Detrol Side Effects

Please note - some side effects for Detrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Detrol - for the Consumer

Detrol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Detrol:

Blurred vision; constipation; dizziness; drowsiness; dry eyes; dry mouth; headache; indigestion; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; confusion; difficult or painful urination; disorientation; fast or irregular heartbeat; hallucinations; memory problems; severe dizziness; swelling of the hands, ankles, or feet.

Detrol LA Extended-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Detrol LA Extended-Release Capsules:

Blurred vision; constipation; dizziness; drowsiness; dry eyes; dry mouth; headache; indigestion; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; confusion, disorientation, or memory problems; difficult or painful urination; fast or irregular heartbeat; hallucinations; severe dizziness; swelling of the hands, ankles, or feet.

Detrol Side Effects - for the Professional

Detrol

The Phase 2 and 3 clinical trial program for Detrol Tablets included 3071 patients who were treated with Detrol (N=2133) or placebo (N=938). The patients were treated with 1, 2, 4, or 8 mg/day for up to 12 months. No differences in the safety profile of tolterodine were identified based on age, gender, race, or metabolism.

The data described below reflect exposure to Detrol 2 mg bid in 986 patients and to placebo in 683 patients exposed for 12 weeks in five Phase 3, controlled clinical studies. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and approximating rates.

Sixty-six percent of patients receiving Detrol 2 mg bid reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving Detrol were dry mouth, headache, constipation, vertigo/dizziness, and abdominal pain. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and xerophthalmia are expected side effects of antimuscarinic agents.

Dry mouth was the most frequently reported adverse event for patients treated with Detrol 2 mg bid in the Phase 3 clinical studies, occurring in 34.8% of patients treated with Detrol and 9.8% of placebo-treated patients. One percent of patients treated with Detrol discontinued treatment due to dry mouth.

The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Seven percent of patients treated with Detrol 2 mg bid discontinued treatment due to adverse events versus 6% of placebo patients. The most common adverse events leading to discontinuation of Detrol were dizziness and headache.

Three percent of patients treated with Detrol 2 mg bid reported a serious adverse event versus 4% of placebo patients. Significant ECG changes in QT and QTc have not been demonstrated in clinical-study patients treated with Detrol 2 mg bid. Table 5 lists the adverse events reported in 1% or more of the patients treated with Detrol 2 mg bid in the 12-week studies. The adverse events are reported regardless of causality.

Post-marketing Surveillance

The following events have been reported in association with tolterodine use in worldwide post-marketing experience: General: anaphylactoid reactions, including angioedema; Cardiovascular: tachycardia, palpitations, peripheral edema; Central/Peripheral Nervous: confusion, disorientation, memory impairment, hallucinations.

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

Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of tolterodine in their causation cannot be reliably determined.

Side Effects by Body System

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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