Is Deferasirox registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 31 valid registrations of Deferasirox, including DEFIROX 125 mg dispersible tablet (125 mg, Dispersible tablet, SAR 410.95); DEFIROX 250 mg dispersible tablet (250 mg, Dispersible tablet, SAR 816.50); DEFIROX 500 mg dispersible tablet (500 mg, Dispersible tablet, SAR 1622.25); Deferajub (360 mg, Film-coated tablet, SAR 1586.55); Deferajub (180 mg, Film-coated tablet, SAR 798.65).

Is Deferasirox approved by the US FDA?

Drugs@FDA lists 38 application product lines for Deferasirox, including EXJADE (Prescription); JADENU (Prescription); DEFERASIROX (Prescription); JADENU SPRINKLE (Prescription); DEFERASIROX (Prescription).

Is Deferasirox authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Deferasirox: Exjade, Deferasirox Mylan, Deferasirox Accord.

Is Deferasirox on the WHO Model List of Essential Medicines?

Yes — 10.3. Medicines for haemoglobinopathies (core list): Other specified sickle cell disorders or other haemoglobinopathies; Thalassaemias.

Are there safety signals or safety updates for Deferasirox?

US FDA: 3 entries (latest 2020-07-23).

Active substance

Deferasirox

SFDA 34
US FDA 38
EMA 3
Health Canada 36
US price lines 2
NHS prices 3
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
DEFIROX 125 mg dispersible tablet	125 mg	Dispersible tablet · Oral use	28 Blister	SAR 410.95	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
DEFIROX 250 mg dispersible tablet	250 mg	Dispersible tablet · Oral use	28 Blister	SAR 816.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
DEFIROX 500 mg dispersible tablet	500 mg	Dispersible tablet · Oral use	28 Blister	SAR 1622.25	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Deferajub	360 mg	Film-coated tablet · Oral use	28 Blister	SAR 1586.55	Generic · Prescription	Alhobail Pharm	Valid
Deferajub	180 mg	Film-coated tablet · Oral use	28 Blister	SAR 798.65	Generic · Prescription	Alhobail Pharm	Valid
Deferajub	90 mg	Film-coated tablet · Oral use	28 Blister	SAR 401.90	Generic · Prescription	Alhobail Pharm	Valid
Dexrofex	90 mg	Film-coated tablet · Oral use	30 Blister	SAR 525.45	Generic · Prescription	Saudi Amarox	Valid
Dexrofex	180 mg	Film-coated tablet · Oral use	30 Blister	SAR 1044.00	Generic · Prescription	Saudi Amarox	Valid
Dexrofex	360 mg	Film-coated tablet · Oral use	30 Blister	SAR 2074.20	Generic · Prescription	Saudi Amarox	Valid
Dexrofex	180 mg	Granules · Oral use	30 Sachet	SAR 1252.80	Generic · Prescription	Saudi Amarox	Valid
EXJADE 125MG DISPERSIBLE TABLETS	125 mg	Dispersible tablet · Oral use	28 Blister	SAR 562.00	NCE · Prescription	NOVARTIS	Valid
EXJADE 250MG DISPERSIBLE TABLETS	250 mg	Dispersible tablet · Oral use	28 Blister	SAR 1116.60	NCE · Prescription	NOVARTIS	Valid
EXJADE 500MG DISPERSIBLE TABLETS	500 mg	Dispersible tablet · Oral use	28 Blister	SAR 2218.45	NCE · Prescription	NOVARTIS	Valid
Ferasiro 180	180 mg	Film-coated tablet · Oral use	30 Blister	SAR 1044.00	Generic · Prescription	Boston Oncology Arabia	Valid
Ferasiro 360	360 mg	Film-coated tablet · Oral use	30 Blister	SAR 2074.20	Generic · Prescription	Boston Oncology Arabia	Valid
Ferasiro 90	90 mg	Film-coated tablet · Oral use	30 Blister	SAR 525.45	Generic · Prescription	Boston Oncology Arabia	Valid
Fermata	500 mg	Dispersible tablet · Oral use	30 Blister	SAR 1713.90	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
IROREST FCT	90 mg	Film-coated tablet · Oral use	30 Blister	SAR 525.45	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Valid
IROREST FCT	180 mg	Film-coated tablet · Oral use	30 Blister	SAR 1044.00	Generic · Prescription	APOTEX	Valid
IROREST FCT	360 mg	Film-coated tablet · Oral use	30 Blister	SAR 2074.20	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Valid
JADENU 180 mg Film-coated Tablet	180 mg	Film-coated tablet · Oral use	30 Blister	SAR 1228.25	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
JADENU 360 mg Film-coated Tablet	360 mg	Film-coated tablet · Oral use	30 Blister	SAR 2440.30	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
JADENU 90 mg Film-coated Tablet	90 mg	Film-coated tablet · Oral use	30 Blister	SAR 618.20	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
Sicfrex	90 mg	Film-coated tablet · Oral use	30 Bottle	SAR 525.45	Generic · Prescription	Med City Pharma	Valid
Sicfrex	180 mg	Film-coated tablet · Oral use	30 Bottle	SAR 1044.00	Generic · Prescription	Med City Pharma	Valid

