Is Arsenic trioxide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Arsenic trioxide, including Arsenic Trioxide (1 mg/ml, concentrate for solution for injection, SAR 8711.90); Arsenic Trioxide Nexus (1 mg/ml, Solution for injection, SAR 8711.90).

Is Arsenic trioxide approved by the US FDA?

Drugs@FDA lists 14 application product lines for Arsenic trioxide, including TRISENOX (Prescription); ARSENIC TRIOXIDE (Prescription); ARSENIC TRIOXIDE (Prescription); ARSENIC TRIOXIDE (Prescription); ARSENIC TRIOXIDE (Prescription).

Is Arsenic trioxide authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Arsenic trioxide: Trisenox, Arsenic trioxide Accord, Arsenic trioxide medac.

Is Arsenic trioxide on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Acute myeloid leukaemia with recurrent genetic abnormalities.

Are there safety signals or safety updates for Arsenic trioxide?

US FDA: 1 entry (latest 2020-10-20).

Active substance

Arsenic trioxide

SFDA 2
US FDA 14
EMA 4
Health Canada 4
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Arsenic Trioxide	1 mg/ml	concentrate for solution for injection · Intravenous use	10 Vial	SAR 8711.90	Generic · Prescription	International pioneers	Valid
Arsenic Trioxide Nexus	1 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 8711.90	Generic · Prescription	Nexus Pharmaceuticals Inc	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
TRISENOX	2MG/ML	injectable · injection	CEPHALON	Prescription	25 Sep 2000
ARSENIC TRIOXIDE	1MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	31 Aug 2018
ARSENIC TRIOXIDE	1MG/ML; 2MG/ML	injectable · injection	ZYDUS PHARMS	Prescription	13 Nov 2018
ARSENIC TRIOXIDE	1MG/ML	injectable · injection	J MOLNER	Prescription	13 Nov 2018
ARSENIC TRIOXIDE	1MG/ML	injectable · injection	INGENUS PHARMS LLC	Prescription	15 Nov 2018
ARSENIC TRIOXIDE	1MG/ML	injectable · injection	NEXUS	Prescription	15 Nov 2018
ARSENIC TRIOXIDE	1MG/ML	injectable · injection	PENN LIFE	Prescription	6 May 2019
ARSENIC TRIOXIDE	1MG/ML; 2MG/ML	injectable · injection	AMNEAL	Prescription	25 Jan 2021
ARSENIC TRIOXIDE	2MG/ML; 1MG/ML	injectable · injection	GLAND	Prescription	7 Oct 2021
ARSENIC TRIOXIDE	2MG/ML	injectable · injection	SANDOZ	Prescription	2 Dec 2021
ARSENIC TRIOXIDE	1MG/ML; 2MG/ML	injectable · injection	MSN	Prescription	20 Apr 2023
TRISENOX	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	CEPHALON	Discontinued	25 Sep 2000
ARSENIC TRIOXIDE	2MG/ML	injectable · injection	INGENUS PHARMS LLC	Discontinued	15 Nov 2018
ARSENIC TRIOXIDE	2MG/ML	injectable · injection	EUGIA PHARMA	Discontinued	15 Oct 2021

EMA European Union — centrally authorised medicines

Trisenox Teva B.V. · Authorised · authorised 5 Mar 2002 · ATC L01XX27

Therapeutic indication (EMA)

Trisenox is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/µl) in combination with all?trans?retinoic acid (ATRA) Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Arsenic trioxide Accord Accord Healthcare S.L.U. · Authorised · authorised 14 Nov 2019 · ATC L01XX27

Therapeutic indication (EMA)

Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/?l) in combination with all-trans-retinoic acid (ATRA) Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Arsenic trioxide medac medac Gesellschaft für klinische Spezialpräparate mbH · Authorised · authorised 17 Sep 2020 · ATC L01XX27

Therapeutic indication (EMA)

Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 10³/?l) in combination with all-trans-retinoic acid (ATRA) Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR?) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Arsenic trioxide Mylan Mylan Ireland Limited · Withdrawn · authorised 1 Apr 2020 · ATC L01XX27

Therapeutic indication (EMA)

Arsenic trioxide Mylan is indicated for induction of remission, and consolidation in adult patients with:- Newly diagnosed low to intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/?l) in combination with all trans retinoic acid (ATRA)- Relapsed/refractory acute promyelocytic leukaemia (APL) (Previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic acid receptor alpha (PML/RAR alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ARSENIC TRIOXIDE FOR INJECTION	02492768	1 MG / ML	SOLUTION · INTRAVENOUS	STERIMAX INC
ARSENIC TRIOXIDE FOR INJECTION	02513420	10 MG / 10 ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
ARSENIC TRIOXIDE FOR INJECTION	02554364	1 MG / ML	SOLUTION · INTRAVENOUS	MARCAN PHARMACEUTICALS INC
ARSENIC TRIOXIDE SOLUTION FOR INJECTION	02487357	10 MG / 10 ML	SOLUTION · INTRAVENOUS	PHEBRA PTY LTD

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Acute myeloid leukaemia with recurrent genetic abnormalities
Parenteral > General injections > IV: 1 mg per mL concentrate for solution for infusion; 2 mg per mL concentrate for solution for infusion

Safety signals and safety-related labeling changes

US FDA 20 Oct 2020 TRISENOX — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for arsenic trioxide →

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.