Xenleta Side Effects

Generic name: lefamulin

Medically reviewed by Drugs.com. Last updated on Jan 8, 2025.

Note: This document provides detailed information about Xenleta Side Effects associated with lefamulin. Some dosage forms listed on this page may not apply specifically to the brand name Xenleta.

Applies to lefamulin: oral tablet.

Other dosage forms:

• intravenous solution

Serious side effects of Xenleta

Along with its needed effects, lefamulin (the active ingredient contained in Xenleta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lefamulin:

Less common side effects

• convulsions
• decreased urine
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• abdominal or stomach tenderness
• chest pain or discomfort
• fainting
• fever
• irregular or slow heart rate
• severe abdominal or stomach cramps and pain
• watery and severe diarrhea, which may also be bloody

Other side effects of Xenleta

Some side effects of lefamulin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common side effects

• headache
• trouble sleeping

For healthcare professionals

Applies to lefamulin: intravenous solution, oral tablet.

Gastrointestinal adverse events

• Very common (10% or more): Diarrhea (up to 12%)
• Common (1% to 10%): Nausea, vomiting
• Frequency not reported: Abdominal pain, constipation, dyspepsia, epigastric discomfort, erosive gastritis, Clostridium difficile-associated diarrhea, C difficile colitis, oropharyngeal candidiasis^[Ref]

Local

• Common (1% to 10%): Administration site reactions (included infusion site pain, infusion site phlebitis, injection site reaction)^[Ref]

Hepatic

• Common (1% to 10%): Hepatic enzyme elevation (included increased ALT, increased AST, increased liver function test)
• Frequency not reported: Increased GGT^[Ref]

Metabolic

• Common (1% to 10%): Hypokalemia^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia
• Frequency not reported: Anxiety^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Frequency not reported: Somnolence^[Ref]

Other

• Common (1% to 10%): Death within 28 days
• Frequency not reported: Increased alkaline phosphatase^[Ref]

Death within 28 days occurred in 1.2% of patients treated with this drug and 1.1% of patients treated with moxifloxacin.^[Ref]

Cardiovascular

• Frequency not reported: Atrial fibrillation, palpitations, prolonged QT on ECG^[Ref]

Genitourinary

• Frequency not reported: Vulvovaginal candidiasis, urinary retention^[Ref]

Hematologic

• Frequency not reported: Anemia, thrombocytopenia^[Ref]

Musculoskeletal

• Frequency not reported: Increased creatine phosphokinase^[Ref]

Further information

Xenleta side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer