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
Along with its needed effects, fesoterodine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fesoterodine:More common
- Difficulty having a bowel movement (stool)
- dry mouth
- 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
- 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
- frequent urge to urinate
- loss of voice
- lower back or side pain
- nasal congestion
- rapid weight gain
- runny nose
- sore throat
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Some side effects of fesoterodine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
- Acid or sour stomach
- back pain
- dry throat
- stomach discomfort, upset, or pain
- trouble sleeping
- unable to sleep
- upper abdominal pain
For Healthcare Professionals
Applies to fesoterodine: oral tablet extended release
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 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 side effects at daily doses of 4 mg and 8 mg, respectively, have included dry eyes (1.4% vs. 3.7%).
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 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 side effects at daily doses of 4 mg and 8 mg, respectively, have included peripheral edema (0.7% vs. 1.2%).
Musculoskeletal side effects at daily doses of 4 mg and 8 mg, respectively, have included back pain (2.0% vs. 0.9%).
Nervous system side effects at daily doses of 4 mg and 8 mg, respectively, have included insomnia (1.3% vs. 0.4%).
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 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.
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.
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.
More about fesoterodine
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