Is Alfuzosin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Alfuzosin, including ALFOSIN XR 10 mg prolonged-release tablet (10 mg, Extended-release tablet, SAR 70.75); Hi-Alfa SR (10 mg, Prolonged-release tablet, SAR 79.65); URITAB XL 10MG EXTENDED RELEASE TABLETS (10 mg, Extended-release tablet, SAR 93.70); XATRAL XL 10 MG (10 mg, Prolonged-release tablet, SAR 93.70); Xyvora XL (10 mg, Prolonged-release tablet, SAR 79.65).

Is Alfuzosin approved by the US FDA?

Drugs@FDA lists 10 application product lines for Alfuzosin, including UROXATRAL (Prescription); ALFUZOSIN HYDROCHLORIDE (Prescription); ALFUZOSIN HYDROCHLORIDE (Prescription); ALFUZOSIN HYDROCHLORIDE (Prescription); ALFUZOSIN HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Alfuzosin?

US FDA: 1 entry (latest 2020-05-22).

Active substance

Alfuzosin

SFDA 8
US FDA 10
Health Canada 6
US price lines 1
NHS prices 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALFOSIN XR 10 mg prolonged-release tablet	10 mg	Extended-release tablet · Oral use	30 Blister	SAR 70.75	Generic · Prescription	APOTEX	Valid
Hi-Alfa SR	10 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 79.65	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
URITAB XL 10MG EXTENDED RELEASE TABLETS	10 mg	Extended-release tablet · Oral use	30 Blister	SAR 93.70	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
XATRAL XL 10 MG	10 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 93.70	NCE · Prescription	Sanofi Aventis France	Valid
Xyvora XL	10 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 79.65	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
XATRAL 2.5MG TAB	2.5 mg	Tablet · Oral use	30 Blister	SAR 48.10	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
XATRAL 5MG S.R.TAB	5 mg	Tablet · Oral use	56 Blister	SAR 124.70	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
XATRAL XL 10 MG	10 mg	Tablet · Oral use	30 Blister	SAR 133.85	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY; RENAL AND URETERIC STONES

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

Product	Strength	Form · route	Applicant	Status	First approved
UROXATRAL	10MG	tablet, extended release · oral	ADVANZ PHARMA	Prescription	12 Jun 2003
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	APOTEX INC	Prescription	18 Jul 2011
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	INVAGEN PHARMS	Prescription	17 Jan 2012
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	AUROBINDO PHARMA LTD	Prescription	30 Aug 2012
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	UNICHEM	Prescription	28 Jan 2016
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	PHARMOBEDIENT	Discontinued	18 Jul 2011
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	TORRENT PHARMS	Discontinued	18 Jul 2011
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	CHARTWELL RX	Discontinued	18 Jul 2011
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	SUN PHARM	Discontinued	18 Jul 2011
ALFUZOSIN HYDROCHLORIDE	10MG	tablet, extended release · oral	WOCKHARDT BIO AG	Discontinued	10 Aug 2012

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALFUZOSIN	02447576	10 MG	TABLET (EXTENDED-RELEASE) · ORAL	SIVEM PHARMACEUTICALS ULC
ALFUZOSIN	02519844	10 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANIS HEALTH INC
APO-ALFUZOSIN	02315866	10 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
AURO-ALFUZOSIN	02443201	10 MG	TABLET (EXTENDED-RELEASE) · ORAL	AURO PHARMA INC
SANDOZ ALFUZOSIN	02304678	10 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
XATRAL	02245565	10 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANOFI-AVENTIS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ALFUZOSIN HCL ER 10 MG TABLET	$0.10513	per EA	23 Sep 2026
NHS Drug Tariff	Alfuzosin 10mg modified-release tablets	£14.83	30 tablet	1 Oct 2026
NHS Drug Tariff	Alfuzosin 2.5mg tablets	£8.27	60 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 22 May 2020 UROXATRAL — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for alfuzosin →

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.