Tamsulosin

Overview

Tamsulosin is a selective alpha-1A and alpha-1B adrenoceptor antagonist that exerts its greatest effect in the prostate and bladder, where these receptors are most common. It is indicated for the treatment of signs and symptoms of benign prostatic hypertrophy. Antagonism of these receptors leads to relaxation of smooth muscle in the prostate and detrusor muscles in the bladder, allowing for better urinary flow. Other alpha-1 adrenoceptor antagonists developed in the 1980s were less selective and more likely to act on the smooth muscle of blood vessels, resulting in hypotension. Tamsulosin was first approved by the FDA on April 15, 1997.

Indication

Tamsulosin is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Tamsulosin is also used off label for the treatment of ureteral stones, prostatitis, and female voiding dysfunction.

Associated Conditions

Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Hypertrophy
Bladder Outlet Obstruction
Ureteral Calculus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparing Tamsulosin and Solifenacin for Relieving Double J Stent Symptoms: Using the USSQ.	2025/08/11	NCT07114848	Not Applicable	Completed	Liaquat National Hospital & Medical College
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed Conditions	2025/07/29	NCT07091669	Not Applicable	Active, not recruiting	Berlin-Chemie AG Menarini Group
Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms	2025/05/13	NCT06966804	Phase 3	Not yet recruiting	Penang Hospital, Malaysia
L-Arginine Role for Stone Lower Ureter : A Randomized Control Study	2025/03/25	NCT06753526	Phase 4	Completed	Sohag University
The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia	2025/03/10	NCT06867315	Not Applicable	Recruiting	First Affiliated Hospital of Zhejiang University
Management of Dysuria and Irritative Symptoms After HoLEP: a Prospective Study Evaluating the Efficacy of Alpha-Blocker Therapy	2025/03/07	NCT06865430	Not Applicable	Recruiting	Ankara Training and Research Hospital
Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery	2025/02/25	NCT06843538	Phase 3	Recruiting	TriHealth Inc.
Efficacy and Safety of Tadalafil, Tamsulosin, and Their Combinations in Treating Lower Urinary Tract Symptoms in BPH Patients with Prostate Volumes ≤ 40 Ml: a Prospective Comparative Study	2025/02/05	NCT06809205	Phase 4	Completed	Fayoum University Hospital
Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms	2025/01/31	NCT06803030	Phase 3	Not yet recruiting	Bir Hospital
Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination With Alpha Blockers: A Prospective Randomized Controlled Study	2024/12/31	NCT06754410	Phase 3	Completed	South Valley University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
TAMSULOSIN HYDROCHLORIDE	DirectRX	61919-298	ORAL	0.4 mg in 1 1	1/21/2020
Dutasteride and tamsulosin hydrochloride	Zydus Pharmaceuticals USA Inc.	68382-640	ORAL	0.4 mg in 1 1	10/6/2022
TAMSULOSIN HYDROCHLORIDE	WOCKHARDT LIMITED	55648-516	ORAL	0.4 mg in 1 1	6/23/2010
Tamsulosin Hydrochloride	Major Pharmaceuticals	0904-7383	ORAL	0.4 mg in 1 1	10/9/2023
Tamsulosin Hydrochloride	MedVantx, Inc.	66116-435	ORAL	0.4 mg in 1 1	7/20/2012
Tamsulosin Hydrochloride	Rising Pharma Holdings, Inc.	57237-014	ORAL	0.4 mg in 1 1	11/17/2023
Tamsulosin Hydrochloride	XLCare Pharmaceuticals, Inc	72865-282	ORAL	0.4 mg in 1 1	1/27/2025
Dutasteride and Tamsulosin Hydrochloride	AvKARE	42291-031	ORAL	0.4 mg in 1 1	11/15/2023
Tamsulosin Hydrochloride	Proficient Rx LP	63187-371	ORAL	0.4 mg in 1 1	1/1/2023
Tamsulosin Hydrochloride	Proficient Rx LP	63187-469	ORAL	0.4 mg in 1 1	1/1/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TAMSIN PROLONGED RELEASE TABLET 0.4MG	Synthon Hispania S.L., GE Pharmaceuticals, Ltd. (Primary & Secondary Packager), Rottendorf Pharma GmbH	SIN15476P	TABLET, FILM COATED, EXTENDED RELEASE	0.4mg	5/3/2018
Harnal OCAS Prolonged Release Film-coated Tablet 400mcg	Astellas Pharma Europe B.V.	SIN13696P	TABLET, FILM COATED, EXTENDED RELEASE	0.4 mg	8/21/2009
TAMSULOSIN-TEVA PROLONGED RELEASE FILM-COATED TABLET 400MCG	Teva Pharmaceutical Works Private Limited Company	SIN16191P	TABLET, FILM COATED, EXTENDED RELEASE	0.40 mg	5/11/2021
TASULOSE PROLONGED-RELEASE FILM-COATED TABLETS 400 mcg	Lek Pharmaceuticals d.d. (Ljubljana), Lek Pharmaceuticals d.d. (Lendava) (Primary and Secondary Packager)	SIN15573P	TABLET, FILM COATED, EXTENDED RELEASE	0.4mg	11/1/2018
DUTABIT PLUS 0.5/0.4 CAPSULES 0.5MG/0.4MG	AUROBINDO PHARMA LIMITED - UNIT VII	SIN16633P	CAPSULE	0.4mg	11/1/2022
Duodart Capsules 0.5mg/0.4mg	Catalent Germany Schorndorf GmbH (formerly Cardinal Health Germany 405 GmbH) - Encapsulation, Catalent France Beinheim SA (formerly Cardinal Health France 404) - Dutasteride Intermediate Product, Rottendorf Pharma GmbH - Tamsulosin HCl Intermediate Product, Delpharm Poznań S.A. - Dutasteride Intermediate Product	SIN14181P	CAPSULE	0.4 mg	7/2/2012
DUOFLOW CAPSULE 0.5mg/0.4mg	LABORATORIOS LEÓN FARMA, SA (DP intermediate dutasteride capsule and final DP), ZENTIVA SA (DP intermediate tamsulosin pellets), LABORATORIOS LICONSA, S.A (Primary packager and Secondary packager)	SIN16558P	CAPSULE	0.4mg	7/20/2022
LOTUFLO-D CAPSULES 0.5 MG/0.4 MG	LABORATORIOS LEÓN FARMA, SA (DP intermediate dutasteride capsule and final DP), S.C. ZENTIVA S.A. (DP Intermediate, Tamsulosin pellet), LABORATORIOS LICONSA, S.A (primary and secondary packager)	SIN16678P	CAPSULE	0.4 mg	1/17/2023

