Darifenacin

Darifenacin is a prescription medication used to treat the symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage). 

• Darifenacin is available under the following different brand names: Enablex

Adult dosage

Tablet, extended-release

• 7.5mg
• 15mg

Overactive Bladder

Adult dosage

• Initial: 7.5 mg orally once a day
• May be increased to 15 mg based on patient response as early as 2 weeks later

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Darifenacin include:

• nausea,
• indigestion,
• constipation,
• headache,
• dizziness,
• dry mouth, and
• blurred vision

Serious side effects of Darifenacin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe stomach pain,
• constipation,
• confusion,
• hallucination,
• little or no urination,
• pain or burning while urinating,
• increased thirst,
• feeling hot,
• inability to urinate,
• heavy sweating, and
• hot or dry skin

Rare side effects of Darifenacin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Darifenacin has severe interactions with the following drugs:
  • Eliglustat
• Darifenacin has serious interactions with at least 45 other drugs.
• Darifenacin has moderate interactions with at least 248 other drugs.
• Darifenacin has minor interactions with at least 77 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity 
• Urinary retention
• Uncontrolled narrow-angle glaucoma
• Severe hepatic impairment
• Paralytic ileus
• GI or Gu obstruction

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Darifenacin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Darifenacin?”

Cautions

• Bladder outflow obstruction, controlled narrow-angle glaucoma, decreased GI motility, renal/hepatic impairment
• Angioedema of the face, lips, tongue, and/or larynx have been reported, in some cases, angioedema occurred after the first dose
• CNS anticholinergic effects were reported including headache, confusion, hallucinations, and somnolence
• Heat prostration may occur in the presence of increased environmental temperature
• Use caution in patients with decreased GI motility, hiatal hernia, reflux esophagitis, and ulcerative colitis
• Use caution in patients with controlled narrow-angle glaucoma and patients with hepatic impairment, or myasthenia gravis

Pregnancy & Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of drugs in human milk, effects on the breastfed infant, or milk production
  • The drug is present in rat milk; when a drug is present in animal milk, the drug will likely be present in human milk
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for darifenacin and any potential adverse effects on the breastfed child from darifenacin or the underlying maternal conditions