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Toviaz (Fesoterodine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Toviaz (Fesoterodine) 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 (915)
Death (10)
Life Threatening Events (12)
Disability (3)

Reports by Reaction Type

Drug Ineffective (164)DRY Mouth (145)Constipation (107)Pollakiuria (65)Urinary Retention (58)Dizziness (50)Urinary Incontinence (44)Vision Blurred (44)Dysuria (33)Malaise (29)Rash (28)Abdominal Pain Upper (26)

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

Possible Toviaz side effects in 83 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 83 year old male, weighing 69.8 kg (153.7 pounds)

Reactions: Abdominal Discomfort, Hypertension

Drug(s) suspected as cause:
Toviaz

Other drugs received by patient: Lanoxin; Metoprolol; Bicalutamide; Diovan; Prilosec; Aspirin; Zolpidem; Fluoxetine; Lovastatin



Possible Toviaz side effects in 79 year old male

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

Patient: 79 year old male, weighing 59.0 kg (129.7 pounds)

Reactions: Weight Decreased, Renal Disorder, Diabetes Mellitus, Incorrect Dose Administered, Pollakiuria, Gastric Disorder

Drug(s) suspected as cause:
Toviaz
    Dosage: 8 mg, 2x/day
    Administration route: Oral
    Start date: 2012-01-01

Toviaz
    Dosage: 8 mg, 1x/day
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-01-01

Toviaz
    Dosage: 4 mg, 1x/day
    Administration route: Oral
    Indication: Renal Disorder
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Toviaz side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in male

Reported by a consumer/non-health professional from Belgium on 2012-08-27

Patient: male

Reactions: Fatigue, Somnolence

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Feeling Abnormal

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in 40 year old male

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

Patient: 40 year old male, weighing 104.0 kg (228.8 pounds)

Reactions: Drug Ineffective, Urinary Incontinence, DRY Mouth

Drug(s) suspected as cause:
Toviaz

Other drugs received by patient: Klonopin; Baclofen; Elavil



Possible Toviaz side effects in 91 year old female

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

Patient: 91 year old female, weighing 43.1 kg (94.8 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Toviaz

Other drugs received by patient: Amlodipine Besilate; Alendronate Sodium



Possible Toviaz side effects in 47 year old male

Reported by a physician from United States on 2012-08-24

Patient: 47 year old male

Reactions: Back Pain, Rhinitis Allergic, Arthralgia, Urinary Incontinence, Irritable Bowel Syndrome, Depression

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg, 3x/day
    Administration route: Oral

Toviaz
    Dosage: 8 mg, (q day)
    Administration route: Oral

Other drugs received by patient: Oxycontin; Motrin; Flexeril; Zoloft; Proventil; Ventolin; Wellbutrin XL; Dalmane; Soma; Zantac; Imodium; Oxycodone HCL; Miralax



Possible Toviaz side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Drug Ineffective, Feeling Abnormal, Stress Urinary Incontinence

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in female

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

Patient: female

Reactions: Pollakiuria

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Vision Blurred

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in 83 year old male

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

Patient: 83 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Drug Ineffective, Dysuria, DRY Mouth, Urinary Retention

Drug(s) suspected as cause:
Toviaz

Other drugs received by patient: Amiodarone; Metoprolol; Norvasc; Lisinopril



Possible Toviaz side effects in 71 year old female

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

Patient: 71 year old female, weighing 107.5 kg (236.5 pounds)

Reactions: Head Injury, Urinary Tract Infection, Fall, Malaise, Concussion, Oedema Peripheral, Dehydration, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lipitor
    Dosage: 40 mg (1/2 tablet) at bedtime
    Administration route: Oral

Lyrica
    Dosage: 150 mg, 2x/day
    Indication: Diabetic Neuropathy

Premarin
    Dosage: unk

Toviaz
    Indication: Bladder Disorder

Toviaz
    Dosage: 4 mg, daily at bedtime
    Indication: Renal Disorder

Other drugs received by patient: Tylenol; Vitamin B6; Vitamin D; Atenolol; Propylene Glycol; Fluoxetine; Glimepiride; Omeprazole; Ascorbic Acid; Calcium; Celebrex; Lysine; Fish OIL; Vision Formula; Fexofenadine; Levothroid; Diovan; Super Vitamin B Complex



Possible Toviaz side effects in female

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

Patient: female

Reactions: Feeling Abnormal

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in female

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

Patient: female

Reactions: Pollakiuria

Drug(s) suspected as cause:
Toviaz
    Dosage: unk
    Indication: Hypertonic Bladder
    Start date: 2011-01-01

