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Enablex (Darifenacin Extended-Release Tablets) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Enablex Side Effects Center

What Is Enablex?

Enablex (darifenacin) is a urinary antispasmodic used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage).

What Are Side Effects of Enablex?

Common side effects of Enablex include:

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

Tell your doctor if you have serious side effects of Enablex including:

Dosage for Enablex

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.

What Drugs, Substances, or Supplements Interact with Enablex?

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 During Pregnancy or Breastfeeding

Enablex should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Enablex (darifenacin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Enablex Consumer Information

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:

  • severe stomach pain or constipation;
  • confusion, hallucinations;
  • little or no urinating;
  • pain or burning when you urinate; or
  • signs of dehydration--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects may include:

  • nausea, indigestion;
  • constipation;
  • headache, dizziness;
  • dry mouth; or
  • blurred vision.

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)

 

Enablex Professional Information

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%, 0.9%, and 0% 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%, 1.2%, and 0.3% 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% 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 greater than or equal to 2% 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 % 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% to 2% 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 greater than 3% of patients treated with Enablex and greater than placebo.

Table 2: Number (%) of Adverse Reactions, Derived from All Adverse Events Reported in greater than 3% 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%) 10 (7.9%)
Dry Mouth 50 (18.7%) 11 (8.7%)
Headache 18 (6.7%) 7 (5.5%)
Dyspepsia 12 (4.5%) 2 (1.6%)
Nausea 11 (4.1%) 2 (1.6%)
Urinary Tract Infection 10 (3.7%) 4 (3.1%)
Accidental Injury 8 (3.0%) 3 (2.4%)
Flu Syndrome 8 (3.0%) 3 (2.4%)

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)

&Copy; Enablex Patient Information is supplied by Cerner Multum, Inc. and Enablex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.