Drug Report: DETROL LA (TOLTERODINE TARTRATE)
Primary Suspect Reports: 10,602 Total Reports: 18,250 FDA AERS Reports from 11/01/1997 to 08/27/2012
Drug Description :

Detrol LA (tolterodine tartrate extended-release capsules) is used to manage the symptoms of overactive bladder (OAB), such as leaks, sudden urges to urinate, and frequency. It is a once-daily capsule that helps calm bladder muscle for up to 24 hours. Detrol LA was FDA approved on December 22, 2000 and is manufactured by Amgen.

From 11/01/1997 to 08/27/2012, there have been 10,602 reports of a serious adverse event where DETROL LA was identified as the primary suspect drug causing that event. During that time period, the top three adverse events reported in cases where DETROL LA was identified as the primary suspect drug were: Drug Ineffective, Dry Mouth and Constipation.

Drug Safety Monitor News :

08/03/2012 - Pfizer Announces Toviaz More Effective than Detrol LA in Treating Overactive Bladder

Other Names : Generic Name : Report Info:

Tolterodine Tartrate

TOLTERODINE TARTRATE

Average Age: 66 Years
Gender: 23% M, 77% F
Average Duration of Treatment: 1 Days

FDA Listed Names (286) : How to read this section Manufacturer: Common Conditions:

(detrusitol /01350202/)
(tolterodine)
Blinded Tolterodine Tartrate
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Pharmacia & Upjohn, Inc. (7,333)
Pfizer, Inc. (3,081)
Kos Life Sciences, Inc. (20)

HYPERTONIC BLADDER
URINARY INCONTINENCE
POLLAKIURIA

DETROL LA Adverse Event Timeline
Top DETROL LA Adverse Events/Side Effects How to read this section
How to read this section
Side Effects
MedDRA Preferred Terms
DETROL LA Primary Suspect Reports DETROL LA Total Reports ROR Score
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PRR Score
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Compare Top Drugs
Drug Ineffective 2,004 (19%) 2,435 (13%) Premium Feature Premium Feature
Dry Mouth 1,943 (18%) 2,086 (11%) Premium Feature Premium Feature
Constipation 784 (7%) 1,024 (6%) Premium Feature Premium Feature
Headache 673 (6%) 1,079 (6%) Premium Feature Premium Feature
Dizziness 602 (6%) 1,089 (6%) Premium Feature Premium Feature
Urinary Incontinence 580 (5%) 751 (4%) Premium Feature Premium Feature
Pollakiuria 485 (5%) 609 (3%) Premium Feature Premium Feature
Dry Eye 402 (4%) 429 (2%) Premium Feature Premium Feature
Condition Aggravated 387 (4%) 676 (4%) Premium Feature Premium Feature
Oedema Peripheral 377 (4%) 679 (4%) Premium Feature Premium Feature
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Reported Report Outcomes for DETROL LA Adverse Events
Report Outcomes DETROL LA Primary Suspect
(# of Reports)
(11/01/1997 to 08/27/2012)
DETROL LA Total
(# of Reports)
(11/01/1997 to 08/27/2012)
Other 2,727 (26%) 5,457 (30%)
Hospitalization - Initial or Prolonged 804 (8%) 3,891 (21%)
Death 163 (2%) 757 (4%)
Disability 140 (1%) 459 (3%)
Life-Threatening 61 (1%) 413 (2%)
Required Intervention to Prevent Permanent Impairment/Damage 41 (0%) 236 (1%)
Congenital Anomaly 9 (0%) 15 (0%)
Most Recent DETROL LA Report Reviews/FDA Reports (Primary Suspect)
Report Date Age Gender Conditions Adverse Events Outcome
08/27/2012 Not Stated F Hypertonic Bladder
Drug Ineffective
Not Stated
08/23/2012 85 YR F Angina Pectoris
Blood Cholesterol Increased
Drug Therapy

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Dry Mouth
Incorrect Dose Administered
Not Stated
08/22/2012 Not Stated F Urinary Incontinence
Drug Ineffective
Not Stated
08/22/2012 61 YR F Bladder Disorder
Diabetes Mellitus
Diuretic Therapy

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Chondropathy
Hospitalization - Initial or Prolonged
08/20/2012 55 YR F Nerve Injury
Urinary Incontinence
Drug Ineffective
Insomnia
Not Stated
08/20/2012 87 YR F Urinary Incontinence
Urinary Incontinence
Urinary Tract Infection
Amnesia

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Other
08/20/2012 25 YR F Contraception
Hypertonic Bladder
Thirst
Malaise
Migraine

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Other
08/17/2012 75 YR M Hypertonic Bladder
Interstitial Lung Disease
Other
08/16/2012 Not Stated F Urinary Incontinence
Drug Ineffective
Not Stated
08/15/2012 51 YR F Hypertension
Hypertonic Bladder
Arthritis
Disability

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