Solifenacin Side Effects

Some side effects of solifenacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to solifenacin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking solifenacin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using solifenacin and call your doctor at once if you have a serious side effect such as:

• hot, dry skin and extreme thirst;

• severe stomach pain, or constipation for 3 days or longer;

• pain or burning when you urinate;

• vision changes, eye pain, or seeing halos around lights;

• urinating less than usual or not at all;

• confusion, hallucinations;

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of solifenacin may include:

• headache, dizziness, drowsiness, feeling tired;

• dry mouth, hoarse voice;

• dry eyes, blurred vision;

• nausea, loss of appetite, upset stomach, heartburn;

• mild constipation; or

• fever, sore throat, body aches, or other flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to solifenacin: oral tablet

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included dry mouth (7.7% to 27.6%) and constipation (3.7% to 13.4%). Dyspepsia (1.4% to 3.9%), nausea (1.7% to 3.3%), abdominal pain (upper) (1.2% to 1.9%), and vomiting (0.2% to 1.1%) have also been reported. Gastrointestinal side effects reported postmarketing have included decreased appetite, gastroesophageal reflux disease, and ileus.
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Respiratory

Respiratory side effects have included cough (0.2% to 1.1%). Respiratory side effects reported postmarketing have included dysphonia.

Psychiatric

Psychiatric side effects have included depression (0.8% to 1.2%). Confusion and hallucinations have been reported during postmarketing experience.

Ocular

Ocular side effects have included blurred vision (3.8% to 5.9%) and dry eyes (0.3 to 1.6%). Anticholinergic side effects including fixed and dilated pupils have been reported in patients with chronic use of or at doses higher than the maximum recommended dose. Ocular side effects reported postmarketing have included glaucoma.

Nervous system

Nervous system side effects have included dizziness (1.8% to 1.9%) and tremors. Headache, confusion, hallucinations, somnolence, and delirium have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included urinary tract infections (2.8% to 4.8%) and urinary retention (1.4%).

General

In general, the most frequently reported side effects have included dry mouth and constipation and the incidence of these side effects was higher in 10 mg compared to 5 mg dose group. In a four 12-week double-blind clinical trial, there were three intestinal serious side effects in patients, all treated with 10 mg. The overall rate of serious side effects was 2%. Compared to twelve weeks of therapy, the incidence and severity of side effects were similar in patients who remained on therapy for up to 12 months. The most frequent reason for discontinuation due to a side effect was dry mouth (1.5%).

Cardiovascular

A cardiac electrophysiologic study evaluating the QT interval at the time of peak plasma concentrations, following 10 and 30 mg solifenacin doses, has reported a QT prolongation effect. The effect appeared greater with the highest solifenacin dosage, although the effect did not appear as large as that of the positive control moxifloxacin at its therapeutic dose.

Cardiovascular side effects have included hypertension (0.5% to 1.4%). A prolonged QT interval effect has been reported during cardiac electrophysiologic studies. Torsades de Pointes have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included dry skin and postmarketing reports of exfoliative dermatitis and erythema multiforme.

Immunologic

Immunologic side effects have included infections. These have included influenza (0.9% to 2.2%) and pharyngitis (0.3% to 1.1%).

Metabolic

Metabolic side effects have included heat prostration with the use of anticholinergic drugs, similar to solifenacin, in hot environments. Metabolic side effects reported postmarketing have included hyperkalemia.

Hypersensitivity

Hypersensitivity side effects including angioedema, rash, pruritus, and urticaria have been reported during postmarketing experience.

Other

Other side effects have included fatigue (1% to 2.1%) and edema of the lower limbs (0.3% to 1.1%).

Renal

Renal side effects reported postmarketing have included renal impairment.

Hepatic

Hepatic side effects reported postmarketing have included liver disorders mostly characterized by abnormal liver function tests (AST, ALT, and GGT).

Musculoskeletal

Musculoskeletal and connective tissue side effects reported postmarketing have included muscular weakness.

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