Bedaquiline
Bedaquiline is an antimycobacterial medication used to treat multidrug-resistant tuberculosis (MDR-TB) when other standard TB medications are ineffective or cannot be tolerated. It belongs to the diarylquinoline drug class and is typically reserved for serious infections where limited treatment options exist.
Bedaquiline is an antibiotic used to treat drug-resistant tuberculosis when other medications fail.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- J04AK05
- RxNorm
- 1364504
- Generic
- Bedaquiline
- Class
- atc-j04
- Brands
- Sirturo
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 400mg once daily for 2 weeks (loading), then 200mg three times weekly
- Maximum
- consult physician
- Frequency
- once daily then thrice weekly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- Weight-based: ≥30kg: 400mg once daily for 2 weeks then 200mg twice weekly
- Maximum
- consult physician
- Frequency
- once daily then twice weekly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg once daily for 2 weeks (loading), then 200mg three times weekly with close monitoring
- Maximum
- consult physician
- Frequency
- once daily then thrice weekly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus
regular fetal monitoring recommended
Use with caution and monitor for adverse effects.
pregnancy
second third trimesteruse lowest effective dose
continue treatment if already initiated, consider risks versus benefits
fetal growth monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 2 years after completing therapy due to prolonged tissue retention
monitor infant for adverse effects
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
adolescents 12 17 yearsweight-based dosing, 20-30kg give 200mg once daily for 2 weeks then 100mg 3 times weekly
use under close supervision, monitor for QT prolongation
regular ECG monitoring, liver function tests
Use with caution and monitor for adverse effects.
geriatric
elderly 65 years and olderno specific dose adjustment, use with caution
assess renal and hepatic function before initiating, monitor closely
baseline and periodic ECG, liver function tests, renal function monitoring
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentno standard dose modification established, use with caution
monitor drug levels if available, assess risk versus benefit
frequent renal function monitoring, drug concentration monitoring if available
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate hepatic impairmentreduce dose to 200mg once daily for 2 weeks then 100mg twice weekly
monitor liver function tests closely
regular liver function tests, ECG monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
severe hepatic impairmentavoid use unless benefits outweigh risks
not recommended due to limited safety data
close hepatic function monitoring if used
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
FDA approval for bedaquiline
Drug class
Drug class information
Primary indication
Therapeutic indication
Mechanism of action
Pharmacological mechanism
Bedaquiline is indicated for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults and children when an effective treatment regimen cannot otherwise be provided. It is used as part of a combination TB therapy regimen.
Bedaquiline works by inhibiting mycobacterial ATP synthase, an essential enzyme for energy production in Mycobacterium tuberculosis. This disruption of bacterial energy metabolism leads to inhibition of bacterial replication and cell death.
Bedaquiline carries a boxed warning for increased risk of death and serious cardiovascular events. Common side effects include nausea, vomiting, and joint pain. Liver function and cardiac rhythm (QT interval) should be monitored during treatment. It should always be used in combination with other anti-TB medications to prevent resistance development.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy