| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | TABLET;ORAL | 1MG | No | No |
| 002 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | TABLET;ORAL | 2MG | No | No |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205399-001 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 1MG | TABLET / ORAL | AB | 2020-08-05 | |
| A205399-002 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | TABLET / ORAL | AB | 2020-08-05 |
| Application-product | TE code |
|---|---|
| A205399-001 | AB |
| A205399-002 | AB |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tolterodine Tartrate | TOLTERODINE TARTRATE | Unichem Pharmaceuticals (USA), Inc. | 56e62829-5371-416a-90b3-4b6429532d25 | 2020-08-07 | Warnings, Adverse reactions |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tartrate should be discontinued and appropriate therapy promptly provided.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
ADVERSE REACTIONS The Phase 2 and 3 clinical trial program for tolterodine tartrate tablets included 3071 patients who were treated with tolterodine tartrate (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 tolterodine tartrate 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 tolterodine tartrate 2 mg bid reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving tolterodine tartrate 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 tolterodine tartrate 2 mg bid in the Phase 3 clinical studies, occurring in 34.8% of patients treated with tolterodine tartrate and 9.8% of placebo-treated patients. One percent of patients treated with tolterodine tartrate 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 tolterodine tartrate 2 mg bid discontinued treatment due to adverse events versus 6% of placebo patients. The most common adverse events leading to discontinuation of tolterodine tartrate were dizziness and headache. Three percent of patients treated with tolterodine tartrate 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 treate...
Table 5. Incidencein nearest integer. (%) of Adverse Events Exceeding Placebo Rate and Reported in >1% of Patients Treated with Tolterodine Tartrate Tablets (2 mg bid) in 12-week, Phase 3 Clinical StudiesBody System Adverse Event % Tolterodine Tartrate N=986 % Placebo N=683 Autonomic Nervous accommodation abnormal dry mouth 2 35 1 10 General chest pain fatigue headache influenza-like symptoms 2 4 7 3 1 3 5 2 Central/Peripheral Nervous vertigo/dizziness 5 3 Gastrointestinal abdominal pain constipation diarrhea dyspepsia 5 7 4 4 3 4 3 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