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Medications Lexicon

How does this medication work? What will it do for me?

Darifenacin belongs to the family of medications known as antimuscarinics. It is used to relieve symptoms associated with an overactive bladder, such as urinary urgency (a need to urinate right away), urinary frequency, and urge incontinence (leaking or wetting caused by an unstoppable urge to urinate).

The medication works by reducing abnormal bladder contractions. It helps to reduce bladder spasms, the urge to pass urine, and the frequency of urination.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended initial dose of darifenacin is 7.5 mg taken once daily at the same time every day. The dose can be increased to 15 mg daily, 2 weeks after starting treatment if needed.

For people with moderate liver function impairment, or for those taking certain medications (e.g., clarithromycin, ketoconacole, itraconazole, miconazole, nefazodone), doses above 7.5 mg daily are not recommended.

Darifenacin should be taken with liquids and swallowed whole. The tablets should not be chewed, divided, or crushed. This medication may be taken with or without food.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

7.5 mg
Each extended release, white, round, shallow, convex film-coated tablet, debossed with "DF" on one side and "7.5" on the reverse contains darifenacin 7.5 mg as darifenacin hydrobromide. Nonmedicinal ingredients: dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, PEG 400, talc, and titanium dioxide.

15 mg
Each extended release, light peach, round, shallow, convex film-coated tablet, debossed with "DF" on one side and "15" on the reverse contains darifenacin 15 mg as darifenacin hydrobromide. Nonmedicinal ingredients: dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, titanium dioxide, iron oxide yellow, iron oxide red, PEG 400, and talc.

Who should NOT take this medication?

Do not take darifenacin if you:

  • are allergic to darifenacin or to any of the ingredients of the medication
  • have or are at risk for gastric retention (delayed emptying of the stomach)
  • have or are at risk for urinary retention (an inability to empty the bladder)
  • have uncontrolled narrow-angle glaucoma

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • constipation
  • diarrhea
  • dizziness
  • dry eyes
  • dry mouth
  • heartburn
  • nausea
  • unusual weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • increased blood pressure
  • signs of a urinary tract infection (e.g., difficult or painful urination, or blood in the urine)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • swelling of the feet, ankles, or lower leg
  • unusual infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • sudden inability to urinate, bladder pain, or abdominal pain

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bladder outflow obstruction: If you have a medical problem that obstructs the flow of urine from the bladder (e.g., enlarged prostate, prostate cancer), this medication may make you unable to urinate. Talk to your doctor about the risks and benefits of using this medication. People with a history of bladder outflow obstruction should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dizziness/blurred vision: Darifenacin may cause dizziness or blurred vision. Avoid activities such as driving, operating machinery, or performing hazardous work until you know how darifenacin affects you.

Gastrointestinal disorders: Because of the risk of intestinal blockage, your doctor should closely monitor your condition if you have:

  • decreased gastrointestinal movement caused by medical problems (e.g., diabetes), surgery, or medications,
  • a medical problem that obstructs the gastrointestinal tract (e.g., pyloric stenosis), or
  • severe constipation (2 or fewer bowel movements per week)

If you have a history of a gastrointestinal disorder of this sort, you should discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Glaucoma: Darifenacin may make the symptoms of narrow-angle glaucoma worse. If you have narrow-angle glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have moderate liver function impairment, you should not take daily doses greater than 7.5 mg of darifenacin and your condition should be monitored closely by your doctor. Darifenacin is not recommended for people with severe liver function impairment. If you have a history of liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if darifenacin passes into breast milk. If you are a breast-feeding mother and are taking darifenacin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between darifenacin and any of the following:

  • alpha-adrenergic blockers (tamsulosin)
  • amiodarone
  • anticholinergic medications, or those with anticholinergic side effects (e.g., diphenhydramine, oxybutynin, benztropine)
  • anticholinesterase inhibitors (e.g., donepezil, galantamine, rivastigmine)
  • antiretroviral medications (atazanavir,darunavir, delaviridine, lopinavir, ritonavir, saquinavir)
  • aprepitant
  • atomoxetine
  • azole antifungals (e.g., fluconazole, itraconazole, ketoconazole)
  • bosentan
  • calcium channel blockers (e.g., diltiazem, nicardipine, verapamil)
  • carbamazepine
  • chloroquine
  • cimetidine
  • codeine
  • cyclosporine
  • dasatinib
  • dextromethorphan
  • digoxin
  • doxorubicin
  • efavirenz
  • flecainide
  • haloperidol
  • imatinib
  • isoniazid
  • macrolide antibiotics (e.g., clarithromycin, erythromycin, troleandomycin)
  • metronidazole
  • nefazodone
  • norfloxacin
  • phenobarbital
  • phenytoin
  • potassium supplements
  • rifabutin
  • rifampin
  • risperidone
  • quinidine
  • select beta-blockers (e.g., carvedilol, metoprolol, propranolol, timolol)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., fluoxetine, paroxetine, sertraline)
  • St. John's wort
  • tamoxifen
  • thioridazine
  • tramadol
  • tricyclic antidepressants (e.g., amitriptyline, imipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, decongestants, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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