Is Ketoconazole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Ketoconazole, including AVORAL 2% SHAMPOO (2 %, Shampoo, SAR 18.30); CLARAZOLE 2% CREAM (2 %, Cream, SAR 13.15); CLARAZOLE 2% SHAMPOO (2 %, Shampoo, SAR 16.95); DROF 2% SHAMPOO (2 %, Shampoo, SAR 15.25); NIZORAL CREAM 2% (2 %, Cream, SAR 19.35).

Is Ketoconazole approved by the US FDA?

Drugs@FDA lists 28 application product lines for Ketoconazole, including NIZORAL ANTI-DANDRUFF (Over-the-counter); KETOCONAZOLE (Prescription); KETOCONAZOLE (Prescription); KETOCONAZOLE (Prescription); KETOZOLE (Prescription).

Is Ketoconazole authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ketoconazole: Ketoconazole Esteve (previously Ketoconazole HRA).

Are there safety signals or safety updates for Ketoconazole?

US FDA: 2 entries (latest 2019-12-26).

Active substance

Ketoconazole

SFDA 14
US FDA 28
EMA 2
Health Canada 4
US price lines 7
NHS prices 3
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
AVORAL 2% SHAMPOO	2 %	Shampoo · Topical	1 Bottle	SAR 18.30	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
CLARAZOLE 2% CREAM	2 %	Cream · Topical	1 Tube	SAR 13.15	Generic · Prescription	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Valid
CLARAZOLE 2% SHAMPOO	2 %	Shampoo · Topical	1 Bottle	SAR 16.95	Generic · Prescription	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Valid
DROF 2% SHAMPOO	2 %	Shampoo · Topical	1 Bottle	SAR 15.25	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
NIZORAL CREAM 2%	2 %	Cream · Topical	1 Tube	SAR 19.35	NCE · Prescription	STADA ARZNEIMITTEL GmbH	Valid
NIZORAL SHAMPOO	2 %	Shampoo · Topical	1 Bottle	SAR 30.55	NCE · Prescription	STADA ARZNEIMITTEL GmbH	Valid
VAVO 2% SHAMPOO	2 %	Shampoo · Topical	1 Bottle	SAR 26.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
AVORAL	2 %	Shampoo · Topical	1 Bottle	SAR 15.25	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Withdrawn by MAH · Not Marketed
KENAZOLE 2% CREAM	2 %	Cream · Topical	1 Tube	SAR 6.75	Generic · Prescription	Pharma International Co.	Withdrawn by MAH · Not Marketed
KENAZOLE 2% SHAMPOO	2 %	Shampoo · Topical	1 Bottle	SAR 15.10	Generic · Prescription	Pharma International Co.	Withdrawn by MAH · Not Marketed
NIZORAL 200MG TAB	200 mg	Tablet · Oral use	10 Blister	SAR 45.70	Generic · Prescription	JANSSEN-CILAG	Withdrawn by regulatory authority · Not Marketed
PHILAZOLE 2% W-W SHAMPOO	2 %	Shampoo · Topical	1 Bottle	SAR 16.75	Generic · Prescription	PHILADELPHIA PHARMACEUTICAL	Withdrawn by MAH · Not Marketed
PHILAZOLE 2%W-W(20MG-GM)TOPICAL CREAM	2 %	Cream · Topical	1 Tube	SAR 6.05	Generic · Prescription	PHILADELPHIA PHARMACEUTICAL	Withdrawn by MAH · Not Marketed
VAVO 2% CREAM	2 %	Cream · Topical	1 Tube	SAR 14.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ECZEMA; HUMAN IMMUNODEFICIENCY VIRUS; TINEA CAPITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
NIZORAL ANTI-DANDRUFF	1%	shampoo · topical	KRAMER	Over-the-counter	10 Oct 1997
KETOCONAZOLE	200MG	tablet · oral	TARO	Prescription	15 Jun 1999
KETOCONAZOLE	2%	cream · topical	TEVA	Prescription	25 Apr 2000
KETOCONAZOLE	200MG	tablet · oral	SENORES PHARMS	Prescription	10 Jan 2002
KETOZOLE	2%	cream · topical	SUN PHARMA CANADA	Prescription	18 Dec 2002
KETOCONAZOLE	2%	shampoo · topical	PADAGIS ISRAEL	Prescription	7 Jan 2004
KETOCONAZOLE	2%	cream · topical	FOUGERA PHARMS	Prescription	28 Apr 2004
KETOCONAZOLE	2%	shampoo · topical	COSETTE PHARMS NC	Prescription	11 Apr 2005
KETOCONAZOLE	2%	aerosol, foam · topical	PADAGIS ISRAEL	Prescription	25 Aug 2011
KETOCONAZOLE	200MG	tablet · oral	STRIDES PHARMA	Prescription	18 Jun 2018
KETOCONAZOLE	2%	cream · topical	ENCUBE	Prescription	20 May 2021
KETOCONAZOLE	2%	aerosol, foam · topical	XIROMED	Prescription	21 May 2021
KETOCONAZOLE	2%	shampoo · topical	NOVITIUM PHARMA	Prescription	16 Sep 2024
KETOCONAZOLE	2%	shampoo · topical	ZYDUS LIFESCIENCES	Prescription	7 Mar 2025
KETOCONAZOLE	200MG	tablet · oral	NOVITIUM PHARMA	Prescription	3 Jul 2025
NIZORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	JANSSEN PHARMS	Discontinued	12 Jun 1981
NIZORAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	cream · topical	JANSSEN PHARMA	Discontinued	31 Dec 1985
NIZORAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	shampoo · topical	JANSSEN PHARMS	Discontinued	31 Aug 1990
KETOCONAZOLE	200MG	tablet · oral	CHARTWELL RX	Discontinued	15 Jun 1999
KETOCONAZOLE	200MG	tablet · oral	TEVA	Discontinued	15 Jun 1999
KETOCONAZOLE	200MG	tablet · oral	SUN PHARM INDUSTRIES	Discontinued	15 Jun 1999
KETOCONAZOLE	200MG	tablet · oral	HERITAGE PHARMA	Discontinued	15 Jun 1999
KETOCONAZOLE	200MG	tablet · oral	AAIPHARMA LLC	Discontinued	27 Jul 1999
KETOCONAZOLE	200MG	tablet · oral	AUROBINDO PHARMA USA	Discontinued	23 Dec 1999
XOLEGEL	2%	gel · topical	INA PHARMS	Discontinued	28 Jul 2006

