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Detrol

"April 9, 2012 -- Drugs that treat incontinence caused by an overactive bladder offer modest benefits to some women, and they often come with significant side effects, a new review of research shows.

The government-funded review compar"...

Detrol

Detrol Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Detrol (tolterodine tartarate) Tablets are not available as a generic drug. Detrol Tablets are prescribed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Side effects include but are not limited to dry mouth, dry eyes, headache, dizziness, drowsiness, constipation, and upset stomach. Drug interactions occur with Detrol. Please read the drug interaction section prior to taking this medication.

Detrol is available in 1 and 2 mg strength tablets. The initial recommended dose of Detrol Tablets is 2 mg twice daily. 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. Detrol is secreted into breast milk in animals; however, it is not known if it is secreted in human 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Detrol in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Detrol Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth, dry eyes, headache, constipation, stomach upset/pain, dizziness, drowsiness, tiredness, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (such as a stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision changes, severe stomach/abdominal pain, trouble urinating, signs of kidney infection (such as burning/painful urination, lower back pain, fever).

Get medical help right away if you have any very serious side effects, including: fast/slow/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Detrol (Tolterodine Tartrate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Detrol FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 12week, Phase 3 Clinical Studies

Body System Adverse Event % DETROL
N=986
% Placebo
N=683
Autonomic Nervous accommodation abnormal 2 1
dry mouth 35 10
chest pain 2 1
fatigue 4 3
headache 7 5
General influenza-like symptoms 3 2
Central/Peripheral Nervous vertigo/dizziness 5 3
abdominal pain 5 3
constipation 7 4
diarrhea 4 3
Gastrointestinal 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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Detrol - User Reviews

Detrol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Detrol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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