Prescription medication · Anticholinergic (Overactive Bladder)

solifenacin

Also sold as Vesicare. This medicine treats overactive bladder in adults.

Data updated 2026-05-15

10,794
FDA reports
4
InteractionsFew interactions
99% less
Generic vs brandHuge savings
1
Recall record

What the data shows

solifenacin (Vesicare) is a prescription Anticholinergic (Overactive Bladder), with 10,794 FDA adverse-event reports on file, whose generic costs a fraction of the brand (about 99% less).

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

solifenacin (Vesicare) is a prescription Anticholinergic (Overactive Bladder). This medicine treats overactive bladder in adults.

Solifenacin (Vesicare) is a medicine that helps control an overactive bladder. It reduces the feeling of needing to go to the bathroom so often.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Brand Price

$12.31/unit

Generic Price

$0.16/unit

Generic Savings

99%

Generic Available

Yes (13 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug →

What it does

This medicine treats overactive bladder in adults.

Common side effects

Dry mouth, Constipation, Urinary tract infection

Key warnings

This medicine may cause swelling of the face, lips, tongue, or throat.

The sections below are summarized in plain English from solifenacin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Solifenacin blocks certain receptors in the bladder called muscarinic receptors. By blocking these receptors, the bladder muscle relaxes. This helps to reduce the urge to urinate frequently and reduces leakage.

Side Effects (from patient reports)

Based on 10,794 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for solifenacin, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

This medicine may cause swelling of the face, lips, tongue, or throat. If this happens, stop taking solifenacin and get medical help right away. This medicine is not recommended if you have a bladder problem that makes it hard to empty your bladder. It is also not recommended if you have slow movement in your stomach or intestines. This medicine may cause sleepiness, so be careful driving or operating heavy machinery until you know how it affects you.

Known Drug Interactions

major darunavir

solifenacin ↑ solifenacin When solifenacin is co-administered with darunavir/ritonavir, do not exceed a solifenacin dose of 5 mg once daily.

Mechanism: Darunavir slows down how quickly your body processes solifenacin, which increases the amount of the drug in your system.

major itraconazole

Solifenacin Patients with severe renal or moderate to severe hepatic impairment : Contraindicated during and 2 weeks after itraconazole treatment.

Mechanism: Itraconazole stops the body from breaking down solifenacin, which can cause the drug to build up to unsafe levels.

minor ketoconazole

Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [ see Clinical Pharmacology ( 12.3 ) ].

Mechanism: Ketoconazole stops the body from breaking down solifenacin, which leads to higher levels of the drug in your system.

minor mirabegron

Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of coadministered drugs (e.g., ketoconazole, rifampin, solifenacin succinate, tamsulosin, and oral contraceptives) [see Clinical Pharmacology ( 12.3 )] .

Mechanism: Taking these two bladder medicines together can slightly change how your body absorbs or handles each drug.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take this medicine if I have glaucoma?
You should not take this medicine if you have uncontrolled narrow-angle glaucoma.
What should I do if I have a severe allergic reaction?
Stop taking the medicine and get medical help right away.
Can I drive while taking this medicine?
Be careful driving or operating heavy machinery until you know how this medicine affects you. It may cause sleepiness.
What if I have kidney problems?
If you have severe kidney problems, do not take more than 5 mg per day.
What if I have liver problems?
If you have moderate liver problems, do not take more than 5 mg per day. Do not take this medicine if you have severe liver problems.
Can I take this with other medications?
Do not take more than 5 mg per day if you are taking strong CYP3A4 inhibitors, such as ketoconazole.
What are the most common side effects?
The most common side effects are dry mouth and constipation.
Can this medicine cause urinary retention?
Yes, this medicine can cause urinary retention, especially if you already have problems emptying your bladder.
How long does it take for this medicine to work?
It may take a few weeks to see the full effects of this medicine.
What do the tablets look like?
The 5 mg tablets are yellow and have 'G 51' printed on them. The 10 mg tablets are pink and have 'G 52' printed on them.
What are the common side effects of solifenacin?
The registry lists Dry mouth, Constipation, Urinary tract infection, Blurred vision among the most-reported FAERS reaction terms for solifenacin. The compiled record contains 10,794 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does solifenacin interact with other medications?
The registry has 4 documented interaction rows for solifenacin. Notable source-record pairings include darunavir, itraconazole, ketoconazole. These rows are not a complete medication review.
What drug class is solifenacin?
solifenacin belongs to the Anticholinergic (Overactive Bladder) drug class. It requires a prescription (Rx). This medicine treats overactive bladder in adults.
Is there a generic version of solifenacin?
Yes, generic solifenacin is available from 13 manufacturers. The generic costs $0.16 per unit compared to $12.31 for the brand version, saving approximately 99%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
What pregnancy or breastfeeding source fields are listed for solifenacin?
The FDA label for solifenacin contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has solifenacin been recalled?
There is 1 recall associated with solifenacin products. CGMP Deviations. Check the recalls section below for full details and affected products.

Active Recalls

Class II March 13, 2025

CGMP Deviations

Glenmark Pharmaceuticals Inc., USA

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darifenacin

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dutasteride/tamsulosin

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Medication Guides

Understanding Drug Interactions

How CYP450 enzymes, inhibitors, and inducers affect your medications

Generic vs Brand Name Drugs

FDA requirements, cost savings, and when the difference matters

Narrow Therapeutic Index Drugs

FDA bioequivalence and label-record context for narrow therapeutic index medicines

Common Drug Interactions

Dangerous medication combinations and how to protect yourself

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What the FDA Data Shows for solifenacin

The FDA label for solifenacin (sold under brand names such as Vesicare) classifies it as a prescription-only medication in the Anticholinergic (Overactive Bladder) class. This medicine treats overactive bladder in adults. Official labeling lists 4 commonly reported side effects, including Dry mouth, Constipation, Urinary tract infection.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 10,794 voluntary reports. The database also lists 4 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.16 versus $12.31 for the brand - a 99% generic savings.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: January 28, 2026

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page