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Tolterodine

Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary i.

Checked against the official label · Updated

Prescription medicine Oral Safety alerts on record

Tolterodine: quick answers

Used for
Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Children
Tolterodine tartrate extended-release capsules are not recommended for use in patients with CCr The effectiveness of tolterodine tartrate extended-release capsules has not been established in pediatric patients.
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Feb 2026). Your prescription and pharmacist come first.

How to use Tolterodine

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Tolterodine 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 ) ].

How to take it and how often
  • 4 mg capsules taken orally once daily with water and swallowed whole. 2 mg capsules taken orally once daily with water and swallowed whole in the presence of: ° mild to moderate hepatic impairment (Child-Pugh class A or B) ° severe renal impairment [Creatinine Clearance (CCr) 10 to 30 mL/min] ° drugs that are potent CYP3A4 inhibitors
  • Tolterodine tartrate extended-release capsules are not recommended for use in patients with CCr
Strengths it comes in

Capsules: 2 mg and 4 mg ( 3 ) The 2 mg capsules are size "4", hard gelatin capsules having a green cap and green body, imprinted "1189" on the cap with white ink, containing off-white to brownish colored pellets. The 4 mg capsules are size "3", hard gelatin capsules having a blue cap and blue body, imprinted "1190" on the cap with white ink, containing off-white to brownish colored pellets.

Children
  • The effectiveness of tolterodine tartrate extended-release capsules has not been established
  • In pediatric patients
  • Efficacy was not established in two randomized, placebo-controlled, double-blind, 12-week studies that enrolled 710
  • Pediatric patients (486 on tolterodine tartrate extended-release capsules, 224 on placebo) aged 5 to 10 years with urinary frequency and urge incontinence
  • The percentage of patients with urinary tract infections was higher in patients treated with tolterodine tartrate extended-release capsules (6.6%) compared to patients who received placebo (4.5%). …
Older adults

No overall differences in safety were observed between the older and younger patients treated with tolterodine. In multiple-dose studies in which tolterodine immediate release 4 mg (2 mg bid) was administered, serum concentrations of tolterodine and of 5-HMT were similar in healthy elderly volunteers (aged 64 through 80 years) and healthy young volunteers (aged less than 40 years). …

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • Antimuscarinic Effects Inform patients that antimuscarinic agents such as tolterodine tartrate extended-release capsules may have side effects including blurred vision, dizziness, or drowsiness
  • Advise patients not to drive, operate machinery, or do other potentially dangerous activities until they know how tolterodine tartrate extended-release capsules affects them
  • Manufactured by: Torrent Pharmaceuticals LTD., India
  • Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920 8106403 Revised: January 2026 Torrent logo
Talk to a doctor first if
  • Tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma
  • 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. …
Medicines it may not mix with

Potent CYP3A4 Inhibitors: Coadministration may increase systemic exposure to tolterodine tartrate extended-release capsules. Reduce tolterodine tartrate extended-release capsules dose to 2 mg once daily. ( 7.2 ) Other Anticholinergics (antimuscarinics): Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, and other anticholinergic pharmacological effects. (7.6 ) 7.1 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. …

Warnings

Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate extended-release capsules. ( 5.1 ) Urinary Retention: use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.2 ) Gastrointestinal Disorders: use caution in patients with gastrointestinal obstructive disorders or decreased gastrointestinal motility because of the risk of gastric retention. ( 5.3 ) Controlled Narrow-Angle Glaucoma: use caution in patients being treated for narrow-angle glaucoma. …

Possible side effects

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 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 . …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary There are no available data with tolterodine tartrate extended-release capsules use in pregnant women to inform drug-associated risks. In animal reproduction studies, oral administration of tolterodine and its 5-HMT metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20 mg/kg/day; however, higher doses pro …

If you take too much

Overdosage with tolterodine tartrate extended-release capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage. In dogs, changes in the QT interval (slight prolongation of 10% to 20%) were observed at a suprapharmacologic dose of 4.5 mg/kg, which is about 68 times higher than the recommended human dose. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-02-09.

How much Tolterodine costs

In other countries

Prices in other countries are not what you will pay where you live; they show how prices compare.

