What the label lists and what reports show
Tolterodine side effects
Tolterodine's FDA label: “The most common adverse reactions (incidence ≥4% and >placebo) were dry mouth, headache, constipation, and abdominal pain.” FAERS holds 12,383 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (847 reports).
- Generic listed
Check it at the source: the tolterodine FDA label on DailyMed (effective February 9, 2026, Torrent Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of tolterodine tartrate extended-release capsules?Tolterodine tartrate extended-release capsules may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat, or tongue. If you experience these symptoms, you should stop taking tolterodine tartrate extended-release capsules and get emergency medical help right away. The most common side effects with tolterodine tartrate extended-release capsules are: Dry mouth • Constipation Headache • Stomach pain Medicines like tolterodine tartrate extended-release capsules can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how tolterodine tartrate extended-release capsules affect you. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. […]
Source: FDA drug label, Torrent Pharmaceuticals Limited, effective February 9, 2026 (SPL set db6e0b6d-0ce5-41d7-881f-881c11f530a4), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥4% and >placebo) were dry mouth, headache, constipation, and abdominal pain.
Table 1. Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in ≥1% of Patients Treated with Tolterodine Tartrate Extended-Release Capsules (4 mg daily) in a 12-week, Phase 3 Clinical Trial
| Adverse Event | % Tolterodine Tartrate Extended-Release Capsules n=505 | % Placebo n=507 |
|---|---|---|
| dry mouth | 23 | 8 |
| headache | 6 | 5 |
| dizziness | 2 | 1 |
| constipation | 6 | 4 |
| xerophthalmia | 3 | 2 |
| somnolence | 3 | 2 |
| sinusitis | 2 | 1 |
| dysuria | 1 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedBecause 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 most common adverse reactions (incidence ≥4% and >placebo) were dry mouth, headache, constipation, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The efficacy and safety of tolterodine tartrate extended-release capsules was evaluated in 1,073 patients (537 assigned to tolterodine tartrate extended-release capsules; 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 1,012 patients (505 randomized to tolterodine tartrate extended-release capsules 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 tolterodine tartrate extended-release capsules and in 49% (n=247) of patients receiving placebo. …
Source: FDA drug label, Torrent Pharmaceuticals Limited, effective February 9, 2026 (SPL set db6e0b6d-0ce5-41d7-881f-881c11f530a4), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,383 reports list tolterodine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 803 are coded as a death and 3,869 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tolterodine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions