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Enablex Side Effects

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Common Enablex Side Effects


The most commonly reported Enablex side effects (click to view or check a box to report):

Dry Mouth (260)
Constipation (194)
Pollakiuria (101)
Dizziness (65)
Vision Blurred (52)
Pruritus (42)
Dyspepsia (40)
Headache (40)
Abdominal Pain (36)
Urinary Incontinence (33)
Fatigue (33)
Rash (33)
Nausea (28)
Somnolence (28)
Oedema Peripheral (25)
Abdominal Pain Upper (24)
Diarrhoea (22)
Dry Eye (21)
Urinary Retention (21)
Insomnia (21)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Enablex Side Effects Reported to FDA



Enablex Side Effect Report#9995326
Pruritus, Dry Mouth, Dry Eye, Visual Acuity Reduced, Headache, Nausea, Fatigue, Dizziness, Nervousness
This is a report of a 81-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypertonic bladder,urinary incontinence, who was treated with Enablex (dosage: By Mouth; 1 Pill, start time:
Jan 22, 2014), combined with: NA. and developed a serious reaction and side effect(s): Pruritus, Dry Mouth, Dry Eye, Visual Acuity Reduced, Headache, Nausea, Fatigue, Dizziness, Nervousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enablex treatment in female patients, resulting in Pruritus side effect.
Enablex Side Effect Report#9677509
Bladder Prolapse, Vaginal Prolapse, Cystocele, Rectocele, Enterocele, Vulvovaginal Pain, Nocturia, Cystitis, Burning Sensation
This report suggests a potential Enablex Bladder Prolapse side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from PR was diagnosed with the following symptoms/conditions: pollakiuria and used Enablex (dosage: 15 Mg, Daily) starting
Aug 14, 2013. After starting Enablex the patient began experiencing various side effects, including: Bladder Prolapse, Vaginal Prolapse, Cystocele, Rectocele, Enterocele, Vulvovaginal Pain, Nocturia, Cystitis, Burning SensationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Enablex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bladder Prolapse, may still occur.
Enablex Side Effect Report#9641993
Bladder Prolapse, Cystitis, Burning Sensation, Nocturia, Vaginal Prolapse, Cystocele, Rectocele, Enterocele, Escherichia Test Positive
This Bladder Prolapse problem was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201308 this consumer started treatment with Enablex (dosage: NA). The following drugs were being taken at the same time: NA. When using Enablex, the patient experienced the following unwanted symptoms/side effects: Bladder Prolapse, Cystitis, Burning Sensation, Nocturia, Vaginal Prolapse, Cystocele, Rectocele, Enterocele, Escherichia Test PositiveAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Prolapse, may become evident only after a product is in use by the general population.
Enablex Side Effect Report#9625506
Asthma, Oesophagitis
This Asthma side effect was reported by a consumer or non-health professional from BR. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertonic bladder,chondropathy,carotid artery occlusion,asthma.The patient was prescribed Enablex (drug dosage: 1 Df, Qd), which was initiated on 201309. Concurrently used drugs:
  • Chondroitin, Glucosamine (Unk Ukn, Unk)
  • Simvastatin (1 Df, A Day)
  • Duovent (2 Df, Prn (when She Had Episodes))
  • Oximax (1 Df, A Day)
  • Foraseq (2 Df, 2 Capsules Of Each Treatment A Day)
  • Citalopram (1 Df, A Day)
  • Alprazolam (1 Df, A Day)
  • Alprazolam
.After starting to take Enablex the consumer reported adverse symptoms, such as: Asthma, OesophagitisThese side effects may potentially be related to Enablex.
Enablex Side Effect Report#9381463
Pneumonia
This is a report of a 84-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: urinary incontinence,osteoporosis, who was treated with Enablex (dosage: 7.5 Mg, Daily, start time: NS), combined with:
  • Caltrate +d (1 Df, Qd)
  • Complex B /00653501/ (1 Df, Qd)
  • Venlift (1 Df, Qd)
  • Lorax /bra/ (1 Df, Qd)
  • Tryptanol /bra/ (1 Df, Qd)
  • Bonviva (1 Df Monthly, Unk)
and developed a serious reaction and side effect(s): Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enablex treatment in female patients, resulting in Pneumonia side effect. The patient was hospitalized.
Enablex Side Effect Report#9357913
Diarrhoea
This report suggests a potential Enablex Diarrhoea side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: urinary incontinence and used Enablex (dosage: NA) starting
May 22, 2013. After starting Enablex the patient began experiencing various side effects, including: DiarrhoeaAdditional drugs used concurrently: NA. Although Enablex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Enablex Side Effect Report#9235768
Unresponsive To Stimuli, Balance Disorder, Dizziness, Dysstasia, Gait Disturbance
This Unresponsive To Stimuli problem was reported by a consumer or non-health professional from US. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: bladder spasm. On
Apr 03, 2013 this consumer started treatment with Enablex (dosage: One Dose One Time Po). The following drugs were being taken at the same time: NA. When using Enablex, the patient experienced the following unwanted symptoms/side effects: Unresponsive To Stimuli, Balance Disorder, Dizziness, Dysstasia, Gait DisturbanceThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Unresponsive To Stimuli, may become evident only after a product is in use by the general population.
Enablex Side Effect Report#9223610
Breast Cancer, Hypertonic Bladder, Irritable Bowel Syndrome, Diarrhoea, Hypoperfusion, Bacterial Infection, Urinary Tract Infection
This Breast Cancer side effect was reported by a consumer or non-health professional from Country Not Specified. A female patient (weight:NA) experienced the following symptoms/conditions: urinary tract infection,hypertension.The patient was prescribed Enablex (drug dosage: 1 Df, Qd), which was initiated on 2009. Concurrently used drugs:
  • Losartan (2 Df, Unk)
  • Hydrochlorothiazide (1 Df, Daily)
  • Allopurinol (1 Df, Daily)
  • Janumet (1 Df, Daily)
.After starting to take Enablex the consumer reported adverse symptoms, such as: Breast Cancer, Hypertonic Bladder, Irritable Bowel Syndrome, Diarrhoea, Hypoperfusion, Bacterial Infection, Urinary Tract InfectionThese side effects may potentially be related to Enablex.
Enablex Side Effect Report#9156421
Muscle Spasms
This is a report of a 64-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: NA, who was treated with Enablex (dosage: NA, start time: NS), combined with:
  • Amantadine
  • Gabapentin (gabapentin)
and developed a serious reaction and side effect(s): Muscle Spasms after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enablex treatment in female patients, resulting in Muscle Spasms side effect.
Enablex Side Effect Report#9153478
Bladder Disorder, Bladder Dilatation, Blood Pressure Increased, Body Temperature Increased, Feeling Cold, Heart Rate Increased, Tremor, Feeling Abnormal, Constipation
This report suggests a potential Enablex Bladder Disorder side effect(s) that can have serious consequences. A 57-year-old patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: NA and used Enablex (dosage: NA) starting NS. After starting Enablex the patient began experiencing various side effects, including: Bladder Disorder, Bladder Dilatation, Blood Pressure Increased, Body Temperature Increased, Feeling Cold, Heart Rate Increased, Tremor, Feeling Abnormal, ConstipationAdditional drugs used concurrently: NA. Although Enablex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bladder Disorder, may still occur.
Enablex Side Effect Report#9053648
Respiratory Failure, Fall, Head Injury
This Respiratory Failure problem was reported by a consumer or non-health professional from Country Not Specified. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: urinary retention. On NS this consumer started treatment with Enablex (dosage: 1 Df, Daily (15 Mg, Daily)). The following drugs were being taken at the same time:
  • Atenolol
  • Monocordil
  • Isosorbide
  • Prolopa
  • Artrodar
When using Enablex, the patient experienced the following unwanted symptoms/side effects: Respiratory Failure, Fall, Head InjuryThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Respiratory Failure, may become evident only after a product is in use by the general population.
Enablex Side Effect Report#9026139
Nausea, Concussion, Headache, Radius Fracture, Abscess, Vertigo, Fall
This Nausea side effect was reported by a health professional from DE. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Enablex (drug dosage: NA), which was initiated on 201504. Concurrently used drugs:
  • Metformin
  • Capecitabine ((2000-0-2500))
  • Ibandronic Acid (Once In Four Weeks)
  • Voltaren /00372301/
  • Arlevert (cinnarizine, Dimenhydrinate)
  • Arimidex (anastrozole)
  • Ibuprofen (ibuprofen)
  • Lasix /00032601/ (furosemide)
.After starting to take Enablex the consumer reported adverse symptoms, such as: Nausea, Concussion, Headache, Radius Fracture, Abscess, Vertigo, FallThese side effects may potentially be related to Enablex. The patient was hospitalized and became disabled.
Enablex Side Effect Report#8921762
Scratch, Hypersensitivity, Pruritus
This is a report of a 93-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: bladder disorder,osteoarthritis, who was treated with Enablex (dosage: Daily, start time:
Nov 04, 2012), combined with:
  • Vimovo (375 Mg/20 Mg)
and developed a serious reaction and side effect(s): Scratch, Hypersensitivity, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enablex treatment in female patients, resulting in Scratch side effect.
Enablex Side Effect Report#8896579
Dyspnoea
This report suggests a potential Enablex Dyspnoea side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Enablex (dosage: NA) starting
Sep 17, 2012. After starting Enablex the patient began experiencing various side effects, including: DyspnoeaAdditional drugs used concurrently: NA. Although Enablex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Enablex Side Effect Report#8730586
Ovarian Cancer, Uterine Cancer, Breast Neoplasm, Nocturia, Asthenia, Pollakiuria, Menorrhagia, Dysuria
This Ovarian Cancer problem was reported by a consumer or non-health professional from BR. A 80-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: urinary incontinence. On NS this consumer started treatment with Enablex (dosage: 15 Mg Daily, Oral). The following drugs were being taken at the same time:
  • Lasix
  • Bromazepam
When using Enablex, the patient experienced the following unwanted symptoms/side effects: Ovarian Cancer, Uterine Cancer, Breast Neoplasm, Nocturia, Asthenia, Pollakiuria, Menorrhagia, DysuriaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ovarian Cancer, may become evident only after a product is in use by the general population.
Enablex Side Effect Report#8681526
Ovarian Cancer, Uterine Cancer, Menstruation Irregular, Breast Neoplasm, Abasia, Fatigue, Micturition Urgency, Nocturia, Dysuria
This Ovarian Cancer side effect was reported by a consumer or non-health professional from Country Not Specified. A female patient (weight:NA) experienced the following symptoms/conditions: urinary incontinence.The patient was prescribed Enablex (drug dosage: 1 Df Per Day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Enablex the consumer reported adverse symptoms, such as: Ovarian Cancer, Uterine Cancer, Menstruation Irregular, Breast Neoplasm, Abasia, Fatigue, Micturition Urgency, Nocturia, DysuriaThese side effects may potentially be related to Enablex. The patient was hospitalized.
Enablex Side Effect Report#8560704-6
Hypertonic Bladder, Urinary Retention
This is a report of a 51-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: hypertonic bladder, who was treated with Enablex (dosage: 15 Mg, start time: NS), combined with:
  • Finasteride
and developed a serious reaction and side effect(s): Hypertonic Bladder, Urinary Retention after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enablex treatment in male patients, resulting in Hypertonic Bladder side effect.
Enablex Side Effect Report#8560692-2
Hallucination
This report suggests a potential Enablex Hallucination side effect(s) that can have serious consequences. A 90-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: hypertonic bladder and used Enablex (dosage: 7.5 Mg, Qd, Oral) starting
Mar 27, 2009. After starting Enablex the patient began experiencing various side effects, including: HallucinationAdditional drugs used concurrently:
  • Lupron
  • Prosed Ec (atropine Sulfate, Benzoic Acid, Hyoscyamine Sulfate, Methen
  • Flomax
Although Enablex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hallucination, may still occur.
Enablex Side Effect Report#8560665-X
Hallucination, Visual, Insomnia
This Hallucination, Visual problem was reported by a consumer or non-health professional from United States. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2009 this consumer started treatment with Enablex (dosage: NA). The following drugs were being taken at the same time:
  • Benadryl ^ache^ (ammonium Chloride, Diphenhydramine Hydrochloride, Men
  • Percocet
When using Enablex, the patient experienced the following unwanted symptoms/side effects: Hallucination, Visual, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hallucination, Visual, may become evident only after a product is in use by the general population.
Enablex Side Effect Report#8556797-2
Confusional State
This Confusional State side effect was reported by a physician from United States. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Enablex (drug dosage: Oral), which was initiated on NS. Concurrently used drugs: NA..After starting to take Enablex the consumer reported adverse symptoms, such as: Confusional StateThese side effects may potentially be related to Enablex.
Enablex Side Effect Report#8556674-7
Confusional State
This is a report of a 85-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Enablex (dosage: Oral, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Confusional State after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enablex treatment in female patients, resulting in Confusional State side effect.
Enablex Side Effect Report#8556670-X
Visual Impairment, Dry Eye
This report suggests a potential Enablex Visual Impairment side effect(s) that can have serious consequences. A 80-year-old patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: hypertonic bladder,incontinence and used Enablex (dosage: 7.5 Mg, Qd, Oral) starting NS. After starting Enablex the patient began experiencing various side effects, including: Visual Impairment, Dry EyeAdditional drugs used concurrently: NA. Although Enablex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Visual Impairment, may still occur.
Enablex Side Effect Report#8556667-X
Treatment Noncompliance, Confusional State
This Treatment Noncompliance problem was reported by a health professional from United States. A 90-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: micturition urgency. On NS this consumer started treatment with Enablex (dosage: 15 Mg, Qd, Oral; No Treatment). The following drugs were being taken at the same time: NA. When using Enablex, the patient experienced the following unwanted symptoms/side effects: Treatment Noncompliance, Confusional StateAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Treatment Noncompliance, may become evident only after a product is in use by the general population.
Enablex Side Effect Report#8499110-1
Myalgia, Fatigue, Arthralgia, Ocular Hyperaemia, Iritis, Headache, Pyrexia, Nausea, Eye Disorder
This Myalgia side effect was reported by a physician from United States. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Enablex (drug dosage: NA), which was initiated on
Feb 12, 2010. Concurrently used drugs:
  • Hydrochlorothiazide
  • Flomax
  • Androgel
  • Aricept
  • Warfarin Sodium
  • Reclast (Intravenous)
  • Lexapro
  • Vitamin D
.After starting to take Enablex the consumer reported adverse symptoms, such as: Myalgia, Fatigue, Arthralgia, Ocular Hyperaemia, Iritis, Headache, Pyrexia, Nausea, Eye DisorderThese side effects may potentially be related to Enablex.
Enablex Side Effect Report#8477376-1
Speech Disorder, Repetitive Speech, Confusional State, Cerebral Haemorrhage, Convulsion
This is a report of a 66-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Enablex /01760401/ (darifenacin) (dosage: NA, start time:
Apr 01, 2010), combined with:
  • Flomax /00889901/ (morniflumate)
  • Proscar
  • Potassium Chloride
  • Copaxone
  • Baclofen
  • Ditropan
  • Ampyra (10 Mg, Bid, Oral)
and developed a serious reaction and side effect(s): Speech Disorder, Repetitive Speech, Confusional State, Cerebral Haemorrhage, Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enablex /01760401/ (darifenacin) treatment in male patients, resulting in Speech Disorder side effect. The patient was hospitalized.


