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Enablex (Darifenacin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Enablex (Darifenacin) 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 (30)
Death (1)

Reports by Reaction Type

Drug Ineffective (7)Constipation (4)Fatigue (4)Urinary Tract Infection (4)Cerebrovascular Accident (4)Amnesia (4)Agitation (3)Confusional State (3)Glaucoma (3)Dementia (3)Pain (3)Myalgia (3)

Possible Enablex 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:
Vesicare
    Dosage: unk

Detrol
    Dosage: unk

Enablex
    Dosage: unk

Ditropan
    Dosage: unk



Possible Enablex side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: 72 year old female

Reactions: Neoplasm Malignant, Cystitis, Constipation

Drug(s) suspected as cause:
Enablex
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

[NO Suspect Product]
    Dosage: unk



Possible Enablex side effects in 80 year old female

Reported by a consumer/non-health professional from Brazil on 2012-07-31

Patient: 80 year old female, weighing 84.0 kg (184.8 pounds)

Reactions: Drug Ineffective, Urinary Incontinence, Nocturia, Breast Neoplasm, Headache, Uterine Cancer, Fatigue, Activities of Daily Living Impaired, Dysuria, Pollakiuria, Menorrhagia, Asthenia, Ovarian Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex
    Dosage: 15 mg daily, oral
    Administration route: Oral
    Indication: Urinary Incontinence

Enablex
    Dosage: 15 mg daily, oral

Other drugs received by patient: Bromazepam; Lasix



Possible Enablex side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-25

Patient: female, weighing 84.0 kg (184.8 pounds)

Reactions: Breast Cancer, Drug Ineffective, Abasia, Nocturia, Headache, Micturition Urgency, Menstruation Irregular, Uterine Cancer, Fatigue, Dysuria, Pollakiuria, Asthenia, Ovarian Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex
    Dosage: 1 df per day
    Administration route: Oral

Enablex
    Dosage: 1 df per day
    Administration route: Oral
    Indication: Urinary Incontinence

Other drugs received by patient: Lasix; Bromazepam



Possible Enablex side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female

Reactions: Fatigue

Drug(s) suspected as cause:
Detrol LA
    Dosage: 2 mg, unk
    Start date: 2012-05-19

Enablex
    Dosage: unk



Possible Enablex side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-17

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Urinary Tract Infection, Hypertonic Bladder, Lymphoma

Drug(s) suspected as cause:
Enablex

Other drugs received by patient: Apresolina; Manidipine Hydrochloride; Allopurinol; Amitriptyline Hydrochloride; Sustrate; Amitriptyline Hydrochloride; Coumadin



Possible Enablex side effects in female

Reported by a consumer/non-health professional from Australia on 2012-07-12

Patient: female

Reactions: Scratch, Agitation, Glaucoma, Drug Ineffective, Restlessness, Urinary Tract Infection, Dementia, Delirium, Amnesia, DRY Mouth, Sneezing, Staring, Cough

Drug(s) suspected as cause:
Enablex

Other drugs received by patient: Echinacea; Lumigan; Isoptin



Possible Enablex side effects in 94 year old female

Reported by a consumer/non-health professional from Australia on 2012-07-11

Patient: 94 year old female

Reactions: Agitation, Glaucoma, Pruritus, Eye Colour Change, Restlessness, Drug Ineffective, Dementia, Urinary Tract Infection, Delirium, Amnesia, DRY Mouth, Sneezing, Staring, Cough

Drug(s) suspected as cause:
Enablex

Other drugs received by patient: Lumigan; Echinacea (Echinacea Purpurea); Isoptin



Possible Enablex side effects in 95 year old male

Reported by a consumer/non-health professional from Puerto Rico on 2012-07-03

Patient: 95 year old male

Reactions: Myalgia, Arthralgia, Pain, Gait Disturbance, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex
    Dosage: 15 mg, unk
    Administration route: Oral

Enablex
    Dosage: 7.5 mg, unk
    Administration route: Oral



Possible Enablex side effects in female

Reported by a consumer/non-health professional from Australia on 2012-07-03

Patient: female

Reactions: Scratch, Agitation, Glaucoma, Drug Ineffective, Restlessness, Urinary Tract Infection, Dementia, Amnesia, Delirium, DRY Mouth, Sneezing, Staring, Cough

Drug(s) suspected as cause:
Enablex

Other drugs received by patient: Isoptin; Echinacea; Lumigan



Possible Enablex side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: female, weighing 96.8 kg (213.0 pounds)

Reactions: Hypersensitivity, Vision Blurred, Oropharyngeal Pain, Constipation

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: female

Reactions: Fatigue

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

Detrol LA
    Dosage: 2 mg, unk
    Start date: 2012-05-19



Possible Enablex side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: male, weighing 111.6 kg (245.5 pounds)

Reactions: Dysuria

Drug(s) suspected as cause:
Enablex
    Dosage: 7.5 mg, daily
    Indication: Obstructive Uropathy
    Start date: 2012-04-22

Toviaz
    Dosage: unk, daily
    Indication: Micturition Disorder
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Enablex side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-30

Patient: 52 year old female

Reactions: Palpitations, Atrial Flutter, Bundle Branch Block, Tachycardia, Heart Rate Increased, Condition Aggravated, Atrioventricular Block

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex

Other drugs received by patient: Warfarin Sodium; Chlorvescent (Potassium Chloride); Flecainide Acetate; Zoloft; Protos (Protoporphyrin); Calcium Carbonate



Possible Enablex side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-05-14

Patient: female

Reactions: Hypertonic Bladder, Lymphoma

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-04-20

Patient: female

Reactions: Motor Dysfunction

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: 77 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Migraine, Middle Insomnia, Chest Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: 77 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Migraine, Middle Insomnia, Pain in Extremity, Chest Pain, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in 80 year old female

