Is Sodium thiosulfate approved by the US FDA?

Drugs@FDA lists 3 application product lines for Sodium thiosulfate, including SODIUM THIOSULFATE (Prescription); PEDMARK (Prescription); SODIUM THIOSULFATE (Discontinued).

Is Sodium thiosulfate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sodium thiosulfate: Pedmarqsi.

Is Sodium thiosulfate on the WHO Model List of Essential Medicines?

Yes — 4.2. Antidotes and other substances used in poisonings > Specific (core list): Harmful effects of or exposure to noxious substances, chiefly nonmedicinal as to source, not elsewhere classified.

Are there safety signals or safety updates for Sodium thiosulfate?

US FDA: 2 entries (latest 2021-01-13).

Active substance

Sodium thiosulfate

US FDA 3
EMA 1
Health Canada 3
WHO EML 2
Safety 2

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
SODIUM THIOSULFATE	12.5GM/50ML (250MG/ML)	solution · intravenous	HOPE PHARMS	Prescription	14 Feb 2012
PEDMARK	12.5GM/100ML (125MG/ML)	solution · intravenous	FENNEC PHARMS INC	Prescription	20 Sep 2022
SODIUM THIOSULFATE	250MG/ML	injectable · injection	US ARMY	Discontinued	14 Feb 1992

EMA European Union — centrally authorised medicines

Pedmarqsi Norgine B.V. · Authorised · authorised 26 May 2023

Therapeutic indication (EMA)

Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SEACALPHYX	02386666	250 MG / ML	SOLUTION · INTRAVENOUS	SEAFORD PHARMACEUTICALS INC
SODIUM THIOSULFATE INJECTION USP	02137186	250 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
SODIUM THIOSULFATE INJECTION USP	02428393	250 MG / ML	SOLUTION · INTRAVENOUS	HOPE PHARMACEUTICALS LTD

WHO WHO Model List of Essential Medicines (2025)

4.2. Antidotes and other substances used in poisonings > Specific · core
Harmful effects of or exposure to noxious substances, chiefly nonmedicinal as to source, not elsewhere classified
Parenteral > General injections > IV: 250 mg per mL in 50 mL ampoule
13.1. Dermatological medicines > Antifungal medicines · core
Pityriasis versicolor
Local > Topical > Solution: 15%

Safety signals and safety-related labeling changes

US FDA 13 Jan 2021 NITHIODOTE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Jun 2020 SODIUM THIOSULFATE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for sodium thiosulfate →

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.