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 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 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 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, Pain in Extremity, Chest Pain, 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, Chest 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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