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
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE SANDOZ CAPSULES 0.5MG/0.4MG	N/A	Sandoz Hong Kong Limited	N/A	N/A	7/11/2024
DUTABIT PLUS 0.5/0.4 CAPSULES 0.5MG/0.4MG	N/A	HANG LUNG TRADING CO	N/A	N/A	9/13/2024
DUODART CAPSULE 0.5MG/0.4MG	N/A	葛兰素史克	N/A	N/A	3/22/2012

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TAMSULOSIN-WGR SR tamsulosin hydrochloride 400 microgram modified release tablet blister pack	433930	Southern Cross Pharma Pty Ltd	Medicine	A	5/13/2024
TAMSULOSIN LUPIN SR tamsulosin hydrochloride 400 microgram modified release tablet blister pack	313160	Southern Cross Pharma Pty Ltd	Medicine	A	2/25/2020
DUTATAM 500/400 dutasteride 500 microgram/tamsulosin hydrochloride 400 microgram modified release capsule bottle	414643	MedTAS Pty Ltd	Medicine	A	6/24/2024
FLOMAXTRA tamsulosin hydrochloride 400 microgram prolonged release tablet blister pack	115534	Astellas Pharma Australia Pty Ltd	Medicine	A	1/18/2006
DUTASTERIDE/TAMSULOSIN ALIDAC 500/400 dutasteride 500 microgram/tamsulosin hydrochloride 400 microgram modified release capsule bottle	414645	KSJ Pharmatech	Medicine	A	6/24/2024
DUTASTERIDE/TAMSULOSIN LUPIN 500/400 dutasteride 500 microgram/tamsulosin hydrochloride 400 microgram modified release capsule bottle	414647	Generic Health Pty Ltd	Medicine	A	6/24/2024
APO-TAMSULOSIN SR tamsulosin hydrochloride 400 microgram modified release tablet blister pack	313161	Southern Cross Pharma Pty Ltd	Medicine	A	2/25/2020
DOUBLUTS dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule bottle	326621	GlaxoSmithKline Australia Pty Ltd	Medicine	A	3/4/2020
DUTASTERIDE/TAMSULOSIN SANDOZ 500/400 dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule blister pack	362953	Sandoz Pty Ltd	Medicine	A	6/19/2024
BLOOMS THE CHEMIST TAMSULOSIN SR tamsulosin hydrochloride 400 microgram modified release tablet blister pack	313163	Southern Cross Pharma Pty Ltd	Medicine	A	2/25/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RAN-TAMSULOSIN	ranbaxy pharmaceuticals canada inc.	02294885	Capsule (Sustained-Release) - Oral	0.4 MG	8/15/2007
MYLAN-TAMSULOSIN	Mylan Pharmaceuticals ULC	02298570	Capsule (Extended Release) - Oral	0.4 MG	8/16/2007
FLOMAX	boehringer ingelheim (canada) ltd ltee	02238123	Capsule (Sustained-Release) - Oral	0.4 MG	6/19/1998
APO-TAMSULOSIN CR	Apotex Inc	02362406	Tablet (Extended-Release) - Oral	0.4 MG	2/9/2012
FLOMAX CR	boehringer ingelheim (canada) ltd ltee	02270102	Tablet (Extended-Release) - Oral	0.4 MG	10/11/2005
TAMSULOSIN CR	sanis health inc	02427117	Tablet (Extended-Release) - Oral	0.4 MG	7/24/2014
RATIO-TAMSULOSIN	teva canada limited	02294265	Capsule (Sustained-Release) - Oral	0.4 MG / CAP	4/27/2007
TAMSULOSIN CR	PRO DOC LIMITEE	02413612	Tablet (Extended-Release) - Oral	0.4 MG	11/21/2013
SANDOZ TAMSULOSIN	Sandoz Canada, Inc.	02319217	Capsule (Sustained-Release) - Oral	0.4 MG	3/19/2014
SANDOZ TAMSULOSIN CR	Sandoz Canada, Inc.	02340208	Tablet (Extended-Release) - Oral	0.4 MG	1/4/2011

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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