Toviaz Side Effects

Please note - some side effects for Toviaz 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 Toviaz - for the Consumer

Toviaz

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 Toviaz:

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.

Toviaz Side Effects - for the Professional

Toviaz

The safety of Toviaz was evaluated in Phase 2 and 3 controlled trials in a total of 2859 patients with overactive bladder of which 2288 were treated with fesoterodine. Of this total, 782 received Toviaz 4 mg/day, and 785 received Toviaz 8 mg/day in Phase 2 or 3 studies with treatment periods of 8 or 12 weeks. Approximately 80% of these patients had >10 weeks exposure to Toviaz in these trials.

A total of 1964 patients participated in two 12-week, Phase 3 efficacy and safety studies and subsequent open-label extension studies. In these 2 studies combined, 554 patients received Toviaz 4 mg/day and 566 patients received Toviaz 8 mg/day.

In Phase 2 and 3 placebo-controlled trials combined, the incidences of serious adverse events in patients receiving placebo, Toviaz 4 mg, and Toviaz 8 mg were 1.9%, 3.5%, and 2.9%, respectively. All serious adverse events were judged to be not related or unlikely to be related to study medication by the investigator, except for four patients receiving Toviaz who reported one serious adverse event each: angina, chest pain, gastroenteritis, and QT prolongation on ECG.

The most commonly reported adverse event in patients treated with Toviaz was dry mouth. The incidence of dry mouth was higher in those taking 8 mg/day (35%) and in those taking 4 mg/day (19%), as compared to placebo (7%). Dry mouth led to discontinuation in 0.4%, 0.4%, and 0.8% of patients receiving placebo, Toviaz 4 mg, and Toviaz 8 mg, respectively. For those patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

The second most commonly reported adverse event was constipation. The incidence of constipation was 2% in those taking placebo, 4% in those taking 4 mg/day, and 6% in those taking 8 mg.

Table 3 lists adverse events, regardless of causality, that were reported in the combined Phase 3, randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with Toviaz 4 or 8 mg once daily for up to 12 weeks.

Patients also received Toviaz for up to three years in open-label extension phases of one Phase 2 and two Phase 3 controlled trials. In all open label trials combined, 857, 701, 529, and 105 patients received Toviaz for at least 6 months, 1 year, 2 years, and 3 years respectively. The adverse events observed during long-term, open-label studies were similar to those observed in the 12-week, placebo-controlled studies, and included dry mouth, constipation, dry eyes, dyspepsia and abdominal pain. Similar to the controlled studies, most adverse events of dry mouth and constipation were mild to moderate in intensity. Serious adverse events, judged to be at least possibly related to study medication by the investigator, and reported more than once during the open-label treatment period of up to 3 years included urinary retention (3 cases), diverticulitis (3 cases), constipation (2 cases), irritable bowel syndrome (2 cases), and electrocardiogram QT corrected interval prolongation (2 cases).

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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