lefamulin
Brand names: Xenleta
Xenleta is an antibiotic medicine. It is used to treat pneumonia caused by bacteria in adults.
What it does
Xenleta treats community-acquired bacterial pneumonia (CABP) in adults.
Common side effects
Diarrhea, Nausea, Vomiting
Key warnings
Xenleta can cause changes in your heart rhythm (QT prolongation).
How It Works
Xenleta is a pleuromutilin antibiotic. It works by stopping bacteria from growing. This helps your body fight off the infection.
How to Take It
Xenleta comes as a tablet and an injection. The usual dose of the tablet is 600 mg taken by mouth every 12 hours for 5 days. Take the tablet at least 1 hour before or 2 hours after eating. The injection is 150 mg given into your vein over 60 minutes every 12 hours for 5 to 7 days.
Pregnancy & Breastfeeding
Xenleta may harm your unborn baby. Use effective birth control while taking Xenleta and for 2 days after your last dose if you are a woman who can get pregnant. Do not breastfeed while taking Xenleta and for 2 days after the last dose. Talk to your doctor about the best way to feed your baby during this time.
Missed Dose
If you miss a dose of Xenleta tablets, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store Xenleta tablets at room temperature, away from moisture and heat. Store Xenleta injection in the refrigerator and do not freeze.
Serious Warnings
Xenleta can cause changes in your heart rhythm (QT prolongation). This can be dangerous if you have heart problems or take other medicines that affect your heart. Xenleta can also harm an unborn baby, so women who can get pregnant should use birth control while taking it and for 2 days after the last dose. Diarrhea can occur with this medicine; tell your doctor if it becomes severe.
Known Drug Interactions
Therefore, avoid concomitant use of XENLETA Injection and XENLETA Tablets with such drugs (for example, Class IA and III antiarrhythmics, antipsychotics, erythromycin, moxifloxacin, tricyclic antidepressants).
Mechanism: Both of these medicines can affect the electrical timing of your heart. Taking them together increases the risk of developing a life-threatening irregular heartbeat.
What to do: Avoid using these two medications at the same time. Your doctor should look for a different treatment to avoid this heart risk.
Therefore, avoid concomitant use of XENLETA Injection and XENLETA Tablets with such drugs (for example, Class IA and III antiarrhythmics, antipsychotics, erythromycin, moxifloxacin, tricyclic antidepressants).
Mechanism: These two drugs can both interfere with the electrical signals that control your heartbeat. Using them at the same time makes a dangerous heart rhythm more likely.
What to do: You should avoid taking these two drugs together. Ask your doctor for a different antibiotic that does not carry this risk.
Concomitant use of sensitive CYP3A substrates with XENLETA Tablets requires close monitoring for adverse effects of these drugs (for example, alprazolam, diltiazem, verapamil, simvastatin, vardenafil).
Mechanism: Lefamulin can slow down how your body breaks down simvastatin. This may cause the cholesterol medicine to build up in your blood and increase the risk of side effects.
What to do: Your doctor should watch you closely for side effects while you are taking both medicines. Tell your healthcare provider if you have any new muscle pain or weakness.
Concomitant use of sensitive CYP3A substrates with XENLETA Tablets requires close monitoring for adverse effects of these drugs (for example, alprazolam, diltiazem, verapamil, simvastatin, vardenafil).
Mechanism: Lefamulin may interfere with the way your body removes alprazolam. This can lead to higher levels of the anxiety medicine in your system and cause more side effects.
What to do: Your healthcare provider should monitor you closely for increased side effects like extreme sleepiness. Your doctor may need to adjust your dose.
Concomitant use of sensitive CYP3A substrates with XENLETA Tablets requires close monitoring for adverse effects of these drugs (for example, alprazolam, diltiazem, verapamil, simvastatin, vardenafil).
Mechanism: Lefamulin can increase the amount of diltiazem in your body by slowing its breakdown. This makes it more likely that you will experience side effects from the blood pressure medicine.
What to do: Your doctor should monitor you carefully for side effects while you are on both medications. Report any signs of a slow heart rate or dizziness to your provider immediately.
Common Questions
What should I tell my doctor before taking Xenleta?
Can I take Xenleta with other medications?
What foods or drinks should I avoid while taking Xenleta?
What are the symptoms of an allergic reaction to Xenleta?
Can Xenleta cause diarrhea?
How long does it take for Xenleta to work?
What if I feel better before I finish all of my Xenleta?
Can I drive or operate machinery while taking Xenleta?
What if I have kidney problems?
What if I have liver problems?
What are the common side effects of lefamulin?
Does lefamulin interact with other medications?
What drug class is lefamulin?
Is lefamulin safe during pregnancy?
Related Medications in Pleuromutilin Antibiotic
Other drugs grouped near lefamulin — same-class peers and common alternatives.
amikacin
Amikin
Amikacin is an antibiotic medicine.
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amoxicillin
Amoxil
Amoxicillin and Clavulanate Potassium is a combination medicine used to fight bacterial infections.
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amoxicillin/clavulanate
Augmentin
Augmentin is a combination of two medicines, amoxicillin and clavulanate.
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ampicillin/sulbactam
Unasyn
Unasyn is a combination of two antibiotics that fights bacteria in your body.
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azithromycin
Zithromax, Z-Pack
Azithromycin is an antibiotic that fights bacteria.
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Medication Guides
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What the FDA Data Shows for lefamulin
The FDA label for lefamulin (sold under brand names such as Xenleta) classifies it as a prescription-only medication in the Pleuromutilin Antibiotic class. Xenleta treats community-acquired bacterial pneumonia (CABP) in adults. Official labeling lists 8 commonly reported side effects, including Diarrhea, Nausea, Vomiting.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 11, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages