Pretomanid
Pretomanid is an antimycobacterial antibiotic used as part of a combination regimen to treat adults with highly drug-resistant or treatment-intolerant pulmonary tuberculosis (TB).
🧬 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 →
📖 Pretomanid: Patient Information Guide
A plain-language walkthrough of Pretomanid — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Pretomanid is an antimycobacterial antibiotic approved for use only in a specific, limited population of adults with difficult-to-treat pulmonary tuberculosis (TB). It is always used as part of a three-drug combination with bedaquiline and linezolid.
- Pretomanid Tablet treats adults with pulmonary TB that is resistant to isoniazid, rifamycins, a fluoroquinolone, and a second-line injectable TB drug (sometimes called extensively drug-resistant or XDR-TB)
- Pretomanid Tablet treats adults with pulmonary TB resistant to isoniazid and rifampin who cannot tolerate standard therapy or whose TB is not responding to it
- Pretomanid Tablets are not indicated for drug-sensitive TB, latent (inactive) TB, TB outside the lungs, or TB in patients who respond to and tolerate standard therapy
- Safety and effectiveness of Pretomanid Tablets have not been established in combination with drugs other than bedaquiline and linezolid
⚙️How it works▾
Pretomanid belongs to a class called nitroimidazooxazines and works against Mycobacterium tuberculosis in two distinct ways. When TB bacteria are actively multiplying, pretomanid blocks the production of mycolic acid — a key building block of the bacterial cell wall — causing the bacteria to fall apart and die. When bacteria are in a dormant, non-replicating state (as often happens deep within TB lesions), pretomanid releases nitric oxide inside the bacterial cell, poisoning the bacteria's energy system and killing them. Both actions require the drug to be chemically activated inside the bacteria by a specific enzyme called Ddn, which depends on a cofactor called F420.
Because pretomanid requires this internal activation step, bacteria that have mutations affecting the Ddn enzyme or F420 production pathway may be resistant to pretomanid. This is one reason susceptibility testing and careful patient selection are critical before starting treatment.
💊How it's taken▾
Pretomanid Tablet is taken by mouth once daily for 26 weeks, always together with bedaquiline and linezolid — never on its own. It must be taken with food, because eating significantly increases the amount of drug your body absorbs. The tablet should be swallowed whole with water; if swallowing is a problem, it can be crushed and mixed with a small amount of room-temperature water and taken right away (do not store the mixture).
- All doses are given under direct supervision by a healthcare provider (directly observed therapy)
- The treatment course can be extended beyond 26 weeks if your doctor determines it is necessary
- If doses are interrupted for safety reasons, your doctor may add make-up doses at the end of treatment — but do not make up missed doses on your own
- If either pretomanid or bedaquiline is stopped, the entire three-drug regimen should be stopped — always follow your doctor's instructions on discontinuation
🤒Side effects — in detail▾
The most common side effects reported with the pretomanid, bedaquiline, and linezolid combination regimen include:
- Peripheral neuropathy — numbness, tingling, burning, or weakness in the hands or feet (very common, especially at higher linezolid doses)
- Anemia — low red blood cell count causing fatigue or shortness of breath
- Nausea and vomiting
- Acne or skin rash
- Headache
- Increased liver enzymes on blood tests
- Musculoskeletal pain (muscles and joints)
- Decreased appetite, stomach pain, or indigestion
Serious reactions requiring prompt medical attention include liver injury, dangerous drops in blood counts (myelosuppression), optic neuropathy (vision loss or changes), heart rhythm problems (QT prolongation), and lactic acidosis. Contact your healthcare provider immediately if you notice any of these.
⚠️Warnings & precautions▾
- Liver injury (hepatotoxicity): Liver problems have been reported with this regimen. Avoid alcohol and other liver-stressing substances during treatment. Your doctor will monitor liver blood tests regularly — report fatigue, yellowing of skin or eyes, dark urine, or stomach pain right away.
