Is Bedaquiline approved by the US FDA?

Drugs@FDA lists 1 application product line for Bedaquiline, including SIRTURO (Prescription).

Is Bedaquiline authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Bedaquiline: Sirturo.

Is Bedaquiline 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 Bedaquiline?

US FDA: 1 entry (latest 2025-07-28).

Active substance

Bedaquiline

US FDA 1
EMA 1
WHO EML 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
SIRTURO	EQ 100MG BASE; EQ 20MG BASE	tablet · oral	JANSSEN THERAP	Prescription	28 Dec 2012

EMA European Union — centrally authorised medicines

Sirturo · Authorised · authorised 5 Mar 2014 · ATC J04AK05

Therapeutic indication (EMA)

Sirturo is indicated for use as part of an appropriate combination regimen in adult and paediatric patients (2 years to less than 18 years of age and weighing at least 7 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

WHO WHO Model List of Essential Medicines (2025)

6.2.5. Antituberculosis medicines · core
Multi-drug resistant Mycobacterium tuberculosis
Oral > Solid > tablet: 100 mg tablet; 20 mg tablet (EMLc)

Safety signals and safety-related labeling changes

US FDA 28 Jul 2025 SIRTURO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for bedaquiline →

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.