Prescription medication · Pleuromutilin Antibiotic
lefamulin
Also sold as Xenleta. Xenleta treats community-acquired bacterial pneumonia (CABP) in adults.
Data updated 2026-05-15
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lefamulin (Xenleta) is a prescription Pleuromutilin Antibiotic. Xenleta treats community-acquired bacterial pneumonia (CABP) in adults.
Xenleta is an antibiotic medicine. It is used to treat pneumonia caused by bacteria in adults.
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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).
The sections below are summarized in plain English from lefamulin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Xenleta is a pleuromutilin antibiotic. It works by stopping bacteria from growing. This helps your body fight off the infection.
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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for lefamulin?
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Medication Guides
Understanding Drug Interactions
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: October 11, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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