Summary

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

Applies to fesoterodine: oral tablet extended release.

Serious side effects of Fesoterodine

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
• rapid weight gain
• runny or stuffy 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

Other side effects of Fesoterodine

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

Incidence not known

• Dizziness
• itching skin

For Healthcare Professionals

Applies to fesoterodine: oral tablet extended release.

General

-Most frequently reported adverse events with a frequency of 4% or greater in adult patients with overactive bladder (OAB) were dry mouth and constipation.

-Most frequently reported adverse reactions with a frequency of 2% or great in pediatric patients with neurogenic detrusor overactivity (NDO) were diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, increased weight, and headache.^[Ref]

Cardiovascular

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

Postmarketing reports: Palpitations

Frequency not reported: Electrocardiogram QT corrected interval prolongation^[Ref]

Dermatologic

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

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

Gastrointestinal

Very common (10% or more): Dry mouth (34.6%)

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

Uncommon (0.1% to 1%): Abdominal discomfort, flatulence, gastroesophageal reflux

Frequency not reported: Diverticulitis, irritable bowel syndrome^[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]

Hepatic

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

Hypersensitivity

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

Immunologic

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

Ocular

Common (1% to 10%): Dry eye

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

Other

Common (1% to 10%): Increased weight

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

Psychiatric

Common (1% to 10%): Insomnia

Rare (0.01% to 0.1%): Confusional state^[Ref]

Respiratory

Common (1% to 10%): Dry throat, Upper respiratory tract infection

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