Is Itraconazole 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 Itraconazole, including ITRAZOL 100 mg capsule (100 mg, Capsule, SAR 34.55); Itranox (10 mg/ml, Oral solution, SAR 484.00); TRACON 100MG CAPSULES (100 mg, Capsule, SAR 101.20).

Is Itraconazole approved by the US FDA?

Drugs@FDA lists 20 application product lines for Itraconazole, including SPORANOX (Prescription); SPORANOX (Prescription); ITRACONAZOLE (Prescription); ITRACONAZOLE (Prescription); ITRACONAZOLE (Prescription).

Is Itraconazole on the WHO Model List of Essential Medicines?

Yes — 6.3. Antifungal medicines (core list): Chronic pulmonary aspergillosis; Paracoccidioidomycosis; Sporotrichosis; Histoplasmosis; Talaromycosis; Chromoblastomycosis.

Are there safety signals or safety updates for Itraconazole?

US FDA: 3 entries (latest 2026-07-07).

Active substance

Itraconazole

SFDA 9
US FDA 20
Health Canada 3
US price lines 3
NHS prices 2
WHO EML 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ITRAZOL 100 mg capsule	100 mg	Capsule · Oral use	4 Blister	SAR 34.55	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
ITRAZOL 100 mg capsule	100 mg	Capsule · Oral use	15 Blister	SAR 112.45	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Itranox	10 mg/ml	Oral solution · Oral use	150 Bottle	SAR 484.00	Generic · Prescription	Saudi Amarox	Valid
TRACON 100MG CAPSULES	100 mg	Capsule · Oral use	15 Blister	SAR 101.20	Generic · Prescription	COOPER PHARMA	Valid
TRACON 100MG CAPSULES	100 mg	Capsule · Oral use	4 Blister	SAR 31.10	Generic · Prescription	COOPER PHARMA	Valid
SPORANOX CAPS 100MG	100 mg	Capsule · Oral use	15 Blister	SAR 35.90	NCE · Prescription	Janssen-Cilag International NV	Withdrawn by MAH · Not Marketed
SPORANOX CAPS 100MG	100 mg	Capsule · Oral use	4 Blister	SAR 9.60	NCE · Prescription	Janssen-Cilag International NV	Withdrawn by MAH · Not Marketed
TRACON 100MG CAPSULES	100 mg	Capsule · Oral use	15 Blister	SAR 101.20	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
TRACON 100MG CAPSULES	100 mg	Capsule · Oral use	4 Blister	SAR 31.10	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; CYSTIC FIBROSIS; ECZEMA; ESOPHAGEAL CANDIDIASIS; FUNGAL GIT - BLASTOMYCOSIS; FUNGAL GIT - COCCIDIOIDOMYCOSIS; FUNGAL GIT - HISTOPLASMOSIS; FUNGAL INFECTIONS OF THE GENITAL TRACT - CANDIDIASIS OF VULVA AND VAGINA; HUMAN IMMUNODEFICIENCY VIRUS; Invasive Candidiasis and Candidemia; LICHEN PLANUS; ONYCHOMYCOSIS ,TINEA UNGUIUM; TRAVEL RELATED INFECTIONS-TREATMENT

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

Product	Strength	Form · route	Applicant	Status	First approved
SPORANOX	100MG	capsule · oral	JANSSEN PHARMS	Prescription	11 Sep 1992
SPORANOX	100MG	capsule · oral	JANSSEN PHARMA	Prescription	6 Dec 1996
ITRACONAZOLE	100MG	capsule · oral	SANDOZ	Prescription	28 May 2004
ITRACONAZOLE	10MG/ML	solution · oral	AMNEAL PHARMS	Prescription	30 Oct 2015
ITRACONAZOLE	100MG	capsule · oral	AMNEAL PHARMS	Prescription	26 Sep 2016
ITRACONAZOLE	100MG	capsule · oral	RISING	Prescription	13 Dec 2016
ITRACONAZOLE	100MG	capsule · oral	ALEMBIC	Prescription	13 Dec 2016
ITRACONAZOLE	100MG	capsule · oral	ALKEM LABS LTD	Prescription	12 Jun 2017
ITRACONAZOLE	100MG	capsule · oral	ZYDUS PHARMS	Prescription	19 Sep 2017
ITRACONAZOLE	100MG	capsule · oral	TORRENT	Prescription	24 Aug 2018
TOLSURA	65MG	capsule · oral	MAYNE PHARMA	Prescription	11 Dec 2018
ITRACONAZOLE	10MG/ML	solution · oral	ANNORA PHARMA	Prescription	1 Sep 2020
SPORANOX	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral	JANSSEN PHARMS	Discontinued	21 Feb 1997
SPORANOX	10MG/ML	injectable · injection	JANSSEN PHARMS	Discontinued	30 Mar 1999
ONMEL	200MG	tablet · oral	SEBELA IRELAND LTD	Discontinued	29 Apr 2010
ITRACONAZOLE	100MG	capsule · oral	MYLAN PHARMS INC	Discontinued	20 Jul 2012
ITRACONAZOLE	100MG	capsule · oral	ACCORD HLTHCARE	Discontinued	26 May 2016
ITRACONAZOLE	100MG	capsule · oral	JUBILANT GENERICS	Discontinued	23 Feb 2017
ITRACONAZOLE	100MG	capsule · oral	STRIDES PHARMA	Discontinued	2 Jul 2019
ITRACONAZOLE	10MG/ML	solution · oral	APOTEX	Discontinued	2 Aug 2019

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAMP ITRACONAZOLE ORAL SOLUTION	02484315	10 MG / ML	SOLUTION · ORAL	JAMP PHARMA CORPORATION
MINT-ITRACONAZOLE	02462559	100 MG	CAPSULE · ORAL	MINT PHARMACEUTICALS INC
ODAN ITRACONAZOLE	02495988	10 MG / ML	SOLUTION · ORAL	ODAN LABORATORIESLTD

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ITRACONAZOLE 10 MG/ML SOLUTION	$1.13566	per ML	23 Sep 2026
US NADAC	ITRACONAZOLE 100 MG CAPSULE	$0.91018	per EA	23 Sep 2026
US NADAC	SPORANOX 100 MG CAPSULE	$28.35676	per EA	2 Jan 2026
NHS Drug Tariff	Itraconazole 100mg capsules	£6.72	15 capsule	1 Oct 2026
NHS Drug Tariff	Itraconazole 50mg/5ml oral solution sugar free	£43.27	150 ml	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.

WHO WHO Model List of Essential Medicines (2025)

6.3. Antifungal medicines · core
Chronic pulmonary aspergillosis; Paracoccidioidomycosis; Sporotrichosis; Histoplasmosis; Talaromycosis; Chromoblastomycosis
Oral > Liquid: 10 mg per mL | Oral > Solid: 100 mg

Safety signals and safety-related labeling changes

US FDA 7 Jul 2026 SPORANOX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Jul 2026 SPORANOX — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 Oct 2024 TOLSURA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for itraconazole →

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.