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The appearance of Enablex on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Enablex Side Effects for Women?

Women Side EffectsReports
Dry Mouth 171
Constipation 121
Pollakiuria 63
Vision Blurred 44
Dizziness 43
Pruritus 35
Abdominal Pain 33
Headache 32
Rash 32
Dyspepsia 29

What are common Enablex Side Effects for Men?

Men Side EffectsReports
Dry Mouth 88
Constipation 69
Pollakiuria 37
Dizziness 22
Urinary Retention 11
Dyspepsia 10
Somnolence 10
Fatigue 9
Urinary Incontinence 9
Abdominal Pain Upper 8

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Enablex reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Enablex Side Effects

    Did You Have a Enablex Side Effect?

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    Yes, Moderate
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    How Effective is Enablex for You?

    Exceeded Expectations
    Effective
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    Enablex Safety Alerts, Active Ingredients, Usage Information

    NDC0430-0170
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameEnablex
    Namedarifenacin
    Dosage FormTABLET, EXTENDED RELEASE
    RouteORAL
    On market since20041222
    LabelerWarner Chilcott (US), LLC
    Active Ingredient(s)DARIFENACIN HYDROBROMIDE
    Strength(s)7.5
    Unit(s)mg/1
    Pharma ClassCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

    Enablex Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1067

    Enablex safety alerts: No

    Reported deaths: 10

    Reported hospitalizations: 78

    Latest Enablex clinical trials