Fesoterodine Side Effects

Some side effects of fesoterodine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fesoterodine: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking fesoterodine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fesoterodine and call your doctor at once if you have a serious side effect such as:

• chest pain, fast or uneven heart rate;

• swelling of your hands or feet;

• urinating less than usual or not at all; or

• painful or difficult urination.

Less serious side effects of fesoterodine may include:

• dry mouth, dry eyes;

• blurred vision;

• dizziness, drowsiness;

• constipation;

• stomach pain or upset;

• cough, dry throat;

• back pain; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fesoterodine: oral tablet extended release

Gastrointestinal

Gastrointestinal side effects at daily doses of 4 mg and 8 mg, respectively, have included dry mouth (18.8% vs. 34.6%), constipation (4.2% vs. 6.0%), dyspepsia (1.6% vs. 2.3%), nausea (0.7% vs. 1.9%), and upper abdominal pain (1.1% vs. 0.5%).

Most adverse events of dry mouth and constipation were mild to moderate in intensity.

Immunologic

Immunologic side effects at daily doses of 4 mg and 8 mg, respectively, have included urinary tract infection (3.2% vs. 4.2%) and upper respiratory tract infection (2.5% vs. 1.8%).

Ocular

Ocular side effects at daily doses of 4 mg and 8 mg, respectively, have included dry eyes (1.4% vs. 3.7%).

Genitourinary

Genitourinary side effects at daily doses of 4 mg and 8 mg, respectively, have included dysuria (1.3% vs. 1.6%) and urinary retention (1.1% vs. 1.4%).

Respiratory

Respiratory side effects at daily doses of 4 mg and 8 mg, respectively, have included cough (1.6% vs. 0.9%) and dry throat (0.9% vs. 2.3%).

General

General side effects at daily doses of 4 mg and 8 mg, respectively, have included peripheral edema (0.7% vs. 1.2%).

Musculoskeletal

Musculoskeletal side effects at daily doses of 4 mg and 8 mg, respectively, have included back pain (2.0% vs. 0.9%).

Nervous system

Nervous system side effects at daily doses of 4 mg and 8 mg, respectively, have included insomnia (1.3% vs. 0.4%).

Hepatic

Hepatic side effects at daily doses of 4 mg and 8 mg, respectively, have included increases in alanine aminotransferase (ALT, 0.5% vs. 1.2%) and gamma glutamyltransferase (GGT, 0.4% vs. 1.2%).

Dermatologic

Dermatologic side effects at daily doses of 4 mg and 8 mg, respectively, have included rash (0.7% vs. 1.1%). Postmarketing dermatologic side effects have included pruritus and urticaria.

Cardiovascular

The increase in heart rate correlates with increasing dose. In one study, the mean increase in heart rate associated with a dose of 4 mg/day and 28 mg/day of fesoterodine was 3 beats/minute and 11 beats/minute, respectively, compared to placebo.

Cardiovascular side effects have included increases in heart rate.

Hypersensitivity

Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine. In some cases angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, fesoterodine should be promptly discontinued and appropriate therapy and/or measures to ensure a patent airway should be promptly provided.

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