Is Thiopental 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 Thiopental, including EPENTAL 0.5G VIAL (500 mg, Solution, SAR 96.50); EPENTAL 1G VIAL (1000 mg, Solution, SAR 124.40).

Is Thiopental approved by the US FDA?

Drugs@FDA lists 1 application product line for Thiopental, including PENTOTHAL (Discontinued).

Is Thiopental on the WHO Model List of Essential Medicines?

Yes — 1.1.2. General anaesthetics and oxygen > Injectable medicines (core list): Therapeutic equivalent to propofol for Anaesthetics and therapeutic gases.

Are there safety signals or safety updates for Thiopental?

EMA PRAC: 2 entries (latest 2013-12-05).

Active substance

Thiopental

SFDA 4
US FDA 1
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
EPENTAL 0.5G VIAL	500 mg	Solution · Intravenous use	25 Vial	SAR 96.50	Generic · Prescription	EIPICO	Valid
EPENTAL 1G VIAL	1000 mg	Solution · Intravenous use	25 Vial	SAR 124.40	Generic · Prescription	EIPICO	Valid
THIOPENTAL 0.5G INJ	500 mg	Solution for injection · Intravenous use	25 Vial	SAR 137.85	NCE · Prescription	SANDOZ	Withdrawn by MAH · Not Marketed
THIOPENTAL 1G VIAL	1000 mg	Solution · Intravenous use	25 Vial	SAR 177.75	NCE · Prescription	SANDOZ	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANESTHESIA; STATUS EPILEPTICUS

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

Product	Strength	Form · route	Applicant	Status	First approved
PENTOTHAL	400MG/GM	suspension · rectal	ABBOTT	Discontinued	23 Sep 1959

WHO WHO Model List of Essential Medicines (2025)

1.1.2. General anaesthetics and oxygen > Injectable medicines · core
Therapeutic equivalent to propofol for Anaesthetics and therapeutic gases

Safety signals and safety-related labeling changes

EMA PRAC 5 Dec 2013 PRAC signal: Hypokalaemia and rebound hyperkalamaemia
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jul 2013 PRAC signal: Hypokalaemia and rebound hyperkalamaemia
Action for MAH: update of the product information: No

All safety entries for thiopental →

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.