Fesoterodine Side Effects

Brand Names: Toviaz

Please note - some side effects for Fesoterodine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fesoterodine - for the Consumer

Fesoterodine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fesoterodine:

Blurred vision; constipation; dizziness; drowsiness; dry eyes; dry mouth; indigestion; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; confusion; difficult or painful urination; disorientation; fast or irregular heartbeat; hallucinations; memory problems; severe dizziness; severe or persistent constipation or diarrhea; severe stomach cramps or pain; swelling of the hands, ankles, or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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%).

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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