Lefamulin
Lefamulin is an antibacterial medicine used to treat community-acquired bacterial pneumonia in adults.
Built from the FDA-approved label, dated Jul 22, 2026 · How this page is built
⚡ Quick answers about Lefamulin
What is Xenleta actually used for?
Xenleta is an antibiotic specifically approved to treat community-acquired bacterial pneumonia — that's pneumonia you pick up in the community, not in a hospital.
Read the full answer →Do I need to take the tablet on an empty stomach?
Yes — this one is important. You should take Xenleta tablets at least 1 hour before eating or 2 hours after a meal.
Read the full answer →What side effects should I expect, and which ones should make me call my doctor?
The most common side effects with the tablet form are diarrhea, nausea, and vomiting — those are bothersome but usually manageable.
Read the full answer →Are there any medications I absolutely cannot take with this antibiotic?
Yes, there are some important ones. If you're taking the tablet form of Xenleta, certain medications that affect heart rhythm — like pimozide, or drugs called Class IA or III antiarrhythmics — must not be…
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 2 clinical label sets 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 →📖 Lefamulin: Patient Information Guide
A plain-language walkthrough of Lefamulin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Lefamulin is used for
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Lefamulin (Xenleta) is approved for one specific use in adults: treating community-acquired bacterial pneumonia.
- Xenleta (IV and oral): Treatment of community-acquired bacterial pneumonia (CABP) in adults caused by susceptible bacteria, including Streptococcus pneumoniae, methicillin-susceptible Staphylococcus aureus, Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae
- Xenleta should only be used when a bacterial cause of pneumonia is confirmed or strongly suspected — not for viral infections like the flu
- Using antibiotics unnecessarily increases the risk of antibiotic-resistant bacteria developing over time
How Lefamulin works
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Lefamulin is a pleuromutilin antibiotic — the first in this class approved for use in humans in the United States. It works by binding to the bacterial ribosome, the machinery bacteria use to build proteins. By blocking this process, lefamulin stops bacteria from growing and reproducing, allowing the immune system to clear the infection.
Because it targets a site on the ribosome that is different from other antibiotic classes, lefamulin can be effective against some bacteria that have developed resistance to older antibiotics.
How Lefamulin is taken (dosage)
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Lefamulin is taken twice a day, either as an intravenous (IV) infusion in a clinical setting or as an oral tablet. The IV form is infused over 60 minutes per dose and may be used for 5 to 7 days, with the option to switch to tablets to finish the course. The tablet form is taken for 5 days.
- Xenleta Tablets: Take on an empty stomach — at least 1 hour before or 2 hours after a meal; swallow whole with a full glass of water
- Missed dose: Take the missed dose as soon as you remember, as long as 8 or more hours remain before the next scheduled dose; otherwise, skip it and resume your normal schedule
- Patients with severe liver disease may need a different dosing schedule for the IV form; the tablet form is not recommended for moderate or severe liver disease
Dosing details from the FDA-approved label
From the Lefamulin 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.
Injection Reduce the dosage of XENLETA Injection to 150 mg infused intravenously over 60 minutes every 24 hours for patients with severe hepatic impairment (Child-Pugh Class C).
