What the label lists and what reports show
Solifenacin side effects
Solifenacin's FDA label: “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.” FAERS holds 1,846 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (137 reports).
- Generic listed
Check it at the source: the solifenacin FDA label on DailyMed (effective February 4, 2026, Bostal LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Solifenacin Succinate Tablets?Solifenacin Succinate Tablets may cause serious side effects including: Serious allergic reaction. Stop taking Solifenacin Succinate Tablets and get medical help right away if you have: • hives, skin rash or swelling • severe itching • swelling of your face, mouth or tongue • trouble breathing The most common side effects of Solifenacin Succinate Tablets include: dry mouth constipation. Call your doctor if you get severe stomach area (abdominal) pain or become constipated for 3 or more days. urinary tract infection blurred vision Other side effects have been observed with anticholinergic drugs such as Solifenacin Succinate Tablets and may include: dry skin due to decreased sweating. Heat exhaustion or heat stroke can happen due to decreased sweating when Solifenacin Succinate Tablets are used in hot environments. […]
Source: FDA drug label, Bostal LLC, effective February 4, 2026 (SPL set d155c739-6870-4938-ba91-8c1b4b90afe4), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe 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.
Table 1: Adverse Reactions Reported by ≥ 1% of Patients and Exceeding Placebo in Studies 1, 2, 3 and 4
| Reaction | Placebo (%) | Solifenacin Succinate Tablets 5 mg (%) | Solifenacin Succinate Tablets 10 mg (%) |
|---|---|---|---|
| Number of Patients | 1216 | 578 | 1233 |
| Dry Mouth | 4.2 | 10.9 | 27.6 |
| Constipation | 2.9 | 5.4 | 13.4 |
| Nausea | 2.0 | 1.7 | 3.3 |
| Dyspepsia | 1.0 | 1.4 | 3.9 |
| Abdominal Pain Upper | 1.0 | 1.9 | 1.2 |
| Vomiting NOS | 0.9 | 0.2 | 1.1 |
| Urinary Tract Infection NOS | 2.8 | 2.8 | 4.8 |
| Influenza | 1.3 | 2.2 | 0.9 |
| Pharyngitis NOS | 1.0 | 0.3 | 1.1 |
| Dizziness | 1.8 | 1.9 | 1.8 |
| Vision Blurred | 1.8 | 3.8 | 4.8 |
| Dry Eyes NOS | 0.6 | 0.3 | 1.6 |
| Urinary Retention | 0.6 | 0 | 1.4 |
| Edema Lower Limb | 0.7 | 0.3 | 1.1 |
| Fatigue | 1.1 | 1.0 | 2.1 |
| Depression NOS | 0.8 | 1.2 | 0.8 |
| Cough | 0.2 | 0.2 | 1.1 |
| Hypertension NOS | 0.6 | 1.4 | 0.5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 AustarPharma LLC at 1-844-375-5410 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 Tablets have been evaluated for safety in 1811 adult patients in four randomized, placebo-controlled trials (Studies 1-4) [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 Tablets was higher in the 10 mg dose group compared to the 5 mg dose group. In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the Solifenacin Succinate Tablets 10 mg group. …
Source: FDA drug label, 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?
1,846 reports list solifenacin among the medicines taken, 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. Of the 22 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Solifenacin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions