Drug Information



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Brand Name
Sandoz Fesoterodine Fumarate
Common Name
fesoterodine
How does this medication work? What will it do for me?

Fesoterodine belongs to the family of medications called anticholinergics. It is also an antispasmodic. Fesoterodine is used to treat symptoms associated with an overactive bladder, such as urinary urgency (a need to urinate right away), urinary frequency, or urge incontinence (leaking or wetting caused by an unstoppable urge to urinate).

This medication works by preventing contractions or spasms of the muscles in the bladder. This helps to increase bladder capacity and to reduce the involuntary loss of urine, 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. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using 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 usual starting dose of fesoterodine for adults is 4 mg once daily. Your doctor may increase the dose to a maximum of 8 mg once daily. Your doctor may recommend the lower 4 mg once-daily dose if you have certain medical conditions such as severe kidney problems. Fesoterodine may be taken with or without food. Swallow the tablet whole with some liquid. Do not chew, crush, or divide the tablet.

Many things can affect the dose of 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 using 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 moisture, and keep it out of reach of children. 

What form(s) does this medication come in?

4 mg

Each light blue, oval, biconvex, film-coated tablet, debossed with "I11" on one side and plain on the other side, contains 4 mg of fesoterodine fumarate. Nonmedicinal ingredients: fumaric acid, glycerol dibehenate, hypromellose (methocel K4M and K100M premium CR), hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, pullulan, and talc; film coating: lecithin (soya), macrogol/PEG, FD&C blue #2/indicgo carmine aluminum lake, polyvinyl alcohol - partially hydrolyzed, talc, and titanium dioxide.

8 mg

Each blue, oval, biconvex, film-coated tablet, debossed with "I17" on one side and plain on the other side, contains 8 mg of fesoterodine fumarate. Nonmedicinal ingredients: fumaric acid, glycerol dibehenate, hypromellose (methocel K4M and K100M premium CR), hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, pullulan, and talc; film coating: lecithin (soya), macrogol/PEG, FD&C blue #2/indicgo carmine aluminum lake, polyvinyl alcohol - partially hydrolyzed, talc, and titanium dioxide.

Who should NOT take this medication?

Do not use fesoterodine if you:

  • are allergic to fesoterodine or any ingredients of the medication
  • are allergic to tolterodine, soya, peanuts, or lactose
  • have urinary retention (problems emptying your bladder)
  • have gastric retention (stomach obstruction or problems affecting the passage and digestion of food)
  • have uncontrolled narrow-angle glaucoma (an eye condition)
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
  • back pain
  • constipation
  • cough
  • dizziness
  • drowsiness
  • dry eyes
  • dry mouth
  • dry, sore, or numb throat
  • headache
  • hives
  • itching
  • nausea
  • painful urination
  • pounding heartbeat
  • swelling of the arms or legs
  • trouble sleeping
  • upset stomach

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

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

  • blurred vision
  • confusion
  • difficulty emptying your bladder
  • numbness (decreased sense of touch, pain, temperature)
  • rash
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
  • upper respiratory tract infection (e.g., nasal congestion, runny nose, headache, sore throat)

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

  • inability to empty your bladder
  • signs of a serious allergic reaction (swelling of face or throat, hives, or difficulty breathing)
  • swelling of face or tongue or difficulty breathing

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 obstruction: If you have bladder obstruction, 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. You may be at risk of developing urinary retention (problems emptying your bladder). People with urinary retention should not take fesoterodine.

Drowsiness/reduced alertness: Fesoterodine may cause drowsiness or blurred vision. Avoid activities requiring mental alertness, such as driving, operating machinery, or performing hazardous work, until you know how this medication affects you.

Gastrointestinal disorders: If you have obstructive gastrointestinal disorder (blockage or narrowing in the digestive system) or severe constipation, 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. You may be at risk of experiencing gastric retention (stomach obstruction or problems affecting the passage and digestion of food). People with gastric retention should not take fesoterodine.

Glaucoma: If you have glaucoma and are receiving treatment for it, 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. If you experience changes in your vision or eye pain, contact your doctor as soon as possible. People with untreated narrow-angle glaucoma should not take fesoterodine.

Heart conditions: The symptoms of heart disease, heart failure, abnormal heart rhythms or heart rate, and high blood pressure can be aggravated by fesoterodine. If you have any of these conditions, 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.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, 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. Fesoterodine is not recommended for people with severely reduced kidney function.

Lactose: If you have a rare hereditary condition of galactose intolerance or the Lapp lactose deficiency, you should not take this medication. Fesoterodine extended-release tablets contain lactose.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, 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. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. Fesoterodine is not recommended for people with severely reduced liver function.

Myasthenia gravis: If you have myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness), 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.

Soy: If you have a family history of soya intolerance or if you are allergic to soya or peanuts, you should not take this medication. Fesoterodine extended-release tablets contain soya lecithin.

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 fesoterodine passes into breast milk. If you are breast-feeding and taking this medication, 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?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, 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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