Uses
DETROL Tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Source: US FDA prescribing information
- Presentations
- 5
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Tolterodine is a cholinergic muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. It is available as extended-release capsules and tablets for oral use. MedsAcross supplies Tolterodine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Cholinergic Muscarinic Antagonist, Cholinergic Muscarinic Antagonists
- ATC classification
- G04BD07 Tolterodine · Urology medicines, subgroup G04B, subgroup G04BD
- US FDA first approval
- 25 March 1998
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Extended-release capsule, Tablet
- Identifiers
- UNII WHE7A56U7KRxCUI 119565CAS 124937-51-5DrugBank DB01036Q424312
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
The initial recommended dose of DETROL Tablets is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on individual response and tolerability. For patients with significantly reduced hepatic or renal function or who are currently taking drugs that are potent inhibitors of CYP3A4, the recommended dose of DETROL is 1 mg twice daily.
Source: US FDA prescribing information
Contraindications
DETROL Tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. DETROL is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like DETROL, are metabolized to 5-hydroxymethyl tolterodine.
Source: US FDA prescribing information
Warnings and precautions
Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of DETROL. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, DETROL should be discontinued and appropriate therapy promptly provided.
Source: US FDA prescribing information
Side effects
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.
Source: US FDA prescribing information
Interactions
CYP3A4 Inhibitors Ketoconazole, an inhibitor of the drug metabolizing enzyme CYP3A4, significantly increased plasma concentrations of tolterodine when coadministered to subjects who were poor metabolizers. For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as other azole antifungals (e.g., itraconazole, miconazole) or macrolide antibiotics (e.g., erythromycin, clarithromycin) or cyclosporine or vinblastine, the recommended dose of DETROL is 1 mg twice daily.
Source: US FDA prescribing information
Storage
Store at 25ºC (77ºF), excursions permitted to 15–30ºC (59–86ºF) (DTL).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
5 presentations of Tolterodine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tolterodine 4 mg extended-release capsuleOralGeneric name | — | US FDA | Available on request |
| Tolterodine 2 mg extended-release capsuleOralGeneric name | — | US FDA | Available on request |
| Tolterodine 1 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tolterodine 2 mg tabletOralGeneric name | — | US FDA | Available on request |
| Detrol 2 mg tabletOral | Viatris Specialty | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 25 March 1998 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Tolterodine in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Tolterodine available for export from India?
Yes, on request. MedsAcross lists 5 presentations of Tolterodine and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Tolterodine have?
The catalogue lists 1 brand names for Tolterodine, including Detrol.
Is Tolterodine approved by the US FDA?
Yes. The US FDA first approved Tolterodine on 25 March 1998, according to Drugs@FDA.
Does Tolterodine need cold chain shipping?
No listed presentation of Tolterodine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Tolterodine in?
Tolterodine is classified under ATC code G04BD07 (Tolterodine).
References
- Detrol prescribing information (Viatris Specialty). U.S. National Library of Medicine, DailyMed. Retrieved 15 February 2023
Request Tolterodine for export supply
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