9 more — full table

Indications — CHI Daman Drug Formulary

HEMOCHROMATOSIS; MYELODYSPLASTIC SYNDROMES- IRON OVERLOAD; SICKLE CELL DISEASE - IRON OVERLOAD MANAGEMENT; THALASSEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
EXJADE	125MG; 250MG; 500MG	tablet, for suspension · oral	NOVARTIS	Prescription	2 Nov 2005
JADENU	90MG; 180MG; 360MG	tablet · oral	NOVARTIS PHARMS CORP	Prescription	30 Mar 2015
DEFERASIROX	125MG; 250MG; 500MG	tablet, for suspension · oral	ACTAVIS ELIZABETH	Prescription	26 Jan 2016
JADENU SPRINKLE	90MG; 180MG; 360MG	granule · oral	NOVARTIS	Prescription	18 May 2017
DEFERASIROX	125MG; 250MG; 500MG	tablet, for suspension · oral	SUN PHARM	Prescription	20 Nov 2019
DEFERASIROX	125MG; 250MG; 500MG	tablet, for suspension · oral	MSN	Prescription	20 Nov 2019
DEFERASIROX	125MG; 250MG; 500MG	tablet, for suspension · oral	ALEMBIC	Prescription	20 Nov 2019
DEFERASIROX	125MG; 250MG; 500MG	tablet, for suspension · oral	ALKEM LABS LTD	Prescription	20 Nov 2019
DEFERASIROX	125MG; 250MG; 500MG	tablet, for suspension · oral	BIONPHARMA	Prescription	20 Nov 2019
DEFERASIROX	90MG; 360MG; 180MG	tablet · oral	MSN	Prescription	20 Nov 2019
DEFERASIROX	90MG; 360MG; 180MG	tablet · oral	ZYDUS PHARMS	Prescription	20 Nov 2019
DEFERASIROX	90MG; 360MG; 180MG	tablet · oral	ALEMBIC	Prescription	20 Nov 2019
DEFERASIROX	90MG; 180MG; 360MG	tablet · oral	ACTAVIS ELIZABETH	Prescription	13 Dec 2019
DEFERASIROX	90MG; 360MG; 180MG	tablet · oral	PIRAMAL	Prescription	30 Dec 2019
DEFERASIROX	125MG; 250MG; 500MG	tablet, for suspension · oral	GLENMARK SPECLT	Prescription	3 Jan 2020
DEFERASIROX	90MG; 360MG; 180MG	tablet · oral	ALKEM LABS LTD	Prescription	30 Mar 2020
DEFERASIROX	90MG; 180MG; 360MG	granule · oral	ALKEM LABS LTD	Prescription	14 Jul 2020
DEFERASIROX	90MG; 180MG; 360MG	granule · oral	AUCTA	Prescription	9 Mar 2021
DEFERASIROX	180MG; 360MG; 90MG	granule · oral	MSN	Prescription	17 Mar 2021
DEFERASIROX	90MG; 180MG; 360MG	tablet · oral	ANNORA PHARMA	Prescription	14 May 2021
DEFERASIROX	90MG; 180MG; 360MG	tablet · oral	CHARTWELL RX	Prescription	27 May 2021
DEFERASIROX	90MG; 180MG; 360MG	granule · oral	CIPLA	Prescription	23 Feb 2022
DEFERASIROX	180MG; 360MG; 90MG	granule · oral	ANNORA PHARMA	Prescription	22 Sep 2022
DEFERASIROX	125MG; 250MG; 500MG	tablet, for suspension · oral	TEVA PHARMS USA	Prescription	23 Sep 2022
DEFERASIROX	90MG; 180MG; 360MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	16 Oct 2023

13 more — full table

EMA European Union — centrally authorised medicines

Exjade Novartis Europharm Limited · Authorised · authorised 28 Aug 2006 · ATC V03AC03

Therapeutic indication (EMA)

Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older. Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged two to five years; in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged two years and older; in patients with other anaemias aged two years and older. Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.

