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Darifenacin Side Effects

In Summary

Commonly reported side effects of darifenacin include: constipation and xerostomia. Other side effects include: dyspepsia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to darifenacin: oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by darifenacin. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking darifenacin:

Less common:
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain
Incidence not known:
  • Decrease in the frequency of urination
  • decrease in the urine volume
  • difficulty in passing urine
  • dribbling or painful urination

If any of the following symptoms of overdose occur while taking darifenacin, get emergency help immediately:

Symptoms of overdose:
  • Changes in vision

Minor Side Effects

Some of the side effects that can occur with darifenacin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Acid or sour stomach
  • belching
  • difficulty having a bowel movement (stool)
  • dry mouth
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain
Less common:
  • Diarrhea
  • dizziness
  • dry eyes
  • lack or loss of strength
  • nausea
Incidence not known:
  • Accidental injury
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • changes in vision
  • chills
  • congestion
  • cough producing mucus
  • difficulty with breathing
  • difficulty with moving
  • dry skin
  • dryness or soreness of the throat
  • fever
  • general feeling of discomfort or illness
  • headache
  • hoarseness
  • itching of the vagina or genital area
  • itching skin
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • muscle stiffness
  • nervousness
  • pain during sexual intercourse
  • pain or tenderness around the eyes and cheekbones
  • pounding in the ears
  • rash
  • runny nose
  • shortness of breath or troubled breathing
  • slow or fast heartbeat
  • sneezing
  • 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
  • vomiting
  • wheezing

For Healthcare Professionals

Applies to darifenacin: oral tablet extended release


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

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.[Ref]


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

Nervous system

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.[Ref]


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


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


Dermatologic side effects have included dry skin, rash, and pruritus. Dermatologic side effects reported postmarketing have included erythema multiforme and interstitial granuloma annulare.[Ref]


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


Cardiovascular side effects reported postmarketing have included heart palpitations.[Ref]

Cardiovascular side effects have included hypertension.[Ref]


Musculoskeletal side effects have included arthralgias.[Ref]


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%).[Ref]


Hypersensitivity side effects have included postmarketing reports of anaphylactic reaction.[Ref]


1. "Product Information. Enablex (darifenacin)." Novartis Pharmaceuticals, East Hanover, NJ.

Not all side effects for darifenacin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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