- Low blood cell counts (myelosuppression): This regimen can lower red blood cells, white blood cells, and platelets — a known risk of linezolid. Severe anemia can be life-threatening. Blood counts are monitored throughout treatment; linezolid doses may be reduced if counts drop too low.
- Nerve damage (peripheral and optic neuropathy): Numbness, tingling, or weakness in the limbs and changes in vision have been reported. These are known risks of linezolid. Vision symptoms need prompt evaluation by an eye specialist. Linezolid dose adjustments can help, and these effects are often reversible.
- Heart rhythm changes (QT prolongation): This combination can lengthen the QT interval on an ECG — a change that can increase the risk of dangerous heart arrhythmias. ECGs are done before and during treatment. Tell your doctor if you have a history of heart rhythm problems, low electrolyte levels, or if you faint.
- Lactic acidosis: A dangerous buildup of acid in the blood has been reported, linked to linezolid. Persistent nausea, vomiting, or extreme weakness require immediate medical evaluation.
- Male fertility: Animal studies showed testicular damage and impaired fertility in male rodents. Effects on human male fertility have not been fully studied — discuss this risk with your doctor before starting treatment.
🔀What it interacts with▾
Several drugs and substances can significantly affect how pretomanid works or increase the risk of side effects when combined with this regimen:
- Rifampin and efavirenz (and other strong or moderate CYP3A4 inducers): These drugs speed up the breakdown of pretomanid, lowering its blood levels substantially — avoid this combination
- Lopinavir/ritonavir: Can be used with this regimen; it had only a small effect on pretomanid levels that is not considered clinically significant
- OAT3 substrate drugs (e.g., methotrexate, indomethacin, ciprofloxacin): Pretomanid may block the OAT3 drug transporter, raising blood levels of these drugs and increasing their side effects — monitor closely and consider dose reduction of the co-administered drug
- OATP1B3 substrates (e.g., certain statins, valsartan): Pretomanid may raise their blood levels — monitor for increased side effects
- BCRP substrates (e.g., rosuvastatin, sulfasalazine, glyburide): Potential for increased exposure — monitor for adverse effects
- P-gp substrates (e.g., digoxin, dabigatran): Potential for increased exposure — monitor for adverse effects
- Alcohol and hepatotoxic substances (including certain herbal supplements): Avoid during treatment due to increased risk of liver injury
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Contraindications to bedaquiline or linezolid: If either partner drug is contraindicated for you, you cannot take this regimen — refer to those drugs' prescribing information
- Liver disease: The full impact of liver impairment on pretomanid safety and effectiveness is unknown — your doctor will assess liver function before and during treatment
- Kidney disease: The effect of kidney impairment on pretomanid is also unknown — inform your doctor of any kidney problems
- Pregnancy: There are no human safety data for pretomanid in pregnancy. Animal studies showed potential harm at high exposures. Active TB in pregnancy itself carries serious risks. Discuss risks and benefits carefully with your doctor.
- Breastfeeding: Breastfeeding is not recommended while taking this regimen, as pretomanid was detected in animal milk and potential effects on nursing infants are unknown
- Males planning to have children: Pretomanid caused testicular damage and impaired fertility in animal studies — effects on human fertility have not been fully evaluated; discuss this with your doctor
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults (65+): Clinical trial data in this age group are limited — use with appropriate caution and monitoring
- Heart rhythm conditions: A history of Torsade de Pointes, congenital long QT syndrome, heart failure, bradyarrhythmia (slow heart rate), hypothyroidism, or low electrolyte levels may increase risk of heart rhythm complications — inform your doctor before starting
🚑If you take too much▾
There is no established experience with pretomanid overdose in humans. If an overdose is suspected — whether accidental or intentional — general supportive measures should be taken, including monitoring of vital signs and an ECG to watch for QT interval changes. Seek emergency medical care immediately.
