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Darifenacin Side Effects

The most commonly reported side effects of darifenacin include dry mouth, constipation, and peripheral swelling, based on 4,658 FDA adverse event reports from 2004 to 2025. 11.6% of reports found the drug to be ineffective.

Darifenacin side effects

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

1
Drug Ineffective11.6%538
2
Dry Mouth7.8%363
3
Drug Ineffective7.0%328
4
Constipation6.5%301
5
Peripheral Swelling4.3%201
6
Herpes Zoster4.2%194
7
Arthralgia3.6%169
8
Anaemia3.6%166
9
Fall3.4%160
10
Pneumonia Viral3.3%153
11
Synovitis3.2%151
12
Arthritis3.2%148
13
Joint Swelling3.1%144
14
Fibromyalgia3.1%143
15
Pollakiuria3.0%139

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

Report severity

46.7%Serious2,173 reports
18.5%Hospitalizations863 reports
5.9%Fatal273 reports

Seriousness is determined by the reporter, not by OpenClaim.

Darifenacin drug interactions

Other drugs that appear in adverse event reports alongside darifenacin. 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
Adalimumab5.5%255
2
Etanercept4.6%212
3
Tocilizumab3.9%180
4
Methotrexate3.8%178
5
Abatacept3.6%170
6
Infliximab3.6%170
7
Hydroxychloroquine-sulfate3.5%164
8
Dalfampridine3.4%159
9
Interferon2.7%126
10
Tofacitinib2.7%124
11
Leflunomide2.6%122
12
Duloxetine-hydrochloride2.3%106
13
Aspirin2.2%103
14
Acetaminophen2.2%102
15
Levothyroxine-sodium2.0%94

Taken alongside

1
Levothyroxine-sodium14.1%657
2
Acetaminophen12.8%595
3
Aspirin10.8%502
4
Furosemide10.4%486
5
Ergocalciferol9.9%463
6
Pantoprazole-sodium8.6%400
7
Omeprazole8.2%381
8
Atorvastatin-calcium7.4%343
9
Lorazepam7.2%336
10
Gabapentin6.9%323
11
Simvastatin6.8%317
12
Metoprolol6.6%306
13
Amlodipine6.4%299
14
Calcium5.9%273
15
Estradiol5.8%272

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 darifenacin side effects

71.6% of darifenacin adverse event reports involve female patients and 23.5% involve male patients. The largest age group is elderly at 65%. These figures reflect who reports side effects, not underlying risk.

Sex

Female71.6%
Male23.5%
Unknown4.9%

Age group

< 20.0%
2–110.1%
12–17<0.1%
18–6435.3%
65+64.6%

What is darifenacin used for

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

Analgesic TherapyAntiinflammatory TherapyAnxietyAutomatic BladderBack PainBenign Prostatic HyperplasiaBladder CancerBladder DilatationBladder DisorderBladder DysfunctionBladder IrritationBladder PainBladder ProlapseBladder SpasmBlood Pressure Abnormal

Showing 15 of 105 indications

Darifenacin brand names and reporting trend

Darifenacin is sold under the brand name Enablex.

Brand names

Enablex396

Quarterly reports (20042025)

20052010201520202025

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

Taking darifenacin with another medication?

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