Bedaquiline
Bedaquiline is an antimycobacterial antibiotic used as part of combination therapy to treat drug-resistant pulmonary tuberculosis (TB) in adults and children 2 years and older.
Built from the FDA-approved label, dated Oct 17, 2025 · How this page is built
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Sirturo can cause a dangerous change in heart rhythm called QTc prolongation. This means the heart's electrical cycle takes longer than it should, which can lead to a serious irregular heartbeat. The risk is even greater if you are also taking other medications that affect heart rhythm. Your doctor will monitor your heart with regular ECG (electrocardiogram) tests. If your heart rhythm becomes significantly abnormal or you develop serious ventricular arrhythmia (a dangerous irregular heartbeat), Sirturo will need to be stopped immediately. Tell your doctor right away if you feel your heart pounding, fluttering, or beating out of rhythm, or if you faint.
⚡ Quick answers about Bedaquiline
Why do I have to take this with so many other TB drugs at once?
Drug-resistant TB is caused by bacteria that have already outsmarted some medications. Using just one drug — or even two — gives the bacteria a better chance of developing resistance to that drug too.
Read the full answer →Why does every dose have to be watched by a healthcare worker?
This is called directly observed therapy, or DOT, and it's standard practice for drug-resistant TB treatment — not a sign that anyone doubts you.
Read the full answer →I heard this medication can affect my heart. What should I watch for?
That's a real and important concern. Bedaquiline can alter the heart's electrical rhythm in a way that sometimes causes dangerous irregular heartbeats.
Read the full answer →What should I do if I feel sick to my stomach or notice yellowing of my skin while taking this?
Nausea is actually one of the most common side effects and often eases up over time — taking the tablet with a full meal can help.
Read the full answer →🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →📖 Bedaquiline: Patient Information Guide
A plain-language walkthrough of Bedaquiline — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Bedaquiline is used for
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Bedaquiline (Sirturo) is an antimycobacterial antibiotic used only for a specific, difficult-to-treat form of tuberculosis.
- Sirturo is indicated as part of combination therapy for pulmonary tuberculosis (TB that affects the lungs) caused by Mycobacterium tuberculosis that is resistant to at least rifampin and isoniazid — a condition known as drug-resistant TB
- Approved for adults and children 2 years and older weighing at least 8 kg
- Sirturo is not used for latent TB infection (no active symptoms), drug-sensitive TB, TB that has spread outside the lungs (extra-pulmonary TB), or infections caused by non-tuberculous mycobacteria
How Bedaquiline works
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Bedaquiline targets an enzyme called ATP synthase, which TB bacteria depend on to produce the energy they need to survive and multiply. By blocking this enzyme, bedaquiline effectively shuts off the bacteria's power supply, killing them. This mechanism is completely different from older TB drugs, which means bedaquiline can work against strains that have already become resistant to standard treatments.
Because the drug works differently from other TB medicines, using it incorrectly — alone or with too few companion drugs — could allow bacteria to develop resistance to bedaquiline itself. That's why it must always be used as part of a carefully designed multi-drug regimen.
How Bedaquiline is taken (dosage)
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Sirturo tablets are taken by mouth with food — food nearly doubles the amount absorbed, so skipping meals with your dose is not an option. Treatment is given in two phases over 24 weeks: a higher daily dose for the first two weeks, then a lower dose three times a week (spaced at least 48 hours apart) for the remaining 22 weeks. Pediatric dosing is based on body weight and follows the same two-phase pattern.
