Is Tolterodine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Tolterodine, including DETRUSITOL 2 mg tablet (2 mg, Film-coated tablet, SAR 52.85); DETRUSITOL RETARD 2 mg capsule (2 mg, Prolonged-release capsule, hard, SAR 71.55); DETRUSITOL RETARD 4 mg capsule (4 mg, Prolonged-release capsule, hard, SAR 71.55); Uridisitol (2 mg, Film-coated tablet, SAR 52.85).

Is Tolterodine approved by the US FDA?

Drugs@FDA lists 18 application product lines for Tolterodine, including DETROL (Prescription); TOLTERODINE TARTRATE (Prescription); TOLTERODINE TARTRATE (Prescription); TOLTERODINE TARTRATE (Prescription); TOLTERODINE TARTRATE (Prescription).

Are there safety signals or safety updates for Tolterodine?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2018-07-13).

Active substance

Tolterodine

SFDA 4
US FDA 18
Health Canada 14
US price lines 4
NHS prices 4
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DETRUSITOL 2 mg tablet	2 mg	Film-coated tablet · Oral use	28 Blister	SAR 52.85	NCE · Prescription	VIATRIS PHARMA S.R.L.	Valid
DETRUSITOL RETARD 2 mg capsule	2 mg	Prolonged-release capsule, hard · Oral use	14 Blister	SAR 71.55	NCE · Prescription	VIATRIS PHARMA S.R.L.	Valid
DETRUSITOL RETARD 4 mg capsule	4 mg	Prolonged-release capsule, hard · Oral use	14 Blister	SAR 71.55	NCE · Prescription	VIATRIS PHARMA S.R.L.	Valid
Uridisitol	2 mg	Film-coated tablet · Oral use	30 Blister	SAR 52.85	Generic · Prescription	Saudi Amarox	Valid

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY; NOCTURNAL ENURESIS; URINARY INCONTINENCE AND OVERACTIVE BLADDER

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DETROL	1MG; 2MG	tablet · oral	UPJOHN	Prescription	25 Mar 1998
TOLTERODINE TARTRATE	1MG; 2MG	tablet · oral	IVAX SUB TEVA PHARMS	Prescription	23 Feb 2015
TOLTERODINE TARTRATE	2MG; 4MG	capsule, extended release · oral	TORRENT	Prescription	11 Aug 2015
TOLTERODINE TARTRATE	1MG; 2MG	tablet · oral	MACLEODS PHARMS	Prescription	31 Aug 2015
TOLTERODINE TARTRATE	2MG; 4MG	capsule, extended release · oral	TEVA PHARMS USA	Prescription	22 Nov 2016
TOLTERODINE TARTRATE	2MG; 4MG	capsule, extended release · oral	HETERO LABS LTD III	Prescription	12 Dec 2017
TOLTERODINE TARTRATE	2MG; 4MG	capsule, extended release · oral	INVENTIA HLTHCARE	Prescription	19 Aug 2019
TOLTERODINE TARTRATE	1MG; 2MG	tablet · oral	RISING	Prescription	30 Dec 2019
TOLTERODINE TARTRATE	1MG; 2MG	tablet · oral	UNIQUE	Prescription	24 Jan 2020
TOLTERODINE TARTRATE	2MG; 4MG	capsule, extended release · oral	AJANTA PHARMA LTD	Prescription	19 May 2020
TOLTERODINE TARTRATE	1MG; 2MG	tablet · oral	UNICHEM	Prescription	5 Aug 2020
TOLTERODINE TARTRATE	2MG; 4MG	capsule, extended release · oral	UTOPIC PHARMS	Prescription	2 Feb 2021
TOLTERODINE TARTRATE	1MG; 2MG	tablet · oral	HETERO LABS LTD V	Prescription	2 Aug 2021
TOLTERODINE TARTRATE	2MG; 4MG	capsule, extended release · oral	UNICHEM	Prescription	27 Aug 2024
DETROL LA	2MG; 4MG	capsule, extended release · oral	UPJOHN	Discontinued	22 Dec 2000
TOLTERODINE TARTRATE	1MG; 2MG	tablet · oral	APOTEX CORP	Discontinued	25 Sep 2012
TOLTERODINE TARTRATE	1MG; 2MG	tablet · oral	PHARMOBEDIENT	Discontinued	27 Nov 2012
TOLTERODINE TARTRATE	2MG; 4MG	capsule, extended release · oral	AUROBINDO PHARMA USA	Discontinued	31 Oct 2013

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DETROL	02239064	1 MG	TABLET · ORAL	BGP PHARMA ULC
DETROL	02239065	2 MG	TABLET · ORAL	BGP PHARMA ULC
DETROL LA	02244612	2 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	BGP PHARMA ULC
DETROL LA	02244613	4 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	BGP PHARMA ULC
JAMP TOLTERODINE	02496836	1 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP TOLTERODINE	02496844	2 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MINT-TOLTERODINE	02423308	1 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-TOLTERODINE	02423316	2 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
SANDOZ TOLTERODINE LA	02413140	2 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TOLTERODINE LA	02413159	4 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
TEVA-TOLTERODINE	02299593	1 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-TOLTERODINE	02299607	2 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-TOLTERODINE LA	02412195	2 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	TEVA CANADA LIMITED
TEVA-TOLTERODINE LA	02412209	4 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TOLTERODINE TART ER 2 MG CAP	$0.2678	per EA	23 Sep 2026
US NADAC	TOLTERODINE TART ER 4 MG CAP	$0.23116	per EA	23 Sep 2026
US NADAC	TOLTERODINE TARTRATE 1 MG TAB	$0.20389	per EA	23 Sep 2026
US NADAC	TOLTERODINE TARTRATE 2 MG TAB	$0.26393	per EA	23 Sep 2026
NHS Drug Tariff	Tolterodine 1mg tablets	£12.80	56 tablet	1 Oct 2026
NHS Drug Tariff	Tolterodine 2mg modified-release capsules	£11.60	28 capsule	1 Oct 2026
NHS Drug Tariff	Tolterodine 2mg tablets	£12.96	56 tablet	1 Oct 2026
NHS Drug Tariff	Tolterodine 4mg modified-release capsules	£12.89	28 capsule	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 13 Jul 2018 DETROL LA — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jul 2018 PRAC signal: Dementia
Action for MAH: update of the product information: No

All safety entries for tolterodine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.