Vesicare (Solifenacin Succinate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

VESIcare has been evaluated for safety in 1811 patients in randomized, placebo-controlled trials. Expected side effects of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The most common adverse events reported in patients treated with VESIcare were dry mouth and constipation and the incidence of these side effects was higher in the 10 mg compared to the 5 mg dose group. In the four 12-week double-blind clinical trials there were three intestinal serious adverse events in patients, all treated with VESIcare 10 mg (one fecal impaction, one colonic obstruction, and one intestinal obstruction). The overall rate of serious adverse events in the double-blind trials was 2%. Angioneurotic edema has been reported in one patient taking VESIcare 5 mg. Compared to twelve weeks of treatment with VESIcare, the incidence and severity of adverse events were similar in patients who remained on drug for up to 12 months. The most frequent reason for discontinuation due to an adverse event was dry mouth, 1.5%. Table 6 lists adverse events, regardless of causality, that were reported in randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with VESIcare 5 or 10 mg once daily for up to 12 weeks.

Table 6. Percentages of Patients with Treatment-emergent Adverse Events Exceeding Placebo Rate and Reported by 1% or More Patients for Combined Pivotal Studies

SYSTEM ORGAN CLASS MedDRA Preferred Term	Placebo (%)	VESIcare 5 mg (%)	VESIcare 10 mg (%)
Number of Patients	1216	578	1233
Number of Patients with Treatment-emergent AE	634	265	773
GASTROINTESTINAL DISORDERS
Dry Mouth	4.2	10.9	27.6
Constipation	2.9	5.4	13.4
Nausea	2.0	1.7	3.3
Dyspepsia	1.0	1.4	3.9
Abdominal Pain Upper	1.0	1.9	1.2
Vomiting NOS	0.9	0.2	1.1
INFECTIONS AND INFESTATIONS
Urinary Tract Infection NOS	2.8	2.8	4.8
Influenza	1.3	2.2	0.9
Pharyngitis NOS	1.0	0.3	1.1
NERVOUS SYSTEM DISORDERS
Dizziness	1.8	1.9	1.8
EYE DISORDERS
Vision Blurred	1.8	3.8	4.8
Dry Eyes NOS	0.6	0.3	1.6
RENAL AND URINARY DISORDERS
Urinary Retention	0.6	0	1.4
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Edema Lower Limb	0.7	0.3	1.1
Fatigue	1.1	1.0	2.1
PSYCHIATRIC DISORDERS
Depression NOS	0.8	1.2	0.8
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Cough	0.2	0.2	1.1
VASCULAR DISORDERS
Hypertension NOS	0.6	1.4	0.5

Post-Marketing Surveillance

The following events have been reported in association with solifenacin use in worldwide postmarketing experience: General: peripheral edema, hypersensitivity reactions, including angioedema, rash, pruritus, and urticaria; Central Nervous: headache, confusion and hallucinations; Cardiovascular: QT prolongation; Torsade de Pointes.Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of solifenacin in their causation cannot be reliably determined.

REPORTS OF SUSPECTED VESICARE SIDE EFFECTS / ADVERSE REACTIONS

Possible Vesicare side effects / adverse reactions in 75 year old male

Reported by a physician from France on 2011-10-03

Patient: 75 year old male weighing 72.4 kg (159.3 pounds)

Reactions: Polydipsia, Dysgeusia, DRY Mouth, Polyuria, Bronchitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Clarithromycin
    Dosage: unk
    Indication: Bronchitis
    Start date: 2011-06-22
    End date: 2011-06-26

Vesicare
    Dosage: 5 mg, unknown/d
    Administration route: Oral
    Indication: Pollakiuria
    Start date: 2011-03-01
    End date: 2011-07-23

Ciprofloxacin
    Dosage: unk
    Indication: Bronchitis
    Start date: 2011-06-26

Other drugs received by patient: Hydrea; Aspirin; Ceclor; Atacand; Iperten

Possible Vesicare side effects / adverse reactions in 67 year old male

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: 67 year old male

Reactions: Postural Orthostatic Tachycardia Syndrome, Loss of Consciousness

Suspect drug(s):
Vesicare
    Dosage: 5 mg, unknown/d
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-04-01

Vesicare
    Dosage: 10 mg, uid/qd
    Administration route: Oral

Other drugs received by patient: Atenolol; Aspirin; Trilipix; Lisinopril; Fludrocortisone Acetate

Possible Vesicare side effects / adverse reactions in 70 year old male

Reported by a consumer/non-health professional from United States on 2011-10-12

Patient: 70 year old male

Reactions: Drug Ineffective

Suspect drug(s):
Jalyn
    Administration route: Oral
    Indication: Prostatomegaly
    End date: 2011-07-10

Vesicare
    End date: 2011-08-01

Other drugs received by patient: NO Concurrent Medication