Is Oxybutynin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Oxybutynin, including Syferid (1 mg/ml, Oral solution, SAR 994.95).

Is Oxybutynin approved by the US FDA?

Drugs@FDA lists 43 application product lines for Oxybutynin, including OXYBUTYNIN CHLORIDE (Prescription); OXYBUTYNIN CHLORIDE (Prescription); OXYBUTYNIN CHLORIDE (Prescription); OXYBUTYNIN CHLORIDE (Prescription); OXYBUTYNIN CHLORIDE (Prescription).

Is Oxybutynin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Oxybutynin: Kentera (previously Oxybutynin Nicobrand).

Are there safety signals or safety updates for Oxybutynin?

EMA PRAC: 6 entries; US FDA: 4 entries (latest 2024-05-29).

Active substance

Oxybutynin

SFDA 1
US FDA 43
EMA 1
Health Canada 5
US price lines 9
NHS prices 7
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Syferid	1 mg/ml	Oral solution · Oral use	1 Bottle	SAR 994.95	Generic · Prescription	Syri Limited t/a SyriMed	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	TEVA PHARMS USA	Prescription	14 Nov 1988
OXYBUTYNIN CHLORIDE	5MG/5ML	syrup · oral	LANNETT CO INC	Prescription	29 Mar 1996
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	AIPING PHARM INC	Prescription	31 Jul 1996
OXYBUTYNIN CHLORIDE	5MG; 2.5MG	tablet · oral	STRIDES PHARMA INTL	Prescription	31 Oct 1997
OXYBUTYNIN CHLORIDE	5MG/5ML	syrup · oral	CHARTWELL RX	Prescription	29 Jan 1999
OXYTROL	3.9MG/24HR	film, extended release · transdermal	ALLERGAN	Prescription	26 Feb 2003
Oxybutynin Chloride	15 MG.	tablet, extended release · oral	MYLAN PHARMS INC	Prescription	10 May 2007
OXYBUTYNIN CHLORIDE	5MG; 10MG; 15MG	tablet, extended release · oral	OSMOTICA PHARM US	Prescription	4 Feb 2009
OXYTROL FOR WOMEN	3.9MG/24HR	film, extended release · transdermal	ABBVIE	Over-the-counter	25 Jan 2013
OXYBUTYNIN CHLORIDE	5MG; 10MG; 15MG	tablet, extended release · oral	AMNEAL PHARMS	Prescription	23 Nov 2015
OXYBUTYNIN CHLORIDE	5MG; 10MG; 15MG	tablet, extended release · oral	ACCORD HLTHCARE	Prescription	29 Feb 2016
OXYBUTYNIN CHLORIDE	5MG; 10MG; 15MG	tablet, extended release · oral	UNIQUE	Prescription	27 May 2016
OXYBUTYNIN CHLORIDE	5MG; 10MG; 15MG	tablet, extended release · oral	ZYDUS PHARMS	Prescription	26 Jun 2017
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	NOVITIUM PHARMA	Prescription	23 Oct 2017
OXYBUTYNIN CHLORIDE	5MG; 2.5MG	tablet · oral	RISING	Prescription	21 Dec 2017
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	ABHAI LLC	Prescription	22 Dec 2017
OXYBUTYNIN CHLORIDE	5MG; 2.5MG	tablet · oral	TP ANDA HOLDINGS	Prescription	6 Sep 2018
OXYBUTYNIN CHLORIDE	5MG; 10MG; 15MG	tablet, extended release · oral	AJANTA PHARMA LTD	Prescription	28 Feb 2019
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	HERITAGE PHARMA AVET	Prescription	10 May 2019
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	NOVAST LABS	Prescription	30 Oct 2019
OXYBUTYNIN CHLORIDE	5MG; 10MG; 15MG	tablet, extended release · oral	BIONPHARMA	Prescription	17 Dec 2019
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	LEADING	Prescription	6 Apr 2020
OXYBUTYNIN CHLORIDE	5MG; 10MG; 15MG	tablet, extended release · oral	RUBICON RESEARCH	Prescription	27 Oct 2020
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	STRIDES PHARMA	Prescription	17 Dec 2020
OXYBUTYNIN CHLORIDE	5MG	tablet · oral	REGCON HOLDINGS	Prescription	14 Jul 2022

