Solifenacin: uses, dosing, side effects & brands
Solifenacin is a cholinergic muscarinic antagonist sold in the U.S. under 3 brand and generic names, for overactive urinary bladder and urge urinary incontinence. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Cholinergic Muscarinic Antagonist
- Treats (across its forms)
- Overactive Urinary Bladder and Urge Urinary Incontinence
- Available as
- Tablet · Suspension
- Sold as
- 3 products — Vesicare, Vesicare Ls and Solifenacin Succinate
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 45 to 68 hours
- What the pharmacy pays
- about $5 for a 30-count supply — not your price
How Vesicare is dosed
From the FDA label for Vesicare (application NDA021518). Other solifenacin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Everything below is the FDA label for Vesicare (tablet). Solifenacin is also sold as suspension, and those are different medicines to take — follow the label for the one you were prescribed.
Vesicare 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.…
Who shouldn’t 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 )
Vesicare drug 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 )] .
Every solifenacin product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $5 | View → | |
| 2 | 72/100 | Prescription | Suspension | Generic | $5 | View → | |
| 3 | 70/100 | Prescription | Tablet | Generic | $5 | View → |
What solifenacin pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Solifenacin recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Can you crush or split solifenacin?
At least one solifenacinproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each solifenacin label says about crushing, splitting and chewingSolifenacin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for solifenacin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause there is no published experience with solifenacin during breastfeeding and it has a long half-life averaging 55 hours, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Long-term use of solifenacin might reduce milk production or milk letdown. During long-term use, observe the infant for signs of decreased milk production (e.g., insatiety, poor weight gain) and for anticholinergic symptoms (e.g., constipation, urinary retention, UTI, dry mouth).
National Institute of Child Health and Human Development, record revised April 19, 2021. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about solifenacin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,041 reports naming solifenacin, and the FDA flagged 77% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue144 reports
- fall140 reports
- dizziness108 reports
- malaise105 reports
- nausea97 reports
- diarrhoea96 reports
- headache95 reports
- constipation86 reports
Read these as a signal, not a rate. A report does not mean solifenacin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
How long solifenacin stays in your system
The elimination half-life of solifenacin is about 45 to 68 hours. 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.
Solifenacin Succinate Tablets — FDA Prescribing Information, Section 12.3 Pharmacokinetics (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Vesicare?
Vesicare (Solifenacin Succinate) is a cholinergic muscarinic antagonist used to treat Overactive Urinary Bladder, Urge Urinary Incontinence.
What kind of drug is solifenacin?
The FDA classifies solifenacin as 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. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does solifenacin stay in your system?
The elimination half-life of solifenacin is about 45 to 68 hours — that is how long the body takes to clear half of a dose. 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. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take solifenacin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run solifenacin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is solifenacin sold under?
We track 3 solifenacin-containing products in the U.S.: Vesicare, Vesicare Ls and Solifenacin Succinate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does solifenacin come in?
Across the brands we track, solifenacin is currently marketed as tablet and suspension, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic solifenacin?
Yes. Our catalog lists 1 generic solifenacin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has solifenacin been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions solifenacin. The most recent: Solifenacin Succinate Tablets 5mg (Mar 13, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Solifenacin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/solifenacin
- MLA
- “Solifenacin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/solifenacin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for solifenacin on DailyMed (NIH) ↗.