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Enablex

"April 9, 2012 -- Drugs that treat incontinence caused by an overactive bladder offer modest benefits to some women, and they often come with significant side effects, a new review of research shows.

The government-funded review compar"...

Enablex

Enablex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Enablex (darifenacin) is used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage). It is a urinary antispasmodic. Common side effects include dry mouth, constipation, nausea, stomach upset, stomach pain, blurred vision, dry eyes, dizziness, or weakness.

The recommended starting dose of Enablex is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily. Other bladder or urinary medications, glycopyrrolate, flecainide, mepenzolate, thioridazine, HIV /AIDS medicines, antibiotics, antifungal medications, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bronchodilators, irritable bowel medications, or antidepressants. Tell your doctor all medications you are taking. Enablex should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding. Our Enablex (darifenacin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Enablex in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using darifenacin and call your doctor at once if you have any of these serious side effects:

  • hot, dry skin and extreme thirst;
  • severe stomach pain or constipation;
  • confusion, hallucinations;
  • pain or burning when you urinate;
  • urinating less than usual or not at all;
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • dry mouth;
  • dry eyes, blurred vision;
  • mild constipation;
  • diarrhea;
  • nausea, mild stomach pain or upset;
  • dizziness, weakness, drowsiness;
  • headache; or
  • fever, sore throat, body aches, or other flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Enablex (Darifenacin Extended-Release Tablets) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Enablex Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth, constipation, nausea, stomach upset, stomach pain, blurred vision, dry eyes, dizziness, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, constipation for 3 or more days, difficulty urinating, signs of kidney infection (such as burning/painful/frequent urination, fever, pink/bloody urine), mental/mood changes (such as confusion, hallucinations).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Enablex (Darifenacin Extended-Release Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Enablex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Enablex was evaluated in controlled clinical trials in a total of 8,830 patients, 6,001 of whom were treated with Enablex. Of this total, 1,069 patients participated in three, 12-week, randomized, placebo-controlled, fixed-dose efficacy and safety studies (Studies 1, 2 and 3). Of this total, 337 and 334 patients received Enablex 7.5 mg daily and 15 mg daily, respectively. In all long-term trials combined, 1,216 and 672 patients received treatment with Enablex for at least 24 and 52 weeks, respectively.

In Studies 1, 2 and 3 combined, the serious adverse reactions to Enablex were urinary retention and constipation.

In Studies 1, 2 and 3 combined, dry mouth leading to study discontinuation occurred in 0 percent, 0.9 percent, and 0 percent of patients treated with Enablex 7.5 mg daily, Enablex 15 mg daily and placebo, respectively. Constipation leading to study discontinuation occurred in 0.6 percent, 1.2 percent, and 0.3 percent of patients treated with Enablex 7.5 mg daily, Enablex 15 mg daily and placebo, respectively.

Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events in 2 percent or more of patients treated with 7.5 mg or 15 mg Enablex, and greater than placebo in Studies 1, 2 and 3. In these studies, the most frequently reported adverse reactions were dry mouth and constipation. The majority of the adverse reactions were mild or moderate in severity and most occurred during the first two weeks of treatment.

Table 1: Incidence of Identified Adverse Reactions, Derived from All Adverse Events Reported in ≥ 2 Percent of Patients Treated with Enablex Extended-Release Tablets and More Frequent with Enablex than with Placebo in Studies 1, 2, and 3

Body System Adverse Reaction Percentage of Subjects
Enablex 7.5 mg
N = 337
Enablex 15 mg
N = 334
Placebo
N = 388
Digestive Dry Mouth 20.2 35.3 8.2
Constipation 14.8 21.3 6.2
Dyspepsia 2.7 8.4 2.6
Abdominal Pain 2.4 3.9 0.5
Nausea 2.7 1.5 1.5
Diarrhea 2.1 0.9 1.8
Urogenital Urinary Tract Infection 4.7 4.5 2.6
Nervous Dizziness 0.9 2.1 1.3
Body as a Whole Asthenia 1.5 2.7 1.3
Eye Dry Eyes 1.5 2.1 0.5

Other adverse reactions reported by 1 percent to 2 percent of Enablex-treated patients include: abnormal vision, accidental injury, back pain, dry skin, flu syndrome, hypertension, vomiting, peripheral edema, weight gain, arthralgia, bronchitis, pharyngitis, rhinitis, sinusitis, rash, pruritus, urinary tract disorder and vaginitis.

Study 4 was a randomized, 12-week, placebo-controlled, dose-titration regimen study in which Enablex was administered in accordance with dosing recommendations [see DOSAGE AND ADMINISTRATION]. All patients initially received placebo or Enablex 7.5 mg daily, and after two weeks, patients and physicians were allowed to adjust upward to Enablex 15 mg if needed. In this study, the most commonly reported adverse reactions were also constipation and dry mouth. Table 2 lists the identified adverse reactions, derived from all adverse events reported in > 3 percent of patients treated with Enablex and greater than placebo.

Table 2: Number (Percent) of Adverse Reactions, Derived from All Adverse Events Reported in > 3 Percent of Patients Treated with Enablex Extended-Release Tablets, and More Frequent with Enablex than Placebo, in Study 4

Adverse Reaction Enablex 7.5 mg/15 mg
N = 268
Placebo
N = 127
Constipation 56 (20.9 percent) 10 (7.9 percent)
Dry Mouth 50 (18.7 percent) 11 (8.7 percent)
Headache 18 (6.7 percent) 7 (5.5 percent)
Dyspepsia 12 (4.5 percent) 2 (1.6 percent)
Nausea 11 (4.1 percent) 2 (1.6 percent)
Urinary Tract Infection 10 (3.7 percent) 4 (3.1 percent)
Accidental Injury 8 (3.0 percent) 3 (2.4 percent)
Flu Syndrome 8 (3.0 percent) 3 (2.4 percent)

Post Marketing Experience

The following adverse reactions have been reported during post approval use of Enablex extended-release tablets (darifenacin). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency or establish a causal relationship to drug exposure.

Dermatologic: erythema multiforme, interstitial granuloma annulare

General: hypersensitivity reactions, including angioedema with airway obstruction and anaphylactic reaction

Central Nervous: confusion, hallucinations and somnolence

Cardiovascular: palpitations and syncope

Read the entire FDA prescribing information for Enablex (Darifenacin Extended-Release Tablets) »

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Enablex - User Reviews

Enablex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Enablex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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.


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