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Detrol LA

"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 LA

Detrol LA

Detrol LA Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Detrol (tolterodine) LA is a drug that reduces spasms of the bladder muscles. Tolterodine is used to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence. It is taken orally in tablet form. Side effects can include dry mouth, dry eyes, blurred vision, dizziness, drowsiness, constipation or diarrhea; stomach pain or upset; or joint pain. Other side effects can include.

There are no studies of tolterodine in pregnant women, so Detrol LA should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus. It is not known whether tolterodine is excreted in human milk; therefore, Detrol should not be administered during nursing.

Our Detrol LA 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 LA 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 LA (Tolterodine Tartrate) »

What is Patient Information Overview?

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

Detrol LA 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 LA (Tolterodine Tartrate)»

What is Prescribing information?

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

Detrol LA FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Clinical Trials Experience

The efficacy and safety of DETROL LA Capsules was evaluated in 1073 patients (537 assigned to DETROL LA; 536 assigned to placebo) who were treated with 2, 4, 6, or 8 mg/day for up to 15 months. These included a total of 1012 patients (505 randomized to DETROL LA 4 mg once daily and 507 randomized to placebo) enrolled in a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study.

Adverse events were reported in 52% (n=263) of patients receiving DETROL LA and in 49% (n=247) of patients receiving placebo. The most common adverse events reported by patients receiving DETROL LA were dry mouth, headache, constipation, and abdominal pain. Dry mouth was the most frequently reported adverse event for patients treated with DETROL LA, occurring in 23.4% of patients treated with DETROL LA and 7.7% of placebo-treated patients. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and dry eyes are expected side effects of antimuscarinic agents. A serious adverse event was reported by 1.4% (n=7) of patients receiving DETROL LA and by 3.6% (n=18) of patients receiving placebo.

Table 1 lists the adverse events, regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than or equal to 1% of patients treated with DETROL LA 4 mg once daily.

Table 1: Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in ≥ 1% of Patients Treated with DETROL LA (4 mg daily) in a 12-week, Phase 3 Clinical Trial

Body System Adverse Event % DETROL LA
n=505
% Placebo
n=507
Autonomic Nervous dry mouth 23 8
General headache 6 5
fatigue 2 1
Central/Peripheral Nervous dizziness 2 1
Gastrointestinal constipation 6 4
abdominal pain 4 2
dyspepsia 3 1
Vision xerophthalmia 3 2
vision abnormal 1 0
Psychiatric somnolence 3 2
anxiety 1 0
Respiratory sinusitis 2 1
Urinary dysuria 1 0
* in nearest integer.

The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Similar percentages of patients treated with DETROL LA or placebo discontinued treatment due to adverse events. Dry mouth was the most common adverse event leading to treatment discontinuation among patients receiving DETROL LA [n=12 (2.4%) vs. placebo n=6 (1.2%)].

Post-marketing Experience

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; Gastrointestinal: diarrhea; 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 LA (Tolterodine Tartrate) »

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Detrol LA - User Reviews

Detrol LA 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 LA 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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