Is Clofazimine 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 Clofazimine.

Is Clofazimine approved by the US FDA?

Drugs@FDA lists 1 application product line for Clofazimine, including LAMPRENE (Discontinued).

Is Clofazimine on the WHO Model List of Essential Medicines?

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

Are there safety signals or safety updates for Clofazimine?

US FDA: 1 entry (latest 2019-01-31).

Active substance

Clofazimine

SFDA 1
US FDA 1
WHO EML 2
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
LAMPRENE CAPS. 100 MG.	100 mg	Capsule · Oral use	100 Tablet Container	SAR 81.80	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
LAMPRENE	100MG; 50MG	capsule · oral	NOVARTIS	Discontinued	15 Dec 1986

WHO WHO Model List of Essential Medicines (2025)

6.2.5. Antituberculosis medicines · core
Multi-drug resistant Mycobacterium tuberculosis
Oral > Solid > dosage form: 100 mg; 50 mg
6.2.4. Antileprosy medicines · core
Leprosy
Oral > Solid > dosage form: 100 mg; 50 mg

Safety signals and safety-related labeling changes

US FDA 31 Jan 2019 LAMPRENE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for clofazimine →

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.