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION For treatment of adults with CABP, the recommended dosage of XENLETA is as follows: *With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course. Dosage Treatment Duration 150 mg every 12 hours by intravenous infusion over 60 minutes* ( 2.1 ) 5 to 7 days 600 mg orally every 12 hours. ( 2.1 ) 5 days Patients with Hepatic Impairment : Reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours in patients with severe hepatic impairment (Child-Pugh Class C). XENLETA Tablets have not been studied in and are not recommended for patients with moderate (Child-Pugh Class B) or severe hepatic impairment ( 2.2 ). Administration Instruction for XENLETA Tablets : Take at least 1 hour before a meal or 2 hours after a meal. Swallow XENLETA Tablets whole with water (6 to 8 ounces). ( 2.3 ) Administration Instruction for XENLETA Injection : Infuse over 60 minutes. ( 2.3 ) See Full Prescribing Information for additional information on the administration and preparation of XENLETA Tablets and Injection. ( 2.4 ) 2.1 Recommended Dosage For treatment of adults with CABP, the recommended dosage of XENLETA is described in Table 1 below. For patients with severe hepatic impairment, dosage adjustment is required [see Dosage and Administration ( 2.2 )] . Table 1: Dosage of XENLETA in Adult CABP Patients *With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course. Dosage Treatment Duration 150 mg every 12 hours by intravenous infusion over 60 minutes* 5 to 7 days 600 mg orally every 12 hours 5 days 2.2 Dosage Adjustment for Patients with Hepatic Impairment Monitor patients with hepatic impairment for adverse reactions associated with XENLETA Injection and Tablets throughout the treatment period [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )]. XENLETA Injection Reduce the dosage of XENLETA Injection to 150 mg infused intravenously over 60 minutes every 24 hours for patients with severe hepatic impairment (Child-Pugh Class C). No dosage adjustment of XENLETA Injection is needed for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Lefamulin side effects in detail
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Common side effects
- Nausea
- Diarrhea
- Vomiting
- Elevated liver enzymes (shown on blood tests)
- Infusion site reactions (with the IV form)
- Low potassium levels (hypokalemia)
- Insomnia
- Headache
When to get medical help
- Call your doctor if you notice irregular heartbeat, dizziness, or fainting — these can be signs of a heart rhythm problem (QT prolongation)
- Get medical help right away for severe or persistent diarrhea, especially if it contains blood or mucus — this could be a serious C. difficile infection
- Tell your doctor immediately if you are pregnant or think you might be pregnant — lefamulin may harm an unborn baby
- Contact your doctor if you develop signs of a severe allergic reaction: rash, swelling, or difficulty breathing
The most common side effects differ slightly depending on the form of Xenleta used.
- Xenleta Injection: Reactions at the infusion site, elevated liver enzymes, nausea, low potassium (hypokalemia), insomnia, headache
- Xenleta Tablets: Diarrhea, nausea, vomiting, elevated liver enzymes
More serious reactions include heart rhythm changes (QT prolongation) and a severe gut infection called Clostridioides difficile-associated diarrhea (CDAD). Contact your doctor right away if you experience an irregular heartbeat, significant diarrhea, or diarrhea that continues after finishing treatment.
Lefamulin warnings and precautions
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- QT prolongation (heart rhythm change): Lefamulin can affect the heart's electrical system in a way that increases the risk of a dangerous irregular heartbeat. This risk is higher in people with existing heart rhythm problems, low potassium, kidney or liver disease, or those taking other QT-prolonging medications. ECG monitoring may be needed during treatment.
- Embryo-fetal toxicity: Animal studies show lefamulin can cause serious harm to a developing baby, including birth defects and fetal loss. Pregnancy must be ruled out before starting treatment. Effective contraception is required during treatment and for 2 days after the last dose.
- C. difficile-associated diarrhea (CDAD): Like all antibiotics, lefamulin can disrupt normal gut bacteria and allow C. difficile to overgrow, causing diarrhea that can range from mild to life-threatening. This can occur even weeks after finishing the antibiotic.
- Antibiotic resistance: Using lefamulin when it isn't clearly needed contributes to drug-resistant bacteria and reduces its future effectiveness.
Lefamulin interactions: what it interacts with
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Lefamulin interacts with several types of medications — some interactions are serious enough to make the combination contraindicated (not allowed).
- QT-prolonging drugs (e.g., antiarrhythmics like quinidine, amiodarone, sotalol; antipsychotics; erythromycin; moxifloxacin; tricyclic antidepressants): Combining these with lefamulin increases the risk of dangerous heart rhythm problems — avoid if possible
- Pimozide and other sensitive CYP3A4 substrates that prolong the QT interval: Contraindicated with Xenleta Tablets — lefamulin raises their blood levels, increasing heart rhythm risk
- Strong CYP3A inducers (e.g., certain seizure medications, rifampin): Lower lefamulin levels in the blood, which may make it less effective — avoid unless benefit outweighs risk
- Strong CYP3A inhibitors (e.g., certain antifungals, HIV medications): Raise lefamulin levels when using Xenleta Tablets — avoid this combination
- Sensitive CYP3A substrates (e.g., midazolam, simvastatin, vardenafil, alprazolam, diltiazem, verapamil): Xenleta Tablets can raise the levels of these drugs — monitor closely for side effects of those medications
- High-fat meals: Eating a large, fatty meal before or with Xenleta Tablets reduces the amount of medicine absorbed — take on an empty stomach
Interactions listed in the FDA-approved label
From the Lefamulin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
Injection Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy.
