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

Along with its needed effects, solifenacin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking solifenacin:

Less common
  • Bladder pain
  • bloody or cloudy urine
  • chills
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficult, burning, or painful urination
  • difficulty in passing urine (dribbling)
  • fever
  • frequent urge to urinate
  • painful urination
  • swelling of the lower legs
  • unusual tiredness or weakness
Incidence not known
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest pain or discomfort
  • fainting
  • irregular heartbeat recurrent
  • irregular or slow heart rate
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • rapid weight gain
  • shortness of breath
  • tingling of the hands or feet
  • unusual weight gain or loss

Some side effects of solifenacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • belching
  • body aches or pain
  • congestion
  • cough
  • diarrhea
  • discouragement
  • feeling sad or empty
  • general feeling of discomfort or illness
  • headache
  • heartburn
  • hoarseness
  • indigestion
  • irritability
  • joint pain
  • lack of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • muscle aches and pains
  • nervousness
  • pounding in the ears
  • runny nose
  • shivering
  • slow or fast heartbeat
  • sore throat
  • stomach discomfort, upset, or pain
  • sweating
  • tender, swollen glands in the neck
  • tiredness
  • trouble concentrating
  • trouble with sleeping
  • trouble with swallowing
  • upper abdominal or stomach pain
  • voice changes
Incidence not known
  • Hives or welts
  • itching
  • redness of the skin
  • skin rash

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. Other cardiovascular side effects reported postmarketing include atrial fibrillation, tachycardia and palpitations.

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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