Is Doxazosin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Doxazosin, including CARDURA 1 mg tablet (1 mg, Tablet, SAR 30.75); CARDURA 2 mg tablet (2 mg, Tablet, SAR 30.75); CARDURA XL 4 mg tablet (4 mg, Prolonged-release tablet, SAR 34.00); UNIPROST 4 MG TABLETS (4 mg, Tablet, SAR 24.90).

Is Doxazosin approved by the US FDA?

Drugs@FDA lists 21 application product lines for Doxazosin, including CARDURA (Prescription); DOXAZOSIN MESYLATE (Prescription); DOXAZOSIN MESYLATE (Prescription); DOXAZOSIN MESYLATE (Prescription); CARDURA XL (Prescription).

Are there safety signals or safety updates for Doxazosin?

US FDA: 2 entries (latest 2017-02-27).

Active substance

Doxazosin

SFDA 8
US FDA 21
Health Canada 9
US price lines 5
NHS prices 6
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CARDURA 1 mg tablet	1 mg	Tablet · Oral use	20 Blister	SAR 30.75	NCE · Prescription	UPJOHN UK LIMITED	Valid
CARDURA 2 mg tablet	2 mg	Tablet · Oral use	20 Blister	SAR 30.75	NCE · Prescription	UPJOHN UK LIMITED	Valid
CARDURA XL 4 mg tablet	4 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 34.00	NCE · Prescription	PFIZER OFG GERMANY GMBH	Valid
UNIPROST 4 MG TABLETS	4 mg	Tablet · Oral use	20 Blister	SAR 24.90	Generic · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
CARDURA 4 mg tablet	4 mg	Prolonged-release tablet · Oral use	20 Blister	SAR 30.75	NCE · Prescription	PFIZER	Invalid · Not Marketed
DOXAGEN 1	1 mg	Tablet · Oral use	20 Blister	SAR 27.65	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
DOXAGEN 2	2 mg	Tablet · Oral use	20 Blister	SAR 27.65	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
DOXAGEN 4	4 mg	Tablet · Oral use	20 Blister	SAR 27.65	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY; HYPERTENSION; RENAL AND URETERIC STONES

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

Product	Strength	Form · route	Applicant	Status	First approved
CARDURA	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	VIATRIS	Prescription	2 Nov 1990
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	TEVA	Prescription	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	APOTEX	Prescription	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	AUROBINDO PHARMA USA	Prescription	19 Oct 2000
CARDURA XL	EQ 4MG BASE; EQ 8MG BASE	tablet, extended release · oral	VIATRIS	Prescription	22 Feb 2005
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	ACCORD HLTHCARE	Prescription	11 Jun 2014
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	ZYDUS PHARMS	Prescription	7 Jul 2017
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	HERITAGE PHARMA	Prescription	13 Feb 2018
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	SOMERSET THERAPS LLC	Prescription	17 Apr 2018
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	RISING	Prescription	15 Mar 2022
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	UNICHEM	Prescription	10 Jan 2024
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	WATSON LABS INC	Discontinued	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	ANI PHARMS	Discontinued	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	IVAX SUB TEVA PHARMS	Discontinued	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	GENPHARM	Discontinued	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	ACTAVIS ELIZABETH	Discontinued	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	NESHER PHARMS	Discontinued	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	CHARTWELL RX	Discontinued	18 Oct 2000
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	TEVA	Discontinued	12 Jan 2001
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	PLIVA	Discontinued	8 Jun 2001
DOXAZOSIN MESYLATE	EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE; EQ 8MG BASE	tablet · oral	STRIDES PHARMA INTL	Discontinued	10 Jun 2004

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-DOXAZOSIN	02240588	1 MG / TAB	TABLET · ORAL	APOTEX INC
APO-DOXAZOSIN	02240589	2 MG / TAB	TABLET · ORAL	APOTEX INC
APO-DOXAZOSIN	02240590	4 MG / TAB	TABLET · ORAL	APOTEX INC
JAMP-DOXAZOSIN	02489937	1 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-DOXAZOSIN	02489945	2 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-DOXAZOSIN	02489953	4 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
TEVA-DOXAZOSIN	02242728	1 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-DOXAZOSIN	02242729	2 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-DOXAZOSIN	02242730	4 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CARDURA XL 4 MG TABLET	$6.98895	per EA	23 Sep 2026
US NADAC	DOXAZOSIN MESYLATE 1 MG TAB	$0.07519	per EA	23 Sep 2026
US NADAC	DOXAZOSIN MESYLATE 2 MG TAB	$0.06355	per EA	23 Sep 2026
US NADAC	DOXAZOSIN MESYLATE 4 MG TAB	$0.08343	per EA	23 Sep 2026
US NADAC	DOXAZOSIN MESYLATE 8 MG TAB	$0.09759	per EA	30 Sep 2026
NHS Drug Tariff	Doxazosin 1mg tablets	£0.79	28 tablet	1 Oct 2026
NHS Drug Tariff	Doxazosin 2mg tablets	£1.05	28 tablet	1 Oct 2026
NHS Drug Tariff	Doxazosin 4mg modified-release tablets	£2.95	28 tablet	1 Oct 2026
NHS Drug Tariff	Doxazosin 4mg tablets	£1.25	28 tablet	1 Oct 2026
NHS Drug Tariff	Doxazosin 8mg modified-release tablets	£9.98	28 tablet	1 Oct 2026
NHS Drug Tariff	Doxazosin 8mg tablets	£53.90	28 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 27 Feb 2017 CARDURA XL — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 9 Jun 2016 CARDURA — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for doxazosin →

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.