Enablex Side Effects
Generic name: darifenacin
Note: This document contains side effect information about darifenacin. Some of the dosage forms listed on this page may not apply to the brand name Enablex.
Some side effects of Enablex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to darifenacin: oral tablet extended release
Along with its needed effects, darifenacin (the active ingredient contained in Enablex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking darifenacin:Less common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- Decrease in the frequency of urination
- decrease in the urine volume
- difficulty in passing urine
- dribbling or painful urination
Get emergency help immediately if any of the following symptoms of overdose occur while taking darifenacin:Symptoms of overdose
- Changes in vision
Some side effects of darifenacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Acid or sour stomach
- difficulty having a bowel movement (stool)
- dry mouth
- stomach discomfort, upset, or pain
- dry eyes
- lack or loss of strength
- Accidental injury
- bloating or swelling of the face, arms, hands, lower legs, or feet
- changes in vision
- cough producing mucus
- difficulty with breathing
- difficulty with moving
- dry skin
- dryness or soreness of the throat
- general feeling of discomfort or illness
- itching of the vagina or genital area
- itching skin
- joint pain
- loss of appetite
- muscle aches and pains
- muscle stiffness
- pain during sexual intercourse
- pain or tenderness around the eyes and cheekbones
- pounding in the ears
- runny nose
- shortness of breath or troubled breathing
- slow or fast heartbeat
- stuffy nose
- tender, swollen glands in the neck
- thick, white vaginal discharge with no odor or with a mild odor
- tightness in the chest
- tingling of the hands or feet
- trouble with swallowing
- unusual weight gain or loss
- voice changes
For Healthcare Professionals
Applies to darifenacin: oral tablet extended release
A higher incidence of GI side effects has been reported with higher dosages.
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.
Genitourinary side effects have included urinary tract infection (3.7% or greater) and vaginitis.
Nervous system side effects have included headache (6.7%) and dizziness (2% or greater). A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose.
Ocular side effects have included abnormal vision (2% or greater) and dry eyes.
General side effects have included flu syndrome (3%), asthenia (2% or greater), arthralgias, peripheral edema, and weight gain.
Dermatologic side effects have included dry skin, rash, and pruritus. Dermatologic side effects reported postmarketing have included erythema multiforme and interstitial granuloma annulare.
Respiratory side effects have included bronchitis, pharyngitis, rhinitis, and sinusitis.
Cardiovascular side effects reported postmarketing have included heart palpitations.
Cardiovascular side effects have included hypertension.
Musculoskeletal side effects have included arthralgias.
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 side effects have included flu syndrome (3%) and accidental injury (3%).
Hypersensitivity side effects have included postmarketing reports of anaphylactic reaction.
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