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Vesicare (Solifenacin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vesicare (Solifenacin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (507)
Death (49)
Life Threatening Events (18)
Disability (17)

Reports by Reaction Type

DRY Mouth (42)Drug Ineffective (37)Vision Blurred (33)Fall (32)Constipation (28)Death (28)Confusional State (23)Urinary Retention (20)Drug Interaction (17)Off Label Use (16)Fatigue (15)Dizziness (15)

Below are a few examples of reports where side effects / adverse reactions may be related to Vesicare (Solifenacin). For a complete list or a specific selection of reports, please use the links above.

Possible Vesicare side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 84.4 kg (185.6 pounds)

Reactions: Back Pain, Breast Cancer, Myalgia, Arthralgia, Haematuria, Urinary Tract Infection, Pyuria, Ovarian Failure, Cystitis Interstitial

Drug(s) suspected as cause:
Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial

Sildenafil Citrate
    Dosage: 1 tablet approximately 1 hour before sexual activity
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Vesicare
    Dosage: for every night
    Administration route: Oral
    Indication: Cystitis Interstitial

Other drugs received by patient: AN Unknown Medication



Possible Vesicare side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Off Label Use, Proteinuria, Diabetic Nephropathy, Renal Cyst

Drug(s) suspected as cause:
Vesicare
    Indication: Lower Urinary Tract Symptoms

Vesicare
    Dosage: 5 mg, uid/qd
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2009-12-01

Vesicare
    Indication: Micturition Urgency

Vesicare
    Indication: Urge Incontinence

Vesicare
    Indication: Urinary Tract Obstruction

Vesicare
    Indication: Pollakiuria

Other drugs received by patient: Vitamin D; Aspirin; Pravastatin; Metformin HCL; Lortab; Bupropion HCL



Possible Vesicare side effects in 80 year old female

Reported by a physician from Japan on 2012-08-27

Patient: 80 year old female

Reactions: Colonic Polyp

Drug(s) suspected as cause:
Celebrex
    Dosage: unk
    Administration route: Oral

Vesicare
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Ganaton; Sigmart; Omeprazole; Famotidine



Possible Vesicare side effects in female

Reported by a pharmacist from Japan on 2012-08-24

Patient: female

Reactions: Ileus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
BUP-4
    Dosage: unk

Chantix
    Dosage: 1 mg, 2x/day
    Administration route: Oral

Vesicare
    Dosage: unk



Possible Vesicare side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Pain, Aphasia, Abasia, Fall, Loss of Consciousness, Rash Pruritic, Myalgia, Eye Disorder, Muscle Spasms, Blood Glucose Increased, Amnesia, Epigastric Discomfort, Arthralgia, Gait Disturbance, DRY Eye, Arthritis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Estrace
    Dosage: unk
    Administration route: Topical
    Indication: Hypertonic Bladder
    Start date: 2008-01-01

Unspecified Diabetic Medications
    Dosage: unk
    Indication: Diabetes Mellitus

Vesicare
    Dosage: unk
    Administration route: Oral
    Indication: Hypertonic Bladder
    Start date: 2008-08-04



Possible Vesicare side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-24

Patient:

Reactions: Electrocardiogram QT Prolonged, Ventricular Tachycardia

Drug(s) suspected as cause:
Famotidine
    Administration route: Oral

Vesicare
    Administration route: Oral

Other drugs received by patient: Pletal



Possible Vesicare side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Surgery

Drug(s) suspected as cause:
Vesicare



Possible Vesicare side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 85 year old female

Reactions: Musculoskeletal Pain

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Vesicare



Possible Vesicare side effects in female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-08-23

Patient: female

Reactions: Urinary Tract Infection, Sepsis, Urinary Retention, Micturition Urgency, Kidney Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vesicare

Other drugs received by patient: Keppra



Possible Vesicare side effects in 80 year old female

Reported by a physician from Japan on 2012-08-23

Patient: 80 year old female

Reactions: Colonic Polyp

Drug(s) suspected as cause:
Celebrex
    Administration route: Oral

Vesicare
    Administration route: Oral

Other drugs received by patient: Omeprazole; Ganaton; Sigmart; Famotidine



Possible Vesicare side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Choking Sensation, Drug Ineffective, Somnolence, Throat Tightness, Eating Disorder, Off Label Use, Abdominal Discomfort, Vision Blurred, Decreased Appetite

Drug(s) suspected as cause:
Vesicare

Other drugs received by patient: Metformin; Aspirin; Metoprolol Tartrate; Synthroid; Simvastatin; Glimepiride



Possible Vesicare side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female, weighing 63.0 kg (138.6 pounds)

Reactions: Fall, Blood Sodium Decreased, Cataract Operation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vesicare

Other drugs received by patient: Synthroid; Calcium / 00060701 /; Fish OIL



Possible Vesicare side effects in female

Reported by a pharmacist from Japan on 2012-08-22

Patient: female

Reactions: Electrocardiogram QT Prolonged, Ventricular Tachycardia

Drug(s) suspected as cause:
Famotidine
    Administration route: Oral

Vesicare
    Administration route: Oral

Other drugs received by patient: Pletal



Possible Vesicare side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: Diarrhoea, Eosinophilia

Drug(s) suspected as cause:
Vesicare



Possible Vesicare side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesicare



Possible Vesicare side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female, weighing 77.0 kg (169.4 pounds)

Reactions: Dyspnoea, Constipation, Mental Impairment, Dysarthria, Dyspepsia, Balance Disorder, DRY Mouth, Vision Blurred, Dizziness

Drug(s) suspected as cause:
Detrol LA
    Dosage: unk
    Indication: Incontinence

Vesicare
    Dosage: 1 df, uid/qd
    Administration route: Oral
    Indication: Hypertonic Bladder
    Start date: 2012-03-01

Vesicare
    Indication: Incontinence

Other drugs received by patient: ONE A DAY / 02262701 /; Ibuprofen (Advil); Calcium + VIT D; Synthroid; Ibuprofen (Advil)



Possible Vesicare side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 55 year old female, weighing 85.7 kg (188.5 pounds)

Reactions: Drug Ineffective, Insomnia

Drug(s) suspected as cause:
Detrol LA
    Dosage: 4 mg, 1x/day
    Administration route: Oral
    Indication: Urinary Incontinence
    End date: 2012-08-01

Vesicare
    Dosage: unk
    Indication: Urinary Incontinence

Other drugs received by patient: Lyrica



Possible Vesicare side effects in 75 year old female

Reported by a pharmacist from Japan on 2012-08-17

Patient: 75 year old female

Reactions: Memory Impairment, Blood Pressure Decreased

Drug(s) suspected as cause:
Vesicare

Other drugs received by patient: Ebrantil / 00631801 /; Antihypertensives



Possible Vesicare side effects in

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient:

Reactions: Pain, Chest Pain

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Vesicare

Other drugs received by patient: Citalopram; Bumetanide; Synthroid; Mirapex; Clonazepam; Clonazepam



Possible Vesicare side effects in 26 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 26 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Impaired Driving Ability, Vision Blurred, Dizziness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Vesicare



Possible Vesicare side effects in male

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-08-16

Patient: male, weighing 130.0 kg (286.0 pounds)

Reactions: Metamorphopsia, DRY Mouth

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vesicare

Other drugs received by patient: Carvetrend; Allopurinol; Isosorbide Mononitrate; Glucovance; Iruzid / 01613901 /; Fursemid / 00032601 /; Kalinor / 00031402 /



Possible Vesicare side effects in

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient:

Reactions: Disease Progression

Drug(s) suspected as cause:
Vesicare



Possible Vesicare side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 64 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Renal Disorder, Micturition Urgency

