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Solifenacin Side Effects

The most commonly reported side effects of solifenacin include off label use, fatigue, and dry mouth, based on 31,554 FDA adverse event reports from 2004 to 2025. 10.2% of reports found the drug to be ineffective.

Solifenacin side effects

Percentages show how often each reaction appears relative to total reports for solifenacin.

1
Drug Ineffective10.2%3,204
2
Off Label Use4.6%1,443
3
Fatigue4.5%1,428
4
Dry Mouth4.4%1,398
5
Fall4.4%1,395
6
Constipation4.4%1,376
7
Dizziness3.3%1,053
8
Nausea2.9%922
9
Headache2.9%915
10
Diarrhoea2.8%894
11
Urinary Tract Infection2.7%845
12
Malaise2.6%810
13
Asthenia2.3%731
14
Dyspnoea2.3%710
15
Pain2.2%694

These are voluntary reports and do not establish that solifenacin caused these reactions.

Report severity

56.4%Serious17,783 reports
25.4%Hospitalizations8,009 reports
5.5%Fatal1,739 reports

Seriousness is determined by the reporter, not by OpenClaim.

Solifenacin drug interactions

Other drugs that appear in adverse event reports alongside solifenacin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dalfampridine3.2%1,024
2
Mirabegron2.0%644
3
Dimethyl1.7%528
4
Omeprazole1.6%502
5
Adalimumab1.5%480
6
Lenalidomide1.5%458
7
Sodium-oxybate1.4%448
8
Pregabalin1.4%446
9
Fingolimod1.4%431
10
Interferon1.3%407
11
Esomeprazole1.2%369
12
Tamsulosin-hydrochloride1.1%336
13
Natalizumab1.0%320
14
Levodopa1.0%319
15
Atorvastatin-calcium1.0%316

Taken alongside

1
Aspirin12.2%3,842
2
Acetaminophen11.9%3,760
3
Ergocalciferol10.9%3,438
4
Omeprazole10.6%3,358
5
Levothyroxine-sodium10.2%3,232
6
Atorvastatin-calcium9.2%2,910
7
Amlodipine8.1%2,544
8
Gabapentin7.9%2,504
9
Metformin6.7%2,121
10
Furosemide6.5%2,065
11
Simvastatin6.3%1,996
12
Albuterol6.2%1,959
13
Metoprolol5.6%1,772
14
Lisinopril5.5%1,738
15
Pantoprazole-sodium5.3%1,658

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports solifenacin side effects

66.1% of solifenacin adverse event reports involve female patients and 28.7% involve male patients. The largest age group is elderly at 61%. These figures reflect who reports side effects, not underlying risk.

Sex

Female66.1%
Male28.7%
Unknown5.2%

Age group

< 2<0.1%
2–110.5%
12–170.3%
18–6438.4%
65+60.7%

What is solifenacin used for

Conditions and purposes for which patients were taking solifenacin when the adverse event was reported.

Abdominal DiscomfortAbdominal Pain LowerAbnormal FaecesAccidental Exposure To Product By ChildAdjuvant TherapyAdverse EventAffective DisorderAnal IncontinenceAngina PectorisArthralgiaAsthmaAtonic Urinary BladderAtrophic VulvovaginitisAttention Deficit/hyperactivity DisorderAutoimmune Thyroiditis

Showing 15 of 399 indications

Solifenacin brand names and reporting trend

Solifenacin is sold under the brand name Vesicare Ls.

Brand names

Vesicare Ls7,760

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking solifenacin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.