Note: This document contains side effect information about solifenacin. Some dosage forms listed on this page may not apply to the brand name VESIcare LS.

Applies to solifenacin: oral suspension, oral tablet.

Serious side effects of VESIcare LS

Along with its needed effects, solifenacin (the active ingredient contained in VESIcare LS) 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:

More common

• Constipation
• stomach pain

Less common

• Bladder pain
• bloody or cloudy urine
• blurred vision
• chills
• decrease in the frequency of urination
• decrease in urine volume
• difficult, burning, or painful urination
• dizziness
• dry eyes
• fever
• frequent urge to urinate
• headache
• lower back or side pain
• nervousness
• pounding in the ears
• slow or fast heartbeat
• swelling of the lower legs
• unusual tiredness or weakness

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• chest pain or discomfort
• confusion
• cough
• decreased or increased sweating
• diarrhea
• discouragement
• dry skin
• fainting
• feeling sad or empty
• general feeling of discomfort or illness
• hives or welts, itching, skin rash
• hoarseness
• irregular heartbeat recurrent
• irritability
• joint pain
• lack of appetite
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of interest or pleasure
• muscle aches and pains
• redness of the skin
• runny or stuffy nose
• seeing, hearing, or feeling things that are not there
• shivering
• sore throat
• tender, swollen glands in the neck
• tingling of the hands or feet
• trouble concentrating
• trouble with sleeping
• trouble with swallowing
• unusual weight gain or loss
• voice changes

Other side effects of VESIcare LS

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:

More common

• Dry mouth

Less common

• Acid or sour stomach
• belching
• heartburn
• indigestion
• nausea
• stomach discomfort or upset
• vomiting

For Healthcare Professionals

Applies to solifenacin: oral suspension, oral tablet.

Gastrointestinal

Very common (10% or more): Dry mouth (up to 28%), constipation (up to 13%)

Common (1% to 10%): Nausea, dyspepsia, upper abdominal pain, vomiting

Uncommon (0.1% to 1%): Gastroesophageal reflux disease, dry throat, flatulence, throat irritation, eructation, thirst

Rare (less than 0.1%): Colonic obstruction, fecal impaction

Postmarketing reports: Ileus^[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, cough, sinusitis, bronchitis

Uncommon (0.1% to 1%): Nasal dryness

Postmarketing reports: Dysphonia^[Ref]

Psychiatric

Common (1% to 10%): Depression

Postmarketing reports: Confusion, hallucinations, delirium, somnolence^[Ref]

Ocular

Common (1% to 10%): Blurred vision, dry eyes

Very rare (less than 0.01%): Glaucoma^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, urinary retention

Uncommon (0.1% to 1%): Cystitis, suprapubic pain, bladder pain, micturition urgency^[Ref]

Cardiovascular

Common (1% to 10%): Lower limb edema, hypertension

Uncommon (0.1% to 1%): Syncope, chest tightness, hot flushes

Postmarketing reports: Peripheral edema, QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, palpitations, atrial fibrillation^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dry skin

Rare (0.01% to 0.1%): Pruritus, rash

Very rare (less than 0.01%): Erythema multiforme, urticaria, angioedema, exfoliative dermatitis^[Ref]

Immunologic

Common (1% to 10%): Influenza^[Ref]

Metabolic

Very rare (less than 0.01%): Decreased appetite, hyperkalemia^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, and anaphylactic reaction)^[Ref]

Other

Common (1% to 10%): Fatigue^[Ref]

Renal

Very rare (less than 0.01%): Renal impairment^[Ref]

Hepatic

Postmarketing reports: Abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl transferase)^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain

Uncommon (0.1% to 1%): Neck pain

Postmarketing reports: Muscular weakness^[Ref]

Nervous system

Common (1% to 10%): Dizziness, insomnia

Uncommon (0.1% to 1%): Dysgeusia

Rare (0.01% to 0.1%): Headache

Postmarketing reports: Headache, tremors^[Ref]