Oxybutynin

Overview

Overactive bladder (OAB) is a common condition negatively impacting the lives of millions of patients worldwide. Due to its urinary symptoms that include nocturia, urgency, and frequency, this condition causes social embarrassment and a poor quality of life. Oxybutynin, also marketed as Ditropan XL, is an anticholinergic medication used for the relief of overactive bladder symptoms that has been optimized for high levels of safety and efficacy since initial FDA approval in 1975. This drug relieves undesirable urinary symptoms, increasing the quality of life for patients affected by OAB. It is often used as first-line therapy for OAB.

Indication

Oxybutynin is indicated for the symptomatic treatment of overactive bladder, which causes urge urinary incontinence and frequency, and urgency. Oxybutynin may also be used for children aged 6 and above for the symptomatic management of detrusor muscle overactivity which has been found to be related to a neurological condition. Spina bifida is an example of a neurological condition in which oxybutynin may be used to control urinary symptoms. On occasion, oxybutynin may be used off-label to relieve bladder spasms associated with ureteral stents or urinary catheters.

Associated Conditions

Bladder Spasms
Detrusor Hyperreflexia
Overactive Bladder Syndrome (OABS)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Transdermal Versus Oral Oxybutynin in Pediatric OAB	2025/07/23	NCT07081906	Not Applicable	Completed	Dr. Lutfi Kirdar Kartal Training and Research Hospital
Treatment of Overactive Bladder With Anticholinergic Agents	2025/07/01	NCT07046156	N/A	Active, not recruiting	Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction	2025/06/18	NCT07027020	Phase 3	Not yet recruiting	Central Hospital, Nancy, France
Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.	2024/12/17	NCT06737016	Phase 3	Recruiting	Mansoura University
A Trial Evaluating the Clinical Efficacy and Safety of Hibero SR (Mirabegron) 50 mg and Ditropan (Oxybutynin Chloride) 10 mg in Children Between 5 and 18 Years With Overactive Bladder (OAB)	2023/12/26	NCT06181591	Phase 2	Not yet recruiting	Seoul National University Hospital
Effectiveness of Oral Boldo in Women With Overactive Bladder	2023/12/08	NCT06162065	Phase 1	ENROLLING_BY_INVITATION	Universidad de Valparaiso
REDucing Hot FLASHes in Women Using Endocrine Therapy.	2023/10/30	NCT06106529	Phase 3	Recruiting	Reinier de Graaf Groep
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats	2023/09/22	NCT06049797	N/A	Active, not recruiting	Astellas Pharma Global Development, Inc.
Efficacy and Safety of Oxybutynin Versus Paroxetine in Aromatase Inhibitor-induced Vasomotor Symptoms	2022/12/05	NCT05637671	Phase 3	Recruiting	Cairo University
Identifying Sleep Apnea Patients That Best Respond to Atomoxetine Plus Oxybutynin Therapy	2022/09/22	NCT05550246	Phase 1	Recruiting	Brigham and Women's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Oxybutynin Chloride	Physicians Total Care, Inc.	54868-5728	ORAL	10 mg in 1 1	1/21/2010
Oxybutynin Chloride	Bryant Ranch Prepack	71335-0519	ORAL	5 mg in 1 1	12/20/2019
Oxybutynin Chloride Extended Release	American Health Packaging	68084-610	ORAL	10 mg in 1 1	2/7/2023
oxybutynin chloride	A-S Medication Solutions	50090-4307	ORAL	10 mg in 1 1	3/15/2023
Oxybutynin Chloride	Marlex Pharmaceuticals Inc	10135-610	ORAL	10 mg in 1 1	12/12/2019
Oxybutynin Chloride	Physicians Total Care, Inc.	54868-2157	ORAL	5 mg in 1 1	3/18/2013
Oxybutynin Chloride	Teva Pharmaceuticals USA, Inc.	50111-456	ORAL	5 mg in 1 1	9/2/2024
oxybutynin	Zydus Pharmaceuticals USA Inc.	68382-255	ORAL	5 mg in 1 1	11/7/2023
Oxybutynin Chloride	Marlex Pharmaceuticals Inc	10135-640	ORAL	5 mg in 1 1	10/30/2019
Oxybutynin Chloride Extended Release	Aphena Pharma Solutions - Tennessee, LLC	43353-322	ORAL	15 mg in 1 1	5/31/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Kentera (previously Oxybutynin Nicobrand)	Teva B.V.,Teva B.V.,Swensweg 5,2031 GA Haarlem,The Netherlands	Authorised	6/15/2004

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
OBUTIN TABLETS 5 mg	HANLIM PHARMACEUTICAL CO LTD	SIN11215P	TABLET	5 mg	11/4/1999

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OXYTROL oxybutynin 3.9 mg/day transdermal drug delivery system	125489	Theramex Australia Pty Ltd	Medicine	A	5/10/2007
OXYBUTYNIN ARW oxybutynin hydrochloride 5 mg tablet bottle	301918	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/12/2019
OXYBUTYNIN TIH oxybutynin hydrochloride 5 mg tablet bottle	301919	Strides Pharma Science Pty Ltd	Medicine	A	4/12/2019
OXYBUPAN oxybutynin hydrochloride 5 mg tablet bottle	301920	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/12/2019
DITROPAN oxybutynin hydrochloride 5mg tablet	48965	Sanofi-Aventis Australia Pty Ltd	Medicine	A	5/30/1994

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DITROPAN XL	Janssen Inc	02243960	Tablet (Extended-Release) - Oral	5 MG	6/22/2001
PAT-OXYBUTYNIN CHLORIDE ER	Janssen Inc	02419998	Tablet (Extended-Release) - Oral	5 MG	N/A
RIVA-OXYBUTYNIN	laboratoire riva inc.	02299364	Tablet - Oral	5 MG	6/9/2008
PMS-OXYBUTYNIN	Pharmascience Inc	02223376	Syrup - Oral	5 MG / 5 ML	9/4/1996
NTP-OXYBUTYNIN	teva canada limited	02347229	Tablet - Oral	5 MG	N/A
DITROPAN XL	Janssen Inc	02243961	Tablet (Extended-Release) - Oral	10 MG	6/22/2001
UROMAX	purdue pharma	02273586	Tablet (Extended-Release) - Oral	15 MG	5/15/2006
PHL-OXYBUTYNIN	pharmel inc	02245827	Tablet - Oral	5 MG	5/29/2002
OXYBUTYNIN	Apotex Inc	02158590	Tablet - Oral	5 MG	N/A
OXYTROL	Allergan, Inc.	02254735	Patch - Transdermal	3.9 MG / 24 HOUR	8/12/2004

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
KENTERA 3,9 mg/24 HORAS, PARCHE TRANSDERMICO	Teva B.V.	03270001	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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