Is Ethambutol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Ethambutol.

Is Ethambutol approved by the US FDA?

Drugs@FDA lists 5 application product lines for Ethambutol, including MYAMBUTOL (Prescription); ETHAMBUTOL HYDROCHLORIDE (Prescription); ETHAMBUTOL HYDROCHLORIDE (Prescription); MYAMBUTOL (Discontinued); ETHAMBUTOL HYDROCHLORIDE (Discontinued).

Is Ethambutol on the WHO Model List of Essential Medicines?

Yes — 6.2.5. Antituberculosis medicines (core list): Tuberculosis.

Are there safety signals or safety updates for Ethambutol?

EMA PRAC: 2 entries (latest 2024-04-11).

Active substance

Ethambutol

SFDA 3
US FDA 5
Health Canada 2
US price lines 2
NHS prices 2
WHO EML 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AFIMOCIL 0.5 GM TAB	500 mg	Tablet · Oral use	25 Blister	SAR 13.00	Generic · Prescription	ALMIRALL PRODES PHARMA S.A.	Withdrawn by MAH · Not Marketed
ETHAMBUTOL	250 mg	Tablet · Oral use	100 Tablet Container	SAR 29.00	Generic · Prescription	THE NILE COMPANY FOR PHARMACEUTICALS AND CHEMICAL IND.	Invalid · Not Marketed
MYAMBUTOL 400 MG. TABLETS	400 mg	Tablet · Oral use	100 Tablet Container	SAR 86.15	NCE · Prescription	WYETH	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
MYAMBUTOL	100MG; 400MG	tablet · oral	KANCHAN HLTHCARE	Prescription	6 Nov 1967
ETHAMBUTOL HYDROCHLORIDE	100MG; 400MG	tablet · oral	EPIC PHARMA LLC	Prescription	30 Nov 1999
ETHAMBUTOL HYDROCHLORIDE	100MG; 400MG	tablet · oral	LUPIN	Prescription	17 Jun 2009
MYAMBUTOL	200MG; 500MG	tablet · oral	KANCHAN HLTHCARE	Discontinued	6 Nov 1967
ETHAMBUTOL HYDROCHLORIDE	400MG	tablet · oral	BARR	Discontinued	26 Nov 2001

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ETIBI	00247960	100 MG	TABLET · ORAL	BAUSCH HEALTH, CANADA INC.
ETIBI	00247979	400 MG	TABLET · ORAL	BAUSCH HEALTH, CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ETHAMBUTOL HCL 100 MG TABLET	$0.30403	per EA	23 Sep 2026
US NADAC	ETHAMBUTOL HCL 400 MG TABLET	$0.458	per EA	23 Sep 2026
NHS Drug Tariff	Ethambutol 100mg tablets	£40.00	56 tablet	1 Oct 2026
NHS Drug Tariff	Ethambutol 400mg tablets	£50.00	56 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)

6.2.5. Antituberculosis medicines · core
Tuberculosis
Oral > Solid > dispersible tablet: 100 mg (EMLc) | Oral > Solid > tablet: 100 mg (hydrochloride); 400 mg (hydrochloride)

Safety signals and safety-related labeling changes

EMA PRAC 11 Apr 2024 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes
EMA PRAC 30 Nov 2023 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No

All safety entries for ethambutol →

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.