- Every dose is given under directly observed therapy (DOT) — a healthcare worker watches you take it
- If you miss a dose in the first 2 weeks, skip it and continue your daily schedule; from week 3 onward, take the missed dose as soon as possible, then resume your three-times-a-week schedule
- In certain situations, treatment may be continued beyond 24 weeks — your doctor will decide this based on your response
Dosing details from the FDA-approved label
From the Bedaquiline prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
SIRTURO (20 mg and 100 mg) must be taken with food.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administer SIRTURO by directly observed therapy (DOT). ( 2.1 ) Emphasize need for compliance with full course of therapy. ( 2.1 ) Prior to administration, obtain ECG, liver enzymes and electrolytes. Obtain susceptibility information for the background regimen against Mycobacterium tuberculosis isolate if possible. ( 2.2 ) Only use SIRTURO in combination with at least 3 other drugs to which the patient's TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, may initiate SIRTURO in combination with at least 4 other drugs to which patient's TB isolate is likely to be susceptible. ( 2.1 ) Recommended dosage in adult patients: 400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) once daily for 2 weeks followed by 200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) 3 times per week (with at least 48 hours between doses) for 22 weeks. ( 2.3 ) Recommended dosage in pediatric patients (2 years and older and weighing at least 8 kg) is based on body weight. ( 2.4 ) Take SIRTURO tablets with food. ( 2.6 ) See full prescribing information for the different methods of administration of SIRTURO 20 mg tablet and administration of the 100 mg tablet. 2.1 Important Administration Instructions Administer SIRTURO by directly observed therapy (DOT). Only use SIRTURO in combination with at least three other drugs to which the patient's TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, SIRTURO treatment may be initiated in combination with at least four other drugs to which the patient's TB isolate is likely to be susceptible. Refer to the prescribing information of the drugs used in combination with SIRTURO for further information. SIRTURO (20 mg and 100 mg) must be taken with food. SIRTURO 20 mg are functionally scored tablets which can be split at the scored lines into two equal halves of 10 mg each to provide doses less than 20 mg [see Dosage and Administration (2.6) ]. As an alternative method of administration, SIRTURO 20 mg tablets can be dispersed in water and administered or dispersed in water and further mixed with a beverage or soft food, or crushed and mixed with soft food, or administered through a feeding tube [see Dosage and Administration (2.6) ]. Emphasize the need for compliance with the full course of therapy.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Bedaquiline side effects in detail
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Common side effects
- Nausea
- Joint pain (arthralgia)
- Headache
- Vomiting
- Coughing up blood (hemoptysis)
- Chest pain
- Elevated liver enzymes (shown on blood tests)
- Rash or skin itching
When to get medical help
- Call your doctor right away if you feel your heart racing, fluttering, or beating irregularly (palpitations), or if you faint — these may be signs of a dangerous heart rhythm problem
- Tell your doctor immediately if you develop yellowing of the skin or eyes, dark urine, unusual fatigue, or abdominal pain — these can be signs of liver injury
- Seek emergency care if you lose consciousness (syncope)
- Let your doctor know immediately about any new or worsening symptoms of liver problems: nausea, loss of appetite, right-sided belly tenderness, or jaundice
- Contact your care team if you notice severe dizziness, which may be related to heart rhythm changes
Like all TB medications, Sirturo can cause side effects — some common, some serious.
- Nausea and vomiting
- Joint pain (arthralgia)
- Headache
- Coughing up blood (hemoptysis)
- Chest pain
- Elevated liver enzymes on blood tests
- Itching (pruritus) and rash
- Dizziness and difficulty sleeping (insomnia)
Get medical help right away if you notice irregular heartbeats, fainting, yellowing of the skin or eyes, dark urine, or severe abdominal pain — these can signal dangerous heart rhythm changes or liver injury that need immediate attention.
Bedaquiline warnings and precautions
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- Heart rhythm (QTc prolongation): Sirturo extends the heart's electrical cycle in a way that can trigger a life-threatening arrhythmia (irregular heartbeat). This risk increases when combined with other drugs that affect heart rhythm (such as clofazimine or levofloxacin) or when blood electrolytes (potassium, calcium, magnesium) are low. ECGs are required before, during, and after treatment.
- Mortality imbalance: In one clinical trial, more deaths occurred in patients who received Sirturo than in those who did not. The reason is unexplained. Sirturo is therefore used only when drug-resistant TB leaves limited alternatives, and always under close supervision.
- Liver injury (hepatotoxicity): Sirturo can damage the liver. Liver function tests are checked monthly. Avoid alcohol and other liver-stressing medications during treatment. Sirturo must be stopped if serious liver injury is detected.
- Risk of drug resistance: Using Sirturo alone or with an inadequate companion regimen can cause the TB bacteria to become resistant to bedaquiline. It must always be used with at least 3 other drugs to which the bacteria are known or likely to be susceptible.
Bedaquiline interactions: what it interacts with
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Bedaquiline interacts with several types of medications — let your entire care team know everything you take.
