Tolterodine Side Effects
It is possible that some side effects of tolterodine 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 tolterodine: oral capsule extended release, oral tablet
As well as its needed effects, tolterodine may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking tolterodine, check with your doctor immediately:More common
- Abnormal vision, including difficulty with adjusting to distances
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- Chest pain
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- pain or tenderness around the eyes and cheekbones
- shortness of breath or troubled breathing
- sore throat
- stuffy or runny nose
- tightness of the chest or wheezing
- trouble with sleeping
- Being forgetful
- bloating or swelling of the face, arms, hands, ankles, lower legs, or feet
- confusion about identity, place, and time
- difficulty with swallowing
- fast, pounding, or irregular heartbeat or pulse
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- mood or mental changes
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- seeing, hearing, or feeling things that are not there
- skin rash
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Some tolterodine 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:More common
- Abdominal or stomach pain
- dry eyes
- dry mouth
- upset stomach
- Acid or sour stomach
- blurred vision
- difficulty with moving
- dizziness or lightheadedness
- dry skin
- fear or nervousness
- feeling of constant movement of self or surroundings
- sensation of spinning
- sleepiness or unusual drowsiness
- stomach discomfort
- weight gain
For Healthcare Professionals
Applies to tolterodine: oral capsule extended release, oral tablet
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 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 side effects have included abnormal or blurred vision (4.7%) and xerophthalmia (3.8%).
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 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 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 side effects including allergic reactions have been reported in less than 1% of patients. Anaphylactoid reactions have been reported during postmarketing experience.
Hepatic side effects have rarely included acute mixed liver injury. Hepatic dysfunction has also been reported during postmarketing experience.
Dermatologic side effects including flushed skin have been reported in less than 1% of patients.
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 side effects including weight gain have been reported in 1% to 10% of patients.
Psychiatric side effects including depression have been reported during postmarketing experience.
Renal side effects including renal dysfunction have been reported during postmarketing experience.
Other side effects including pyrexia have been reported in 4% of patients.
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