Is Dutasteride registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Dutasteride, including AVODART 0.5MG CAPSULE (0.5 mg, Capsule, SAR 111.90); Duserex (0.5 mg, Capsule, soft, SAR 81.80); Dusta (0.5 mg, Capsule, soft, SAR 90.90).

Is Dutasteride approved by the US FDA?

Drugs@FDA lists 20 application product lines for Dutasteride, including AVODART (Prescription); DUTASTERIDE (Prescription); DUTASTERIDE (Prescription); DUTASTERIDE (Prescription); DUTASTERIDE (Prescription).

Are there safety signals or safety updates for Dutasteride?

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

Active substance

Dutasteride

SFDA 3
US FDA 20
Health Canada 12
US price lines 1
NHS prices 1
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
AVODART 0.5MG CAPSULE	0.5 mg	Capsule · Oral use	30 Blister	SAR 111.90	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
Duserex	0.5 mg	Capsule, soft · Oral use	30 Blister	SAR 81.80	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Dusta	0.5 mg	Capsule, soft · Oral use	30 Blister	SAR 90.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY

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

Product	Strength	Form · route	Applicant	Status	First approved
AVODART	0.5MG	capsule · oral	WAYLIS THERAP	Prescription	20 Nov 2001
DUTASTERIDE	0.5MG	capsule · oral	BARR	Prescription	21 Dec 2010
DUTASTERIDE	0.5MG	capsule · oral	CHARTWELL	Prescription	20 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	AUROBINDO PHARMA LTD	Prescription	20 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	AMNEAL PHARMS	Prescription	20 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	ONESOURCE	Prescription	20 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	ACELLA	Prescription	17 Mar 2016
DUTASTERIDE	0.5MG	capsule · oral	ASCENT PHARMS INC	Prescription	21 Oct 2016
DUTASTERIDE	0.5MG	capsule · oral	MARKSANS PHARMA	Prescription	7 Apr 2017
DUTASTERIDE	0.5MG	capsule · oral	ZYDUS LIFESCIENCES	Prescription	4 Oct 2017
DUTASTERIDE	0.5MG	capsule · oral	HUMANWELL PURACAP	Prescription	21 Nov 2017
DUTASTERIDE	0.5MG	capsule · oral	PH HEALTH	Discontinued	20 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	RISING	Discontinued	20 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	ACTAVIS LABS FL INC	Discontinued	20 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	PHARMOBEDIENT	Discontinued	20 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	HIKMA PHARMS	Discontinued	23 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	APOTEX	Discontinued	24 Nov 2015
DUTASTERIDE	0.5MG	capsule · oral	PHARMOBEDIENT	Discontinued	14 Jun 2016
DUTASTERIDE	0.5MG	capsule · oral	HERITAGE PHARMS INC	Discontinued	13 Oct 2017
DUTASTERIDE	0.5MG	capsule · oral	STRIDES PHARMA	Discontinued	22 Jun 2018

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-DUTASTERIDE	02485672	0.5 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
APO-DUTASTERIDE	02404206	0.5 MG	CAPSULE · ORAL	APOTEX INC
AURO-DUTASTERIDE	02469308	0.5 MG	CAPSULE · ORAL	AURO PHARMA INC
AVODART	02247813	0.5 MG	CAPSULE · ORAL	GLAXOSMITHKLINE INC
DUTASTERIDE	02429012	0.5 MG	CAPSULE · ORAL	SIVEM PHARMACEUTICALS ULC
DUTASTERIDE	02443058	0.5 MG	CAPSULE · ORAL	SANIS HEALTH INC
JAMP DUTASTERIDE CAPSULES	02546167	0.5 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
MINT-DUTASTERIDE	02428873	0.5 MG	CAPSULE · ORAL	MINT PHARMACEUTICALS INC
NRA-DUTASTERIDE	02490587	0.5 MG	CAPSULE · ORAL	NORA PHARMA INC
PRO-DUTASTERIDE	02543990	0.5 MG	CAPSULE · ORAL	PRO DOC LIMITEE
SANDOZ DUTASTERIDE	02424444	0.5 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
TEVA-DUTASTERIDE	02408287	0.5 MG	CAPSULE · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DUTASTERIDE 0.5 MG CAPSULE	$0.15702	per EA	23 Sep 2026
NHS Drug Tariff	Dutasteride 500microgram capsules	£2.45	30 capsule	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
EMA PRAC 17 Apr 2020 PRAC signal: Type 2 diabetes mellitus
Action for MAH: update of the product information: No
US FDA 30 Jan 2020 AVODART — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 31 Oct 2019 PRAC signal: Type 2 diabetes mellitus
Action for MAH: update of the product information: No
EMA PRAC 16 May 2019 PRAC signal: Type 2 diabetes mellitus
Action for MAH: update of the product information: No

All safety entries for dutasteride →

Combinations containing Dutasteride

Dutasteride + 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.