- Strong or moderate CYP3A4 inducers (rifampin, rifapentine, rifabutin, efavirenz) — these speed up bedaquiline's breakdown in the body, lowering its levels and potentially making it less effective; avoid combining these with Sirturo
- CYP3A4 inhibitors — these slow the breakdown of bedaquiline, raising its blood levels and increasing the risk of side effects; close monitoring of liver function is required if used together
- Other QTc-prolonging drugs (such as clofazimine, levofloxacin, moxifloxacin) — combining these with Sirturo adds to the heart rhythm risk; regular ECG monitoring is essential
- Alcohol and hepatotoxic medications — these increase the risk of liver damage and should be avoided during treatment
Interactions listed in the FDA-approved label
From the Bedaquiline prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
Avoid use of strong and moderate CYP3A4 inducers with SIRTURO. ( 7.1 ) Closely monitor patient safety (e.g., liver function) when SIRTURO is coadministered with CYP3A4 inhibitors.
Read the label’s full interactions text
7 DRUG INTERACTIONS Avoid use of strong and moderate CYP3A4 inducers with SIRTURO. ( 7.1 ) Closely monitor patient safety (e.g., liver function) when SIRTURO is coadministered with CYP3A4 inhibitors. ( 5.4 , 7.1 ) 7.1 Effect of Other Drugs on SIRTURO Strong and Moderate CYP3A4 Inducers Coadministration of SIRTURO with moderate or strong CYP3A4 inducers may decrease systemic exposure of bedaquiline. Avoid coadministration of SIRTURO with strong or moderate CYP3A4 inducers [see Clinical Pharmacology (12.3) ] . CYP3A4 Inhibitors Coadministration of SIRTURO with CYP3A4 inhibitors increases the systemic exposure of bedaquiline which may increase the risk of adverse reactions. Closely monitor patient safety (e.g., liver function) when SIRTURO is coadministered with CYP3A4 inhibitors. No dose adjustment of SIRTURO is needed when coadministered with CYP3A4 inhibitors [see Clinical Pharmacology (12.3) ] . 7.2 Other Antimicrobial Medications No dose adjustment of isoniazid or pyrazinamide is required during coadministration with SIRTURO. 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. 7.3 QTc Interval Prolonging Drugs In clinical trials of adult patients, additional QTc interval prolongation was observed during combination treatment with SIRTURO and other QTc prolonging drugs. 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 change from Day-1 of 12 ms).
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Bedaquiline
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- Tell your doctor if you have any heart condition, especially Long QT syndrome, Torsade de Pointes, slow heart rate (bradyarrhythmia), or heart failure — these increase the risk of dangerous heart rhythm problems
- Tell your doctor if you have low blood levels of potassium, calcium, or magnesium, or a thyroid condition (hypothyroidism) — these also raise heart rhythm risk
- Tell your doctor about all medications, supplements, and herbal products you take, especially any that affect the liver or heart rhythm
- Sirturo has not been shown safe or effective in children under 2 years of age or weighing less than 8 kg
- If you are pregnant, discuss risks carefully with your doctor — untreated drug-resistant TB in pregnancy carries serious risks, and the safety of bedaquiline in pregnancy has not been fully established
- Breastfeeding is not recommended during treatment or for approximately 27.5 months after the last dose, as bedaquiline concentrates in breast milk and may harm a nursing infant; if formula is unavailable, monitor the infant for signs of liver problems
- If you have liver disease (mild or moderate), no dose change is needed, but you should be monitored closely; severe liver impairment requires extra caution and medical judgment
- If you have severe kidney disease or are on hemodialysis or peritoneal dialysis, use Sirturo with caution and under close monitoring
- Older adults (65+): limited data exist, but age alone does not appear to significantly change how the body handles bedaquiline; your doctor will monitor you carefully
Bedaquiline overdose: if you take too much
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There is no established treatment specifically for a Sirturo overdose. If too much is taken, general supportive care is recommended — including monitoring vital signs and performing an ECG to check for heart rhythm changes. Contact a poison control center immediately for the most current guidance. Because bedaquiline binds very tightly to blood proteins, dialysis is unlikely to remove a meaningful amount of the drug.
Pharmacodynamics: what Bedaquiline does in the body
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Bedaquiline works directly against Mycobacterium tuberculosis bacteria. One of its breakdown products in the body (called M2) is much less active against TB bacteria than the parent drug and is not thought to contribute meaningfully to fighting the infection. However, M2 levels in the blood are linked to the heart rhythm effects (QTc prolongation) seen with this medication. In clinical studies, Sirturo increased the QTc interval by an average of 16 to 35 milliseconds during treatment; this effect gradually resolved after the drug was stopped.
