Toviaz Side Effects

Generic Name: fesoterodine

Note: This page contains side effects data for the generic drug fesoterodine. It is possible that some of the dosage forms included below may not apply to the brand name Toviaz.

It is possible that some side effects of Toviaz may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to fesoterodine: oral tablet extended release

As well as its needed effects, fesoterodine (the active ingredient contained in Toviaz) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking fesoterodine, check with your doctor immediately:

More common
  • Difficulty having a bowel movement (stool)
  • dry mouth
Less common
  • Bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • body aches or pain
  • burning while urinating
  • chills
  • cough
  • decrease in frequency of urination
  • decrease in urine volume
  • difficult, burning, or painful urination
  • difficulty in breathing
  • difficulty in passing urine (dribbling)
  • dry eyes
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • rapid weight gain
  • runny nose
  • sneezing
  • sore throat
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss

Some fesoterodine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Acid or sour stomach
  • back pain
  • belching
  • dry throat
  • heartburn
  • indigestion
  • nausea
  • rash
  • sleeplessness
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • unable to sleep
  • upper abdominal pain

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 (the active ingredient contained in Toviaz) 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 (the active ingredient contained in Toviaz) 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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