Navigation

Detrol LA

Detrol LA(Tolterodine Tartrate) side effects drug center

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Detrol LA Side Effects Center

What Is Detrol LA?

Detrol (tolterodine) LA is a muscarinic receptor antagonist that reduces spasms of the bladder muscles and is used to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence.

What Are Side Effects of Detrol LA?

Side effects of Detrol LA include:

Dosage for Detrol LA

The recommended dose of Detrol LA Capsules is 4 mg once daily with water and swallowed whole.

What Drugs, Substances, or Supplements Interact with Detrol LA?

Detrol LA 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.

Detrol LA During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Detrol LA; it is unknown if it will harm a fetus. It is unknown if Detrol LA passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

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

 

Detrol LA 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 LA (Tolterodine Tartrate)

 

Detrol LA Professional Information

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, doubleblind, 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 postmarketing 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)

&Copy; Detrol LA Patient Information is supplied by Cerner Multum, Inc. and Detrol LA Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.