurs at low concentrations and is unlikely to contribute significantly to clinical activity — no half-life is given for it. Solifenacin is cleared mainly by CYP3A4 in the liver, so the half-life stretches in several groups: about 20 to 25% longer in adults 65 to 80 compared with adults 18 to 55; about 1.6-fold longer with severe kidney impairment (AUC 2.1-fold higher); and about 2-fold longer with moderate liver impairment. It has not been studied in severe liver impairment. Strong CYP3A4 inhibitors such as ketoconazole raise exposure about 2.7-fold. In the US solifenacin is sold as immediate-release tablets and an oral suspension; there is no extended-release form, so no ER-versus-IR difference applies.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Solifenacin Succinate Tablets — FDA Prescribing Information, Section 12.3 Pharmacokinetics (DailyMed).
Drug class
How this class works, per Muscarinic Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Vesicare treat?
- Vesicare (Solifenacin Succinate) may be used to treat overactive urinary bladder, urge urinary incontinence, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Vesicare work?
- Vesicare is a cholinergic muscarinic antagonist. These drugs block muscarinic receptors, the docking sites for the nerve signal acetylcholine. By preventing acetylcholine from acting, they calm the 'rest-and-digest' nervous system, which can dry secretions, relax airway and bladder muscles, and speed up the heart, depending on the drug.
- How is Vesicare rated?
- pharmaranks gives Vesicare a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Vesicare cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $5.40 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Oxytrol — about $1.42 on the same basis.
- Is there a coupon or discount for Vesicare?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Vesicare. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Vesicare?
- Vesicare is marketed by Astellas. You can see Astellas's full profile, rating, and other products on pharmaranks.
- Is Vesicare a brand-name or generic drug?
- Vesicare is a brand-name product with the active ingredient Solifenacin Succinate. Lower-cost generic equivalents containing Solifenacin Succinate are available — ask your pharmacist.
- Is Vesicare available over the counter?
- No. Vesicare is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Vesicare come in?
- Vesicare is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Vesicare?
- Vesicare is classified as cholinergic muscarinic antagonist, per the FDA's Established Pharmacologic Class.
- Is Vesicare FDA-registered?
- Vesicare is on record with the U.S. FDA under application number NDA021518. You can verify this on its official FDA label.
- Has Vesicare been recalled by the FDA?
- Vesicare has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Vesicare safe?
- There's no single safe-or-not verdict. pharmaranks gives Vesicare a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Vesicare?
- Vesicare's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (> 4% in VESIcare-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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