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Vesicare Adverse Events Reported to the FDA Over Time

How are Vesicare adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Vesicare, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Vesicare is flagged as the suspect drug causing the adverse event.

Most Common Vesicare Adverse Events Reported to the FDA

What are the most common Vesicare adverse events reported to the FDA?

Drug Ineffective
662 (6.57%)
Dry Mouth
448 (4.45%)
Constipation
443 (4.4%)
Vision Blurred
325 (3.23%)
Dizziness
179 (1.78%)
Urinary Retention
154 (1.53%)
Fatigue
112 (1.11%)
Headache
107 (1.06%)
Oedema Peripheral
106 (1.05%)
Pollakiuria
95 (.94%)
Nausea
90 (.89%)
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Confusional State
88 (.87%)
Dyspepsia
83 (.82%)
Dry Eye
77 (.76%)
Urinary Incontinence
77 (.76%)
Fall
75 (.74%)
Abdominal Pain
67 (.67%)
Dyspnoea
65 (.65%)
Malaise
64 (.64%)
Condition Aggravated
63 (.63%)
Somnolence
63 (.63%)
Pruritus
62 (.62%)
Abdominal Pain Upper
61 (.61%)
Loss Of Consciousness
60 (.6%)
Asthenia
59 (.59%)
Diarrhoea
59 (.59%)
Dysuria
55 (.55%)
Rash
55 (.55%)
Vomiting
55 (.55%)
Insomnia
54 (.54%)
Nocturia
52 (.52%)
Hepatic Function Abnormal
51 (.51%)
Hallucination
48 (.48%)
Chest Pain
47 (.47%)
Drug Interaction
47 (.47%)
Pain
47 (.47%)
Death
46 (.46%)
Dementia
44 (.44%)
Blood Pressure Increased
43 (.43%)
Muscle Spasms
43 (.43%)
Muscular Weakness
43 (.43%)
Dehydration
42 (.42%)
Aspartate Aminotransferase Increase...
41 (.41%)
Pain In Extremity
40 (.4%)
Palpitations
40 (.4%)
Alanine Aminotransferase Increased
39 (.39%)
Tremor
39 (.39%)
Dysgeusia
37 (.37%)
Back Pain
36 (.36%)
Micturition Urgency
36 (.36%)
Alopecia
35 (.35%)
Cough
35 (.35%)
Medication Error
35 (.35%)
Bradycardia
34 (.34%)
Electrocardiogram Qt Prolonged
34 (.34%)
Pyrexia
34 (.34%)
Weight Increased
34 (.34%)
Arthralgia
33 (.33%)
Gait Disturbance
33 (.33%)
Decreased Appetite
31 (.31%)
Abdominal Distension
30 (.3%)
Feeling Abnormal
30 (.3%)
Liver Disorder
30 (.3%)
Urinary Tract Infection
30 (.3%)
Urticaria
30 (.3%)
Cardiac Failure
29 (.29%)
Cystitis
29 (.29%)
Disorientation
29 (.29%)
Cerebrovascular Accident
28 (.28%)
Hyperkalaemia
28 (.28%)
Syncope
28 (.28%)
Amnesia
27 (.27%)
Blood Glucose Increased
27 (.27%)
Glaucoma
27 (.27%)
Pneumonia
27 (.27%)
Delirium
26 (.26%)
Dry Throat
26 (.26%)
Balance Disorder
25 (.25%)
Heart Rate Increased
25 (.25%)
Myalgia
25 (.25%)
Convulsion
24 (.24%)
Hypertension
24 (.24%)
Anorexia
23 (.23%)
Chest Discomfort
23 (.23%)
Gastrooesophageal Reflux Disease
23 (.23%)
Inappropriate Schedule Of Drug Admi...
23 (.23%)
Interstitial Lung Disease
23 (.23%)
Weight Decreased
23 (.23%)
Cognitive Disorder
22 (.22%)
Depression
22 (.22%)
Dry Skin
22 (.22%)
Flatulence
22 (.22%)
Hypotension
22 (.22%)
Overdose
22 (.22%)
Renal Failure Acute
22 (.22%)
Rhabdomyolysis
22 (.22%)
Atrial Fibrillation
21 (.21%)
Fluid Retention
21 (.21%)
Gamma-glutamyltransferase Increased
21 (.21%)
Haematuria
21 (.21%)
Memory Impairment
21 (.21%)

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This graph shows the top adverse events submitted to the FDA for Vesicare, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Vesicare is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Vesicare

What are the most common Vesicare adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Vesicare, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Vesicare is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Vesicare According to Those Reporting Adverse Events

Why are people taking Vesicare, according to those reporting adverse events to the FDA?

Hypertonic Bladder
1531
Drug Use For Unknown Indication
768
Urinary Incontinence
374
Pollakiuria
344
Product Used For Unknown Indication
302
Bladder Disorder
229
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Incontinence
207
Micturition Urgency
124
Urge Incontinence
71
Nocturia
56
Benign Prostatic Hyperplasia
52
Urinary Tract Disorder
47
Dysuria
40
Bladder Spasm
37
Neurogenic Bladder
35
Micturition Disorder
23
Stress Urinary Incontinence
20
Cystitis Interstitial
13
Cystitis
10
Bladder Irritation
9
Urinary Tract Infection
8
Prophylaxis
8
Mixed Incontinence
8
Multiple Sclerosis
7
Prostatic Disorder
7
Enuresis
6
Urinary Retention
5
Automatic Bladder
5
Prostatomegaly
5
Adverse Event
5
Bladder Operation
4
Urine Output Decreased
4
Prostate Cancer
4
Stress Incontinence
4
Prostatism
4
Prostatic Operation
3
Colonoscopy
3
Renal Disorder
3
Bladder Dysfunction
3
Prostate Examination Abnormal
3
Bladder Pain
3
Bladder Discomfort
3
Gallbladder Disorder
2
Urinary Tract Obstruction
2
Ovarian Cancer
2
Post Procedural Urine Leak
2
Drug Exposure During Pregnancy
2
Polyuria
2
Sleep Disorder
2
Urine Abnormality
2
Back Disorder
2

Drug Labels

LabelLabelerEffective
VesicarePhysicians Total Care, Inc.06-MAR-12
VesicareCardinal Health05-MAR-13
VesicareAstellas Pharma Technologies, Inc.01-APR-13

Vesicare Case Reports

What Vesicare safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Vesicare. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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