Pharmacokinetics: how your body processes Bedaquiline
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Bedaquiline is absorbed from the gut and reaches peak blood levels in about 5 hours after a dose; taking it with food roughly doubles the amount absorbed. It binds very tightly to proteins in the blood (more than 99.9%) and is broken down mainly by a liver enzyme called CYP3A4 into its primary metabolite, M2. The drug is eliminated mostly through the stool, with almost none leaving unchanged in the urine. Bedaquiline has an unusually long half-life of about 5.5 months, meaning it stays in the body for a very long time after treatment ends — which is important for breastfeeding decisions and for thinking about potential interactions.
How to store Bedaquiline
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Store in original container. Protect from light and moisture. Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) .
📄 Written from Bedaquiline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Bedaquiline
146 supplements and herbal products have documented interactions with Bedaquiline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 98
- Minor · 40
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Bedaquiline: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Bedaquiline — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I have to take this with so many other TB drugs at once?
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Why does every dose have to be watched by a healthcare worker?
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I heard this medication can affect my heart. What should I watch for?
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What should I do if I feel sick to my stomach or notice yellowing of my skin while taking this?
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Can I breastfeed while taking bedaquiline?
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Is it safe to drink alcohol while on this treatment?
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Is Bedaquiline available over the counter?
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When was Bedaquiline first available?
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Who makes Bedaquiline?
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💬 Answers drafted from Bedaquiline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Bedaquiline on HelloPharmacist
💊 Bedaquiline forms and strengths (how it comes)
Bedaquiline is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Sirturo tablets are used as part of combination therapy to treat pulmonary (lung) tuberculosis caused by bacteria resistant to at least rifampin and isoniazid, in adults and children 2 years and older weighing at least 8 kg
- Sirturo tablets are not for latent TB, drug-sensitive TB, TB outside the lungs, or non-tuberculous mycobacterial infections
- Sirturo tablets must always be taken with food to improve absorption
- Sirturo 100 mg tablets should be swallowed whole with water
- Sirturo 20 mg tablets can be swallowed whole, split in half, dispersed in water and mixed with a soft food or beverage, crushed and mixed with soft food, or given through a feeding tube (8 French or larger) for patients who cannot swallow intact tablets
- Sirturo doses are administered under directly observed therapy (DOT) — a healthcare worker should watch each dose being taken
🖼️ What Bedaquiline products look like
Images from the FDA-filed labels on DailyMed — packaging and, where the labeler provides one, the tablet or capsule itself. Appearance varies by manufacturer; your pharmacy's product may differ.
Source: DailyMed label media (National Library of Medicine).
📊 Bedaquiline on the U.S. market: products, makers and brands
How Bedaquiline appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 7 Bedaquiline product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2012. Brand names on the directory include Sirturo; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Bedaquiline is used (Medicaid data)
A general measure of how commonly Bedaquiline is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Bedaquiline is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Bedaquiline prescribed? Of the 1,599 medications we measure, Bedaquiline ranks #1,469 by Medicaid prescriptions — more than 8% of them.
Utilization by Bedaquiline product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
bedaquiline 100 MG Oral Tablet Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1364509
bedaquiline 20 MG Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2373939
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Bedaquiline, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 2 listed Bedaquiline NDCs with Medicaid activity.
🔍 Compare Bedaquiline products
A representative set of FDA-listed product records for Bedaquiline — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 20 mg | Oral | Janssen Products, LP × 3 listings | NDA | View NDC → |
| 100 mg | Oral | Janssen Products, LP × 3 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Bedaquiline NDCs →
📈 Bedaquiline side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Bedaquiline — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Bedaquiline are electrocardiogram qt prolonged, hepatotoxicity, anaemia; about 96% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Bedaquiline in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Bedaquiline FDA approval history
How Bedaquiline went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Bedaquiline was first approved by the FDA in 2012 (Brand: SIRTURO · Janssen Therap). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
🚨 Bedaquiline recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
No recall of any Bedaquiline product is on record in the FDA enforcement database.
✅No recalls found for Bedaquiline in the FDA databaseSource: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1364504 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1364508In current FDA listings
Look up RxCUI 1364504 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Bedaquiline supply and shortage status
Whether Bedaquiline is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Bedaquiline brand names
Bedaquiline is sold under one brand name in the FDA directory — Sirturo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
🏭 Who makes Bedaquiline: manufacturers and labelers
2 companies list Bedaquiline products with the FDA. By number of product records, the largest are Janssen Products, LP, MSN Life Sciences Private Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Bedaquiline drug class (RxNorm)
Bedaquiline belongs to the Diarylquinoline Antimycobacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Bedaquiline page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Janssen Products, LP is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.