Tolterodine Side Effects

Some side effects of tolterodine 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 tolterodine: oral capsule extended release, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tolterodine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tolterodine and call your doctor at once if you have any of these serious side effects:

• chest pain, fast or uneven heart rate;

• confusion, hallucinations;

• urinating less than usual or not at all; or

• painful or difficult urination.

Less serious side effects of tolterodine may include:

• dry mouth, dry eyes;

• blurred vision;

• dizziness, drowsiness;

• constipation or diarrhea;

• stomach pain or upset;

• joint pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tolterodine: oral capsule extended release, oral tablet

General

General side effects reported during postmarketing experience have included hallucinations. Most of the side effects of tolterodine are extensions of its pharmacologic activity and are anticholinergic in nature. In clinical trials, 8% of patients discontinued treatment due to adverse events. Among the most common complaints leading to discontinuation was headache, which occurred in 11% of patients.

Gastrointestinal

Gastrointestinal side effects reported the most frequently have included dry mouth (19.7% to 39.5%). Dyspepsia, constipation, abdominal pain, and flatulence have been reported in 1% to 10% of patients. Diarrhea (1.8%), nausea (1.2%), and gastroesophageal reflux (1%) have been reported. Decreased motility and GI hemorrhage have been reported during postmarketing experience.

Most reports of dry mouth were mild to moderate in intensity. Severe dry mouth was reported during therapy with tolterodine by 1% to 5% of patients in several large, placebo controlled studies.

Ocular

Ocular side effects have included abnormal or blurred vision (4.7%) and xerophthalmia (3.8%).

Nervous system

Reports of aggravation of symptoms of dementia (e.g., confusion, disorientation, and delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.

A 73-year-old female presented with a two-year history of decreased short-term memory and vivid hallucinations of deceased relatives that occurred only during nighttime sleep; she awoke regularly to converse with these relatives. The symptoms began several weeks after taking tolterodine (2 mg twice daily) for urinary incontinence. These hallucinations did not distress the patient and resolved after three months of donepezil treatment. Her memory impairment improved after tolterodine was discontinued for several months. It recurred after tolterodine therapy was restarted.

Nervous system side effects including headache, vertigo or dizziness, and fatigue have been reported in 1% to 10% of patients. Somnolence (0.4% to 10%), asthenia (3.6%), insomnia (0.4% to 1.6%), nervousness (1%), confusion (less than 1%), and hallucinations (less than 1%) have been reported. Syncope, convulsions, disorientation, memory impairment, and aggravation of symptoms of dementia (e.g., confusion, disorientation, and delusion) have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects including dysuria (1% to 10%), urinary tract infection (0.4% to 9%), urinary retention (less than 1% to 1.7%), and impaired urination (0.4%) have been reported.

Cardiovascular

Cardiovascular side effects have infrequently included hypertension or minor increases in heart rate. Peripheral edema has been reported in 1% of patients. Tachycardia, peripheral edema, chest pain, ventricular arrhythmia, atrial fibrillation, cardiac failure, palpitations, bradycardia, collapse, and transient ischemic attacks have been reported during postmarking experience.

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported in less than 1% of patients. Anaphylactoid reactions have been reported during postmarketing experience.

Hepatic

Hepatic side effects have rarely included acute mixed liver injury. Hepatic dysfunction has also been reported during postmarketing experience.

Dermatologic

Dermatologic side effects including flushed skin have been reported in less than 1% of patients.

Respiratory

Respiratory side effects including bronchitis and sinusitis have been reported in 1% to 10% of patients. Cough (4% to 7%), rhinitis (4% to 7%), sore throat (4% to 7%), respiratory infection (4% to 6%), and influenza (0.4% to 1%) have been reported.

Metabolic

Metabolic side effects including weight gain have been reported in 1% to 10% of patients.

Psychiatric

Psychiatric side effects including depression have been reported during postmarketing experience.

Renal

Renal side effects including renal dysfunction have been reported during postmarketing experience.

Other

Other side effects including pyrexia have been reported in 4% of patients.

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