Drug(s) suspected as cause:
Toviaz
    Dosage: 4 mg, daily
    Indication: Pollakiuria
    Start date: 2012-08-01

Toviaz
    Indication: Micturition Urgency

Vesicare
    Dosage: unk, (on and off )
    Indication: Pollakiuria

Vesicare
    Indication: Micturition Urgency

Other drugs received by patient: Lisinopril; Amlodipine Besilate



Possible Vesicare side effects in 82 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 82 year old male, weighing 58.0 kg (127.7 pounds)

Reactions: Memory Impairment

Drug(s) suspected as cause:
Chantix
    Dosage: 0.5 mg, 1x/day
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2012-06-01
    End date: 2012-01-01

Chantix
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-01

Vesicare
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Prostatic Disorder

Other drugs received by patient: Prednisone



Possible Vesicare side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-15

Patient: female

Reactions: Visual Acuity Reduced

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vesicare



Possible Vesicare side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Detrol
    Dosage: unk

Ditropan
    Dosage: unk

Enablex
    Dosage: unk

Vesicare
    Dosage: unk



Possible Vesicare side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 77 year old female, weighing 74.8 kg (164.6 pounds)

Reactions: Therapeutic Response Unexpected, Pain, Suicidal Ideation, Weight Increased, Fatigue, Balance Disorder, Oedema Peripheral, Disturbance in Attention, Musculoskeletal Stiffness, Vision Blurred

Drug(s) suspected as cause:
Lyrica
    Dosage: 25 mg, 2x/day
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2012-06-01

Lyrica
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-01

Vesicare
    Dosage: unk
    Indication: Bladder Disorder
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Vesicare side effects in male

Reported by a physician from United Kingdom on 2012-08-10

Patient: male, weighing 92.0 kg (202.4 pounds)

Reactions: Urinary Tract Obstruction, Syncope, DRY Mouth, Urinary Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vesicare

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

Vesicare
    Indication: Urge Incontinence

Vesicare
    Dosage: 5 mg, uid/qd
    Administration route: Oral
    Start date: 2012-03-16
    End date: 2012-04-27

Other drugs received by patient: Dutasteride; Amlodipine; Escitalopram



Possible Vesicare side effects in 70 year old female

Reported by a physician from United States on 2012-08-10

Patient: 70 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Allegra
    Dosage: 60 mg, unk

Amaryl
    Dosage: 4 mg, 2x/day
    Start date: 2002-08-03

Avandia
    Dosage: 4 mg, 2x/day
    Start date: 2002-10-08

Celebrex
    Dosage: unk

Daypro
    Dosage: unk

Hydromorphone Hydrochloride
    Dosage: unk

Lipitor
    Dosage: 20 mg, unk
    Start date: 2003-05-27

Metformin HCL
    Dosage: 500 mg, 2x/day
    Start date: 2008-07-24

Mobic
    Dosage: 7.5 mg, unk
    Start date: 2012-06-18

Moxifloxacin
    Dosage: unk

Oxycodone Hydrochloride
    Dosage: unk

Pataday
    Dosage: unk, daily
    Start date: 2010-11-02

Phenergan
    Dosage: unk

Pred-G
    Dosage: unk

Promethazine HCL
    Dosage: 12.5 mg, unk
    Administration route: Oral
    Indication: Nausea

Propylene Glycol
    Dosage: unk

Vesicare
    Dosage: unk

Vicodin



Possible Vesicare side effects in 32 year old male

Reported by a physician from Japan on 2012-08-10

Patient: 32 year old male

Reactions: Drug Ineffective, Muscle Spasticity, Hypertonic Bladder

Drug(s) suspected as cause:
Myrbetriq
    Dosage: 50 mg, uid/qd
    Administration route: Oral
    Indication: Hypertonic Bladder

Vesicare
    Dosage: unk
    Administration route: Oral
    Indication: Hypertonic Bladder

Other drugs received by patient: Uritos

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