Darifenacin Side Effects

Brand Names: Enablex

Please note - some side effects for Darifenacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Darifenacin - for the Consumer

Darifenacin Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Darifenacin Extended-Release Tablets:

Blurred vision; constipation; diarrhea; dizziness; dry eyes; dry mouth; flu-like symptoms; headache; nausea; stomach pain; stomach upset; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; bloody or cloudy urine; chills; confusion; fever; hallucinations; inability to urinate despite an urge to do so; irregular heartbeat; pain below the ribs; pain or burning when you urinate; unusual or severe headache.

Side Effects by Body System

Gastrointestinal

Gastrointestinal (GI) side effects have been reported the most frequently. These have included constipation (14.8% to 20.9% or greater), dry mouth (18.7% or greater), dyspepsia (2.7% to 4.5% or greater), and nausea (4.1% or greater). Abdominal pain, vomiting, and diarrhea have been reported in greater than or equal to 2% of patients.

A higher incidence of GI side effects has been reported with higher dosages.

Genitourinary

Genitourinary side effects have included urinary tract infection (3.7% or greater) and vaginitis.

Nervous system

Nervous system side effects have included headache (6.7%) and dizziness (2% or greater).

Ocular

Ocular side effects have included abnormal vision (2% or greater) and dry eyes.

General

General side effects have included flu syndrome (3%), asthenia (2% or greater), arthralgias, peripheral edema, and weight gain.

Dermatologic

Dermatological side effects have included dry skin, rash, and pruritus.

Respiratory

Respiratory side effects have included bronchitis, pharyngitis, rhinitis, and sinusitis.

Cardiovascular

Cardiovascular side effects have included hypertension.

Musculoskeletal

Musculoskeletal side effects have included arthralgias.

Metabolic

Metabolic side effects have included weight gain.

Other

Other side effects have included flu syndrome (3%) and accidental injury (3%).

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