Brands around the world

Products with Tolterodine as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Tolterodine TartrateTOLTERODINE TARTRATE 2 mg/1 · Tablet, Film Coated · Macleods Pharmaceuticals Limited
NDC 33342-098Label
Tolterodine TartrateTOLTERODINE TARTRATE 1 mg/1 · Tablet, Film Coated · Macleods Pharmaceuticals Limited
NDC 33342-097Label
Tolterodine TartrateTOLTERODINE TARTRATE 2 mg/1 · Tablet, Film Coated · Teva Pharmaceuticals USA, Inc.
NDC 0093-0018Label
Tolterodine TartrateTOLTERODINE TARTRATE 50 kg/50kg · Powder · Aurobindo Pharma Limited
NDC 65862-394Label
Tolterodine TartrateTOLTERODINE TARTRATE 50 kg/50kg · Powder · Emcure Pharmaceuticals Limited
NDC 14593-901Label

Nigeria (NAFDAC)

NAFDACRoliten Tablets 2 mg A4-1498

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USAU.S. FDA Class III
4 Mar 2025 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · TerminatedFailed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.U.S. FDA Class III
20 Jun 2014 · Mylan Pharmaceuticals Inc. · TerminatedFailed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519101.U.S. FDA Class II
2 Jul 2013 · Aidapak Services, LLC · TerminatedLabeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as one of the following drugs: HYDRALAZINE HCL, Tablet, 25 mg, NDC 50111032701, Pedigree: AD49610_4, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, 0 m
TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519001.U.S. FDA Class II
2 Jul 2013 · Aidapak Services, LLC · TerminatedLabeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as one of the following drugs: RANOLAZINE ER , Tablet, 500 mg, NDC 61958100301, Pedigree: AD62995_7, EXP: 5/29/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe),

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Tolterodine

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Tolterodine

What is Tolterodine used for?

Tolterodine 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 ) ]. (From the official U.S. FDA label.)

How do I take Tolterodine?

Follow your prescription or the leaflet in your pack. The official label says: 4 mg capsules taken orally once daily with water and swallowed whole. ( 2.1 ) 2 mg capsules taken orally once daily with water and swallowed whole in the presence of: ° mild to moderate hepatic impairment (Child-Pugh class A or B) ( 2.2 ) ° severe renal impairment [Creatinine Clearance (CCr) 10 to 30 mL/min] ( 2.2 ) ° drugs that are potent CYP3A4 inhibitors. ( 2.2 ) Tolterodine…

Can I drive after taking Tolterodine?

Antimuscarinic Effects Inform patients that antimuscarinic agents such as tolterodine tartrate extended-release capsules may have side effects including blurred vision, dizziness, or drowsiness.

Do I need a prescription for Tolterodine?

Usually yes. Tolterodine is a prescription medicine in most countries. Rules differ by country.

What brands contain Tolterodine?

Tolterodine is sold under names such as Detrol, Tolterodine Tartrate. Brand names differ between countries.

What are the side effects of Tolterodine?

The official label lists: 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 most common adverse reactions (incidence ≥4% and >placebo) were dry mouth, headache, constipation, and abdominal… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Tolterodine?

The effectiveness of tolterodine tartrate extended-release capsules has not been established in pediatric patients. Efficacy was not established in two randomized, placebo-controlled, double-blind, 12-week studies that enrolled 710 pediatric patients (486 on tolterodine tartrate extended-release capsules, 224 on placebo) aged 5 to 10 years with urinary frequency and urge incont… Always use the dose for the child's age or weight on the pack or prescription.

Can I take Tolterodine when pregnant or breastfeeding?

8.1 Pregnancy Risk Summary There are no available data with tolterodine tartrate extended-release capsules use in pregnant women to inform drug-associated risks. In animal reproduction studies, oral administration of tolterodine and its 5-HMT metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the… Ask your doctor or midwife first.

What medicines interact with Tolterodine?

Potent CYP3A4 Inhibitors: Coadministration may increase systemic exposure to tolterodine tartrate extended-release capsules. Reduce tolterodine tartrate extended-release capsules dose to 2 mg once daily. ( 7.2 ) Other Anticholinergics (antimuscarinics): Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurr… Use the free interaction checker before combining medicines.

What happens if I take too much Tolterodine?

Overdosage with tolterodine tartrate extended-release capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage. In dogs, changes in the QT interval (slight prolongation of 10% to 20%) were ob… Get medical help right away.

How can I check that my Tolterodine is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.