Prescription medicine
Bedaquiline Brand names: Sirturo
Bedaquiline (Sirturo) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the bedaquiline FDA label on DailyMed (effective October 17, 2025, Janssen Products, LP); the NDA 204384 record on Drugs@FDA; every bedaquiline label on DailyMed.
Highlights of the record
FDA label of October 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
QTc PROLONGATION QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops [see Warnings and Precautions (5.1) ]. WARNING: QTc PROLONGATION See full prescribing information for complete boxed warning. QTc Prolongation QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops.
Used for
From the label: indications and usageSIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid.
Forms and strengths
- 20 mg
- 100 mg
Tablet.
On the market
- Earliest approval on file
- December 28, 2012 Sirturo, Janssen Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 19, 2029 Sirturo tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,417 through July 30, 2026
What is bedaquiline used for?
From the label: indications and usageSIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. […]
FDA pharmacologic class: Diarylquinoline Antimycobacterial.
Source: FDA drug label (SIRTURO), Janssen Products, LP, effective October 17, 2025 (SPL set 1534c9ae-4948-4cf4-9f66-222a99db6d0e), via openFDA; the full label on DailyMed
What does the patient leaflet for bedaquiline say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SIRTURO?SIRTURO can cause serious side effects, including: A serious heart rhythm problem called QTc prolongation. This condition can cause an abnormal heartbeat in people who take SIRTURO. Your healthcare provider should check your heart and do blood tests before and during treament with SIRTURO. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat) or if you feel dizzy or faint.
From the patient leaflet: What should I avoid while taking SIRTURO?You should not drink alcohol while taking SIRTURO.
From the patient leaflet: How should I store SIRTURO?Store SIRTURO at room temperature between 68°F to 77°F (20°C to 25°C). Keep SIRTURO in the original container. Protect SIRTURO from light. The SIRTURO 20 mg container contains a desiccant packet to keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant. Keep SIRTURO and all medicines out of reach of children.
Source: FDA drug label (SIRTURO), Janssen Products, LP, effective October 17, 2025 (SPL set 1534c9ae-4948-4cf4-9f66-222a99db6d0e), via openFDA; the full label on DailyMed
Is there a generic for bedaquiline (Sirturo)?
No generic bedaquiline is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Sirturo tablets: the compound patent runs to March 19, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the bedaquiline label say about other medicines?
The bedaquiline label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name bedaquiline. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clofazimine | drug interactions | In Study 3, concurrent use of clofazimine with SIRTURO resulted in QTc prolongation: mean increases in QTc were larger in the 17 adult patients who were taking clofazimine with bedaquiline at Week 24 (mean change from Day-1 of 32 ms) than in patients who were not taking clofazimine with bedaquiline at Week 24 (mean … |
| Cycloserine | drug interactions | In a placebo-controlled clinical trial in adult patients, no major impact of coadministration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed. |
| Efavirenz | warnings and precautions | Avoid coadministration of SIRTURO with moderate or strong CYP3A4 inducers, such as efavirenz and rifamycins (i.e., rifampin, rifapentine and rifabutin) [see Drug Interactions (7.1) ]. |
| Ethambutol | drug interactions | In a placebo-controlled clinical trial in adult patients, no major impact of coadministration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed. |
| Isoniazid | drug interactions | No dose adjustment of isoniazid or pyrazinamide is required during coadministration with SIRTURO. |
| Levofloxacin | warnings and precautions | In Study 4, where SIRTURO was administered with the QTc prolonging drugs clofazimine and levofloxacin, 5% of patients in the 40-week SIRTURO treatment group experienced a QTc ≥500 ms and 43% of patients experienced an increase in QTc ≥60 ms over baseline. |
| Ofloxacin | drug interactions | In a placebo-controlled clinical trial in adult patients, no major impact of coadministration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed. |
| Pyrazinamide | drug interactions | No dose adjustment of isoniazid or pyrazinamide is required during coadministration with SIRTURO. |
| Rifabutin | warnings and precautions | Avoid coadministration of SIRTURO with moderate or strong CYP3A4 inducers, such as efavirenz and rifamycins (i.e., rifampin, rifapentine and rifabutin) [see Drug Interactions (7.1) ]. |
| Rifampin | warnings and precautions | WARNINGS AND PRECAUTIONS A mortality imbalance was seen in clinical trials in SIRTURO-treated patients with pulmonary TB due to Mycobacterium tuberculosis resistant to at least rifampin. ( 5.2 ) Hepatotoxicity may occur with use of SIRTURO. Monitor liver-related laboratory tests. |
| Rifapentine | warnings and precautions | Avoid coadministration of SIRTURO with moderate or strong CYP3A4 inducers, such as efavirenz and rifamycins (i.e., rifampin, rifapentine and rifabutin) [see Drug Interactions (7.1) ]. |
Other labels that name bedaquiline
Source: FDA drug label (SIRTURO), Janssen Products, LP, effective October 17, 2025 (SPL set 1534c9ae-4948-4cf4-9f66-222a99db6d0e), via openFDA; the full label on DailyMed
What do FAERS reports show for bedaquiline?
The FDA Adverse Event Reporting System holds 1,417 reports that list bedaquiline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 340 are coded as a death and 470 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Bedaquiline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other