Read the label’s full interactions text
7 DRUG INTERACTIONS XENLETA Injection Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. ( 7.1 ) XENLETA Tablets Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. ( 7.1 ) Strong CYP3A inhibitors or P-gp inhibitors Avoid XENLETA. ( 7.1 ) Moderate CYP3A inhibitors or P-gp inhibitors Monitor for adverse reactions. ( 7.1 ) CYP3A substrates that prolong the QT interval Concomitant use is contraindicated. ( 4.2 , 7.2 ) Midazolam and other sensitive CYP3A substrates Monitor for adverse reactions. ( 7.2 ) 7.1 Effect of Other Drugs on XENLETA Strong and Moderate CYP3A Inducers or P-gp Inducers Concomitant use of oral or intravenous XENLETA with strong CYP3A4 inducers or P-gp inducers decreases lefamulin AUC and C max [see Clinical Pharmacology ( 12.3 )] , which may reduce the efficacy of XENLETA. Avoid concomitant use of XENLETA Injection and XENLETA Tablets with strong and moderate CYP3A4 inducers or P-gp inducers unless the benefit outweighs the risks. Strong and Moderate CYP3A Inhibitors or P-gp Inhibitors Concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors increases lefamulin AUC [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse reactions with XENLETA Tablets. Avoid concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors. Monitor for adverse effects of XENLETA Tablets when administered concomitantly with moderate CYP3A inhibitors or P-gp inhibitors. 7.2 Effect of XENLETA on Other Drugs CYP3A4 Substrates Concomitant use of XENLETA Tablets with sensitive CYP3A4 substrates increases the AUC and C max of CYP3A4 substrates [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of toxicities associated with cardiac conduction.
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 Lefamulin
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- Allergy: Do not take lefamulin if you are allergic to it, to other pleuromutilin antibiotics, or to any ingredient in Xenleta
- Heart rhythm problems: Tell your doctor if you have a history of QT prolongation, torsades de pointes, or ventricular arrhythmias — lefamulin may worsen these
- Liver disease: Xenleta Tablets are not recommended for moderate or severe liver disease; the IV form requires a dose adjustment in severe liver disease
- Kidney disease/dialysis: No dose adjustment is needed for kidney disease, but patients on dialysis may be at higher risk for heart rhythm changes and should be monitored
- Pregnancy: Lefamulin may harm an unborn baby based on animal studies; verify you are not pregnant before starting treatment and use effective birth control during treatment and for 2 days after the last dose
- Breastfeeding: Do not breastfeed during treatment or for 2 days after the last dose — pump and discard milk during this time
- Children: Xenleta is not approved for anyone under 18 years of age; its safety and effectiveness have not been established in this age group
- Older adults: Adults 65 and older were included in clinical trials and responded similarly to younger patients; standard precautions apply
Lefamulin overdose: if you take too much
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If too much lefamulin is taken, treatment focuses on observation and general supportive care. Lefamulin and its main breakdown product cannot be removed from the body by dialysis, so monitoring and supportive measures are the main approach.
Pharmacodynamics: what Lefamulin does in the body
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Lefamulin affects the heart's electrical activity in a concentration-dependent way — meaning higher drug levels cause greater QT interval prolongation (a measurable change on an ECG that reflects the heart's recovery time between beats). In clinical trials, this effect was observed with both the IV and tablet forms. Infusing the IV form faster than recommended or exceeding the recommended dose can increase this effect, which is why the prescribed infusion rate and dose must not be exceeded.
Pharmacokinetics: how your body processes Lefamulin
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When taken as a tablet, Xenleta has about 25% oral bioavailability — meaning roughly a quarter of the dose reaches the bloodstream. Eating a high-fat meal before the tablet reduces absorption, which is why it should be taken on an empty stomach. The drug is highly bound to proteins in the blood and spreads well into lung tissue, which is important for treating pneumonia. Lefamulin is broken down mainly by the liver enzyme CYP3A4, with most of it leaving the body through the feces. Its half-life — the time it takes for half the drug to clear the body — is about 8 hours in pneumonia patients, though this is longer in people with severe liver disease.
How to store Lefamulin
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XENLETA Injection should be stored at 2°C to 8°C (36°F to 46°F). Store in a refrigerator. Do not freeze.
