This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Solifenacin 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. (1)
Solifenacin succinate tablets are 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 solifenacin succinate tablets. 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 )
Angioedema and Anaphylactic Reactions : Promptly discontinue solifenacin succinate and provide appropriate therapy. ( 5.1 ) Urinary Retention : Solifenacin succinate is not recommended for use in patients with clinically significant bladder outlet obstruction. ( 5.2 ) Gastrointestinal Disorders : Solifenacin succinate is not recommended for use in patients with decreased gastrointestinal motility. ( 5.3 ) Central Nervous System Effects : Somnolence has been reported with solifenacin succinate. Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate affects them. ( 5.4 ) Controlled Narrow-Angle Glaucoma : Use solifenacin succinate with caution in patients being treated for narrow-angle glaucoma. ( 5.5 ) QT Prolongation in Patients at High Risk of QT Prolongation : Solifenacin succinate is not recommended for use in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. ( 5.6 ) 5.1 Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin succinate. In some cases, a...
The most common adverse reactions (> 4% in solifenacin succinate-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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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. Solifenacin succinate has been evaluated for safety in 1811 adult patients in four randomized, placebo-controlled trials (Studies 1 to 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 solifenacin succinate was higher in the 10 mg dose group compared to the 5 mg dose group. In the four 12-week doub...
Source: FDA SPL label for Solifenacin Succinate (Aurobindo Pharma Limited), effective 20240509. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 2,135 | 1,666 | 1,231 | 1,242 | 1,200 | 1,137 | 1,367 | 717 |
2,295 reports blaming this drug for every million Medicare prescriptions filled, which is 0.8× the typical drug on this site. (3,178 reports in 2024–2026, against 1,384,915 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 03/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| 03/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $563 in payments to US physicians and hospitals tied to this drug across 31 transactions (Vesicare $563).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Solifenacin Succinate | 1,379,426 | $49 |
| Vesicare | 5,390 | $738 |
| Vesicare Ls | 99 | $340 |
1 drug in the same class grades a letter or more higher than solifenacin on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.