18 more — full table

EMA European Union — centrally authorised medicines

Kentera (previously Oxybutynin Nicobrand) Teva B.V. · Authorised · authorised 15 Jun 2004 · ATC G04BD04

Therapeutic indication (EMA)

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-OXYBUTYNIN	02163543	5 MG	TABLET · ORAL	APOTEX INC
PMS-OXYBUTYNIN	02223376	5 MG / 5 ML	SYRUP · ORAL	PHARMASCIENCE INC
PMS-OXYBUTYNIN	02240549	2.5 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-OXYBUTYNIN	02240550	5 MG	TABLET · ORAL	PHARMASCIENCE INC
TEVA-OXYBUTYNIN	02230394	5 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	OXYBUTYNIN 2.5 MG TABLET	$1.96614	per EA	23 Sep 2026
US NADAC	OXYBUTYNIN 5 MG TABLET	$0.04798	per EA	7 Oct 2026
US NADAC	OXYBUTYNIN 5 MG/5 ML SOLUTION	$0.03271	per ML	23 Sep 2026
US NADAC	OXYBUTYNIN 5 MG/5 ML SYRUP	$0.03271	per ML	23 Sep 2026
US NADAC	OXYBUTYNIN CL ER 10 MG TABLET	$0.09973	per EA	23 Sep 2026
US NADAC	OXYBUTYNIN CL ER 15 MG TABLET	$0.125	per EA	23 Sep 2026
US NADAC	OXYBUTYNIN CL ER 5 MG TABLET	$0.08414	per EA	23 Sep 2026
US NADAC	OXYTROL 3.9 MG/24HR PATCH	$81.28545	per EA	23 Sep 2026
US NADAC	OXYTROL FOR WOMEN 3.9 MG/24HR	$2.7424	per EA	23 Sep 2026
NHS Drug Tariff	Oxybutynin 10mg modified-release tablets	£32.07	28 tablet	1 Oct 2026
NHS Drug Tariff	Oxybutynin 2.5mg tablets	£5.42	56 tablet	1 Oct 2026
NHS Drug Tariff	Oxybutynin 2.5mg/5ml oral solution sugar free	£94.99	150 ml	1 Oct 2026
NHS Drug Tariff	Oxybutynin 3.9mg/24hours transdermal patches	£27.20	8 patch	1 Oct 2026
NHS Drug Tariff	Oxybutynin 5mg modified-release tablets	£15.45	28 tablet	1 Oct 2026
NHS Drug Tariff	Oxybutynin 5mg tablets	£8.29	56 tablet	1 Oct 2026
NHS Drug Tariff	Oxybutynin 5mg/5ml oral solution sugar free	£89.78	150 ml	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 29 May 2024 OXYTROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Mar 2021 DITROPAN XL — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
EMA PRAC 4 Oct 2018 PRAC signal: Drug interaction between oxybutynin and carbamazepine resulting in seizures and carbamazepine overdose secondary to carbamazepine plasma level variations
Action for MAH: update of the product information: No
EMA PRAC 12 Jul 2018 PRAC signal: Dementia
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Drug interaction between oxybutynin and carbamazepine resulting in seizures and carbamazepine overdose secondary to carbamazepine plasma level variations
Action for MAH: update of the product information: No
US FDA 25 Oct 2017 GELNIQUE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 3 Mar 2016 OXYTROL FOR WOMEN — safety-related labeling change
Labeling sections changed: Warnings and Precautions
EMA PRAC 14 Jan 2016 PRAC signal: Psychiatric disorders
Action for MAH: update of the product information: Yes
EMA PRAC 6 Nov 2015 PRAC signal: Psychiatric disorders
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2015 PRAC signal: Psychiatric disorders
Action for MAH: update of the product information: No

All safety entries for oxybutynin →

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.