📄 Written from Lefamulin’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 →
🩺 Lefamulin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Lefamulin — the kind of thing our pharmacy team would talk through with you at the counter.
What is Xenleta actually used for?
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Do I need to take the tablet on an empty stomach?
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What side effects should I expect, and which ones should make me call my doctor?
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Are there any medications I absolutely cannot take with this antibiotic?
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Can I take this medication if I'm pregnant or trying to get pregnant?
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Can I breastfeed while taking Xenleta?
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Is Lefamulin available over the counter?
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When was Lefamulin first available?
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Who makes Lefamulin?
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💬 Answers drafted from Lefamulin’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 Lefamulin on HelloPharmacist
💊 Lefamulin forms and strengths (how it comes)
Lefamulin is available in 2 forms. 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.
Injection
How this form is used
- Xenleta Injection is used to treat community-acquired bacterial pneumonia (CABP) in adults caused by susceptible bacteria
- Xenleta Injection may be followed by a switch to Xenleta Tablets to complete the treatment course
- Xenleta Injection is administered by intravenous infusion over 60 minutes
- Xenleta Injection must be diluted in the citric buffered normal saline solution supplied with it before use
- Xenleta Injection is given every 12 hours for 5 to 7 days, or every 24 hours in patients with severe liver disease
- Do not add other medications to the Xenleta Injection infusion bag
Tablet
How this form is used
- Xenleta Tablets are used to treat community-acquired bacterial pneumonia (CABP) in adults caused by susceptible bacteria
- Xenleta Tablets are not recommended for patients with moderate or severe liver disease
- Xenleta Tablets should be taken on an empty stomach — at least 1 hour before or 2 hours after a meal
- Swallow Xenleta Tablets whole with 6 to 8 ounces of water; do not crush or split them
- Xenleta Tablets are taken every 12 hours for 5 days
- If you miss a dose, take it as soon as possible — but skip it if less than 8 hours remain before your next dose
🖼️ What Lefamulin 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).
📊 Lefamulin on the U.S. market: products, makers and brands
How Lefamulin 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.
3 companies list 7 Lefamulin product records with the FDA, mostly as injection, tablet; the earliest marketing or approval year on record is 2019. Brand names on the directory include Xenleta, Citric Buffered Normal Saline; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are 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 Lefamulin products
A representative set of FDA-listed product records for Lefamulin — 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 |
|---|---|---|---|---|
| 💊Injection | ||||
| 150 mg/15 mL | Intravenous | Meitheal Pharmaceuticals Inc. | NDA | View NDC → |
| 150 mg/15 mL | Intravenous | Nabriva Therapeutics US, Inc. × 2 listings | NDA | View NDC → |
| 150 mg/15 mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Tablet | ||||
| 600 mg | Oral | Meitheal Pharmaceuticals Inc. | NDA | View NDC → |
| 600 mg | Oral | Nabriva Therapeutics US, Inc. × 2 listings | NDA | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Lefamulin NDCs →
📈 Lefamulin 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 Lefamulin — 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 Lefamulin 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.
🏛️ Lefamulin FDA approval history
How Lefamulin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Lefamulin 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 Lefamulin product is on record in the FDA enforcement database.
✅No recalls found for Lefamulin 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 2198944 2 dose forms · 2 strengths
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Dose form (SCDF) Injection RxCUI 2198947In current FDA listingsClinical drug / strength (SCD) 15 ML lefamulin 10 MG/MLRxCUI 2198948 -
Dose form (SCDF) Oral Tablet RxCUI 2198960In current FDA listingsClinical drug / strength (SCD) 600 MGRxCUI 2198961
Look up RxCUI 2198944 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.
📦 Lefamulin supply and shortage status
Whether Lefamulin 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.
🏷️ Lefamulin brand names
Lefamulin is sold under 2 brand names in the FDA directory — Xenleta, Citric Buffered Normal Saline. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
🏭 Who makes Lefamulin: manufacturers and labelers
3 companies list Lefamulin products with the FDA. By number of product records, the largest are Nabriva Therapeutics US, Inc., Meitheal Pharmaceuticals Inc., Patheon Italia S.p.A.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Lefamulin drug class (RxNorm)
Lefamulin belongs to the Pleuromutilin Antibacterial 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 Lefamulin 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 2 FDA-filed SPL label sets 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. Meitheal Pharmaceuticals Inc. 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.