Is Ethionamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Ethionamide, including ETHIONAMIDE 250 MG FCT (250 mg, Film-coated tablet, SAR 190.00).

Is Ethionamide approved by the US FDA?

Drugs@FDA lists 1 application product line for Ethionamide, including TRECATOR (Discontinued).

Is Ethionamide on the WHO Model List of Essential Medicines?

Yes — 6.2.5. Antituberculosis medicines (core list): Tuberculous meningitis; Multi-drug resistant Mycobacterium tuberculosis.

Are there safety signals or safety updates for Ethionamide?

US FDA: 1 entry (latest 2023-08-03).

Active substance

Ethionamide

SFDA 1
US FDA 1
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
ETHIONAMIDE 250 MG FCT	250 mg	Film-coated tablet · Oral use	100 Blister	SAR 190.00	NCE · Prescription	Macleods Pharmaceuticals Ltd.	Valid

Indications — CHI Daman Drug Formulary

TUBERCULOSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
TRECATOR	250MG	tablet · oral	WYETH PHARMS	Discontinued	30 Apr 1965

WHO WHO Model List of Essential Medicines (2025)

6.2.5. Antituberculosis medicines · core
Tuberculous meningitis; Multi-drug resistant Mycobacterium tuberculosis
Oral > Solid > dispersible tablet: 125 mg (EMLc) | Oral > Solid > tablet: 250 mg

Safety signals and safety-related labeling changes

US FDA 3 Aug 2023 TRECATOR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for ethionamide →

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.