📡Pharmacodynamics — effects in the body▾
In dedicated heart rhythm studies, pretomanid alone — even at doses much higher than the approved amount — did not cause significant QT prolongation (a lengthening of the heart's electrical recovery time that can raise arrhythmia risk). However, when used in the three-drug regimen with bedaquiline and linezolid in clinical trials, QT prolongation was observed, primarily attributed to bedaquiline. Regular ECG monitoring is required throughout treatment. No patients in the main trials had dangerously prolonged QT intervals (above 480 ms), though isolated cases of significant increases from baseline did occur.
🔬Pharmacokinetics — how your body processes it▾
Pretomanid is absorbed by mouth and its absorption is significantly increased when taken with food — a high-fat meal nearly doubles the amount of drug that reaches the bloodstream, which is why taking it with food is required. The drug reaches steady levels in the blood after about 4 to 6 days of daily dosing, and has a half-life (the time it takes the body to clear half the drug) of roughly 16 to 17 hours. Pretomanid is broken down by the liver through multiple pathways, with the CYP3A4 enzyme responsible for up to about 20% of its metabolism. The drug and its breakdown products are eliminated roughly 53% through urine and 38% through feces, mostly as metabolites.
📦How to store it▾
Store below 30°C (86°F).
📄 Written from Pretomanid’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 Pretomanid
143 supplements and herbal products have documented interactions with Pretomanid in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 10
- Moderate · 122
- Minor · 11
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.
Nutrient depletion considerations
Pretomanid has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Pretomanid — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I have to take three drugs at once — can't I just take pretomanid by itself? ▾
Does it matter if I take pretomanid with food or on an empty stomach? ▾
What side effects are most likely, and which ones should I call my doctor about right away? ▾
Are there medications I should avoid while I'm on this treatment? ▾
I'm a male and want to have children someday — should I be concerned? ▾
What happens if I miss a dose or need to stop treatment early? ▾
Is Pretomanid available over the counter? ▾
When was Pretomanid first available? ▾
Who makes Pretomanid? ▾
💬 Answers drafted from Pretomanid’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 →
🧰 Keep exploring
💊 How Pretomanid comes
Pretomanid 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
- Pretomanid Tablet is used as part of a combination regimen with bedaquiline and linezolid to treat adults with pulmonary TB resistant to isoniazid, rifamycins, a fluoroquinolone, and a second-line injectable TB drug
- Pretomanid Tablet is used as part of a combination regimen with bedaquiline and linezolid to treat adults with pulmonary TB resistant to isoniazid and rifampin who are treatment-intolerant or nonresponsive to standard therapy
- Pretomanid Tablet must always be taken with food to maximize absorption — do not take on an empty stomach
- Pretomanid Tablet should be swallowed whole with water; for patients who have difficulty swallowing, the tablet may be crushed and suspended in a small amount of room-temperature water and taken immediately
- Pretomanid Tablet is taken once daily and must be administered as part of a directly observed therapy (DOT) program alongside bedaquiline and linezolid
- Do not store any crushed or water-mixed Pretomanid Tablet mixture for later use — prepare and take it right away
📊 Pretomanid across the U.S. market
How Pretomanid 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Pretomanid products
A representative set of FDA-listed product records for Pretomanid — 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 | ||||
| 200 mg | Oral | Mylan Specialty L.P. × 2 listings | NDA | View NDC → |
| 200 mg | Oral | Viatris Specialty LLC | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Pretomanid NDCs →
📈 What people report — real-world data (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 Pretomanid — a signal of what to watch for, not proof the drug caused it.
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 Pretomanid 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.
🏛️ The road to your pharmacy
How Pretomanid went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: 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 2198359 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 2198369In current FDA listingsClinical drug / strength (SCD) 200 MGRxCUI 2198370
Look up RxCUI 2198359 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.
📦 Supply & shortage status
Whether Pretomanid 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.
🏭 Manufacturers & labelers
RxNorm drug class
Pretomanid belongs to the 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.
🔬 Where this comes from
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. Mylan Specialty L.P. 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.