Prescription medicine
Tolterodine Brand names: Detrol
Tolterodine (Detrol) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.268 per tolterodine tart ER 2 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tolterodine FDA label on DailyMed (effective February 9, 2026, Torrent Pharmaceuticals Limited); the NDA 20771 record on Drugs@FDA; every tolterodine label on DailyMed.
Highlights of the record
FDA label of February 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Forms and strengths
- 1 mg
- 2 mg
- 4 mg
Extended-release capsule; film-coated tablet; tablet.
On the market
- Earliest approval on file
- March 25, 1998 Detrol, Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first September 25, 2012; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 14 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.268 per capsule Tolterodine tart ER 2 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 0 Class I among all firms' recalls; latest March 4, 2025
- FAERS reports
- 12,383 through July 30, 2026
What is tolterodine used for?
From the label: indications and usageTolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 ) Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [ see CLINICAL STUDIES ( 14 ) ].
Conditions named in the indications of tolterodine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cholinergic Muscarinic Antagonist.
Source: FDA drug label (TOLTERODINE TARTRATE), Torrent Pharmaceuticals Limited, effective February 9, 2026 (SPL set db6e0b6d-0ce5-41d7-881f-881c11f530a4), via openFDA; the full label on DailyMed
Is there a generic for tolterodine (Detrol)?
The FDA approved the first generic tolterodine on September 25, 2012. 16 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists tolterodine from 14 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tolterodine (Detrol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.268 per Tolterodine tart ER 2 mg capsule, down 27% from $0.365 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tolterodine tart ER 4 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tolterodine tart ER 2 mg capsule | Generic | $0.268 per capsule | $8.03 | -27% |
| Tolterodine tart ER 4 mg capsule | Generic | $0.231 per capsule | $6.93 | -24% |
| Tolterodine tartrate 1 mg tablet | Generic | $0.204 per tablet | $6.12 | -26% |
| Tolterodine tartrate 2 mg tablet | Generic | $0.264 per tablet | $7.92 | +18% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tolterodine been recalled?
The FDA's Enforcement Report lists 4 recalls naming tolterodine since 2013: 0 Class I (the most serious), 2 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 4, 2025 | Class III | The Harvard Drug Group LLC dba Major Pharmaceuticals and … | Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. |
| June 20, 2014 | Class III | Mylan Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as one of the following drugs: RANOLAZINE ER , Tablet, 500 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as one of the following drugs: HYDRALAZINE HCL, Tablet, 25 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tolterodine label say about other medicines?
The tolterodine label names 19 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name tolterodine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | … QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. |
| Caffeine | drug interactions | Metabolized by Cytochrome P450 Isoenzymes In vivo drug-interaction data show that tolterodine immediate release does not result in clinically relevant inhibition of CYP1A2, 2D6, 2C9, 2C19, or 3A4 as evidenced by lack of influence on the marker drugs caffeine, debrisoquine, S-warfarin, and omeprazole [ see CLINICAL … |
| Clarithromycin | drug interactions | For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as itraconazole, clarithromycin, or ritonavir, the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily [ see DOSAGE AND ADMINISTRATION ( 2.2) and CLINICAL PHARMACOLOGY ( 12.3) ]. |
| Cyclosporine | drug interactions | 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 (see DOSAGE AND ADMINISTRATION ). |
| Erythromycin | drug interactions | 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 (see DOSAGE AND ADMINISTRATION ). |
| Fesoterodine | contraindications | Tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine. … |
| Fluoxetine | drug interactions | Potent CYP2D6 Inhibitors Fluoxetine, a potent inhibitor of CYP2D6 activity, significantly inhibited the metabolism of tolterodine immediate release in CYP2D6 extensive metabolizers, resulting in a 4.8-fold increase in tolterodine AUC. |
| Itraconazole | drug interactions | For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as itraconazole, clarithromycin, or ritonavir, the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily [ see DOSAGE AND ADMINISTRATION ( 2.2) and CLINICAL PHARMACOLOGY ( 12.3) ]. |
| Ketoconazole | drug interactions | Ketoconazole (200 mg daily), a potent CYP3A4 inhibitor, increased the mean C max and AUC of tolterodine by 2- and 2.5-fold, respectively, in CYP2D6 poor metabolizers. |
| Levonorgestrel | drug interactions | No clinically relevant interactions have been observed when tolterodine was co-administered with warfarin, with a combined oral contraceptive drug containing ethinyl estradiol and levonorgestrel, or with diuretics [ see CLINICAL PHARMACOLOGY ( 12.3 ) ]. |
| Miconazole | drug interactions | 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 (see DOSAGE AND ADMINISTRATION ). |
| Moxifloxacin | warnings and precautions | The effect of tolterodine 8 mg/day was not as large as that observed after four days of therapeutic dosing with the active control moxifloxacin. However, the confidence intervals overlapped. |
| Omeprazole | drug interactions | … 2C19, or 3A4 as evidenced by lack of influence on the marker drugs caffeine, debrisoquine, S-warfarin, and omeprazole [ see CLINICAL PHARMACOLOGY ( 12.3 ) ]. |
| Procainamide | warnings and precautions | … patients with a known history of QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. |
Every other medicine the tolterodine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Quinidine | warnings and precautions | … history of QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. |
| Ritonavir | drug interactions | For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as itraconazole, clarithromycin, or ritonavir, the recommended dose of tolterodine tartrate extended-release capsules is 2 … |
| Sotalol | warnings and precautions | … IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. |
| Vinblastine | drug interactions | … antibiotics (e.g., erythromycin, clarithromycin) or cyclosporine or vinblastine, the recommended dose of DETROL is 1 mg twice daily (see DOSAGE AND ADMINISTRATION ). |
| Warfarin | drug interactions | No clinically relevant interactions have been observed when tolterodine was co-administered with warfarin, with a combined oral contraceptive drug containing ethinyl estradiol and levonorgestrel, or … |
Other labels that name tolterodine
Source: FDA drug label (TOLTERODINE TARTRATE), 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 for tolterodine?
The FDA Adverse Event Reporting System holds 12,383 reports that list tolterodine among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tolterodine?
7 other medicines are given the same way (oral) and in the same FDA class as tolterodine or labeled mainly for the same use (overactive bladder), the same class first. Overactive bladder lists all 9 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxybutynin | Overactive bladder | 41 labelers | $0.048 per tablet 5 mg tablet | No current entry |
| Solifenacin | Overactive bladder | 20 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Trospium | Overactive bladder | 20 labelers | $0.211 per tablet 20 mg tablet | No current entry |
| Darifenacin | Overactive bladder | 8 labelers | $0.432 per tablet 15 mg tablet | No current entry |
| Fesoterodine | Overactive bladder | 11 labelers | $0.794 per tablet 4 mg tablet | No current entry |
| Mirabegron | Overactive bladder | 8 labelers | $9.39 per tablet 50 mg tablet | No current entry |
| Vibegron | Overactive bladder | none listed | $16.46 per tablet 75 mg tablet | No current entry |
Every medicine labeled for the same conditions as tolterodine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tolterodine compare with medicines for the same use?
5 side-by-side pages set tolterodine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tolterodine
- 7 medicines for the same use
- Other cholinergic muscarinic antagonists
- the pharmacologic class, with prices and generics
- Tolterodine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other