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Detrol (Tolterodine Tartrate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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

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.



REPORTS OF SUSPECTED DETROL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Detrol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Detrol side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient: 60 year old female weighing 43.1 kg (94.8 pounds)

Reactions: Pruritus, Insomnia, Rash, Discomfort

Adverse event resulted in: hospitalization

Suspect drug(s):
Detrol



Possible Detrol side effects / adverse reactions in 66 year old female

Reported by a consumer/non-health professional from United States on 2011-11-29

Patient: 66 year old female weighing 42.0 kg (92.4 pounds)

Reactions: Asthma, Contusion, Pruritus, Urinary Incontinence, Erythema, Weight Increased, Road Traffic Accident, Dyspepsia, Iron Deficiency Anaemia, Mouth Breathing, Poor Peripheral Circulation, DRY Mouth, Oedema Peripheral, Hypertonic Bladder, Breast Cancer, Intervertebral Disc Protrusion, Stomatitis, Nausea, Hypoaesthesia, Dysgeusia, Dehydration, Visual Impairment, Renal Pain, Multiple Allergies

Suspect drug(s):
Plavix
    Administration route: Oral
    Start date: 2004-06-01

Plavix
    Administration route: Oral
    Start date: 2011-09-23

Plavix
    Administration route: Oral
    Start date: 2004-06-01

Plavix
    Administration route: Oral

Plavix
    Administration route: Oral
    Start date: 2011-09-23

Detrol
    Start date: 2009-02-01

Plavix
    Administration route: Oral
    End date: 2011-09-20

Plavix
    Administration route: Oral
    End date: 2011-09-20

Plavix
    Administration route: Oral

Amlodipine Besylate
    Start date: 2005-05-01

Other drugs received by patient: Diphenhydramine HCL; Ascorbic Acid; Brethine; Feldene



Possible Detrol side effects / adverse reactions in 81 year old male

Reported by a consumer/non-health professional from United States on 2011-12-14

Patient: 81 year old male weighing 79.8 kg (175.6 pounds)

Reactions: Heart Rate Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Detrol

Other drugs received by patient: Fosamax; Flovent



See index of all Detrol side effect reports >>

Drug label data at the top of this Page last updated: 2011-08-01

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