Toviaz
    Indication: Incontinence



Possible Toviaz side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: female, weighing 82.6 kg (181.6 pounds)

Reactions: Urinary Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Toviaz
    Dosage: 4mg by mouth, once daily
    Indication: Nocturia
    Start date: 2011-09-26
    End date: 2011-10-21

Toviaz
    Dosage: 4mg by mouth, once daily
    Indication: Hypertonic Bladder
    Start date: 2011-09-26
    End date: 2011-10-21



Possible Toviaz side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Oral Discomfort, Dysphagia, DRY Mouth, Dysuria

Drug(s) suspected as cause:
Toviaz
    Dosage: 4 mg, unk

Toviaz
    Dosage: 8 mg, unk



Possible Toviaz side effects in 75 year old male

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

Patient: 75 year old male

Reactions: Dysuria, Urinary Retention

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in 75 year old female

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

Patient: 75 year old female, weighing 90.7 kg (199.5 pounds)

Reactions: DRY Mouth, Somnolence, Hyperhidrosis

Drug(s) suspected as cause:
Toviaz

Other drugs received by patient: Lipitor; Prednisone



Possible Toviaz side effects in 75 year old male

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

Patient: 75 year old male

Reactions: Memory Impairment, Micturition Urgency

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in 68 year old female

Reported by a physician from United States on 2012-08-20

Patient: 68 year old female, weighing 127.0 kg (279.4 pounds)

Reactions: Arthropathy

Drug(s) suspected as cause:
Toviaz

Other drugs received by patient: Lorazepam; Lyrica; Bactrim



Possible Toviaz side effects in 80 year old male

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

Patient: 80 year old male, weighing 89.8 kg (197.6 pounds)

Reactions: Eye Discharge, Metamorphopsia, Platelet Count Decreased, Vision Blurred, Ocular Discomfort, DRY Eye

Drug(s) suspected as cause:
Toviaz

Other drugs received by patient: Primidone; Avastin; Metoprolol; Avastin



Possible Toviaz side effects in male

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

Patient: male

Reactions: Hypersensitivity, Headache, Oropharyngeal Pain, Pyrexia, Rash, Gastric Disorder, Accidental Overdose, Abdominal Distension, Dermatitis Bullous, Bladder Disorder

Drug(s) suspected as cause:
Toviaz
    Dosage: 4 mg, 1x/day

Toviaz
    Dosage: 4 mg, 2x/day



Possible Toviaz side effects in male

Reported by a consumer/non-health professional from Germany on 2012-08-17

Patient: male

Reactions: Hypersensitivity, Oropharyngeal Pain, Headache, Pyrexia, Rash, Gastric Disorder, Accidental Overdose, Dermatitis Bullous, Abdominal Distension, Bladder Disorder

Drug(s) suspected as cause:
Toviaz
    Dosage: 4 mg, 1x/day

Toviaz
    Dosage: 4 mg, 2x/day



Possible Toviaz side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Pollakiuria, Micturition Urgency

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in male

Reported by a consumer/non-health professional from Belgium on 2012-08-17

Patient: male

Reactions: Fatigue, Somnolence

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in 45 year old

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 45 year old

Reactions: Drug Ineffective, Urinary Incontinence

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in 61 year old female

Reported by a pharmacist from United States on 2012-08-17

Patient: 61 year old female

Reactions: Oral Mucosal Blistering, Hypersensitivity

Drug(s) suspected as cause:
Toviaz

Other drugs received by patient: Orphine; Vitamin D; Omeprazole



Possible Toviaz side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-17

Patient: male

Reactions: Dizziness, Gait Disturbance, Somnolence

Drug(s) suspected as cause:
Toviaz



Possible Toviaz side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 74 year old female, weighing 60.3 kg (132.7 pounds)

Reactions: Bladder Spasm, Drug Dose Omission, Bladder Prolapse, Drug Ineffective, Vulvovaginal Dryness, Pollakiuria, Expired Drug Administered, Vulvovaginal Pain

Drug(s) suspected as cause:
Oxybutynin
    Dosage: unk
    Indication: Urge Incontinence

Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Vulvovaginal Dryness

Premarin
    Dosage: 0.625 mg, 2x/day
    Indication: Vulvovaginal Dryness
    Start date: 2012-06-08

Premarin
    Indication: Vulvovaginal Discomfort

Toviaz
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Urge Incontinence
    Start date: 2012-06-08

Vagifem
    Dosage: unk

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