Fesoterodine Side Effects

In Summary

Commonly reported side effects of fesoterodine include: xerostomia. Other side effects include: constipation. See below for a comprehensive list of adverse effects.

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
• 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 feeling while urinating
• chills
• cough
• decrease in frequency of urination
• decrease in urine volume
• difficult 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

Incidence Not Known

• Blurred vision
• fast, irregular, pounding, or racing heartbeat or pulse

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

• Back pain
• belching
• dry throat
• heartburn
• indigestion
• nausea
• rash
• stomach discomfort, upset, or pain
• trouble sleeping
• upper abdominal pain

Incidence Not Known

• Dizziness
• itching skin

For Healthcare Professionals

Applies to fesoterodine: oral tablet extended release

Gastrointestinal

Very common (10% or more): Dry mouth

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, constipation, nausea, upper abdominal pain

Uncommon (0.1% to 1%): Abdominal discomfort, flatulence, gastroesophageal reflux^[Ref]

Immunologic

Common (1% to 10%): Infections^[Ref]

Ocular

Common (1% to 10%): Dry eye

Uncommon (0.1% to 1%): Blurred vision^[Ref]

Genitourinary

Common (1% to 10%): Dysuria

Uncommon (0.1% to 1%): Urinary tract infection, urinary retention (e.g., feeling of residual urine, micturition disorder), urinary hesitation^[Ref]

Respiratory

Common (1% to 10%): Dry throat

Uncommon (0.1% to 1%): Pharyngolaryngeal pain, cough, nasal dryness^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Dysgeusia, somnolence^[Ref]

Hepatic

Uncommon (0.1% to 1%): Alanine aminotransferase (ALT) increased, gamma glutamyltransferase (GGT) increased^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, dry skin, pruritus

Rare (less than 0.1%): Angioedema, urticaria^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, palpitations

Postmarketing reports: Palpitations^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (e.g., angioedema with airway obstruction, face edema)^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Peripheral edema^[Ref]

Other

Uncommon (0.1% to 1%): Vertigo, fatigue^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer