tolterodine Side Effects
Also known as: Detrol
Analysis of 6,323 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
6,323
Death-Related
449
7.1% of reports
Hospitalizations
1,986
31.4% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 449 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 151 |
| PNEUMONIA | 40 |
| COMPLETED SUICIDE | 35 |
| FALL | 27 |
| ASTHENIA | 20 |
| DYSPNOEA | 19 |
| URINARY TRACT INFECTION | 19 |
| RESPIRATORY FAILURE | 18 |
| SEPSIS | 17 |
| CARDIAC ARREST | 16 |
| RENAL FAILURE | 16 |
| GASTROINTESTINAL HAEMORRHAGE | 14 |
| ACUTE KIDNEY INJURY | 13 |
| DIARRHOEA | 13 |
| CARDIO-RESPIRATORY ARREST | 12 |
| HYPOTENSION | 11 |
| MYOCARDIAL INFARCTION | 11 |
| OFF LABEL USE | 11 |
| PYREXIA | 10 |
| TOXICITY TO VARIOUS AGENTS | 10 |
Reactions in Hospitalization Reports
Top reactions in 1,986 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 238 |
| PNEUMONIA | 148 |
| VOMITING | 129 |
| DIARRHOEA | 114 |
| URINARY TRACT INFECTION | 114 |
| CONFUSIONAL STATE | 111 |
| ASTHENIA | 108 |
| NAUSEA | 106 |
| DYSPNOEA | 102 |
| DIZZINESS | 99 |
| FATIGUE | 92 |
| PYREXIA | 86 |
| PAIN | 79 |
| DRUG INTERACTION | 75 |
| DRUG INEFFECTIVE | 68 |
| HYPONATRAEMIA | 67 |
| CONSTIPATION | 66 |
| OFF LABEL USE | 65 |
| ABDOMINAL PAIN | 64 |
| HYPOTENSION | 63 |
Nearby — Related Medications
What the FAERS Data Reveals About tolterodine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 6,323 voluntary reports linked to tolterodine and its brand equivalents (Detrol), spanning 2003 through 2025. Of those, 449 (7.1%) listed death as an outcome and 1,986 (31.4%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 69% were female and 30% male; age distribution skews toward 75+, with 1,350 reports in that bracket. The single most reported reaction is drug ineffective with 466 submissions, followed by fall and fatigue.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.