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Tolterodine

Detrusitol, Tolterodin Accord, Tolterodin Aristo · ATC code G04BD07

Also known as: Tolterodin, Detrol · Brand names: Detrusitol, Tolterodin Accord, Tolterodin Aristo, Detrexa SR, Ginloba SR, Tolteridex SR, Toltex, Toreda, Uridyn, Urıstat

Key facts
Active substance
Tolterodine
ATC code
G04BD07
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Tolterodine is, per the US prescribing information, a competitive muscarinic receptor antagonist used to treat overactive bladder with urge urinary incontinence, urgency and frequency.

What it is used for

  • Overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Dosing

  • Initial dose 2 mg twice daily; may be lowered to 1 mg twice daily based on response and tolerability.
  • Significantly reduced hepatic or renal function: 1 mg twice daily.
  • With potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, cyclosporine): 1 mg twice daily.

Contraindications

  • Urinary retention, gastric retention or uncontrolled narrow-angle glaucoma.
  • Hypersensitivity to tolterodine, its ingredients or fesoterodine (both are metabolized to 5-hydroxymethyl tolterodine).

Important warnings

  • Anaphylaxis and angioedema, even after the first dose; stop immediately if breathing difficulty, airway obstruction or a fall in blood pressure occurs.
  • Caution in bladder outflow obstruction (urinary retention), gastrointestinal obstruction or decreased gastrointestinal motility.
  • Anticholinergic CNS effects such as dizziness and somnolence; blurred vision may impair driving.
  • Caution in treated narrow-angle glaucoma, myasthenia gravis and congenital or acquired QT prolongation.

Side effects

  • Most common: dry mouth (34.8% vs. 9.8% with placebo), headache, constipation, vertigo/dizziness and abdominal pain.
  • Expected antimuscarinic effects: accommodation abnormalities, urinary retention, dry eyes.
  • Anaphylaxis and angioedema have been reported.

Interactions

  • Potent CYP3A4 inhibitors (e.g. azole antifungals, macrolides, cyclosporine, vinblastine) raise tolterodine levels; reduce the dose to 1 mg twice daily.

Pregnancy and breastfeeding

  • Embryolethal in mice at high doses; use in pregnancy only if the benefit justifies the risk to the fetus.
  • It is not known whether tolterodine is excreted in human milk.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • DetrusitolViatris Healthcare Limited · 1 register entry
  • Tolterodin AccordAccord Healthcare B.V. · 1 register entry
  • Tolterodin AristoAristo Pharma Gmbh (Art 57) · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • DetrusitolViatris Pharma Gmbh · 2 register entries
  • Tolterodin1 A Pharma Gmbh, Ratiopharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Aristo Pharma Gmbh (Art 57), Puren Pharma Gmbh & Co. Kg, Abz-Pharma Gmbh · 6 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • Detrexa SRBİLİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • DetrusitolVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 5 register entries
  • Ginloba SRGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 2 register entries
  • Tolteridex SREİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 2 register entries
  • ToltexKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 4 register entries
  • ToredaBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • UridynHUMANİS SAĞLIK A.Ş. · 4 register entries
  • UrıstatVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • DetrolViatris Specialty LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 20 more European countries
Belgium
Detrusitol, Tolterodine Retard Teva, Tolterodine Teva, Urolina
Bulgaria
Толтеродин Акорд
Cyprus
Detrusitol, Tolterana, Tolterodine Accord
Denmark
Detrusitol Retard, Tolterodin Rivopharm, Tolterodin Stada, Tolterodine "sandoz", Tolterodine Sandoz, Tolterodintartrat Accord, Tolterodintartrat Teva
Estonia
Uroflow
Finland
Detrusitol, Tolterodin Ratiopharm, Tolterodin Viatris, Tolterodine Sandoz
Greece
Detrusitol, Toldesor, Trudenia
Iceland
Detrusitol Retard, Tolterodin Actavis
Ireland
Detrusitol, Tendrotil Sr, Tolterodine Tartrate Accord Healthcare Ireland, Tolterodine Tartrate Syri Pharma, Toltertan Sr, Trusitev Sr
Italy
Detrusitol, Tolterodina Doc
Latvia
Uroflow
Lithuania
Detrusitol, Tolterodine Actavis, Uroflow
Luxembourg
Detrusitol, Tolterodin Ratiopharm, Urolina
Netherlands
Detrusitol, Tolterodine Tartrate Teva, Tolterodinetartraat Accord, Tolterodinetartraat Sandoz, Tolterodinetartraat Sr Aurobindo, Tolterodinetartraat Syri Pharma, Tolterodinetartraat Viatris
Norway
Detrusitol Sr, Tolterodine Sandoz
Poland
Defur, Titlodine, Urimper, Uroflow
Romania
Uroflow
Slovenia
Detrusitol
Spain
Detrusitol, Tolterodina Neo Aurovitas, Tolterodina Neo Cinfa, Tolterodina Neo Combix, Tolterodina Neo Kern Pharma, Tolterodina Neo Stada, Tolterodina Neo Teva-Ratiopharm, Tolterodina Normon, Tolterodina Pharmathen, Tolterodina Sandoz, Urotrol
Sweden
Detrusitol, Protol Sr, Tolterodin Rivopharm, Tolterodin Stada, Tolterodin Upjohn, Tolterodine Accord, Tolterodine Sandoz, Tolterodine Teva

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. Detrol (Viatris Specialty LLC) – Prescribing Information, 2023-02-15. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=41eb00d2-64e3-4ec9-8732-4bfc81b04180
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.