Prescription medicine
Solifenacin First approved as Vesicare
Solifenacin (Vesicare) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.162 per solifenacin 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the solifenacin FDA label on DailyMed (effective February 4, 2026, Bostal LLC); the NDA 21518 record on Drugs@FDA; every solifenacin label on DailyMed.
Highlights of the record
FDA label of February 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSolifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Forms and strengths
- 5 mg
- 10 mg
Film-coated tablet; coated tablet; tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- November 19, 2004 Vesicare, Astellas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 26 first April 2, 2014; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 20 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- May 18, 2031 Vesicare Ls oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.162 per tablet Solifenacin 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest March 13, 2025
- FAERS reports
- 1,846 through July 30, 2026
What is solifenacin used for?
From the label: indications and usageSolifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin Succinate Tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Conditions named in the indications of solifenacin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Solifenacin Succinate), Bostal LLC, effective February 4, 2026 (SPL set d155c739-6870-4938-ba91-8c1b4b90afe4), via openFDA; the full label on DailyMed
What does the patient leaflet for solifenacin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking Solifenacin Succinate Tablets?Solifenacin Succinate Tablets can cause blurred vision or drowsiness. Do not drive or operate heavy machinery until you know how Solifenacin Succinate Tablets affect you.
From the patient leaflet: How should I store Solifenacin Succinate Tablets?Store Solifenacin Succinate Tablets between 59°F to 86°F (15°C to 30°C). Keep the bottle closed. Safely throw away medicine that is out of date or no longer need. Keep Solifenacin Succinate Tablets and all medicines out of the reach of children.
Source: FDA drug label (Solifenacin Succinate), Bostal LLC, effective February 4, 2026 (SPL set d155c739-6870-4938-ba91-8c1b4b90afe4), via openFDA; the full label on DailyMed
Is there a generic for solifenacin (Vesicare)?
The FDA approved the first generic solifenacin on April 2, 2014. 26 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists solifenacin from 20 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Vesicare Ls oral suspension, the last expiring on May 18, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2014 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for solifenacin (Vesicare)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.162 per Solifenacin 10 mg tablet, down 3% from $0.167 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Solifenacin 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Solifenacin 10 mg tablet | Generic | $0.162 per tablet | $4.85 | -3% |
| Solifenacin 5 mg tablet | Generic | $0.141 per tablet | $4.24 | -17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has solifenacin been recalled?
The FDA's Enforcement Report lists 6 recalls naming solifenacin since 2013: 0 Class I (the most serious), 6 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| June 10, 2021 | Class II | CIPLA | CGMP Deviations |
| January 24, 2020 | Class II | Breckenridge Pharmaceutical, Inc | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; SOLIFENACIN SUCCINATE Tablet, 5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010601, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the solifenacin label say about other medicines?
The solifenacin label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name solifenacin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology (12.3) ]. |
| Moxifloxacin | warnings and precautions | The QTprolonging effect appeared less with solifenacin succinate 10 mg than with solifenacin succinate 30 mg, and the effect ofsolifenacin succinate 30 mg did not appear as large as that of the positive control moxifloxacin at its therapeutic dose. |
Other labels that name solifenacin
Source: FDA drug label (Solifenacin Succinate), Bostal LLC, effective February 4, 2026 (SPL set d155c739-6870-4938-ba91-8c1b4b90afe4), via openFDA; the full label on DailyMed
What do FAERS reports show for solifenacin?
The FDA Adverse Event Reporting System holds 1,846 reports that list solifenacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 133 are coded as a death and 648 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as solifenacin?
7 other medicines are given the same way (oral) and in the same FDA class as solifenacin or labeled mainly for the same use (overactive bladder), the same class first. Overactive bladder lists all 9 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxybutynin | Overactive bladder | 41 labelers | $0.048 per tablet 5 mg tablet | No current entry |
| Tolterodine | Overactive bladder | 14 labelers | $0.268 per capsule 2 mg capsule | No current entry |
| Trospium | Overactive bladder | 20 labelers | $0.211 per tablet 20 mg tablet | No current entry |
| Darifenacin | Overactive bladder | 8 labelers | $0.432 per tablet 15 mg tablet | No current entry |
| Fesoterodine | Overactive bladder | 11 labelers | $0.794 per tablet 4 mg tablet | No current entry |
| Mirabegron | Overactive bladder | 8 labelers | $9.39 per tablet 50 mg tablet | No current entry |
| Vibegron | Overactive bladder | none listed | $16.46 per tablet 75 mg tablet | No current entry |
Every medicine labeled for the same conditions as solifenacin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does solifenacin compare with medicines for the same use?
6 side-by-side pages set solifenacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to solifenacin
- 7 medicines for the same use
- Other cholinergic muscarinic antagonists
- the pharmacologic class, with prices and generics
- Solifenacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other