Deferasirox Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 26 Sep 2019 · ATC V03AC03

Therapeutic indication (EMA)

Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion dependent thalassaemia syndromes aged 10 years and older.

Deferasirox Accord Accord Healthcare S.L.U. · Authorised · authorised 9 Jan 2020 · ATC V03AC03

Therapeutic indication (EMA)

Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. Deferasirox Accord is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-DEFERASIROX	02461544	125 MG	TABLET FOR SUSPENSION · ORAL	APOTEX INC
APO-DEFERASIROX	02461552	250 MG	TABLET FOR SUSPENSION · ORAL	APOTEX INC
APO-DEFERASIROX	02461560	500 MG	TABLET FOR SUSPENSION · ORAL	APOTEX INC
APO-DEFERASIROX (TYPE J)	02485265	90 MG	TABLET · ORAL	APOTEX INC
APO-DEFERASIROX (TYPE J)	02485273	180 MG	TABLET · ORAL	APOTEX INC
APO-DEFERASIROX (TYPE J)	02485281	360 MG	TABLET · ORAL	APOTEX INC
AURO-DEFERASIROX (TYPE J)	02527774	90 MG	TABLET · ORAL	AURO PHARMA INC
AURO-DEFERASIROX (TYPE J)	02527782	180 MG	TABLET · ORAL	AURO PHARMA INC
AURO-DEFERASIROX (TYPE J)	02527790	360 MG	TABLET · ORAL	AURO PHARMA INC
EXJADE	02287420	125 MG	TABLET FOR SUSPENSION · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
EXJADE	02287439	250 MG	TABLET FOR SUSPENSION · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
EXJADE	02287447	500 MG	TABLET FOR SUSPENSION · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
JADENU	02452219	90 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
JADENU	02452227	180 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
JADENU	02452235	360 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
JAMP DEFERASIROX (TYPE J)	02549832	90 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP DEFERASIROX (TYPE J)	02549840	180 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP DEFERASIROX (TYPE J)	02549859	360 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
PMS-DEFERASIROX	02474328	125 MG	TABLET FOR SUSPENSION · ORAL	PHARMASCIENCE INC
PMS-DEFERASIROX	02474336	250 MG	TABLET FOR SUSPENSION · ORAL	PHARMASCIENCE INC
PMS-DEFERASIROX	02474344	500 MG	TABLET FOR SUSPENSION · ORAL	PHARMASCIENCE INC
PMS-DEFERASIROX (TYPE J)	02528290	90 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-DEFERASIROX (TYPE J)	02528304	180 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-DEFERASIROX (TYPE J)	02528312	360 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ DEFERASIROX	02464454	125 MG	TABLET FOR SUSPENSION · ORAL	SANDOZ CANADA INCORPORATED

11 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DEFERASIROX 180 MG TABLET	$0.875	per EA	22 Oct 2025
US NADAC	DEFERASIROX 360 MG TABLET	$1.24749	per EA	23 Sep 2026
NHS Drug Tariff	Deferasirox 180mg tablets	£252.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Deferasirox 360mg tablets	£504.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Deferasirox 90mg tablets	£126.00	30 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.

WHO WHO Model List of Essential Medicines (2025)

10.3. Medicines for haemoglobinopathies · core
Other specified sickle cell disorders or other haemoglobinopathies; Thalassaemias
Oral > Solid > dispersible tablet: 100 mg; 125 mg; 250 mg; 400 mg; 500 mg | Oral > Solid > tablet: 90 mg; 180 mg; 360 mg

Safety signals and safety-related labeling changes

US FDA 23 Jul 2020 EXJADE — 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 23 Jul 2020 JADENU — 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 23 Jul 2020 JADENU SPRINKLE — 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

All safety entries for deferasirox →

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.