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Detrol

Last reviewed on RxList: 1/9/2017
Detrol Side Effects Center

Last reviewed on RxList 01/05/2017

Detrol (tolterodine tartarate) Tablets prescribed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Side effects of Detrol include:

Tell your doctor if you have serious side effects of Detrol including:

Detrol is available in 1 and 2 mg strength tablets. The initial recommended dose of Detrol Tablets is 2 mg twice daily. Detrol may interact with arsenic trioxide, chloroquine, halofantrine, cyclosporine, droperidol, narcotics, pentamidine, vinblastine, antibiotics, medicines to treat psychiatric disorders, or heart rhythm medicines. Tell your doctor all medications and supplements you use. There are no studies of Detrol in pregnant women; therefore, Detrol should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus. It is unknown if Detrol passes into breast milk. Women who are thinking about breastfeeding or are breastfeeding should not breastfeed while taking Detrol, or discontinue taking the medication. Efficacy or safety of Detrol in the pediatric population has not been demonstrated.

Our Detrol (tolterodine tartrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Detrol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Detrol (Tolterodine Tartrate)

Detrol Professional Information

SIDE EFFECTS

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.

Table 5: Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in > 1% of Patients Treated with DETROL Tablets (2 mg bid) in 12-week, Phase 3 Clinical Studies

Body System Adverse Event % DETROL
N = 986
% Placebo
N=683
Autonomic Nervous accommodation abnormal 2 1
dry mouth 35 10
General chest pain 2 1
fatigue 4 3
headache 7 5
influenza-like symptoms 3 2
Central/Peripheral Nervous vertigo/dizziness 5 3
Gastrointestinal abdominal pain 5 3
constipation 7 4
diarrhea 4 3
dyspepsia 4 1
Urinary dysuria 2 1
Skin/Appendages dry skin 1 0
Musculoskeletal arthralgia 2 1
Vision xerophthalmia 3 2
Psychiatric somnolence 3 2
Metabolic/Nutritional weight gain 1 0
Resistance Mechanism infection 1 0
* in nearest integer.

Post-marketing Surveillance

The following events have been reported in association with tolterodine use in worldwide post-marketing experience: General: anaphylaxis and 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.

Read the entire FDA prescribing information for Detrol (Tolterodine Tartrate)

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