Enablex Side Effects

Generic Name: darifenacin

Please note - some side effects for Enablex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Enablex - for the Consumer

Enablex Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Enablex Extended-Release Tablets:

Blurred vision; constipation; diarrhea; dizziness; dry eyes; dry mouth; flu-like symptoms; headache; nausea; stomach pain; stomach upset; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Enablex Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; bloody or cloudy urine; chills; confusion; fever; hallucinations; inability to urinate despite an urge to do so; irregular heartbeat; pain below the ribs; pain or burning when you urinate; unusual or severe headache.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Enablex Side Effects - for the Professional

Enablex

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 ≥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	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% 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 (2)]. 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% of patients treated with Enablex and greater than placebo.

Table 2: Number (%) of Adverse Reactions, Derived from All Adverse Events Reported in >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 identified 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 their frequency or establish a causal relationship to drug exposure.

General: hypersensitivity reactions, including angioedema with airway obstruction

Central Nervous: confusion and hallucinations

Cardiovascular: palpitations

Top

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal (GI) side effects have been reported the most frequently. These have included constipation (14.8% to 20.9% or greater), dry mouth (18.7% or greater), dyspepsia (2.7% to 4.5% or greater), and nausea (4.1% or greater). Abdominal pain, vomiting, and diarrhea have been reported in greater than or equal to 2% of patients.

A higher incidence of GI side effects has been reported with higher dosages.

Genitourinary

Genitourinary side effects have included urinary tract infection (3.7% or greater) and vaginitis.

Nervous system

Nervous system side effects have included headache (6.7%) and dizziness (2% or greater).

Ocular

Ocular side effects have included abnormal vision (2% or greater) and dry eyes.

General

General side effects have included flu syndrome (3%), asthenia (2% or greater), arthralgias, peripheral edema, and weight gain.

Dermatologic

Dermatological side effects have included dry skin, rash, and pruritus.

Respiratory

Respiratory side effects have included bronchitis, pharyngitis, rhinitis, and sinusitis.

Cardiovascular

Cardiovascular side effects have included hypertension.

Cardiovascular side effects reported postmarketing have included heart palpitations.

Musculoskeletal

Musculoskeletal side effects have included arthralgias.

Metabolic

Metabolic side effects have included weight gain and swelling (angioedema) of the face, lips, tongue, and/or throat which may result in airway obstruction.
.

Other

Other side effects have included flu syndrome (3%) and accidental injury (3%).

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.