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 →
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.
How to Take It
Take one 5 mg tablet by mouth once a day with water. You can take it with or without food. If the 5 mg dose works well, your doctor may increase it to 10 mg once a day. Do not crush or chew the tablet; swallow it whole.
This is a plain-language summary of solifenacin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if solifenacin can harm your unborn baby. It is also not known if solifenacin passes into breast milk.
This is a plain-language summary of solifenacin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of solifenacin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store solifenacin tablets at room temperature, between 68°F and 77°F.
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
- Dry mouth
Dry mouth
1,616 reports
- Constipation
Constipation
1,613 reports
- Tiredness
Tiredness
1,275 reports
- Fall
Fall
1,226 reports
- Dizziness
Dizziness
1,032 reports
- Nausea
Nausea
899 reports
- Headache
Headache
859 reports
- Blurred vision
Blurred vision
785 reports
- Urinary tract infection
Urinary tract infection
763 reports
- Diarrhea
Diarrhea
726 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.
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
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.
What to do: If you take these drugs together, your doctor should limit your solifenacin dose to 5 mg once daily.
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.
What to do: Do not take these medicines together if you have kidney or liver problems.
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.
What to do: Your doctor may need to adjust your solifenacin dose to prevent side effects.
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.
What to do: These medicines can be used together, but you should let your healthcare provider know if you experience any new symptoms.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take this medicine if I have glaucoma?
What should I do if I have a severe allergic reaction?
Can I drive while taking this medicine?
What if I have kidney problems?
What if I have liver problems?
Can I take this with other medications?
What are the most common side effects?
Can this medicine cause urinary retention?
How long does it take for this medicine to work?
What do the tablets look like?
What are the common side effects of solifenacin?
Does solifenacin interact with other medications?
What drug class is solifenacin?
Is there a generic version of solifenacin?
Is solifenacin safe during pregnancy?
Has solifenacin been recalled?
Active Recalls
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
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: January 28, 2026
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages