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solifenacin

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Brand names: Vesicare

Anticholinergic (Overactive Bladder) Rx

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

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.

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.

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.

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.

Storage

Store solifenacin tablets at room temperature, between 68°F and 77°F.

Side Effects (from patient reports)

Based on 14,141 FDA adverse event reports.

Medicine not working
3,600
Dry mouth
1,616
Constipation
1,613
Tiredness
1,275
Using medicine for unapproved purpose
1,236
Fall
1,226
Dizziness
1,032
Nausea
899
Headache
859
Blurred vision
785

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.

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 most commonly reported side effects of solifenacin include Dry mouth, Constipation, Urinary tract infection, Blurred vision. Based on 14,141 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does solifenacin interact with other medications?
Yes, solifenacin has 4 known drug interactions. Notable interactions include darunavir, itraconazole, ketoconazole. Always inform your doctor about all medications you are taking.
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.
Is solifenacin safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
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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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 14,141 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

All federal data sources used on this page