DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Vesicare (Solifenacin Succinate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

VESIcare has been evaluated for safety in 1811 patients in randomized, placebo-controlled trials. Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with VESIcare was higher in the 10 mg compared to the 5 mg dose group.

In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the VESIcare 10 mg group. Angioneurotic edema has been reported in one patient taking VESIcare 5 mg. Compared to 12 weeks of treatment with VESIcare, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months.

The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events, 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 1. Percentages of Patients with Identified Adverse Reactions, Derived from All Adverse Events Exceeding Placebo Rate and Reported by 1% or More Patients for Combined Pivotal Studies
Placebo
(%)
VESIcare
5 mg
(%)
VESIcare
10 mg
(%)

Number of Patients

1216

578

1233

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 Experience

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.

The following events have been reported in association with solifenacin use in worldwide postmarketing experience:

General : peripheral edema, hypersensitivity reactions, including angioedema with airway obstruction, rash, pruritus, urticaria, and anaphylactic reaction;

Central Nervous : headache, confusion, hallucinations, delirium and somnolence;

Cardiovascular : QT prolongation; Torsade de Pointes, atrial fibrillation, tachycardia, palpitations;

Hepatic : liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl transferase);

Renal : renal impairment;

Metabolism and nutrition disorders : decreased appetite, hyperkalemia;

Dermatologic : exfoliative dermatitis and erythema multiforme;

Eye disorders: glaucoma;

Gastrointestinal disorders: gastroesophageal reflux disease and ileus;

Respiratory, thoracic and mediastinal disorders: dysphonia;

Musculoskeletal and connective tissue disorders: muscular weakness;



REPORTS OF SUSPECTED VESICARE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Vesicare. The information is not vetted and should not be considered as verified clinical evidence.

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



See index of all Vesicare side effect reports >>

Drug label data at the top of this Page last updated: 2014-07-22

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017