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Solifenacin Side Effects

In Summary

Commonly reported side effects of solifenacin include: constipation and xerostomia. Other side effects include: urinary tract infection and blurred vision. See below for a comprehensive list of adverse effects.

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

For Healthcare Professionals

Applies to solifenacin: 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]

References

1. "Product Information. VESIcare (solifenacin)." GlaxoSmithKline, Research Triangle Park, NC.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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