Vesicare (Solifenacin) Side Effects
The most common side effects of Vesicare are dry mouth (occurring in 11-28% of patients depending on dose), constipation (5-13%), and blurred vision (4-5%), with the 10 mg dose causing significantly more side effects than the 5 mg dose. 1
Most Common Side Effects (Occurring in ≥1% of Patients)
Gastrointestinal Effects
- Dry mouth: 10.9% with 5 mg dose, 27.6% with 10 mg dose (compared to 4.2% placebo) 1
- Constipation: 5.4% with 5 mg dose, 13.4% with 10 mg dose (compared to 2.9% placebo) 1
- Nausea: 1.7% with 5 mg, 3.3% with 10 mg 1
- Dyspepsia: 1.4% with 5 mg, 3.9% with 10 mg 1
- Upper abdominal pain: 1.9% with 5 mg, 1.2% with 10 mg 1
Eye Disorders
- Blurred vision: 3.8% with 5 mg dose, 4.8% with 10 mg dose (compared to 1.8% placebo) 1
- Dry eyes: 0.3% with 5 mg, 1.6% with 10 mg 1
Other Common Effects
- Urinary tract infection: 2.8% with 5 mg, 4.8% with 10 mg 1
- Dizziness: 1.9% with both doses 1
- Fatigue: 1.0% with 5 mg, 2.1% with 10 mg 1
- Urinary retention: 0% with 5 mg, 1.4% with 10 mg 1
Serious Side Effects and Warnings
Central Nervous System Effects
- Solifenacin is associated with antimuscarinic CNS adverse reactions including headache, confusion, hallucinations, and somnolence 1
- Patients should not drive or operate heavy machinery until they know how the medication affects them 1
Cardiovascular Effects
- QT prolongation: Solifenacin 30 mg (three times the maximum recommended dose) was associated with a mean QT interval increase of 8 msec 1
- Postmarketing reports include QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, and palpitations 1
Severe Gastrointestinal Complications
- Severe fecal impaction, colonic obstruction, and intestinal obstruction were each reported in one patient taking the 10 mg dose 1
- Patients should call their doctor if they develop severe abdominal pain or become constipated for 3 or more days 1
Allergic Reactions
- Angioedema (including airway obstruction), rash, pruritus, urticaria, and anaphylactic reactions have been reported 1
- One case of angioneurotic edema occurred with the 5 mg dose 1
Postmarketing Adverse Reactions
Hepatobiliary Disorders
- Liver disorders characterized by abnormal liver function tests (AST, ALT, GGT) 1
Renal and Urinary Disorders
- Renal impairment and urinary retention 1
Metabolic Disorders
- Decreased appetite and hyperkalemia 1
Skin Disorders
- Exfoliative dermatitis, erythema multiforme, and dry skin 1
- Decreased sweating can lead to heat exhaustion or heat stroke in hot environments 1
Other Postmarketing Effects
- Glaucoma 1
- Gastroesophageal reflux disease, ileus, dysgeusia, sialadenitis 1
- Dysphonia, nasal dryness 1
- Muscular weakness 1
Treatment Discontinuation Rates
Solifenacin has the lowest discontinuation rate due to adverse effects among antimuscarinics, with a number needed to harm (NNTH) of 78 (compared to 33 for fesoterodine and 16 for oxybutynin). 2
- Dry mouth was the most frequent adverse reaction leading to study discontinuation (1.5%) 1
- Overall discontinuation due to adverse effects: 9.7% of patients 3
- High-quality evidence shows solifenacin has significantly better tolerability than oxybutynin, particularly regarding dry mouth severity 2, 4
Dose-Dependent Effects
The 10 mg dose causes substantially more side effects than the 5 mg dose, particularly dry mouth (28% vs 11%) and constipation (13% vs 5%), without proportionally greater efficacy. 1, 2
- Higher doses (10 mg vs 5 mg) do not decrease UI frequency significantly but are associated with increased adverse effects 2
- Solifenacin 5 mg is better tolerated than oxybutynin 15 mg in both younger (≤65 years) and older (>65 years) patients 4