3 more — full table

EMA European Union — centrally authorised medicines

Ketoconazole Esteve (previously Ketoconazole HRA) Esteve Pharmaceuticals, S.A. · Authorised · authorised 18 Nov 2014 · ATC H02CA03

Therapeutic indication (EMA)

Ketoconazole Esteve is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.

Ketoconazole AID-SCFM Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare · Application withdrawn · ATC V03

Therapeutic indication (EMA)

Treatment of Cushings syndrome

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-KETOCONAZOLE	02237235	200 MG	TABLET · ORAL	APOTEX INC
KETODERM CREAM 2%	02245662	2 %	CREAM · TOPICAL	TAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.
NIZORAL	02182920	2 %	SHAMPOO · TOPICAL	KRAMER LABORATORIES, INC
TEVA-KETOCONAZOLE	02231061	200 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	KETOCONAZOLE 2% CREAM	$0.28477	per GM	23 Sep 2026
US NADAC	KETOCONAZOLE 2% CREAM	$0.24861	per GM	23 Sep 2026
US NADAC	KETOCONAZOLE 2% CREAM	$0.16221	per GM	23 Sep 2026
US NADAC	KETOCONAZOLE 2% FOAM	$5.59715	per GM	23 Sep 2026
US NADAC	KETOCONAZOLE 2% FOAM	$3.44062	per GM	23 Sep 2026
US NADAC	KETOCONAZOLE 2% SHAMPOO	$0.07537	per ML	23 Sep 2026
US NADAC	KETOCONAZOLE 200 MG TABLET	$0.64566	per EA	23 Sep 2026
NHS Drug Tariff	Ketoconazole 2% cream	£4.24	30 gram	1 Oct 2026
NHS Drug Tariff	Ketoconazole 2% shampoo	£4.59	120 ml	1 Oct 2026
NHS Drug Tariff	Ketoconazole 200mg tablets	£648.90	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 26 Dec 2019 XOLEGEL — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 20 Jun 2018 EXTINA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ketoconazole →

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.