Reported by a consumer/non-health professional from United States on 2012-04-17

Patient: 80 year old female

Reactions: Confusional State, Diabetes Mellitus, Disorientation, Cerebrovascular Accident, Amnesia, Transient Ischaemic Attack, Asthenia, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-17

Patient: female, weighing 65.8 kg (144.7 pounds)

Reactions: Abdominal Pain Lower, Drug Ineffective, Constipation, Drug Dispensing Error, Abdominal Pain Upper

Drug(s) suspected as cause:
Detrol LA
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Urinary Incontinence
    Start date: 2011-11-21
    End date: 2011-12-01

Toviaz
    Dosage: unk
    Indication: Urinary Incontinence
    Start date: 2012-01-01
    End date: 2012-03-01

Enablex
    Dosage: unk
    Indication: Urinary Incontinence

Vesicare
    Dosage: unk
    Indication: Urinary Incontinence

Detrol
    Dosage: 2 mg, daily
    Administration route: Oral
    Indication: Urinary Incontinence
    Start date: 2012-01-23
    End date: 2012-01-01

Other drugs received by patient: Aspirin; Vitamin TAB; Evista; Levothyroxine; Calcium



Possible Enablex side effects in 95 year old male

Reported by a individual with unspecified qualification from United States on 2012-04-04

Patient: 95 year old male

Reactions: Myalgia, Arthralgia, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in 95 year old male

Reported by a individual with unspecified qualification from United States on 2012-03-23

Patient: 95 year old male

Reactions: Myalgia, Arthralgia, Pain, Gait Disturbance, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in 78 year old male

Reported by a consumer/non-health professional from United States on 2012-03-19

Patient: 78 year old male, weighing 95.3 kg (209.6 pounds)

Reactions: Constipation

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-02-23

Patient: male

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Diovan
    Dosage: 320 mg a day
    Administration route: Oral
    Indication: Hypertension

Enablex
    Dosage: 7.5 mg, daily
    Administration route: Oral
    Indication: Urinary Incontinence



Possible Enablex side effects in 37 year old female

Reported by a consumer/non-health professional from United States on 2012-02-21

Patient: 37 year old female

Reactions: Diarrhoea, Swelling, Breast Atrophy, Paraesthesia

Drug(s) suspected as cause:
Viibryd
    Dosage: 5 mg (5 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Depression
    Start date: 2011-10-01
    End date: 2011-10-05

Enablex
    Indication: Urinary Incontinence
    Start date: 2011-10-01

Other drugs received by patient: Topamax (Topiramate) (200 Milligram, Tablets) (Topiramate); Adderall (Obetrol) (Obetrol)



Possible Enablex side effects in 72 year old male

Reported by a physician from Brazil on 2012-02-16

Patient: 72 year old male

Reactions: Confusional State, Vomiting, Nausea, Quality of Life Decreased, Condition Aggravated, Cognitive Disorder, Tremor, Apathy, Activities of Daily Living Impaired

Drug(s) suspected as cause:
Enablex

Other drugs received by patient: Fludrocortisone Acetate; Rivastigmine Tartrate; Amantadine HCL; Lactulose; Quetiapine Fumarate; Tolcapone (Tolcapone); Domperidone (Domperidone); ALL Other Therapeutic Products; Rasagiline; Entacapone; Clonazepam; Benserazide (Benserazide); Sertraline Hydrochloride; Rasagiline; Rasagiline; Benserazide Hydrochloride W / Levodopa (Benserazide Hydrochloride, Levod



Possible Enablex side effects in 72 year old male

Reported by a physician from Brazil on 2012-02-09

Patient: 72 year old male

Reactions: Confusional State, Apathy, Activities of Daily Living Impaired, Quality of Life Decreased, Cognitive Disorder

Drug(s) suspected as cause:
Enablex
    Dosage: 7.5 mg, unk
    Administration route: Oral

Quetiapine
    Dosage: 50 mg, unk

Other drugs received by patient: Rasagiline; Domperidone; Benserazide Hydrochloride W / Levodopa; Entacapone; Lactulose; Rivastigmine; Amantadine HCL; Tolcapone; Fludrocortisone Acetate; Clonazepam; Rivastigmine; Sertraline Hydrochloride



Possible Enablex side effects in female

Reported by a individual with unspecified qualification from United States on 2012-02-07

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Dysstasia, Dizziness

Drug(s) suspected as cause:
Enablex



Possible Enablex side effects in 79 year old female

Reported by a consumer/non-health professional from Brazil on 2012-01-20

Patient: 79 year old female

Reactions: Drug Interaction, Somnolence, Slow Response To Stimuli, Respiratory Failure, Cardiac Failure, Mood Altered, Depressed Mood, Bradyphrenia, Hypersomnia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Antiepileptics ()

Enablex
    Dosage: 15mg daily, oral
    Administration route: Oral
    Indication: Hypertonic Bladder
    Start date: 2010-11-07
    End date: 2010-12-22

Other drugs received by patient: Bromopride (Bromopride); Mirtazapine



Possible Enablex side effects in male

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

Patient: male, weighing 82.0 kg (180.4 pounds)

Reactions: Retching, Dyspepsia, Tachycardia, Hyperchlorhydria, Depression, Decreased Appetite

Drug(s) suspected as cause:
Enablex

Other drugs received by patient: Tylenol-500; Tamsulosin HCL; Lorax; Etilefrine Hydrochloride; Paroxetine HCL; Tylenol-500; Atacand; Avodart; Omeprazole; Hygroton

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