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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.

In Summary

Common side effects of Enablex 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

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
Incidence not known
  • 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
  • belching
  • difficulty having a bowel movement (stool)
  • dry mouth
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain
Less common 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

Cardiovascular

Postmarketing reports: Palpitations, syncope[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 35%), constipation (up to 21%)
Common (1% to 10%): Abdominal pain, nausea, dyspepsia, diarrhea
Uncommon (0.1% to 1%): Vomiting, flatulence, mouth ulceration, hyperhidrosis
Frequency not reported: Angioedema[Ref]

Dermatologic

Common (1% to 10%): Dry skin, pruritus, rash
Postmarketing reports: Erythema multiforme, interstitial granuloma annulare[Ref]

Respiratory

Common (1% to 10%): Nasal dryness, bronchitis, respiratory tract infection, pharyngitis
Uncommon (0.1% to 1%): Dyspnea, cough, rhinitis[Ref]

General

Most adverse events were mild or moderate and mostly occurred during the first 2 weeks of treatment.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection, urinary retention, urinary tract disorder, bladder pain, erectile dysfunction, vaginitis[Ref]

Metabolic

Uncommon (0.1% to 1%): Weight gain[Ref]

Hepatic

Uncommon (0.1% to 1%): Aspartate aminotransferase increased, alanine aminotransferase increased[Ref]

Hypersensitivity

Postmarketing reports: Generalized hypersensitivity reactions including angioedema[Ref]

Immunologic

Common (1% to 10%): Influenza syndrome[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Arthralgia[Ref]

Nervous system

Very common (10% or more): Headache
Uncommon (0.1% to 1%): Dizziness, dysgeusia, somnolence[Ref]

Ocular

Common (1% to 10%): Dry eye
Uncommon (0.1% to 1%): Visual disturbance, blurred vision[Ref]

Other

Uncommon (0.1% to 1%): Edema, peripheral edema, face edema, asthenia, aspartate aminotransferase increased, alanine aminotransferase increased, accidental injury, pain[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia, abnormal thinking
Postmarketing reports: Depressed mood, altered mood, hallucination[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Darifenacin ER (darifenacin)." Cipla USA Inc., Miami, FL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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