Fesoterodine

Fesoterodine is a prescription medication used to treat symptoms of overactive bladder in adults. Fesoterodine belongs to a group of drugs called antimuscarinics, which help the bladder muscles to relax.

This medication comes in tablet form and is taken once a day, with or without food. It should be taken with liquid and swallowed whole.

Common side effects include dry mouth and constipation. Fesoterodine can cause blurred vision, dizziness, and drowsiness.  Do not drive or operate machinery until you know how it will affect you. 

Fesoterodine is a prescription medicine used in adults to treat symptoms of a condition called overactive bladder, including:

• urinary incontinence -- leaking or wetting accidents due to a strong need to urinate,
• urinary urgency -- having a strong need to urinate right away,
• urinary frequency -- having to urinate too often.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Fesoterodine may be found in some form under the following brand names:

• Toviaz

Fesoterodine may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat or tongue. If you experience these symptoms, you should stop taking fesoterodine and get emergency medical help right away.

The most common side effects of fesoterodine are:

• Dry mouth
• Constipation

Fesoterodine may cause other less common side effects, including:

• Dry eyes
• Trouble emptying the bladder

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

These are not all of the possible side effects of fesoterodine. For a complete list, ask your doctor.

Do not take fesoterodine if you:

• Are not able to empty your bladder (urinary retention).
• Have delayed or slow emptying of your stomach (gastric retention).
• Have an eye problem called "uncontrolled narrow-angle glaucoma".
• Are allergic to fesoterodine or any of its ingredients. 
• Are allergic to Detrol or Detrol LA, which contains tolterodine.
• Do not drive, operate machinery, or do other dangerous activities until you know how fesoterodine affects you. Blurred vision, dizziness, and drowsiness are possible side effects of medicines such as fesoterodine.
• Use caution in hot environments. Decreased sweating and severe heat illness can occur when medicines such as fesoterodine are used in a hot environment.
• Drinking alcohol while taking medicines such as fesoterodine may cause increased drowsiness.

Grapefruit and grapefruit juice may interact with fesoterodine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
 

Before starting fesoterodine, tell your doctor about all of your medical and other conditions that may affect the use of fesoterodine, including:

• Stomach or intestinal problems or problems with constipation
• Problems emptying your bladder or if you have a weak urine stream
• Treatment for an eye problem called narrow-angle glaucoma
• Kidney problems
• Liver problems
• A condition called myasthenia gravis
• If you are pregnant or breastfeeding

Before starting on fesoterodine, tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fesoterodine falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding.

It is not known if fesoterodine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using fesoterodine.

• Take fesoterodine exactly as your doctor tells you to take it.
• Your doctor may give you the lower 4 mg dose of fesoterodine if you have certain medical conditions, such as severe kidney problems.
• Take fesoterodine with liquid and swallow the tablet whole. Do not chew, divide, or crush the tablet.
• You can take fesoterodine with or without food.
• If you miss a dose of fesoterodine, begin taking fesoterodine again the next day. Do not take 2 doses of fesoterodine in the same day.

The recommended starting dose of fesoterodine is 4 mg once daily. The dose may be increased to 8 mg once daily, if necessary.

The daily dose of fesoterodine should not exceed 4 mg in people with severe kidney disease and patients taking potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin.

If you take too much fesoterodine, call your doctor or go to an emergency department right away.

• Store fesoterodine at room temperature, 68° to 77°F (20° to 25°C); brief periods permitted between 59° to 86°F (15° to 30°C)
• Protect the medicine from moisture by keeping the bottle closed tightly.
• Safely throw away fesoterodine that is out of date or no longer needed.

Keep fesoterodine and all medicines out of the reach of children.