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Darifenacin Hydrobromide

Darifenacin hydrobromide Prescription
Generic Name: darifenacin (dar e FEN a sin)
Brand Name: Enablex
Physician reviewed darifenacin patient information - includes darifenacin description, dosage and directions.
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Darifenacin Hydrobromide Drug Information:

Darifenacin reduces muscle spasms of the bladder and urinary tract. Darifenacin is used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage). Darifenacin may also be used for purposes not listed in this medication guide. You should not take darifenacin if you are have untreated or uncontrolled narrow-angle glaucoma, a stomach disorder causing delayed emptying, or if you have trouble emptying your bladder. You should not take darifenacin if you are allergic to it, or if you have: Learn more

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Darifenacin Hydrobromide 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

Side effects requiring immediate medical attention

Along with its needed effects, darifenacin 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

Side effects not requiring immediate medical attention

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

  • 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

Cardiovascular

Postmarketing reports: Palpitations, syncope

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

Dermatologic

Common (1% to 10%): Dry skin, pruritus, rash

Postmarketing reports: Erythema multiforme, interstitial granuloma annulare

Respiratory

Common (1% to 10%): Nasal dryness, bronchitis, respiratory tract infection, pharyngitis

Uncommon (0.1% to 1%): Dyspnea, cough, rhinitis

General

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

Genitourinary

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

Metabolic

Uncommon (0.1% to 1%): Weight gain

Hepatic

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

Hypersensitivity

Postmarketing reports: Generalized hypersensitivity reactions including angioedema

Immunologic

Common (1% to 10%): Influenza syndrome

Musculoskeletal

Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Arthralgia

Nervous system

Very common (10% or more): Headache

Uncommon (0.1% to 1%): Dizziness, dysgeusia, somnolence

Ocular

Common (1% to 10%): Dry eye

Uncommon (0.1% to 1%): Visual disturbance, blurred vision

Other

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

Psychiatric

Uncommon (0.1% to 1%): Insomnia, abnormal thinking

Postmarketing reports: Depressed mood, altered mood, hallucination

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Darifenacin Hydrobromide (www.drugs.com/mtm/darifenacin.html).