Is Tamsulosin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Tamsulosin, including GAMCET 0.4MG PROLONGED RELEASE F.C.TABLET (0.4 mg, Prolonged-release film-coated tablet, SAR 50.30); HARNAL 0.4MG MODIFIED RELEASE CAPSULES (0.4 mg, Modified-release capsule, SAR 86.90); NOSTAM 0.4 MG PROLONGED RELEASE TABLET (0.4 mg, Prolonged-release tablet, SAR 28.30); OMNIC OCAS 0.4 MG F-C TABLETS (0.4 mg, Film-coated tablet, SAR 71.70); Oxintel (0.4 mg, Capsule, SAR 63.00).

Is Tamsulosin approved by the US FDA?

Drugs@FDA lists 16 application product lines for Tamsulosin, including TAMSULOSIN HYDROCHLORIDE (Prescription); TAMSULOSIN HYDROCHLORIDE (Prescription); TAMSULOSIN HYDROCHLORIDE (Prescription); TAMSULOSIN HYDROCHLORIDE (Prescription); TAMSULOSIN HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Tamsulosin?

EMA PRAC: 3 entries; US FDA: 2 entries (latest 2020-12-28).

Active substance

Tamsulosin

SFDA 10
US FDA 16
Health Canada 9
US price lines 1
NHS prices 2
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GAMCET 0.4MG PROLONGED RELEASE F.C.TABLET	0.4 mg	Prolonged-release film-coated tablet · Oral use	30 Blister	SAR 50.30	Generic · Prescription	DAR ALDAWA	Valid
HARNAL 0.4MG MODIFIED RELEASE CAPSULES	0.4 mg	Modified-release capsule · Oral use	30 Blister	SAR 86.90	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
NOSTAM 0.4 MG PROLONGED RELEASE TABLET	0.4 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 28.30	Generic · Prescription	SANDOZ	Valid
OMNIC OCAS 0.4 MG F-C TABLETS	0.4 mg	Film-coated tablet · Oral use	30 Blister	SAR 71.70	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Oxintel	0.4 mg	Capsule · Oral use	30 Blister	SAR 63.00	Generic · Prescription	Doctors Pharmaceutical manufacturer	Valid
PROSTA TAB	0.4 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 77.80	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
TAMFREX	0.4 mg	Prolonged-release capsule · Oral use	30 Blister	SAR 63.00	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
Tamosymp	0.4 mg	Modified-release capsule, hard · Oral use	30 Blister	SAR 63.05	Generic · Prescription	ADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANY	Valid
CIGAPRO 0.4 mg Prolonged Release Tablet	0.4 mg	Prolonged-release film-coated tablet · Oral use	30 Blister	SAR 70.00	Generic · Prescription	CIGALAH PHARMA	Withdrawn by regulatory authority · Not Marketed
OMNIC 0.4MG MODFIED RELEASE CAPSULE	0.4 mg	Film-coated tablet · Oral use	30 Blister	SAR 99.75	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE MANIA; BENIGN PROSTATIC HYPERTROPHY; RENAL AND URETERIC STONES

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

Product	Strength	Form · route	Applicant	Status	First approved
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	IMPAX LABS	Prescription	2 Mar 2010
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	TEVA PHARMS	Prescription	27 Apr 2010
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	ZYDUS PHARMS USA INC	Prescription	27 Apr 2010
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	SYNTHON BV	Prescription	27 Apr 2010
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	SCIEGEN PHARMS	Prescription	27 Apr 2010
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	AUROBINDO PHARMA LTD	Prescription	30 Apr 2013
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	MACLEODS PHARMS	Prescription	20 Jan 2017
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	ALKEM LABS LTD	Prescription	11 Aug 2017
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	CHARTWELL RX	Prescription	17 Oct 2019
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	ASCENT PHARMS INC	Prescription	4 May 2022
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	RISING	Prescription	1 May 2025
FLOMAX	0.4MG	capsule · oral	SANOFI	Discontinued	15 Apr 1997
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	SANDOZ	Discontinued	27 Apr 2010
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	PHARMOBEDIENT	Discontinued	27 Apr 2010
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	SUN PHARM INDS LTD	Discontinued	15 Jul 2010
TAMSULOSIN HYDROCHLORIDE	0.4MG	capsule · oral	PH HEALTH	Discontinued	4 Jan 2013

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-TAMSULOSIN CR	02362406	0.4 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
AURO-TAMSULOSIN CR	02545179	0.4 MG	TABLET (EXTENDED-RELEASE) · ORAL	AURO PHARMA INC
JAMP TAMSULOSIN	02352419	0.4 MG	CAPSULE (SUSTAINED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
SANDOZ TAMSULOSIN	02319217	0.4 MG	CAPSULE (SUSTAINED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TAMSULOSIN CR	02340208	0.4 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
TAMSULOSIN CR	02413612	0.4 MG	TABLET (EXTENDED-RELEASE) · ORAL	PRO DOC LIMITEE
TAMSULOSIN CR	02427117	0.4 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANIS HEALTH INC
TAMSULOSIN CR	02429667	0.4 MG	TABLET (EXTENDED-RELEASE) · ORAL	SIVEM PHARMACEUTICALS ULC
TEVA-TAMSULOSIN CR	02368242	0.4 MG	TABLET (EXTENDED-RELEASE) · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TAMSULOSIN HCL 0.4 MG CAPSULE	$0.04997	per EA	23 Sep 2026
NHS Drug Tariff	Tamsulosin 400microgram modified-release capsules	£1.17	30 capsule	1 Oct 2026
NHS Drug Tariff	Tamsulosin 400microgram modified-release tablets	£10.47	30 tablet	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 28 Dec 2020 JALYN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Jan 2019 FLOMAX — safety-related labeling change
Labeling sections changed: Use in Specific Populations
EMA PRAC 10 Sep 2015 PRAC signal: Urinary incontinence
Action for MAH: update of the product information: No
EMA PRAC 7 May 2015 PRAC signal: Urinary incontinence
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2013 PRAC signal: Dry mouth syndrome
Action for MAH: update of the product information: Yes

All safety entries for tamsulosin →

Combinations containing Tamsulosin

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.